Which Covid-19 vaccine would you get?

[RexRex]

Indian members, has anyone taken the locally made Covaxin ?

What is the verdict on its efficacy on recipients ? Has anyone caught Covid after taking this vaccine ?

 

[Robert]

Looks like Pfizer is more effective against the Indian Variant than AstraZenica is.

 

[RexRex]

Looks like Pfizer is more effective against the Indian Variant than AstraZenica is.

It is clearly the best Covid vaccine on the planet right now.

 

[Last Monetarist]

https://www.reuters.com/business/healthcare-pharmaceuticals/moderna-says-its-covid-19-vaccine-found-safe-effective-teens-2021-05-25/

Moderna’s COVID-19 vaccine was shown to be effective in adolescents aged 12-17 and showed no new or major safety problems in a clinical trial, the developer said on Tuesday, potentially setting the stage for a second vaccine for school-aged children to be authorized in July.

Moderna Inc, whose vaccine is authorized for adults 18 and older, said it will submit the findings of its adolescent study to the U.S. Food and Drug Administration and other regulators for emergency use authorization in early June.

U.S. regulators took about a month to review a similar study from Pfizer/BioNtech, which was authorized for ages 12-15 on May 10. If Moderna gets the same treatment, its authorization would come in early July.

Most children with COVID-19 develop only mild symptoms or no symptoms. Yet children remain at risk of becoming seriously ill, and they can spread the virus. Widely vaccinating 12- to 18-year olds could allow U.S. schools and summer camps to relax masking and social distancing measures suggested by the CDC.

“We are encouraged that mRNA-1273 was highly effective at preventing COVID-19 in adolescents," Stéphane Bancel, Moderna's chief executive, said in a statement.

Moderna's trial evaluated the vaccine in 3,732 adolescents aged 12 to 17, two thirds of whom got the vaccine and one third of whom got a placebo. The main goal was to produce an immune response on par with that seen in the company's large, Phase 3 trial in adults, which was 94.1% effective at preventing COVID-19.

Two weeks after the second dose, researchers found no cases of COVID-19 in the vaccine group compared to 4 cases in the placebo group, resulting in a vaccine efficacy of 100%, based on case definitions from the company's adult trial.

Using a case definition from the U.S. Centers for Disease Control and Prevention, which requires only 1 COVID-19 symptom, the vaccine was found to be 93% effective, suggesting the vaccine may be protective against cases with milder symptoms, the company said.

The researchers found no new safety issues. The most common side effects after the second dose were headache, fatigue, body aches and chills.

The company said it is still accumulating safety data. All study participants will be monitored for 12 months after their second dose to determine long-term protection and safety.

Moderna said it plans to submit the data to a peer-reviewed publication. The company is currently testing its vaccine in children as young as 6 months of age.

In addition to the United States, Pfizer's vaccine is also authorized for use in younger teens aged 12 to 15 in Canada and Algeria.

 

[Firebat]

Pakistan launches locally made anti-Covid vaccine ‘PakVac’

ISLAMABAD: Pakistan launched on Tuesday its homemade Covid-19 vaccine ‘PakVac’, a week after it announced successfully developing it with the help of China’s CanSino Bio.

Addressing the ceremony, Special Assistant to Prime Minister on National Health Services Dr Faisal Sultan said there is always an opportunity to overcome even the most difficult challenges.

“We found our friend China closest to us in overcoming the Covid-19 challenge,” he added.

He said developing a vaccine through raw materials is not an easy task as a lot of hard work goes into maintaining the required standards.

Dr Sultan added that the country must respect the efforts of the staff at the National Institute of Health Sciences (NIH), adding that local production of the vaccine will begin in Pakistan in the coming days.

‘An important day’

National Command and Operations Centre (NCOC) chief Asad Umar termed the day an important one for Pakistan.

“Only nations that focus on increasing their knowledge and have the capacity to translate that knowledge equation into technology progress,” Umar said, adding that today’s achievement was part of the same link.

Umar said the entire nation was proud of the team that developed the vaccine.

He said the pandemic was not just a challenge for Pakistan but for the whole world. However, he said thankfully the situation in Pakistan did not turn as grim as in many parts of the world.

Umar added that the NCOC played an important role in managing the pandemic in Pakistan. He said efforts were taken to bring about some immediate changes in the country’s existing hospitals.

According to the minister, health and education were the government’s main focus besides the pandemic.

“The budget for higher education was doubled in just two years, whereas the budget for health was tripled,” he said.

Umar added that, “We have witnessed a huge ‘revolution’ take place in this country right in front of our eyes in just a matter of months.”

Referring to poet Allama Iqbal, the NCOC chief said that Iqbal had known that Pakistan was on its way to become a great country.

https://tribune.com.pk/story/2302863/pakistan-launches-locally-made-anti-covid-vaccine-pakvac

 

[Last Monetarist]

https://www.reuters.com/world/middle-east/israel-sees-probable-link-between-pfizer-vaccine-small-number-myocarditis-cases-2021-06-01/

Israel’s Health Ministry said on Tuesday it had found the small number of heart inflammation cases observed mainly in young men who received Pfizer’s COVID-19 vaccine in Israel were likely linked to their vaccination.

Pfizer said in a statement that it was aware of the Israeli observations of myocarditis and said no causal link to its vaccine had been established.

It said adverse events are thoroughly reviewed and Pfizer meets regularly with the Vaccine Safety Department of the Israeli Ministry of Health to review data.

In Israel, 275 cases of myocarditis were reported between December 2020 and May 2021 among more than 5 million vaccinated people, the ministry said in disclosing the findings of a study it commissioned to examine the matter.

Most patients who experienced heart inflammation spent no more than four days in the hospital and 95% of the cases were classified as mild, according to the study, which the ministry said was conducted by three teams of experts.

The study found "there is a probable link between receiving the second dose (of Pfizer) vaccine and the appearance of myocarditis among men aged 16 to 30," it said in a statement. According to the findings, such a link was observed more among men aged 16 to 19 than in other age groups.

A U.S. Centers for Disease Control and Prevention (CDC) advisory group last month recommended further study of the possibility of a link between myocarditis and mRNA vaccines, which include those from Pfizer and Moderna Inc.

In a May 24 meeting, the CDC advisory group said that the data from the Vaccine Adverse Event Reporting System (VAERS) - which relies on individuals to report results - showed a higher than expected number of observed myocarditis or pericarditis cases in 16– to 24-year-olds.

However, the group also said data from another database -Vaccine Safety Datalink (VSD) - did not show that rates of myocarditis or pericarditis after COVID-19 vaccination differed from expectations. The VSD has data from nine healthcare organizations and can be used to compare vaccinated populations to unvaccinated ones.

Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia, said that parents should still vaccinate their kids because of the known risks of COVID-19, including multi-system inflammatory syndrome.

"This issue of a transient myocarditis associated with a vaccine is at the moment a theoretical and unproven risk," Offit said. "So I think that in the world of trying to weigh relative risks, the disease is a greater risk."

The European Medicines Agency (EMA) said last week that heart inflammation after receiving the Pfizer vaccine had been no cause for concern as such incidents were similar rate to those in the general population. It added at the time that young men were particularly prone to the condition.

Israel had held off making its 12- to 15-year-old population eligible for the vaccines, pending the Health Ministry report. In parallel to publishing those findings, a ministry committee approved vaccinating the adolescents, a senior official said.

"The committee gave the green light for vaccinating 12- to 15-year-olds, and this will be possible as of next week," Nachman Ash, Israel's pandemic-response coordinator, told Radio 103 FM. "The efficacy of the vaccine outweighs the risk."

Israel has been a world leader in its vaccination rollout.

With COVID-19 infections down to just a handful a day and total active cases at just 340 across the country, the economy has fully opened, though restrictions remain on incoming tourism.

About 55% of Israel's population has already been vaccinated. As of Tuesday, restrictions on social distancing and the need for special green vaccination passes to enter certain restaurants and venues were scrapped.

 

[OMB]

Pfizer Jab Has 5 Times Less Antibodies Against Covid Delta Variant: Lancet Study

COVID-19 Delta Strain: The study also shows that levels of these antibodies that are able to recognise and fight the virus are lower with increasing age, and that levels decline over time, providing additional evidence in support of plans to deliver a booster dose to vulnerable people.

People fully vaccinated with the Pfizer-BioNTech vaccine are likely to have more than five times lower levels of neutralising antibodies against the Delta variant first identified in India compared to the original strain, according to research published in The Lancet journal.
The study also shows that levels of these antibodies that are able to recognise and fight the virus are lower with increasing age, and that levels decline over time, providing additional evidence in support of plans to deliver a booster dose to vulnerable people.

It supports current plans in the UK to reduce the dose gap between vaccines since they found that after just one dose of the Pfizer-BioNTech vaccine, people are less likely to develop antibody levels against the B.1.617.2 variant as high as those seen against the previously dominant B.1.1.7 (Alpha) variant, first found in Kent.

The team, led by researchers from the Francis Crick Institute in the UK, noted that levels of antibodies alone do not predict vaccine effectiveness and prospective population studies are also needed. Lower neutralising antibody levels may still be associated with protection against COVID-19, they said.

The study analysed antibodies in the blood of 250 healthy people who received either one or two doses of the Pfizer-BioNTech Covid-19 vaccine, up to three months after their first dose.

The researchers tested the ability of antibodies to block entry of the virus into cells, so called 'neutralising antibodies', against five different variants of SARS-CoV-2.

They then compared concentrations of these neutralising antibodies between all variants.

Data from previous clinical studies suggests that higher antibody titres or concentration is a good predictor of vaccine efficacy and greater protection against COVID-19.

The researchers found that in people who had been vaccinated with two doses of the Pfizer-BioNTech vaccine, levels of neutralising antibodies were more than five times lower against the B.1.617.2 variant when compared to the original strain, upon which current vaccines are based.

This antibody response was even lower in people who had only received one dose, they said.

After a single dose of Pfizer-BioNTech, 79 per cent of people had a quantifiable neutralising antibody response against the original strain, but this fell to 50 per cent for B.1.1.7, 32 per cent for B.1.617.2 and 25 per cent for B.1.351 or Beta variant first discovered in South Africa.

While antibody levels decreased with age against all variants, no correlation was observed for sex or body mass index (BMI).

"This virus will likely be around for some time to come, so we need to remain agile and vigilant, said Emma Wall, an Infectious Diseases consultant at University College London Hospitals NHS Foundation Trust (UCLH).

"Our study is designed to be responsive to shifts in the pandemic so that we can quickly provide evidence on changing risk and protection," Wall said.

The researchers noted that the most important thing is to ensure that vaccine protection remains high enough to keep as many people out of hospital as possible.

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The study suggests that the best way to do this is to quickly deliver second doses and provide boosters to those whose immunity may not be high enough against these new variants, they said.

https://www.ndtv.com/world-news/pfizer-jab-has-5-times-less-antibodies-against-covid-delta-variant-lancet-study-2456362

 

[OMB]

UAE, Bahrain make Pfizer/BioNTech shot available to those who got Sinopharm vaccine

Bahrain is currently fighting its biggest wave of infections

The United Arab Emirates and Bahrain have made the Pfizer/BioNTech, coronavirus vaccine available as a booster shot to those initially immunised with a vaccine developed by the China National Pharmaceutical Group (Sinopharm).

The Gulf states, which have vaccinated large portions of their populations, initially started inoculating residents and citizens with the Sinopharm Covid-19 shot before later introducing other vaccines.

Bahrain is currently fighting its biggest wave of infections, while the UAE is recording nearly twice as many Covid-19 cases as it was seven months ago.

In Abu Dhabi, the UAE capital, a booster shot is available six months after the second shot had been administered, said a representative of Mubadala Health, part of the state fund.

A different vaccine can be provided as a booster shot but it is at the recipient's discretion and health professionals do not make recommendations, the representative said.

Abu Dhabi has offered the Sinopharm shot to the general public since December and started using the Pfizer/BioNTech vaccine in April. It has been offering third Sinopharm doses since at least last month after it was discovered the shot had not created enough antibodies for some recipients.

