Russia becomes first country to approve a COVID-19 vaccine [Update Post #339]

[sweep_shot]

Israel to start human trials of COVID vaccine on Nov 1

Israel Institute for Biological Research (IIBR) will start human clinical trials of its COVID-19 vaccine candidate Brilife from November 1 after receiving all necessary approvals from the Ministry of Health and the Helsinki Committee, the Israeli Defence Ministry said.

Israel Institute for Biological Research (IIBR) will start human clinical trials of its COVID-19 vaccine candidate Brilife from November 1 after receiving all necessary approvals from the Ministry of Health and the Helsinki Committee, the Israeli Defence Ministry said. The Helsinki Committee deals with research approval and human experiments. The committee is mandated to ensure the well being and rights of trial volunteers and to ensure that the experiment is conducted as per the approved medical guidelines and ethics, besides various domestic laws, rules and regulations.

The guidelines are outlined in the Declaration of Helsinki and various relevant international conventions. The three stages of the human clinical trial involving over 30,000 volunteers are likely to last till mid-2021 and if all goes well, the vaccine could be ready for mass use only after that. "This is a day of hope for the citizens of Israel, thanks to the IIBR researchers. Just two months ago I received the first bottle of the vaccine. Today we already have 25,000 vaccine doses and are starting the next phase of the test," said Alternate Prime Minister-cum-Defence Minister Benny Gantz.

"I would like to thank the dozens of researchers who work day and night on this national mission in full cooperation with the Ministry of Health. In this complex period, you are the 'commando unit' paving the way for the citizens of Israel. You took on a mission of international and historical importance," Gantz was quoted as saying in an official statement. "The defence establishment, the Israeli government, and I will continue to provide you with the support and resources required to produce a safe and effective 'blue-and-white' vaccine," he stressed.

"Blue and White" refers to the colours in the Israeli flag, which also happens to be the name of the defence minister's party. The first phase of the human trial will include a series of safety tests with the participation of 80 healthy volunteers (aged 18-55), designated by Sheba and Hadassah medical centres. The trial will begin on November 1 with two participants initially. Depending on their responses, the vaccine will then be gradually administered to a total of 80 volunteers -- 40 in each medical centre. Each volunteer will receive an injection and discharged after a few hours of observation. They will then be monitored over three weeks.

Scientists will check for any possible side effects and will examine if the volunteers develop antibodies to the virus. The second phase includes extensive safety tests with the participation of 960 healthy volunteers over the age of 18. The trial is expected to begin in December and will be held simultaneously in several medical centres across Israel. In the second phase, scientists aim to complete vaccine safety precautions, determine the effective dosage, and further determine the vaccine’s effectiveness, the statement said. The third phase will be a large-scale trial to test the effectiveness of the vaccine with the participation of up to 30,000 volunteers. If all goes well, the third and last phase of the trial is scheduled to begin in April or May 2021 and its successful completion would pave the way for approval for the mass use of the vaccine.

"We are now beginning a crucial phase in the development of the vaccine -- the clinical trials phase. I believe in the abilities of our scientists and I am confident that we can produce a safe and effective vaccine," said IIBR Director, Prof Shmuel Shapira. "The commercial name of the vaccine is 'BriLife'. The first part of the name, 'Bri', alludes to the Hebrew word for health, 'briut' and the second part, 'il' alludes to Israel, and 'life' speaks to the importance of the vaccine," he added.

The vaccine developed by IIBR is based on an existing virus (VSV). Coronavirus spikes have been 'engineered' onto VSV, allowing the vaccine to attach to cells in the body. The vaccine has been successfully tested on several "animal models". The vaccine elicited an effective immune response in both small animals (mice, hamsters and rabbits) and large animals (pigs). The safety of the vaccine has been demonstrated in several tests, thus opening the door for clinical trials with human participants, the statement said. The institute has evolved a device for large-scale production of vaccines (approximately 15 million). It has produced more than 25,000 vaccine doses for the first and second phases of the clinical trials to date, it added. IIBR was established in 1952 as part of the Israel Defence Forces' Science Corps, and later became a civilian organisation.

Israel had claimed in August that it already has the vaccine against the coronavirus "in hand" but it has to go through regulatory processes that would begin with human trials following the autumn holidays. Prime Minister Benjamin Netanyahu is said to have asked the institute in February to devote resources to develop a vaccine for COVID-19.

Source: https://www.devdiscourse.com/articl...eports-half-a-million-covid-19-cases-and-more.

 

[Firebat]

Vaccine hopes rise as Oxford jab prompts immune response among old as well as young adults

LONDON (Reuters) - One of the world’s leading COVID-19 experimental vaccines produces a immune response in both young and old adults, raising hopes of a path out of the gloom and economic destruction wrought by the novel coronavirus.

The vaccine, developed by the University of Oxford, also triggers lower adverse responses among the elderly, British drug maker AstraZeneca Plc AZN.L, which is helping manufacture the vaccine, said on Monday.

A vaccine that works is seen as a game-changer in the battle against the novel coronavirus, which has killed more than 1.15 million people, shuttered swathes of the global economy and turned normal life upside down for billions of people.

“It is encouraging to see immunogenicity responses were similar between older and younger adults and that reactogenicity was lower in older adults, where the COVID-19 disease severity is higher,” an AstraZeneca spokesman said.

“The results further build the body of evidence for the safety and immunogenicity of AZD1222,” the spokesman said, referring to the technical name of the vaccine.

The Oxford/AstraZeneca vaccine is expected to be one of the first from big pharma to secure regulatory approval, along with Pfizer PFE.N and BioNTech's 22UAy.F candidate, as the world tries to plot a path out of the COVID-19 pandemic.

