BioNTech/Pfizer to seek emergency approval for coronavirus vaccine within days

Grant Boone
November 20, 2020

United States pharmaceutical giant Pfizer looks set to apply for emergency authorization of its vaccine candidate, which it says was found to be 95 percent effective against the coronavirus. "There are around a dozen in the final stages of testing - known as a phase 3 trial - but this is the first to show any results".

The companies say they will now apply for authorisation for emergency use of the jab in the US.

"With respect to the flu vaccine we did prioritize people in long-term care, people in hospitals and people living in congregate settings because we know that they are the most vulnerable and need to be protected".

The BioNTech/Pfizer shot and another one being developed by US firm Moderna have taken the lead in the global chase for a vaccine, after large-scale trial data this month showed that their jabs were around 95 per cent effective against COVID-19.

Speaking with CP24 on Wednesday afternoon, infectious disease specialist Dr. Abdu Sharkawy said that while the news that two of those vaccines are proving effective is positive, they won't necessarily be approved for distribution in Canada as quickly as they may be in the U.S.

The drug-makers said there were 170 confirmed cases of COVID-19 in the study of 43,000 volunteers. If granted, the Pfizer and BioNTech vaccine would be the first shot based on a new mRNA technology to receive FDA authorization.

There is also evidence that the vaccine protects against severe Covid - but this is based on only 10 cases.

Oxford-AstraZeneca vaccine shows promise in elderly, trial results by Christmas
The first interim results of efficacy readings for this trial are expected to be reported in the coming weeks. The results of the peer-reviewed study were published Thursday in the Lancet , an worldwide medical journal.

Pfizer and BioNTech said that the vaccine's efficacy was consistent across age, race and ethnicity. The vaccine was equally effective in older as well as younger people; the shot was 94% effective in protecting against COVID-19 illness among those over age 65. It reported fatigue among 3.8 percent of participants and 2 percent suffering headaches, both after getting the second vaccine dose. The only adverse effects experienced by volunteers were fatigue and headache. The Japanese government has an agreement to receive a supply of 120 million vaccine doses, enough for 60 million people or roughly half its population.

The biggest difference between the two vaccines is how they are stored.

Pfizer and BioNTech said they expect to produce up to 50 million vaccine doses globally in 2020 and up to 1.3 billion doses in 2021.

Pfizer and BioNTech have also developed thermal shippers utilizing dry ice to maintain temperature conditions at around minus 70 C, with the packaging able to serve as temporary storage units for 15 days if refilled with dry ice, according to their press release.

That means that initially, doses will be limited and until researchers learn more about how long the vaccine-induced protection against the COVID-19 virus lasts, we will still be wearing masks, washing our hands frequently, and social distancing to curb spread of the virus.

When asked directly to confirm the dates and numbers, federal Health Minister Patty Hajdu would only say it was "really exciting" that Canada is well-positioned to receive millions of doses from both companies.

German Chancellor Angela Merkel, a former scientist who has been praised for her handling of the coronavirus crisis so far, on Thursday said "we don't want to take any risks" on a vaccine, and that the latest news was encouraging.

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