In Bahrain, a government representative similarly said those eligible could receive a booster dose of the Pfizer/BioNTech or Sinopharm vaccines regardless of which vaccine they had initially taken.

"The government is not recommending which booster shot is chosen," they said.

Bahrain saw daily infections peak last month at around 3,000. The UAE is currently reporting around 2,000 cases a day, down from a February peak of 3,977 but about twice as many as it was reporting in early December.

There have been concerns about the efficacy of the Sinopharm vaccine, granted emergency approval by the World Health Organisation (WHO) in May, due to limited published clinical data being available.

The Chinese vaccine is 78.1% effective against symptomatic Covid-19, according to a study published last month in the JAMA medical journal.

However, researchers said the data from the study, conducted in countries including the UAE and Bahrain, was insufficient for the elderly and those with chronic diseases.

The Wall Street Journal on Thursday cited Bahrain’s undersecretary of health Waleed Khalifa Al Manea as saying the Sinopharm vaccine provided a high degree of protection.

However, those in Bahrain who are older than 50, are obese or have chronic illnesses were being urged to take a Pfizer booster shot six months after receiving their second Sinopharm dose, he told the paper.

https://tribune.com.pk/story/2303478/uae-bahrain-make-pfizerbiontech-shot-available-to-those-who-got-sinopharm-vaccine

 

[Last Monetarist]

https://www.reuters.com/business/healthcare-pharmaceuticals/fda-asks-johnson-johnson-discard-60-mln-vaccine-doses-made-baltimore-plant-nyt-2021-06-11/

The U.S. Food & Drug Administration on Friday said Johnson & Johnson must throw away millions of doses of its COVID-19 vaccine that were manufactured at a problem-plagued Baltimore factory but also cleared millions for use.

Two sources familiar with the situation told Reuters that the agency had cleared about 10 million doses. The New York Times said that the batches being discarded amount to around 60 million doses, citing people familiar with the matter.

Without disclosing or confirming the number of vaccine doses, the FDA said in a news release that it had authorized two batches of the vaccine for use, that several other batches were not suitable for use and that others were being evaluated.

The agency said it was not yet ready to authorize Emergent BioSolutions Inc's plant for manufacturing the J&J vaccine. Production of J&J's vaccine at the Baltimore site was halted by U.S. authorities in April and J&J was put in charge of manufacturing at the plant.

One source familiar with the matter told Reuters that the J&J doses are expected to be exported to other countries. The doses are already in vials and ready for use, the other source said.

Safety concerns about the J&J vaccine paired with flagging U.S. demand for vaccinations in general have slowed rollout of the one-shot vaccine to a crawl. Close to half of the 21 million doses produced for the United States sit unused.

The FDA said its decision allows for the J&J doses to be used in the United States or exported. The agency said the drugmaker and Emergent must agree that the FDA can share relevant information about the manufacturing of the doses with regulators where the vaccine is shipped.

J&J, in a statement, confirmed that the FDA authorized the two batches, but did not acknowledge the doses regulators decided should be tossed.

"Today's decisions represent progress in our continued efforts to make a difference in this pandemic on a global scale," Kathy Wengel, J&J's chief global supply chain officer, said in the statement.

The FDA declined to comment beyond its statement.

Last month, Emergent Chief Executive Robert Kramer said it was his understanding that there are 100 million doses of J&J's vaccine ready for FDA review and that regulators had begun the review process.

The April halt followed the discovery that ingredients from AstraZeneca's COVID-19 vaccine, also being produced at the plant at the time, contaminated a batch of J&J's vaccine. AstraZeneca's shot is no longer being made there.

An FDA inspection also turned up a long list of sanitary problems and bad manufacturing practices at the Emergent plant.

Separately, Europe's drug regulator said on Friday that batches of J&J COVID-19 vaccine made for the region around the time the contamination issues were revealed at the Baltimore plant would, as a precaution, not be used.

The European Medicines Agency did not say how many shots were affected, but Reuters has reported it involves millions of doses, making it harder for J&J to meet a target of delivering 55 million to Europe by end of June.

 

[Last Monetarist]

https://www.theguardian.com/society/2021/jun/14/novavax-covid-vaccine-has-efficacy-of-90-say-manufacturers

A Covid vaccine that is a critical part of the effort to vaccinate the developing world, as well as the UK, has an efficacy of 90% overall, its manufacturers have said after trials in the US and Mexico.

The UK has ordered 60m doses of Novavax, which has manufacturing agreements in Britain. Novavax has signed an agreement to provide 1.1bn doses to Covax, the UN-led initiative to get vaccines to poorer countries. The Serum Institute of India is contracted to make 100m doses, but has been making vaccines only for India in recent months in response to the Covid crisis there.

Announcing the US trial results, Novavax said it would file for regulatory approval in the third quarter of the year. UK trials showed 89.3% efficacy in March, but in May the company said there were delays caused by manufacturing issues that would prevent any earlier application.

In the trial in 29,960 participants across 119 sites in the US and Mexico, the vaccine was 100% effective against moderate to severe disease. It was 93% effective against variants that were circulating at the time of the trial – the alpha, beta and gamma variants that originated in the UK, South Africa and Brazil. The delta variant that originated in India was not in circulation, however. It had 91% efficacy in high-risk populations.

“Today, Novavax is one step closer to addressing the critical and persistent global public health need for additional Covid-19 vaccines. These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe Covid-19 infection,” said Stanley C Erck, he company’s president and chief executive officer.

“Novavax continues to work with a sense of urgency to complete our regulatory submissions and deliver this vaccine, built on a well understood and proven platform, to a world that is still in great need of vaccines.”

The company said it remained on track to reach manufacturing capacity of 100m doses a month by the end of the third quarter and 150m doses a month by the end of the fourth quarter of 2021.

Production of the UK’s 60m doses will take place in the north-east courtesy of Fujifilm, which has manufacturing capacity in Stockton-on-Tees. The “fill and finish” stage will take place in Barnard Castle at the plant of the British pharmaceutical company GlaxoSmithKline.

 

[Last Monetarist]

https://www.reuters.com/business/healthcare-pharmaceuticals/german-lab-jj-still-hashing-out-details-covid-19-vaccine-clot-collaboration-2021-06-18/

A scientist investigating rare blood clots possibly linked to AstraZeneca’s and Johnson & Johnson’s COVID-19 vaccines has yet to start a planned collaboration with the U.S. company, he said, as talks over their research pact continue.

Dr. Andreas Greinacher, a transfusion medicine expert at Germany's Greifswald University, has been studying clotting with low blood platelets in people who got AstraZeneca's vaccine.

In April, when clotting developed in a few people who got J&J’s shot, Greinacher announced his lab would work with the U.S. company to explore causes. J&J, whose shot relies on technology similar to AstraZeneca’s, confirmed it was “exploring a potential collaboration”.

International drug regulators have added warning labels, while saying both vaccines’ benefits outweigh extremely rare clotting risks. Some countries are not using the shots, while others have restricted them to older people.

In a telephone interview on Friday, Greinacher said scientists at his lab at Greifswald, as well from J&J, are eager to get started, in hopes of gaining a better understanding of the clotting, though lawyers from both sides are still working out details, like non-disclosure agreements.

"Their job obviously seems to take longer than the work of the scientists," Greinacher said. "It's a painful undertaking, to get all of the necessary paperwork done."

J&J did not immediately comment.

Greinacher’s conclusions so far about clots in people who got AstraZeneca’s vaccine have been published in the New England Journal of Medicine and are among several theories seeking to explain the side effect.

He suggests a strong post-vaccination inflammatory reaction and subsequent generation of powerful platelet-activating antibodies is likely driving Vaccine-induced Immune Thrombotic Thrombocytopenia, or VITT.

Greinacher has not found similar issues in people who got COVID-19 vaccines from Moderna or Pfizer and BioNTech.

Greinacher said he has acquired samples of J&J's vaccine, having received left-overs following its deployment in Europe.

His team is analyzing J&J's vaccine components and hopes to have a comparison with AstraZeneca's vaccine in a week, he said.

 

[Last Monetarist]

https://www.reuters.com/business/healthcare-pharmaceuticals/argentina-says-az-sputnik-v-single-dose-cuts-mortality-up-80-2021-06-25/

A single dose of Russia's Sputnik V or the Oxford University-AstraZeneca vaccine reduces mortality from COVID-19 by between 70% and 80% in people aged 60-plus, real-world data from Argentina's national inoculation program show.

The preliminary study data, released on Friday by the country's health ministry, involved some 450,000 people aged 60 years of age and above who received one or two doses of either vaccine, which are the most widely used in Argentina.

"The first dose generates almost 80% immunity, the second, in general, increases that response and makes it more durable over time," Health Minister Carla Vizzotti said in a statement, adding with a second dose mortality decreased around 90%.

Argentina's inoculation campaign has been built around the Sputnik V and AstraZeneca vaccines, as well as using Sinopharm and CoviShield shots. The country has vaccinated over 19 million people, of which 3.8 million have received two doses.

This week the country passed 90,000 deaths from COVID-19 as it tries to leave behind a painful second wave of the virus. It currently has one of the highest average daily death tolls in the world, behind only Brazil, India and Colombia.

Vizzotti said that the data supported the country's immunization strategy of having a 12-week gap between the first and second shot, saying this was done in order to cover as much of the population at risk as possible with a single dose.

"It was an appropriate decision and the results of this study confirm that high protection has been achieved in the vaccinated population," she said.

 

[King_Kohli]

Indian members, has anyone taken the locally made Covaxin ?

What is the verdict on its efficacy on recipients ? Has anyone caught Covid after taking this vaccine ?

Completed my first dose Covaxin , no side effects.
My parents took Covishield (AstraZeneca, Serum Institute of India), they experience side effects such as headache and fatigue.

 

[Last Monetarist]

https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-adds-warning-about-rare-heart-inflammation-pfizer-moderna-covid-vaccines-2021-06-26/

The U.S. drug regulator on Friday added a warning to the literature that accompanies Pfizer Inc /BioNTech and Moderna COVID vaccine shots to indicate the rare risk of heart inflammation after its use.

For each vaccine, the fact sheets for healthcare providers have been revised to include a warning that reports of adverse events suggest increased risks of myocarditis and pericarditis, particularly after the second dose and with onset of symptoms within a few days after vaccination, the FDA said.

As of June 11, more than 1,200 cases of myocarditis or pericarditis have been reported to the U.S. Vaccine Adverse Event Reporting System (VAERS), out of about 300 million mRNA vaccine doses administered.

The cases appear to be notably higher in males and in the week after the second vaccine dose. The CDC identified 309 hospitalizations from heart inflammation in persons under the age of 30, of which 295 have been discharged.

Health regulators in several countries have been investigating cases of myocarditis and pericarditis, more frequently found in young men, after a shot of Pfizer or Moderna, vaccines that are based on the mRNA technology.

The latest update from FDA follows an extensive review of information and the discussion by CDC's Advisory Committee on Immunization Practices meeting on Wednesday.

Pfizer and Moderna did not immediately respond to requests for comment after business hours.

 

[Last Monetarist]

https://www.reuters.com/business/healthcare-pharmaceuticals/modernas-covid-19-vaccine-shows-promise-against-delta-variant-lab-study-2021-06-29/

Moderna Inc's COVID-19 vaccine showed promise against the Delta variant first identified in India in a lab study, with a modest decrease in response compared to the original strain, the drugmaker said on Tuesday.

The study was conducted on blood serum from eight participants obtained one week after they received the second dose of the vaccine, mRNA-1273.

The vaccine provoked an antibody response against all the variants tested, according to Moderna, but one that remained inferior in all cases to the vaccine's neutralizing activity against the original coronavirus strain first found in China.

The vaccine was far more effective in producing antibodies against the Delta variant than it was against the Beta variant first identified in South Africa, the data showed.

Against three versions of the Beta variant, the vaccine-elicited neutralizing antibodies reduced six-to-eight fold compared to those produced against original strain, while modest 3.2 to 2.1 fold reductions were seen for lineages of the variant first identified in India including Delta and Kappa.