The news that older people get an immune response from the vaccine is positive because the immune system weakens with age and older people are those most at risk of dying from the virus.

If it works, a vaccine would allow the world to return to some measure of normality after the tumult of the pandemic.

British Health Secretary Matt Hancock said a vaccine was not yet ready but he was preparing logistics for a possible roll out mostly in the first half of 2021.

Asked if some people could receive a vaccine this year he told the BBC: “I don’t rule that out but that is not my central expectation.”

“The programme is progressing well, (but) we’re not there yet,” Hancock said.

Read more: https://www.reuters.com/article/us-...ong-old-as-well-as-young-adults-idUSKBN27B0IV

 

[Gabbar Singh]

<blockquote class="twitter-tweet"><p lang="en" dir="ltr">BREAKING: The trial of Chinese Covid-19 vaccine Coronavac has been halted by Brazil, citing a serious adverse event. China has already given the vaccine to people. <a href="https://t.co/MXIYuL8inJ">https://t.co/MXIYuL8inJ</a> <a href="https://t.co/GKqMnjjpCE">pic.twitter.com/GKqMnjjpCE</a></p>— Bloomberg (@business) <a href="https://twitter.com/business/status/1325978338276626432?ref_src=twsrc%5Etfw">November 10, 2020</a></blockquote> <script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>

 

[Giannis]

Moderna beats Pfizer; covid vaccine is 95% effective and has storage and logistical advantages

https://www.cnn.com/world/live-news...16-20-intl/h_3c91c6f3b13c0b6d96bd126d9cda9018

They're also saying that if approved soon, they will have 60 million shots available next month!

Moderna's vaccine has a significant advantage over Pfizer's

From CNN's Elizabeth Cohen

Moderna announced this morning that its coronavirus vaccine is 94.5% effective against the virus, making it the second vaccine in the United States to have a stunningly high success rate.

Last week, Pfizer announced that early data show its vaccine is more than 90% effective against the disease.

While the two vaccines appear to have very similar safety and efficacy profiles, Moderna's vaccine has a significant practical advantage over Pfizer's.

Pfizer's vaccine has to be kept at minus 75 degrees Celsius — or about minus 103 degrees Fahrenheit. No other vaccine in the US needs to be kept that cold, and doctors' offices and pharmacies do not have freezers that go that low.

Moderna's vaccine can be kept at minus 20 degrees Celsius, which is about minus 4 degrees Fahrenheit. Other vaccines, such as the one against chickenpox, need to be kept at that temperature.

That means Moderna's vaccine can be kept in "a readily available freezer that is available in most doctors' offices and pharmacies," said Dr. Tal Zacks, Moderna's chief medical officer. "We leverage infrastructure that already exists for other marketed vaccines."

Another advantage of Moderna's vaccine is that it can be kept for 30 days in the refrigerator, the company announced Monday. Pfizer's vaccine can last only five days in the refrigerator.

CORRECTION: A previous version of this post misstated the temperature the Moderna vaccine can be kept. It's minus 4 degrees Fahrenheit.

 

[sweep_shot]

Russia, Israel discuss mutual efforts related to COVID-19 vaccine

(MENAFN) Russian President Vladimir Putin had a telephone conversation with Israeli Prime Minister Benjamin Netanyahu on Monday, and the dictators debated bilateral ties and futures for enhanced collaboration on the Russian vaccine COVID-19.

According to a report issued by the Kremlin, the conversation focused on bilateral ties in combatting the spread of the coronavirus pandemic, including a debate on the subject on current preventive measures implemented by both countries.

The statement revealed that "The two sides covered "prospects for cooperation on the Russian vaccine, including its possible supply and the organization of production in Israel."

The leaders spoke further about the situation in the Middle East.

Source: https://menafn.com/1101134178/Russi...efforts-related-to-COVID-19-vaccine&source=30.

 

[Firebat]

Covid: Russia begins vaccinations in Moscow

Russia is starting its Covid-19 vaccination programme, with clinics in the capital Moscow inoculating those most at risk from the virus.

Its own vaccine Sputnik V, which was registered in August, is being used.

Developers say it is 95% effective and causes no major side effects, but it is still undergoing mass testing.

Thousands of people have already registered to get the first of two jabs over the weekend, but it is unclear how much Russia can manufacture.

Producers are only expected to make two million doses of the vaccine by the end of the year.

Moscow Mayor Sergei Sobyanin, who announced the programme earlier in the week, said it was being offered to people in the city of 13 million who work in schools and the health service, and social workers.

He said the list would grow as more of the vaccine became available.

An online registration service allows city residents in the above professions aged 18-60 to book free appointments at 70 sites around the city.

https://www.bbc.com/news/world-europe-55198166

 

[Firebat]

Russia approves Sputnik V COVID-19 vaccine for people over 60: media

MOSCOW (Reuters) - Russia on Saturday approved its main COVID-19 vaccine, Sputnik V, for use by people over the age of 60, Russian news agencies cited the health ministry as saying.

People over 60 have thus far been excluded from Russia’s national inoculation programme, as the shot was tested on this age group separately.

https://www.reuters.com/article/us-...accine-for-people-over-60-media-idUSKBN29005A

 

[MenInG]

The EU is launching a co-ordinated vaccine rollout to fight Covid-19, in what the bloc's top official says is a "touching moment of unity".

European Commission President Ursula von der Leyen said on Saturday the Pfizer-BioNTech vaccine had been delivered to all 27 member states.

Some countries started administering the jabs on Saturday, saying they were not prepared to wait another day.

The EU has so far reported more than 335,000 Covid-related deaths.