"These new data are encouraging and reinforce our belief that the Moderna COVID-19 vaccine should remain protective against newly detected variants," Chief Executive Stéphane Bancel said.

Earlier in the day, India granted permission to drugmaker Cipla Ltd to import Moderna's vaccine to the country for restricted use.

The drugmaker's shares were up 5.5% at $235.39 in mid-day trading.

Moderna has submitted the data as a preprint to the website bioRxiv ahead of peer review.

 

[King_Kohli]

Covaxin "Effectively Neutralises" Delta Variant: Top US Health Institute

The National Institute of Health said results of two studies of blood serum from people who had received Covaxin suggest that the vaccine generates antibodies that effectively neutralise the B.1.1.7 (Alpha) and B.1.617 (Delta) variants of SARS-CoV-2

Washington: India's Covaxin, developed by Bharat Biotech in collaboration with the Indian Council of Medical Research, effectively neutralises both Alpha and Delta variants of coronavirus, the US' National Institute of Health has said.
The NIH said results of two studies of blood serum from people who had received Covaxin suggest that the vaccine generates antibodies that effectively neutralise the B.1.1.7 (Alpha) and B.1.617 (Delta) variants of SARS-CoV-2, first identified in the UK and India, respectively.

The top American health research institute, which has a history of strong scientific collaboration with India, also said that an adjuvant developed with funding from it has contributed to the success of the highly efficacious Covaxin, which has been administered to roughly 25 million people till date in India and elsewhere.

Adjuvants are substances formulated as part of a vaccine to boost immune responses and enhance a vaccine's effectiveness.

Covaxin comprises a disabled form of SARS-CoV-2 that cannot replicate but still stimulates the immune system to make antibodies against the virus. Published results from a phase 2 trial of the vaccine indicate that it is safe and well tolerated, the NIH said, adding that safety data from a phase 3 trial of Covaxin will become available later this year.

"Meanwhile, unpublished interim results from the phase 3 trial indicate that the vaccine has 78 per cent efficacy against symptomatic disease, 100 per cent efficacy against severe COVID-19, including hospitalisation, and 70 per cent efficacy against asymptomatic infection with SARS-CoV-2, the virus that causes COVID-19," it said.

"The results from two studies of blood serum from people who had received Covaxin suggest that the vaccine generates antibodies that effectively neutralise the B.1.1.7 (Alpha) and B.1.617 (Delta) variants of SARS-CoV-2, first identified in the UK and India, respectively," the NIH said.

Ending a global pandemic requires a global response, said Anthony S Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH.

"I am pleased that a novel vaccine adjuvant developed in the US with NIAID support is part of an efficacious COVID-19 vaccine available to people in India," he said.

The adjuvant used in Covaxin, Alhydroxiquim-II, was discovered and tested in a laboratory by the biotech company ViroVax LLC of Lawrence, Kansas with support from the NIAID Adjuvant Development Program.


Alhydroxiquim-II is the first adjuvant in an authorised vaccine against an infectious disease to activate receptors TLR7 and TLR8 that play a vital role in the immune response to viruses.

In addition, the alum in Alhydroxiquim-II stimulates the immune system to search for an invading pathogen. Molecules that activate TLR receptors stimulate the immune system powerfully, but the side effects of Alhydroxiquim-II are mild, the NIH said.

According to the NIH, the NIAID Adjuvant Program has supported the research of the founder and chief executive officer of ViroVax, Sunil David, MD, PhD, since 2009. His work has focused on searching for novel molecules that activate innate immune receptors and developing them as vaccine adjuvants.

The collaboration between Dr David and Bharat Biotech International Ltd. of Hyderabad was initiated during a 2019 meeting in India coordinated by the NIAID Office of Global Research under the auspices of NIAID's Indo-US Vaccine Action Program.

A delegation of five NIAID-funded adjuvant investigators, including Dr David; two members of the NIAID Division of Allergy, Immunology, and Transplantation; and the NIAID India representative, visited four leading biotechnology companies to learn about their work and discuss potential collaborations.

The delegation also attended a consultation in New Delhi co-organised by NIAID and India's Department of Biotechnology and hosted by India's National Institute of Immunology.

Among the scientific collaborations sparked by these activities, Bharat Biotech signed a licensing agreement with Dr David to use Alhydroxiquim-II in their candidate vaccines. This license was expanded during the COVID-19 pandemic to include Covaxin, which has received Emergency Use Authorisation in India and more than a dozen other countries.

"The company conducted extensive safety studies of Alhydroxiquim-II and undertook the complex process of scaling up production of the adjuvant under Good Manufacturing Practice standards. Bharat Biotech expects to produce an estimated 700 million doses of Covaxin by the end of 2021," the NIH said.

https://www.ndtv.com/india-news/covaxin-effectively-neutralises-delta-covid-variant-top-us-health-research-institute-2475611

 

[Last Monetarist]

https://www.theguardian.com/australia-news/2021/jul/09/pfizer-says-no-change-to-australian-covid-vaccine-doses-contradicting-reports-of-game-changing-deal

The pharmaceutical giant Pfizer says there is no change in the number of doses the company has contracted to deliver to Australia over 2021 – contradicting reports asserting the Morrison government had secured a “game-changing deal” to triple its access to the jabs.

The prime minister – who has been under significant political pressure because of the slow pace of the vaccination rollout, pressure that has ramped up during the lockdown of greater Sydney – embarked on a media blitz on Friday to argue the pace of the vaccination rollout was accelerating.

The prime minister’s comments came ahead of New South Wales confirming 44 new locally acquired cases of Covid-19, including 29 where people were infectious in community, and ahead of a national cabinet meeting later on Friday.

During Friday’s media blitz, Morrison told 2GB that, in June, Australia was getting 1.7m doses of Pfizer a month. He said this month that would increase to 2.8m doses and by August Australia would get 4.5m doses, “so that is quite a ramp-up”.

Morrison said this was something the federal health secretary, Brendan Murphy, and the health minister, Greg Hunt, had been working on with Pfizer. “We are in constant contact with them,” the prime minister said.

He said the government was always trying to get deliveries brought forward “and so this is very very welcome” and “that work has paid off”.

Morrison said the government would also ensure another 1,300 GPs would be administering doses by next month and, on current inoculation rates, it was now very likely that all eligible Australians would be offered a dose before year’s end.

But Pfizer issued a statement saying there was no change in the number of doses the company had agreed to deliver to Australia.

“The total number of 40 million doses we are contracted to deliver to Australia over 2021 has not changed,” the company said in a statement. “We continue to work closely with the government to support their rollout program.”

Adding to the confusion on Friday about what exactly had changed, Morrison’s numbers on Friday appear consistent with what Hunt said would happen at the beginning of this week. On 5 July, Hunt said Australia would have have 2.8m doses of Pfizer “this month”.

“That is an increase of 400,000 compared with what had been expected – and so we’ve been able to secure those by working with Pfizer in Australia and Pfizer internationally,” Hunt said.

Hunt said “that 2.8m will average about 700,000 a week, but it starts at 300, 500, a million and a million over the course”.

A spokesman for the prime minister said the change Morrison pointed to on Friday was the supply numbers for the month of August were higher than anticipated.

The absolute number of deliveries Pfizer was dispatching to Australia in 2021 had not changed, but there was a re-phasing in the program.

“From 19 July, Australia’s Pfizer supply now plans to increase to approximately 1m doses per week,” Morrison’s spokesman said. “This is compared to an average of 300,000 to 350,000 per week in May and June.”

The government now anticipates getting 4.5m deliveries in August. But Morrison’s spokesman cautioned “due to the nature of pandemic vaccine supply these numbers are subject to change and will be confirmed closer to the delivery date”.

Morrison told the Seven Network the government had been “working steadily with [Pfizer] for many months to bring forward the supply”.

“We will go to 4.5m next month in August. That is a real uplift in what we are seeing with Pfizer. We are just ensuring we can get as much as we can from Pfizer, bringing that forward”.

The Labor leader, Anthony Albanese, argued Friday’s re-phasing was more spin than substance.

“If the government put the same effort into doing deals with pharmaceutical companies to get access to vaccines as they do into marketing and spin for their own failures, then Australians would be better off.”

 

[Last Monetarist]

https://www.reuters.com/world/us/pfizer-us-health-officials-discuss-covid-boosters-monday-company-2021-07-11/

COVID-19 vaccine maker Pfizer Inc will meet with federal health officials as soon as Monday to discuss the need for a booster dose of the coronavirus vaccine as it prepares to seek authorization, the company said on Sunday.

The meeting comes days after the drugmaker and its partner BioNTech SE announced plans to seek U.S. and European regulatory approval for a third dose of their COVID-19 shot amid the spread of variants and data they said showed heightened risk of infection six months after initial inoculation.

That push prompted a quick response from the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention, saying Americans do not need a booster right now.

On Monday, Pfizer is scheduled to meet with representatives of the FDA, a company spokesperson said. The meeting was first reported by the Washington Post.

Representatives for the U.S. Department of Health and Human Services did not immediately respond to a request for comment.

Anthony Fauci, President Joe Biden’s chief medical adviser who also directs the National Institute of Allergy and Infectious Diseases, as well as the heads of the National Institutes of Health and the CDC were also among those invited to the briefing, which could move to another day, according to the Post's report.

Fauci, in several television interviews on Sunday, said U.S. health officials were not dismissing the possible future need for boosters -- especially as breakthrough infections among those who have been vaccinated have emerged -- but that more data is needed for any formal recommendation.

"There's a lot of dynamic things going on right now," he told ABC News' "This Week" program.

"There are studies being done now ongoing as we speak about looking at the feasibility about if and when we should be boosting people... there's a lot of work going on to examine this in real time," he added on CNN's "State of the Union."

Despite the FDA and CDC's statement, "that doesn't mean that we're not very, very actively following and gathering all of this information to see if and when we might need it and if and when we do, we'll have everything in place to do it."

U.S. health officials are still struggling to get people in some areas to receive their initial inoculations as the highly contagious Delta variant has grown to be the nation's dominant strain, with COVID-19 cases rising mostly among the unvaccinated. European officials has also said vaccines currently seem protective against variants. Canada has also said it is monitoring variants and the possible need for boosters.

While some scientists have also questioned the need for booster shots, others have said they could be beneficial for the elderly and other vulnerable populations, although it is unclear when they would be needed. Some public health experts have also expressed concern that authorizing boosters in wealthy developed nations while other countries are still struggling against initial inoculations will further exacerbate vaccine inequity.

 

[SangasCoverDrive]

I got Pfizer. Had a heavy arm for a few days but that was it. I am glad that I got it and can't wait to get the second one.

 

[ahsan17]

https://www.reuters.com/world/us/pfizer-us-health-officials-discuss-covid-boosters-monday-company-2021-07-11/

It clearly appears to be a sales pitch to appeal to their investors. I highly doubt a booster is required so soon. Influenza boosters are required because it mutates in ways existing immunity doesn't work on it. Can't say the same for Covid-19. There may be boosters required with a long timeline, e.g. after 3 or 5 years. But 6 months to a year sounds ridiculous.

 

[Last Monetarist]

https://www.theguardian.com/world/2021/jul/23/pfizer-vaccine-second-dose-has-sweet-spot-after-eight-weeks-uk-scientists-say

An eight-week gap between the first and second doses of the Pfizer/BioNTech Covid-19 vaccine is a “sweet spot” when it comes to generating strong immune response while protecting the UK population against the Delta variant of coronavirus, scientists have said.

In a study funded by the Department of Health and Social Care (DHSC), researchers have found that when compared with a four-week gap, a 10-week interval between the doses produces higher antibody levels, as well as a higher proportion of a group of infection-fighting cells in the body known as “helper” T-cells.

At the start of the second wave of the Covid-19 pandemic, the Joint Committee on Vaccination and Immunisation (JCVI) made a decision to recommend a 12-week gap between two doses for the two vaccines that were available at the time: Pfizer and Oxford/AstraZeneca.

This was at a time when vaccines were in short supply and preliminary research suggested that widening the gap from the manufacturer-recommended four weeks to 12 increased the immune response.

But in May the guidance was changed to eight weeks as cases associated with the Delta variant continued to rise in the UK.

Prof Susanna Duanchie, of the University of Oxford, who is the joint chief investigator in the study, known as Pitch, said: “The original recommendation from JCVI was 12 weeks and this was based on a lot of knowledge from other vaccines that often having a longer interval [between doses] gives your immune system a chance to make the highest response.

“The decision to put it to eight weeks is really balancing all the wider issues, the pros and cons – two doses is better than one overall.

“Also, other factors need to be balanced, [such as] vaccine supply, the desire to open up, and so on.”

She added: “I think that eight weeks is about the sweet spot for me, because people do want to get the two vaccine [doses] and there is a lot of Delta out there right now.

“Unfortunately, I can’t see this virus disappearing so you want to balance that against getting the best protection that you can.”

For the Pitch study, the researchers recruited 503 healthcare workers, 44% (223) of whom previously had Covid-19, and studied the immune responses generated by the Pfizer jab.

They found that both short (three to four-week) and long (10-week) dosing intervals of the Pfizer vaccine generated strong antibody and T-cell immune responses.

But the longer schedule led to higher antibody levels and a higher proportion of helper T-cells, which according to the researchers supports immune memory.

The scientists found that after the second dose, a wider gap also resulted in higher neutralising antibody levels against the Delta variant and all other variants of concern.

But in this instance antibody levels dropped off between first and second dose – leaving the recipients vulnerable against the Delta variant after one jab.

However, Dr Rebecca Payne, one of the study authors from Newcastle University, said that the cellular response from T-cells remained consistent across both long and short dosing schedules, “indicating they may contribute to important protection against Sars-CoV-2 during this time”.

Payne said: “After the second dose on the longer dosing schedule, antibody levels surpassed those seen at the same timepoint after a shorter dosing interval.

“Although T-cell levels were comparatively lower, the profile of T-cells present suggested more support of immune memory and antibody generation.”

The researchers said there may be exceptions where the dosing schedule may need to be shortened from eight weeks to four, such as for those who are about to have treatments that may affect the immune system, such as cancer or organ transplant.

Dr Lance Turtle, of the University of Liverpool, who specialises in T-cell studies, said: “I would then say they should be vaccinated as soon as possible.”

The vaccines minister Nadhim Zahawi said: “As we raced to offer a vaccine to all adults, we took the JCVI’s advice to shorten the dosing interval from 12 to eight weeks to help protect more people against the Delta variant.

“This latest study provides further evidence that this interval results in a strong immune response and supports our decision.

“I urge every adult to get both doses of the vaccine to protect yourself and those around you and we are looking to offer millions of the most vulnerable a booster jab from September to ensure this protection is maintained.”

 

[Last Monetarist]

https://www.reuters.com/business/healthcare-pharmaceuticals/pfizer-says-us-govt-buying-200-mln-more-doses-covid-19-vaccine-2021-07-23/

Pfizer Inc and German partner BioNTech said on Friday the U.S. government has purchased 200 million additional doses of their COVID-19 vaccine to help with pediatric vaccination as well as possible booster shots - if they are needed.

A Biden administration official with knowledge of the contract said that as part of the agreement, Pfizer will provide the United States with 65 million doses intended for children under 12, including doses available immediately after the vaccine is authorized for that age group.

The U.S. government also has the option to buy an updated version of the vaccine targeting new variants of the virus.

The deal comes as the Delta variant of the coronavirus sweeps across the country and drives up infections, contributing to the debate over whether or not Americans will need a booster dose this fall.

It also follows the government's move in June to buy 200 million more doses of Moderna Inc's COVID-19 vaccine.

The purchase brings the total number of doses of the Pfizer/BioNTech vaccine to be supplied to the United States to 500 million, of which roughly 208 million doses have already been delivered, as of Thursday's data from the government.

"These additional doses will help the U.S. government ensure broad vaccine access into next year," Pfizer Chief Executive Officer Albert Bourla said in a statement.

Pfizer last year signed a deal with the U.S. government for 100 million doses of the vaccine for nearly $2 billion, with an option to buy 500 million more doses.

A majority of the new doses will be supplied by the end of the year, and the remaining 90 million will be delivered by April 30, the companies said.

Pfizer and BioNTech have designed a new version of their vaccine targeting the Delta variant, which they plan to test in the coming weeks, but have said the current vaccine could also provide protection against the variant.

Pfizer earlier this month said the companies plan to seek authorization from U.S. and European regulators for a booster dose of their COVID-19 vaccine.

The U.S. government has said Americans who have been fully vaccinated do not need a booster COVID-19 shot at this time.

Advisers to the U.S. Centers for Disease Control and Prevention on Thursday considered evidence suggesting that a booster dose of COVID-19 vaccines could increase protection among people with compromised immune systems.

CDC scientists told advisers that boosters for the immunocompromised would need to wait for regulatory action from the U.S. Food and Drug Administration - either full approval of vaccines or amendments to their current emergency use authorizations - before the CDC could make a recommendation.

 

[Last Monetarist]

https://www.theguardian.com/business/2021/jul/29/astrazeneca-sales-of-covid-vaccine-triple-in-first-half-of-2021

AstraZeneca has reported a boost in sales of its Covid-19 vaccine, which tripled to $1.2bn (£900m) in the first half of this year – but remained significantly below the earnings of its US rival Pfizer.

Britain’s biggest drugmaker revealed that it had generated $894m from Covid-19 vaccine sales in the three months to the end of June, following $275m in the first three months of the year. It has pledged to provide the jab, which it developed with Oxford University, on a not-for-profit basis during this pandemic.

The figures came a day after Pfizer said it made $7.8bn from the Covid jab it developed with Germany’s BioNTech, more than doubling its first-quarter takings of $3.5bn. It raised its 2021 sales forecast for the vaccine to $33.5bn from $26bn, as the Delta variant spreads rapidly and scientists debate whether people will need booster shots. Pfizer and BioNTech have tweaked their mRNA vaccine to target the Delta variant and will begin testing the modified jab on humans next month.

Moderna will reveal next Thursday how much it made from its coronavirus jab between April and June. The US drugs company brought in $1.7bn from sales of its Covid vaccine between January and March, helping it to its first quarterly profit since its foundation in 2010. In May, the firm forecast revenues of $19.2bn from the vaccine this year, but that estimate could rise next week.

GlaxoSmithKline posted £276m of Covid-19 sales on Wednesday, mainly from sales of its adjuvant – which boosts the efficacy of vaccines – to other drug makers. The UK’s second biggest pharmaceutical firm has not developed its own coronavirus shot, but is working with France’s Sanofi and Germany’s CureVac on new vaccines.

AstraZeneca said about $572m of vaccine sales came from Europe during the first half of 2021, in a period when the company was embroiled in a court battle with the European Commission over delivery delays, and a further $455m from emerging markets.

The firm’s overall revenues grew 23% to $15.5bn in the first half of the year, boosted by new medicines, beating analysts’ expectations. Excluding Covid-19 vaccine sales, revenues were up 14% to nearly $14.4bn. Profit before tax rose by 25% to $2.4bn. The company upped its sales and profit forecasts for this year after the $39bn acquisition of Alexon, a US firm that specialises in drugs for rare diseases.

AstraZeneca has postponed its application to US regulators for approval of the vaccine to the second half of this year. Chief executive Pascal Soriot said: “The simple answer is, it’s an important vaccine. And we believe it may play a role in the future, so we want to file and get approval for it.”

The filing has been delayed because the US Food and Drug Administration has requested large data sets, including from the rollout in the UK and elsewhere.

AstraZeneca is also testing booster jabs for people who have already been vaccinated with two doses of either its own shot or the mRNA-based vaccines produced by Pfizer and Moderna.

As well as supply delays, AstraZeneca has been linked to a small but concerning number of cases of blood clots, some of them fatal. A new study from researchers in Spain, the UK and the Netherlands found that patients developed blood clots after receiving the vaccine at a “similar”, very low rate to those who had received the Pfizer-BioNTech jab.

“In this study including 1,372,213 people vaccinated against Sars-CoV-2, similar safety profiles were seen for both vaccines,” the researchers wrote in their pre-print paper, which is due to be published in the Lancet medical journal. It has not been peer-reviewed yet.

 

[MenInG]

An anti-vaxxer who filmed himself downplaying Covid-19 before posting it on Facebook has died of the coronavirus, Evening Standard reported.

Solicitor Leslie Lawrenson, 58, died at his home in England’s Bournemouth town, nine days after he released a video on why coronavirus is “nothing to be afraid of”.

Lawrenson, who reportedly had no underlying health conditions, had previously refused to take up the vaccine because he felt he “did not need it”.

Instead, he put faith in his immune system and took his social media followers on his journey.

The 58-year-old recorded two vlogs in June, where he explained his symptoms and described them as “no worse than a cold”.

He later criticised the government’s approach to the coronavirus restrictions, saying “these are things we have to suffer, it’s part of living”, before urging viewers to “trust” their own immune systems over vaccines.

As his condition worsened, Lawrenson struggled to breathe and said he felt pain “everywhere”, but stated he did not feel like he was in any real “danger”.

“I didn’t get the point where I would have had to be hospitalised,” he said.

“Things did get worse, but I am glad I got Covid-19.”

Reacting to his death, Lawrenson’s partner Amanda Mitchell, who also tested positive with Covid-19 said: “I feel incredibly foolish. Les died unnecessarily. Les made a terrible mistake and he’s paid the ultimate price for that.”

Mitchell said her partner, a Cambridge University graduate, decided against having a coronavirus jab after reading material on social media.

She said: “It was a daily thing that he said to us: ‘You don’t need to have it, you’ll be fine, just be careful. Les was highly educated... so if he told me something, I tended to believe it.”

 

[Last Monetarist]

https://www.theguardian.com/world/2021/aug/07/india-approves-johnson-johnson-covid-vaccine-for-emergency-use

India has approved Johnson & Johnson’s single-dose Covid-19 vaccine for emergency use, the health minister, Mansukh Mandaviya, said.

The pharmaceutical giant had applied for emergency use approval of its vaccine, the company said on Friday. The shot will be brought to India through a supply agreement with the homegrown vaccine-maker Biological E Ltd, J&J had said.

Indian health authorities have so far approved the use of vaccines developed by AstraZeneca, Bharat Biotech, Russia’s Gamaleya Institute and Moderna.

Coronavirus cases worldwide surpassed 200 million earlier in the week, according to a Reuters tally, as the more infectious Delta variant threatens areas with low vaccination rates and strains healthcare systems.

India has reported an average of 30,000 to 40,000 new coronavirus cases every day since July, and the federal government has warned that although cases have dipped from a high of 400,000 daily at the peak of the deadly second wave, the danger has not abated yet.

 

[Babbar]

Got Covaxin by choice - both doses by mid-May. No one in my family has been tested positive till date. Touch wood.

 

[Last Monetarist]

https://www.reuters.com/business/healthcare-pharmaceuticals/pfizer-moderna-seen-reaping-billions-covid-19-vaccine-booster-market-2021-08-13/

Drugmakers Pfizer Inc, BioNTech and Moderna Inc are expected to reap billions of dollars from COVID-19 booster shots in a market that could rival the $6 billion in annual sales for flu vaccines for years to come, analysts and healthcare investors say.

For several months, the companies have said they expect that fully inoculated people will need an extra dose of their vaccines to maintain protection over time and to fend off new coronavirus variants.

Now a growing list of governments, including Chile, Germany and Israel, have decided to offer booster doses to older citizens or people with weak immune systems in the face of the fast-spreading Delta variant.

Late on Thursday, the U.S. Food and Drug Administration authorized a booster dose of vaccines from Pfizer Inc and Moderna Inc for people with compromised immune systems.

Pfizer, along with its German partner BioNTech , and Moderna have together locked up over $60 billion in sales of the shots just in 2021 and 2022. The agreements include supply of the initial two doses of their vaccines as well as billions of dollars in potential boosters for wealthy nations.

Going forward, analysts have forecast revenue of over $6.6 billion for the Pfizer/BioNTech shot and $7.6 billion for Moderna in 2023, mostly from booster sales. They eventually see the annual market settling at around $5 billion or higher, with additional drugmakers competing for those sales.

The vaccine makers say that evidence of waning antibody levels in vaccinated people after six months, as well as an increasing rate of breakthrough infections in countries hit by the Delta variant, support the need for booster shots.

Some early data suggests that the Moderna vaccine, which delivers a higher dose at the outset, may be more durable than Pfizer’s shot, but more research is needed to determine whether that is influenced by the age or underlying health of the people vaccinated.

As a result, it is far from clear how many people will need boosters, and how often. The profit potential of booster shots may be limited by the number of competitors who enter the market. In addition, some scientists question whether there is enough evidence that boosters are needed, particularly for younger, healthy people. The World Health Organization has asked governments to hold off on booster shots until more people worldwide receive their initial doses.

"We don't know what the market forces will be," Moderna President Stephen Hoge said in an interview last week. "At some point, this will become a more traditional market - we'll look at what are the populations at risk, what value are we creating, and what are the number of products that serve that value. That will ultimately impact price."

Pfizer declined to comment for the story. During the company’s second-quarter earnings call, executives said they believe a third dose will be necessary 6 to 8 months after vaccination, and regularly afterward.

If regular COVID-19 boosters are needed among the general population, the market would most resemble the flu shot business, which distributes more than 600 million doses per year. Four competitors split the U.S. flu market, which is the most lucrative and accounts for around half the global revenue, according to Dave Ross, an executive at CSL's flu vaccine unit Seqirus.

Flu vaccination rates in developed countries have settled at around 50% of the population, and COVID boosters would likely follow a similar pattern if approved widely, said Atlantic Equities analyst Steve Chesney.

Flu shots cost around $18 to $25 a dose, according to U.S. government data and competition has kept price increases in check, with producers raising prices 4 or 5 percent in 2021.

Pfizer and Moderna may have greater pricing power for their boosters, at least at the outset, until competitors arrive. Pfizer initially charged $19.50 per dose for its vaccine in the United States and 19.50 euros for the European Union, but has already raised those prices 24% and 25%, respectively, in subsequent supply deals.

AstraZeneca Plc and Johnson & Johnson are both gathering additional data on boosters of their vaccines. Novavax, Curevac, and Sanofi could also potentially be used as boosters, though their vaccines have yet to receive any regulatory authorization.

"A lot of these firms aren't even in the market yet. I think within a year's time, all these companies will have booster strategies," said Morningstar analyst Damien Conover, who covers Pfizer.

Mizuho Securities analyst Vamil Divan expects at least 5 players in the COVID-19 booster market within a few years.

There's still a lot of uncertainty around how boosters would be rolled out in the United States. Still, it is possible or even likely that people will be boosted with different vaccines than they were originally vaccinated with. The National Institute of Allergy and Infectious Diseases is already testing mixed boosting, and other countries that have used so-called mix and match vaccination have not had problems with that strategy.

One factor that could curb prices is if the U.S. government continues paying for most or all of the shots administered in the country, rather than leave it in the hands of private health insurers. In that scenario, the government would still be negotiating prices directly with vaccine makers, and could use its buying power to stave off price increases.

Bijan Salehizadeh, managing director at healthcare investment firm Navimed Capital, said the U.S. government is likely going to want to keep paying in order to keep vaccination rates high and prevent new COVID surges, particularly if a Democratic administration is still in power.

"It's going to be paid for until the virus disappears or mutates to be less virulent," Salehizadeh said.

 

[Last Monetarist]

https://www.theguardian.com/society/2021/aug/23/fda-full-approval-pfizer-vaccine-covid-19

The US Food and Drug Administration (FDA) has given full approval to the Pfizer vaccine for Covid-19. The vaccine and others have been in use for months under emergency use authorisation.

‘While there are approved uses for ivermectin in people and animals, it is not approved for the prevention or treatment of Covid-19,’ says the FDA’s fact sheet.

The decision is likely to trigger a wave of formal vaccine requirements from government departments, businesses, schools and other bodies.

On Monday a Pentagon spokesman said: “Now that the Pfizer vaccine has been approved, the Department [of Defense] is prepared to issue updated guidance requiring all service members to be vaccinated.”

In New York, city authorities announced that all public school teachers and other staffers will have to get vaccinated.

Many observers hope formal approval will also spur an increase in vaccine take-up among sections of the population, particularly in Republican-led states, so far resistant to government advice.

More than 200m Pfizer doses have been administered in the US since emergency use began in December, and hundreds of millions more worldwide.

“The public can be very confident that this vaccine meets the high standards for safety, effectiveness and manufacturing quality the FDA requires of an approved product,” said Janet Woodcock, the acting FDA commissioner.

“While millions of people have already safely received Covid-19 vaccines, we recognise that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the US.”

The US is struggling with a wave of cases, hospitalisations and deaths from the infectious Delta variant of the coronavirus. The overwhelming majority of hospitalisations and deaths are among unvaccinated people.

According to Johns Hopkins University, nearly 630,000 people have died in the US of Covid-19.

US vaccinations bottomed out in July. But as Delta patients fill hospital beds, shots are on the rise again – with a million a day given Thursday, Friday and Saturday. Just over half of the US population is fully vaccinated with one of three options, from Pfizer, Moderna or Johnson & Johnson.

In a statement, the FDA said: “Today, the US Food and Drug Administration approved the first Covid-19 vaccine. The vaccine has been known as the Pfizer-BioNTech Covid-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of Covid-19 disease in individuals 16 years of age and older.

“The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.”

In New York, the new vaccine policy for the largest US school system was the city’s first flat-out vaccination mandate, with no alternative for regular testing. The city did not immediately say what the penalty will be for refusing, or if there will be exemptions.

This month, New York, New Orleans and San Francisco all imposed proof-of-vaccination requirements at restaurants, bars and other indoor venues. At the federal level, Joe Biden is requiring government workers to sign forms attesting that they have been vaccinated or else submit to regular testing and other requirements.

Americans increasingly are on board with such mandates: close to six in 10 favor requiring people to be fully vaccinated to travel on airplanes or attend crowded public events, according to a recent poll by the Associated Press-NORC Center for Public Affairs Research.

“Mandating becomes much easier when you have full approval,” said Dr Carlos del Rio of Emory University. “I think a lot of businesses have been waiting for it.”

The FDA, like regulators in Europe and much of the world, initially allowed emergency use of Pfizer’s vaccine based on a study that tracked 44,000 people 16 and older for at least two months – the time period when serious side effects typically arise.

That’s shorter than the six months of safety data normally required for full approval. Pfizer therefore kept the study going. The FDA also examined real-world safety evidence in deciding to fully license the vaccine for people 16 and older, those studied the longest. Pfizer’s shot still has emergency authorization for 12- to 15-year-olds.

Serious side effects – such as chest pain and heart inflammation in teens and young adults – remain exceedingly rare, the FDA said.

As for effectiveness, six-month tracking of Pfizer’s original study showed the vaccine remained 97% protective against severe Covid-19. Protection against milder infection waned slightly, from a peak of 96% two months after the second dose to 84% by six months.

That data came before the extra-contagious Delta variant began spreading, but other data from the Centers for Disease Control and Prevention (CDC) shows the vaccine is still doing a good job preventing severe disease caused by the mutation.

The FDA licensure doesn’t cover booster shots. The agency will decide that issue separately. The FDA already is allowing emergency use of a third dose of either the Pfizer or Moderna vaccine for people with severely weakened immune systems. For everyone else who got those vaccinations, the Biden administration is planning ahead for boosters starting in the fall – if the FDA and CDC agree.

Also still to be decided is vaccination of children under 12. Both Pfizer and Moderna are studying youngsters, with data expected in the fall.

 

[marlonbrowndo]

Hate that I need to get vaccinated again after coming to Canada to do anything because they don’t except the vaccine that I got in Pak

 

[pakistani pride]

You all waiting for the booster one?

 

[cric_man]

You all waiting for the booster one?

I think all will need it. CDC in the US has already hinted at a booster shot by October.

Last week, 2 of my friends one vaccinated with Pfizer other with Moderna contracted COVID. One had mild cold symptoms. Other is still quarantined with 101 fever.
This Indian (Delta) variant is very transmissible and even fully vaccinated people need to keep taking full precautions like masking and avoiding indoor gathering with other people.

 

[Giannis]

I think all will need it. CDC in the US has already hinted at a booster shot by October.

Last week, 2 of my friends one vaccinated with Pfizer other with Moderna contracted COVID. One had mild cold symptoms. Other is still quarantined with 101 fever.
This Indian (Delta) variant is very transmissible and even fully vaccinated people need to keep taking full precautions like masking and avoiding indoor gathering with other people.

But why is big pharma boosters of the same vaccine instead of making one that is designed to target the molecular structure of specifically the Indian virus?

 

[cric_man]

But why is big pharma boosters of the same vaccine instead of making one that is designed to target the molecular structure of specifically the Indian virus?

That is a very good question. I would think they will be doing some tweaking to counter this variant. However by the time booster comes out, we may have some other more vicious variant that will wreck havoc. Also someone who had Moderna as initial dose, be given Pfizer as a booster?

 

[Giannis]

That is a very good question. I would think they will be doing some tweaking to counter this variant. However by the time booster comes out, we may have some other more vicious variant that will wreck havoc. Also someone who had Moderna as initial dose, be given Pfizer as a booster?

From what I've read most of the Big pharma execs don't want to develop a new vaccine and think it's useless, they think a booster of the same vaccine is better cause they think they just have to increase the amount of antibodies in our immune system but that doesn't make sense to me cause the molecular structure of the indian virus is different from the original virus so I'm not sure how that'd help. I feel like they're trying to cut costs on R&D and try to maximize profits by pushing the booster, which the FDA has been opposed to. I don't think we'll be mixing doses as we have no shortage in the US but in countries like Canada they've already been mixing up different vaccines.

 

[ahsan17]

Even if there's a new dominant variant in several months, it will likely have a lot more in common with Delta variant than the original virus that the vaccines are based on. So they should be making a vaccine based on the delta variant. I agree though, it's just a measure to save cost.

 

[cric_man]

From what I've read most of the Big pharma execs don't want to develop a new vaccine and think it's useless, they think a booster of the same vaccine is better cause they think they just have to increase the amount of antibodies in our immune system but that doesn't make sense to me cause the molecular structure of the indian virus is different from the original virus so I'm not sure how that'd help. I feel like they're trying to cut costs on R&D and try to maximize profits by pushing the booster, which the FDA has been opposed to. I don't think we'll be mixing doses as we have no shortage in the US but in countries like Canada they've already been mixing up different vaccines.

All fair points. The issue in the US has been compounded by the right wing Anti-Vaxxers. We are stuck at ~ 50%. Majority of the south FL/AL/TX have most of the cases requiring hospitalization but is also impeding us getting to herd immunity. Here in Seattle, we have reached same level of hospitalization as Apr-May 2020!

 

[Giannis]

All fair points. The issue in the US has been compounded by the right wing Anti-Vaxxers. We are stuck at ~ 50%. Majority of the south FL/AL/TX have most of the cases requiring hospitalization but is also impeding us getting to herd immunity. Here in Seattle, we have reached same level of hospitalization as Apr-May 2020!

That's scary. Honestly I don't think we'll ever be ever convince the hardcore anti vaxxers, we just gotta let natural selection take care of them. My bigger fears is that this vaccine continues to mutate into far more dangerous variants, I read about the lab l*ak the*ry and there's a strong belief that this virus was a result of a security failure at a research lab in China that was doing Gain-of-function research funded by Uncle Sam and Fa*ci was the man in charge, so if the whole purpose of the study was to try to create the most potent virus that could continously mutate into more aggressive forms then my fears are that it will continue to evade future vaccines and reach a state where no one will be able to have any immunity from it, it's a wild theory but only time will tell if they're able to get this beast back in its cage.

 

[Arsal_AK]

But why is big pharma boosters of the same vaccine instead of making one that is designed to target the molecular structure of specifically the Indian virus?

Because they have tried a a specific delta variant booster and also looked at just giving the already established vaccine as the booster. The latter works better than the delta one. There are a few studies already available on this and more will follow.

You can also look at Israel as a case study. The drop in infection and hospitalizations post a third dose is incredible.

In short we don't need a delta specific vaccine, the current one works just as well, studies suggest it's even better.

That is a very good question. I would think they will be doing some tweaking to counter this variant. However by the time booster comes out, we may have some other more vicious variant that will wreck havoc. Also someone who had Moderna as initial dose, be given Pfizer as a booster?

As to your second question, yes. People have been getting mixed vaccines for a while now and a mixed regimen actually improves efficacy, especially with an mRNA and a viral vector combination against delta.

A bigger gap between the two doses like what UK followed also seems to offer much better protection against delta.

Moderna is seemingly better than than Pfizer here and the reason could be two fold, first Moderna is a much higher dose (100 micrograms) and second it the second shot is after four weeks rather than three (Pfizer).

 

[OMB]

Japan Withdraws 1 Million More Moderna Shots As Foreign Substances Found

Coronavirus: The suspension of Moderna supplies in Japan, more than 2.6 million does in total, comes as the country battles its worst wave of COVID-19.

Moderna Inc's COVID-19 vaccine contamination problems in Japan have widened with another million doses being temporarily suspended, after foreign substances were found in more batches and two people died following shots from affected lots.
The suspension of Moderna supplies, affecting more than 2.6 million does in total, comes as Japan battles its worst wave of COVID-19 yet, driven by the contagious Delta variant, with new daily infections exceeding 25,000 this month for the first time amid a slow vaccine rollout.

The latest reports of vaccine contamination came from Gunma prefecture near Tokyo and the southern prefecture of Okinawa, prompting the suspension on Sunday of two more lots in addition to the 1.63 million doses already pulled last week.

A tiny black substance was found in a Moderna vaccine vial in Gunma, an official from the prefecture said, while in Okinawa, black substances were spotted in syringes and a vial, and pink material was found in a different syringe.

Japan's health ministry said some of the incidents may have been due needles being incorrectly inserted into vials, breaking off bits of the rubber stopper. Other vials from the lots can continue to be used, the ministry said on Monday.

The contamination cases followed a government report on Saturday that two people died after receiving Moderna shots that were among lots later suspended.

The government had said that no safety or efficacy issues had been identified and that the suspension was a precaution. The causes of death are being investigated.

"It is unlikely, in my opinion, that contamination of foreign substances led directly to sudden deaths," said Takahiro Kinoshita, a physician and vice chair of Cov-Navi, a vaccine information group.

"If the contaminated substances were dangerous enough to cause death for some people, probably many more people would have suffered from some symptoms after the vaccination.

"However, further investigations are definitely needed to evaluate the harm of the particular doses in question."

'LOOK AT THE BIGGER PICTURE'

Japan earlier halted the use of 1.63 million Moderna doses, shipped to 863 vaccination centres nationwide after the domestic distributor, Takeda Pharmaceutical, received reports of contaminants in some vials.

Some 500,000 people received shots from those supplies, Taro Kono, the minister in charge of the vaccine push, has said.

Moderna and Spanish pharma company Rovi, which bottles Moderna vaccines for markets other than the United States, said at the time that the contamination could be due to a manufacturing issue in one of Rovi's production lines.

Takeda said on Monday that the investigation is ongoing.

Rovi shares plunged more than 20% in early trade.

The affected vaccines in Gunma are from a Moderna lot that is different from those whose use has already been suspended, the Gunma official said.

Vaccines from the same lot have been administered to 4,575 people in Gunma, but the prefecture has heard no reports of ill health, the official said.

The contamination "is a serious problem" and there is need to investigate, but given rising COVID-19 cases, Moderna vaccinations should "continue with appropriate precautions", said Nicholas Rennick, an Australian doctor practicing at the NTT Medical Centre in Tokyo.

Severe COVID-19 cases are at record levels in Japan, leaving many people to recuperate at home amid a shortage of critical care beds. Only 44% of its population has been fully vaccinated, lagging vaccination rates of several developed countries.

Japan is looking into the possibility of mixing shots of AstraZeneca's vaccine with those developed by other drugmakers to speed up vaccination.

"We've got thousands of Delta variant patients around Japan as we speak, spreading the virus, and so many of the population remain unvaccinated and unprotected," Rennick said.

"We have to look at the bigger picture."

https://www.ndtv.com/world-news/coronavirus-japan-withdraws-1-million-more-contaminated-moderna-vaccine-shots-2523465

 

[Last Monetarist]

https://www.reuters.com/business/healthcare-pharmaceuticals/what-we-know-about-japans-contaminated-moderna-covid-19-vaccine-supplies-2021-08-30/

Japan's COVID-19 vaccination push suffered a blow from widening reports of contamination in supplies of Moderna Inc's vaccine.

Here are key aspects of the concerns.

WHEN WAS IT FIRST REPORTED AND HOW HAS IT WIDENED?

The first contamination was reported to Moderna's local distributor, Takeda Pharmaceutical Co (4502.T), on Aug. 16. That led to the discovery of 39 vials containing foreign material, all from the same lot of 57,000, or about 570,000 doses.

On Aug. 26, Japan said that, as a precaution, it had halted use of 1.63 million Moderna doses shipped to 863 vaccination centres nationwide.

It suspended the use of lot 3004667 that included those vials and two similarly sized lots - 3004734 and 3004956.

On Sunday, a vaccination centre in Okinawa prefecture reported finding contaminants from a fourth lot, 3005293.

Black substances were spotted in syringes and a vial, with pink substances found in another syringe, the health ministry said.

A vaccine centre in Gunma prefecture near Tokyo found a tiny, black substance in a vial from lot 3005236.

Regional authorities temporarily halted use of the affected lots from Okinawa and Gunma. Later, the health ministry and Takeda said there were no safety concerns and no suspension of use was necessary.

The Okinawa cases were probably caused by needles being incorrectly inserted into vials, breaking off bits of the rubber stopper, Health Minister Norihisa Tamura told reporters on Tuesday.

WHAT ARE THE CONTAMINANTS?

The contaminants that triggered suspensions of the first three lots are believed to be metallic particles, public broadcaster NHK said, citing health ministry sources.

The ministry has not officially identified the particles, pending an investigation by Takeda, Moderna, and its Spanish contract manufacturing partner Rovi. The firms have also yet to comment on what the foreign material is.

IS THERE A SAFETY ISSUE?

Japan and Moderna have said no safety issues were identified.

Two men, aged 38 and 30, died this month within days of receiving their second Moderna doses, the health ministry said on Saturday. Each had a dose from one of the suspended lots, 3004734. The causes of death are being investigated.

Each had a fever the day after his second dose and died two days after getting the fever. There has been no evidence of contaminants in their shots, a health ministry official told reporters.

By Aug. 8, 991 people had died in Japan after receiving COVID-19 shots from Pfizer/BioNTech, and 11 after receiving Moderna's. No causality has been established between the injections and deaths, according to the health ministry.

About 500,000 people have had shots from the first three suspended batches, Taro Kono, the minister in charge of the vaccine push, told reporters on Friday.

ARE OTHER COUNTRIES ALSO AFFECTED?

Rovi, which packages Moderna vaccines for markets other than the United States, said last week the batch in question was meant for distribution only in Japan.

South Korea, which also receives the Moderna vaccines produced from sites in the United States and Spain, said it was not affected.

Last week, the European Union drugs regulator said it was investigating the incident but an initial assessment yielded no reason to seek a temporary suspension of production.

 

[Last Monetarist]

https://www.reuters.com/world/asia-pacific/australias-victoria-state-records-small-decline-covid-19-infections-2021-09-11/

Australia has purchased an additional 1 million doses of Moderna's COVID-19 vaccine from the European Union, Prime Minister Scott Morrison said, as the country accelerates its inoculation programme to fight record high infections.

The purchase is a boost for Australia's A$2 trillion ($1.5 trillion) economy, which is at risk of slipping into its second recession in as many years as a result of lockdowns of the country's two most populous cities, Sydney and Melbourne.

These lockdowns will remain until 70% of the country's near 26 million population are fully vaccinated, which is not expected until late October.

But Morrison said the million doses will arrive later this week. Australia has ordered 25 million vaccines from Moderna.

"Some good news today. A family sized dose of hope for our vaccination programme," Morrison told reporters in Sydney.

The purchase comes as Australia struggles to contain an outbreak of the highly transmissible Delta variant, with daily infections on Saturday topping 2,000 cases for the first time.

Australia has recorded 73,610 COVID-19 cases since the pandemic begun. The death toll rose by 7 to 1,091.

 

[OMB]

I am due a Pfizer second dose but for some reason couldnt find time to get the shot.

My body in alchemy: 2 doses of sinopharm and 2 doses of pfizer
who knows what it will do to me?

 

[Last Monetarist]

https://www.reuters.com/business/healthcare-pharmaceuticals/cuba-kicks-off-covid-19-vaccine-exports-with-shipment-vietnam-2021-09-25/

Cuba said on Saturday it had exported its three-shot Abdala coronavirus vaccine for the first time, sending an initial shipment to Vietnam as part of a contract to supply five million doses to the Southeast Asian country.

Scientists in the Communist-run island have developed three home-grown vaccines against COVID-19, all of which are waiting to receive official recognition from the World Health Organization.

State-run pharmaceutical corporation BioCubaFarma made Saturday's export announcement on Twitter after saying earlier this week it had produced enough doses to meet a target to immunize more than 90% of the local population by mid-November.

BioCubaFarma says it has the annual capacity to produce 100 million doses of the Abdala, Soberana 2 and Soberana Plus vaccines, which it said recently reduced by about 90% the risk of becoming seriously ill or dying from the disease.

Hard-hit by the pandemic, the Caribbean nation has seen vital exports such as tourism collapse and other foreign exchange earnings dwindle - creating shortages of food, medicine and other essential goods.

BioCubaFarma Corporate Vice President Mayda Mauri said once domestic supply goals had been met, Cuba would also start supplying vaccines to countries including Iran and Venezuela.

"There are very advanced conversations and exchanges on regulatory matters with Argentina and with other countries in various regions of the world," state media quoted Mauri as stating.

Iran is already producing the Soberana-2 vaccine.

Vietnam, Argentina and Mexico have said they hope to produce the Cuban vaccines soon, while a number of countries are using other Cuban drugs in their COVID-19 treatment protocols.

 

[Major]

WHO says it ‘cannot cut corners’ in approving India’s Covaxin shot

BENGALURU: The World Health Organisation on Monday asked for further data from India’s Bharat Biotech to consider the company’s request for an emergency-use listing for its Covid-19 shot, saying the WHO could not “cut corners” in making a decision.

Bharat Biotech, which developed Covaxin with an Indian state research body, started sharing data with the WHO from early July. The vaccine was given emergency-use authorisation in India in January even before the completion of a late-stage trial, which later found the shot to be 78pc efficacious.

Without a WHO nod, the two-dose Covaxin is unlikely to be accepted as a valid vaccine around the world and would complicate travel plans for tens of millions of Indians who have taken it. Covaxin accounts for 11pc of the 985.5 million total doses administered in India, and has also been exported.

“We are aware that many people are waiting for WHO’s recommendation for Covaxin to be included in the #COVID19 Emergency Use Listing, but we cannot cut corners,” the WHO said on Twitter.

“Before recommending a product for emergency use, we must evaluate it thoroughly to make sure it is safe and effective.” The WHO was expecting “one additional piece of information from the company today”, it added, without specifying.

Bharat Biotech, which has struggled to meet production timelines for Covaxin, had no immediate comment.

WHO Chief Scientist Soumya Swaminathan said on Sunday its technical advisory group would meet on Oct 26 to consider the listing for Covaxin. She said the WHO’s goal was to “have a broad portfolio of vaccines approved for emergency use & to expand access to populations everywhere”.

India is the world’s biggest producer of vaccines, with a capacity to make more than 3 billion Covid shots a year, mainly the AstraZeneca one.

Dose gap trumps output jump

India’s vaccination campaign has slowed despite amassing record stockpiles of vaccine, health ministry data showed on Monday, as authorities maintain a wider-than-usual gap between doses in a strategy that has boosted coverage.

Domestic production of the AstraZeneca vaccine, which accounts for nearly 90pc of administered doses, has more than tripled since May, when a supply shortage prompted India to double the period between doses to between 12 and 16 weeks.

That gap, exceeding the 8 to 12 weeks recommended by the World Health Organisation, has allowed India to give at least one vaccine dose to 74pc of its 944 million adults, with just 30pc getting the full complement of two.

The AstraZeneca vaccine, known as Covishield, accounts for 861 million doses of India’s total injected figure of 977.6 million, while its other main vaccine, Covaxin has a dose interval of four to six weeks.

Over the last few days, daily stocks of all Covid-19 vaccines have exceeded 100 million doses, the health ministry figures show, for states and federally controlled territories taken together.

In contrast, daily vaccinations have dropped to an average of 5 million doses this month and even less in the past week, off a daily peak of 25 million last month.

The ministry said it followed recommendations from a group of experts in making any changes to dosage, arrived at by weighing up “scientific and empirical” evidence.

Published in Dawn, October 19th, 2021

 

[Kroll]

BENGALURU: The World Health Organisation on Monday asked for further data from India’s Bharat Biotech to consider the company’s request for an emergency-use listing for its Covid-19 shot, saying the WHO could not “cut corners” in making a decision.

Bharat Biotech, which developed Covaxin with an Indian state research body, started sharing data with the WHO from early July. The vaccine was given emergency-use authorisation in India in January even before the completion of a late-stage trial, which later found the shot to be 78pc efficacious.

Without a WHO nod, the two-dose Covaxin is unlikely to be accepted as a valid vaccine around the world and would complicate travel plans for tens of millions of Indians who have taken it. Covaxin accounts for 11pc of the 985.5 million total doses administered in India, and has also been exported.

“We are aware that many people are waiting for WHO’s recommendation for Covaxin to be included in the #COVID19 Emergency Use Listing, but we cannot cut corners,” the WHO said on Twitter.

“Before recommending a product for emergency use, we must evaluate it thoroughly to make sure it is safe and effective.” The WHO was expecting “one additional piece of information from the company today”, it added, without specifying.

Bharat Biotech, which has struggled to meet production timelines for Covaxin, had no immediate comment.

WHO Chief Scientist Soumya Swaminathan said on Sunday its technical advisory group would meet on Oct 26 to consider the listing for Covaxin. She said the WHO’s goal was to “have a broad portfolio of vaccines approved for emergency use & to expand access to populations everywhere”.

India is the world’s biggest producer of vaccines, with a capacity to make more than 3 billion Covid shots a year, mainly the AstraZeneca one.

Dose gap trumps output jump

India’s vaccination campaign has slowed despite amassing record stockpiles of vaccine, health ministry data showed on Monday, as authorities maintain a wider-than-usual gap between doses in a strategy that has boosted coverage.

Domestic production of the AstraZeneca vaccine, which accounts for nearly 90pc of administered doses, has more than tripled since May, when a supply shortage prompted India to double the period between doses to between 12 and 16 weeks.

That gap, exceeding the 8 to 12 weeks recommended by the World Health Organisation, has allowed India to give at least one vaccine dose to 74pc of its 944 million adults, with just 30pc getting the full complement of two.

The AstraZeneca vaccine, known as Covishield, accounts for 861 million doses of India’s total injected figure of 977.6 million, while its other main vaccine, Covaxin has a dose interval of four to six weeks.

Over the last few days, daily stocks of all Covid-19 vaccines have exceeded 100 million doses, the health ministry figures show, for states and federally controlled territories taken together.

In contrast, daily vaccinations have dropped to an average of 5 million doses this month and even less in the past week, off a daily peak of 25 million last month.

The ministry said it followed recommendations from a group of experts in making any changes to dosage, arrived at by weighing up “scientific and empirical” evidence.

Published in Dawn, October 19th, 2021

Bizzare, I'm sure 'corners were cut' when the western vaccines were rushed in.

 

[Robert]

That's scary. Honestly I don't think we'll ever be ever convince the hardcore anti vaxxers, we just gotta let natural selection take care of them. My bigger fears is that this vaccine continues to mutate into far more dangerous variants, I read about the lab l*ak the*ry and there's a strong belief that this virus was a result of a security failure at a research lab in China that was doing Gain-of-function research funded by Uncle Sam and Fa*ci was the man in charge, so if the whole purpose of the study was to try to create the most potent virus that could continously mutate into more aggressive forms then my fears are that it will continue to evade future vaccines and reach a state where no one will be able to have any immunity from it, it's a wild theory but only time will tell if they're able to get this beast back in its cage.

Humanity will carry on. Spanish Flu killed 50 million people, but then herd immunity kicked in. This beast has killed 1/10 of that so far, due to mass vaccination.

 

[Robert]

Looks like I will be offered my COVID booster in January.

 

[IMMY69]

So in the press conference with the Health Secretary, the last slide was eye opening.
The vast majority of hospitalisations are of those that have yet to be vaccinated.

 

[Last Monetarist]

https://www.reuters.com/world/us/us-cdc-endorses-five-month-gap-pfizers-covid-19-booster-dose-2022-01-04/

The U.S. Centers for Disease Control and Prevention (CDC) on Tuesday recommended shortening the interval between Pfizer-BioNTech's second COVID-19 vaccine dose and the booster shot to five months from six.

The move follows the U.S. Food and Drug Administration's decision on Monday to reduce the interval for the booster dose and authorize the use of a third dose of Pfizer-BioNTech vaccine for children aged 12 to 15 years.

The CDC has also recommended that moderately or severely immunocompromised children aged five to 11 years receive an additional dose of vaccine 28 days after their second shot.

The Pfizer-BioNTech vaccine, authorized by the U.S. Food and Drug Administration in late October last year, is the only vaccine available for children aged five to 11 years in the United States.

The CDC has not changed the booster interval recommendation for people who have received the Johnson & Johnson or the Moderna vaccine, which remains at two and six months respectively.

A CDC advisory panel is set to meet on Wednesday to discuss the use of a booster dose of Pfizer-BioNTech COVID-19 vaccine for children aged 12 to 15 years.

 

[Saj]

Had the Pfizer booster jab.

Sore arm and headache for a couple of days but nothing too serious.

 

[James]

Myself and Mrs James carefully made our decision and we both had the Moderna booster jab on 30th Dec.

Felt mildly dodgy for a couple days afterwards but that’s it.

Antibodies topped up.

 

[Robert]

Myself and Mrs James carefully made our decision and we both had the Moderna booster jab on 30th Dec.

Felt mildly dodgy for a couple days afterwards but that’s it.

Antibodies topped up.

Good decision.

 

[khan-92]

Looking at research I will go with Natural immunity.
Had covid last year in September so Alhumdulilah have Natural antibodies now to fight the virus if I am down again with it God forbidding.

 

[MenInG]

A man in India got jabbed with a Covid-19 vaccine at least eight times last year, a health official said.

Brahmdeo Mandal, 65, has claimed that he received 11 doses of the vaccine in Bihar state.

The retired postman said the jabs had helped him to get rid of aches and pains and "stay healthy". He claimed he had not suffered any adverse effects.

Mr Mondal was finally stopped from taking what he claimed was his 12th jab at a camp last week.

A probe is underway to find out how Mr Mandal, who lives with his family in Madhepura district, managed to get multiple jabs.

"We have already found evidence that he took eight jabs from four places," Amarendra Pratap Shahi, civil surgeon of Madhepura, told the BBC.

Since vaccination began on 16 January last year, India has been mainly administering two locally-manufactured vaccines, Covishield and Covaxin. The two-dose vaccines have a gap from 12-16 weeks and four to six weeks after the first dose respectively.

Vaccination is voluntary, and more than 90,000 centres, mostly state-run, are offering jabs across the country.

These include vaccination camps offering walk-in jabs without prior online registration. The beneficiary needs to furnish identity proof - a biometric card, voter ID or driving licence, among 10 documents - to register.

The data gathered from the sites is uploaded to India's vaccine portal, CoWin.

https://www.bbc.com/news/world-asia..._custom4=CF74B84A-6F8D-11EC-B5AC-41FA4744363C

 

[finalfantasy7]

A man in India got jabbed with a Covid-19 vaccine at least eight times last year, a health official said.

Brahmdeo Mandal, 65, has claimed that he received 11 doses of the vaccine in Bihar state.

The retired postman said the jabs had helped him to get rid of aches and pains and "stay healthy". He claimed he had not suffered any adverse effects.

Mr Mondal was finally stopped from taking what he claimed was his 12th jab at a camp last week.

A probe is underway to find out how Mr Mandal, who lives with his family in Madhepura district, managed to get multiple jabs.

"We have already found evidence that he took eight jabs from four places," Amarendra Pratap Shahi, civil surgeon of Madhepura, told the BBC.

Since vaccination began on 16 January last year, India has been mainly administering two locally-manufactured vaccines, Covishield and Covaxin. The two-dose vaccines have a gap from 12-16 weeks and four to six weeks after the first dose respectively.

Vaccination is voluntary, and more than 90,000 centres, mostly state-run, are offering jabs across the country.

These include vaccination camps offering walk-in jabs without prior online registration. The beneficiary needs to furnish identity proof - a biometric card, voter ID or driving licence, among 10 documents - to register.

The data gathered from the sites is uploaded to India's vaccine portal, CoWin.

https://www.bbc.com/news/world-asia..._custom4=CF74B84A-6F8D-11EC-B5AC-41FA4744363C

has he really or has he been selling his certificate off? as that's occurred here in the UK - few people have been caught doing this scam

 

[MenInG]

A doctor spoke to Sajid Javid about his refusal to be vaccinated - despite working in ICU since the start of the pandemic.

<div style="width: 100%; height: 0px; position: relative; padding-bottom: 50%;"><iframe src="https://streamable.com/e/cozj7k" frameborder="0" width="100%" height="100%" allowfullscreen style="width: 100%; height: 100%; position: absolute;"></iframe></div>

 

[khan-92]

A doctor spoke to Sajid Javid about his refusal to be vaccinated - despite working in ICU since the start of the pandemic.

<div style="width: 100%; height: 0px; position: relative; padding-bottom: 50%;"><iframe src="https://streamable.com/e/cozj7k" frameborder="0" width="100%" height="100%" allowfullscreen style="width: 100%; height: 100%; position: absolute;"></iframe></div>

Agree with the doctor natural immunity is much better then the vaccine.

 

[James]

Good video, also interesting to see the other NHS staff clamming up with their heads down and not wanting to engage with Sajid…

 

[Last Monetarist]

https://www.reuters.com/business/healthcare-pharmaceuticals/who-urges-manufacturers-provide-covid-19-vaccine-data-2022-01-18/

A World Health Organization committee urged COVID-19 vaccine manufacturers on Tuesday to provide it with the data it requires in order to list their shots for emergency use, saying the delays were affecting equitable vaccine access.

An emergency use listing with the U.N. agency means shots can be shipped to multiple developing nations that rely on WHO guidance for their regulatory decisions. It also allows them to be used by the COVAX vaccine-sharing programme that aims to ramp up vaccinations in poorer countries.

"The Committee recognized the challenges posed by some manufacturers’ delayed submission of vaccine data to WHO," its Emergency Committee said in a statement, urging vaccine producers to supply the data as soon as possible.

The statement, the outcome of a closed-door meeting held last week, did not clarify which manufacturers had not yet submitted data.

A WHO document dated Dec. 23 listed the Sputnik V vaccine, produced by the Gamaleya Institute, as having submitted incomplete data.

The Emergency Committee, made up of independent experts, meets every three months and makes policy recommendations on key issues relating to the coronavirus pandemic, such as international travel measures and COVID-19 vaccines.

It is also the body within the WHO that first declared COVID-19 a global health emergency, or 'PHEIC' (Public Health Emergency of International Concern) in WHO jargon, nearly two years ago. Its members unanimously agreed last week to maintain the current state of emergency.

 

[BreadPakoda]

A doctor spoke to Sajid Javid about his refusal to be vaccinated - despite working in ICU since the start of the pandemic.

<div style="width: 100%; height: 0px; position: relative; padding-bottom: 50%;"><iframe src="https://streamable.com/e/cozj7k" frameborder="0" width="100%" height="100%" allowfullscreen style="width: 100%; height: 100%; position: absolute;"></iframe></div>

Logically explained by the doctor. Sajid couldn’t properly respond to any of his points. His only response was that he takes advice from “vaccine experts”.

 

[Stewie]

is Sajid Javid a doctor? if he is not I can understand if he is unable to discuss this with a qualified doctor.

But my take on this is, doctors are also not well aware or fully qualified to answer some of the vaccine questions as the expert scientists/doctors who work on them. This doctor's logic is fine, but what he is failing to realize is that the natural immunity he has from the infection he got, is not going to last long. Also a fully vaccinated immunity does not las only a couple of months. It lasts 6-8 months. You can easily get a booster after that to extend that immunity. You can choose not to get it, but you are leaving yourself susceptible to catching it, and then spreading it to your patients, so for people in healthcare it is even more of an issue.

 

[BreadPakoda]

is Sajid Javid a doctor? if he is not I can understand if he is unable to discuss this with a qualified doctor.

But my take on this is, doctors are also not well aware or fully qualified to answer some of the vaccine questions as the expert scientists/doctors who work on them. This doctor's logic is fine, but what he is failing to realize is that the natural immunity he has from the infection he got, is not going to last long. Also a fully vaccinated immunity does not las only a couple of months. It lasts 6-8 months. You can easily get a booster after that to extend that immunity. You can choose not to get it, but you are leaving yourself susceptible to catching it, and then spreading it to your patients, so for people in healthcare it is even more of an issue.

Immunity through booster wanes against Omicron in little over 2 months. I believe that’s what the doc is referring to. As protection completely nullifies in that period, you probably need a booster every month or so.

 

[moghul]

A doctor spoke to Sajid Javid about his refusal to be vaccinated - despite working in ICU since the start of the pandemic.

<div style="width: 100%; height: 0px; position: relative; padding-bottom: 50%;"><iframe src="https://streamable.com/e/cozj7k" frameborder="0" width="100%" height="100%" allowfullscreen style="width: 100%; height: 100%; position: absolute;"></iframe></div>

We see these kind of idiots here in USA also but they are in extreme minority now . There are some people who are anti-vaccine and they make all kind of idiotic logics not to have and misguide others also many of them pay the price for that . Immunity from vaccine is not for ever but its much more longer lasting and stronger than having covid infection, no comparison.

 

[khan-92]

is Sajid Javid a doctor? if he is not I can understand if he is unable to discuss this with a qualified doctor.

But my take on this is, doctors are also not well aware or fully qualified to answer some of the vaccine questions as the expert scientists/doctors who work on them. This doctor's logic is fine, but what he is failing to realize is that the natural immunity he has from the infection he got, is not going to last long. Also a fully vaccinated immunity does not las only a couple of months. It lasts 6-8 months. You can easily get a booster after that to extend that immunity. You can choose not to get it, but you are leaving yourself susceptible to catching it, and then spreading it to your patients, so for people in healthcare it is even more of an issue.

Disagree it doesn't mean you won't get infected again if you have natural immunity.
Basically if you had covid and you catch it again your immune system will deal with better.
How do I know this because I had covid, 1st time I had severe symptoms was not well for 10 days with fever, cough & body aches.
Last week I had cold like symptoms took pcr test was positive.
And the symptoms I have now are mild with occasional cough and light headache.
So this proves my body had produced antibodies to tackle any type variant that will appear in future Insha'Allah.
Don't need to Jab myself every few months to tackle new variants like these vaccines manufacturers are telling people to do now.

 

[Firebat]

Covid: South Africa makes its own version of Moderna vaccine

Scientists in South Africa have made a copy of the Moderna Covid vaccine, a move which they say could help boost vaccination rates across Africa.

The continent currently has the lowest uptake of Covid shots in the world.

The company behind the new vaccine - Afrigen Biologics - says it hopes to start clinical trials in November.

Moderna previously said it would not enforce the patents on its vaccine, allowing scientists in Cape Town to make their own version of it.

The researchers were backed by the World Health Organization (WHO).

Petro Terblanche, director of Afrigen Biologics, said they were starting small, but had ambitions to scale up quickly.

"We have used the sequence, which is the same sequence as the Moderna vaccine 1273," she told the BBC.

"This is part of a global initiative to build capacity and capability in low and middle-income countries to become self-sufficient."

The shot being copied is a messenger RNA vaccine made by US firm Moderna. Pfizer-BioNTech also made its vaccine using the same technology. They were some of the first Covid vaccines to be authorised for use around the world.

This type of vaccine teaches cells how to make a protein that will trigger an immune response inside our bodies, rather than putting a weakened or inactivated germ into the body.

The company's chief scientist, Dr Caryn Fenner, called the achievement "really significant".

"It puts the power in our hands to be able to produce our own vaccines for the future, to be ready for further pandemics, to produce clinical trial material on African soil and then to look at other diseases of relevance in Africa."

Many of Africa's countries have fully vaccinated less than 10% of their populations, compared to 60% in North America, 63% in Europe and 61% across Asia. Despite having one of the best rates on the continent, South Africa has only vaccinated 27% of its people.

It's been reported that BioNTech - the company which partnered Pfizer in producing an mRNA vaccine - also has plans to open a vaccine manufacturing plant on the continent.

A number of other Covid-19 vaccine production facilities are in the pipeline in Africa, mainly focused on Russian and Chinese-made vaccines.

https://www.bbc.co.uk/news/health-60258088

 

[MenInG]

A COVID-19 vaccine developed by Valneva has been granted regulatory approval by the Medicines and Healthcare products Regulatory Agency (MHRA).

It is the sixth coronavirus vaccine to be granted an MHRA authorisation.

The UK's independent medicines regulator is the first in the world to approve the Valneva product, MHRA said in a statement.

MHRA chief executive Dr June Raine said: "Our approval of the COVID-19 vaccine made by Valneva today follows a rigorous review of the safety, quality and effectiveness of this vaccine, and expert advice from the government's independent scientific advisory body, the Commission on Human Medicines."

The Valneva jab - developed by the French firm, which has a factory in Livingston near Edinburgh - is the first whole-virus inactivated COVID-19 vaccine to gain regulatory approval in the UK.

With this type of vaccine, the virus is grown in a lab and then made completely inactive so that it cannot infect cells or replicate in the body but can still trigger an immune response to the COVID-19 virus.

This process for creating vaccines is widely used already in the production of flu and polio vaccines, the MHRA said.

The UK had been due to receive 100 million doses of the Valneva jab, but the government cancelled the deal in September due to a "breach of obligations".

The former chairwoman of the country's vaccine taskforce last year criticised the decision to pull out of the agreement before Valneva had finished clinical testing of the vaccine.

Dame Kate Bingham, who stood down from her role at the end of 2020, said the government may have "acted in bad faith" in the way it cancelled the deal.

The Valneva approval follows the authorisation of the Moderna, Oxford/AstraZeneca, Pfizer/BioNTech, Janssen and Novavax vaccines in the UK.

It comes as the number of deaths involving coronavirus registered each week in England and Wales continues to rise, although levels remain well below those reached during previous waves of the virus.

Official data released last Friday, showed the recent surge in COVID infections had levelled off and may have started to decline.

Figures from the Office for National Statistics (ONS) show 4,883,100 people in the UK had the virus in the week to 2 April. This was a fall of 0.5% from the week before.

The NHS Confederation has said very high infection rates are having a "major impact" on the health service, which is facing pressures it would see in a "bad winter" well into spring.

But Downing Street has rejected calls to reintroduce greater mask-wearing and a push to encourage mixing outdoors.

SKY

 

[MenInG]

The Omicron variant of COVID-19 is less likely than Delta to result in long COVID in people who have had two doses of vaccine, new figures have suggested.

Data from the Office for National Statistics (ONS) has shown the odds of double-vaccinated adults infected with the Omicron BA.1 strain reporting having long COVID four to eight weeks later were 50% lower than those who had Delta.

https://news.sky.com/story/double-j...omicron-than-delta-ons-data-suggests-12606623

 

[MenInG]

A fourth COVID jab pushes antibody levels even higher than those seen after the third, a new study suggests.

A team of academics led by the University of Southampton have been tracking a group of people and their levels of antibodies and T cells - both measures which indicate a person's level of protection against a virus.

 

[MenInG]

Moderna said it is suing Pfizer and its German partner BioNTech for patent infringement linked to the development of the first Covid-19 vaccines.

The US biotech company is alleging that mRNA technology it developed before the pandemic was copied.

The lawsuit, which is seeking unspecified financial damages, was filed in the US and Germany.

Pfizer said it was "surprised" by the action and would "vigorously defend" itself against the allegations.

In a statement, Moderna said Pfizer/BioNTech copied two key elements of its intellectual property.

One involves a "chemical modification" which Moderna says its scientists were the first to demonstrate in human trials in 2015, and means the vaccine "avoids provoking an undesirable immune response".

The second alleged infringement is related to the way both vaccines target the distinctive spike protein on the outside of the virus.

"We are filing these lawsuits to protect the innovative mRNA technology platform that we pioneered, invested billions of dollars in creating, and patented during the decade preceding the Covid-19 pandemic," Moderna chief executive Stephane Bancel said.

Moderna, which was only formed as a company in 2010, was an early developer of the mRNA technology used commercially for the first time in Covid vaccines.

The jabs use a molecule of genetic code called messenger RNA to generate an immune response.

That trains the body to fight off the real virus when it comes into contact with it.

Early in the pandemic, Moderna said it would not enforce its patents to help other drug companies develop their own jabs, particularly for low- and middle-income countries.

In March 2022 it said rivals such as Pfizer and BioNTech would have to respect its intellectual property rights in some higher-income countries, though it would not claim damages for activity before that date.

Patent disputes often take place when new technology is developed and both Pfizer/BioNTech and Moderna are already facing other lawsuits relating to their respective mRNA platforms.

Moderna itself is in an ongoing dispute with the US National Institutes of Health over the credit for key patents relating to mRNA technology.

In July, German biotech company CureVac filed a lawsuit against BioNTech claiming it violated patents linked to the engineering of certain mRNA molecules and seeking "fair compensation".

In a statement Pfizer said it had not yet fully reviewed Moderna's complaint but was "surprised" given that its vaccine was based on its own proprietary mRNA technology.

A spokesperson for the company said: "We remain confident in our intellectual property supporting the Pfizer/BioNTech vaccine and will vigorously defend against the allegations of the lawsuit."

BBC

 

[KingKhanWC]

If anyone has suffered vaccine damage, dont feel as healthy as before, please seek advice from a specialist. Then make sure you claim against the UK government for vaccine damages.

See below.

https://www.gov.uk/vaccine-damage-payment

 

[FearlessRoar]

The Nobel Prize in Physiology or Medicine has been awarded to a pair of scientists who developed the technology that led to the mRNA Covid vaccines.

Prof Katalin Kariko and Prof Drew Weissman will share the prize.

The technology was experimental before the pandemic but has now been given to millions of people around the world.
The same mRNA technology is now being researched for other diseases, including cancer.

The Nobel Prize Committee said: The laureates contributed to the unprecedented rate of vaccine development during one of the greatest threats to human health in modern times.

Both were told they had won by telephone this morning and were said to be overwhelmed.

Vaccines train the immune system to recognize and fight threats such as viruses or bacteria.

Traditional vaccine technology has been based on dead or weakened versions of the original virus or bacterium - or by using fragments of the infectious agent.

In contrast, mRNA vaccines used a completely differently approach.

During the Covid pandemic, the Moderna and Pfizer/BioNTech vaccines were both based on mRNA technology.

Source: BBC