Pfizer, BioNTech to seek emergency COVID-19 vaccine nod on Friday

Darnell Taylor
November 20, 2020

A decision on Pfizer's vaccine won't affect other COVID-19 vaccine candidates in the pipeline, which will be judged separately.

About 42% of global participants and 30% of USA participants in the Phase 3 study have racially and ethnically diverse backgrounds, the companies said in a news release, and 41% of global and 45% of USA participants are ages 56 to 85.

Fauci said the coronavirus vaccines quickly created by Moderna and Pfizer are the result of "extraordinary" advances in medicine and the developers did not compromise safety or scientific integrity.

The government will allocate the vaccines to states proportionally based on population, Alex Azar, secretary of the Department of Health and Human Services, said on a conference call with reporters on Wednesday.

More data released from their continuing phase three trial suggests it works equally well in people of all ages and ethnicities.

Although Pfizer is moving fast toward getting an approval from the FDA, its CEO Albert Bourla has urged people not to get complacent and keep following the safety rules diligently.

Of the dozens of drugmakers and research groups racing to develop COVID-19 vaccines, the next late-stage data will likely be from AstraZeneca Plc with the University of Oxford in November or December.

They'll recommend not just whether FDA should allow broader use of the vaccine generally but if so, for whom. First, regulators need to be absolutely sure in their own minds that it's safe - not least because Moderna and Pfizer both use an experimental technology that's never been approved before. Then there's the massive issue of availability. Production will be ramped up in 2021 and 1.3 billion doses can be expected by the end of next year.

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Perhaps one of the biggest problems is that wealthy countries have already swooped in to buy up the first batches that will be ready. That's good news for a country such as the United Kingdom, but not such good news for developing countries which haven't got the money to place bids. Pfizer and BioNTech, who revealed earlier this week that their vaccine was 95% effective based on Phase 3 clinical trial data, are submitting for the emergency authorization in the USA, as well as in Australia, Canada, Europe, Japan and the United Kingdom, and says that could pave the way for use of the vaccine to begin in "high-risk populations" by the end of next month. "By contrast, two doses of the measles vaccine are 97 percent effective".

On Wednesday, Pfizer said it had offered to provide Brazil with millions of doses in the first half of 2021. " But given the moment we are in this pandemic and the process of developing the vaccine, I could not have asked for a better result".

That messenger RNA, or mRNA, instructs the body to make some harmless spike protein, training immune cells to recognize it if the real virus eventually comes along.

Also, results showed that ten severe Covid-19 cases were observed in the trial.

The Pfizer vaccine must be stored at about minus 80C, although it can be kept in a fridge for five days. "The Moderna vaccine also requires freezer temperatures, which is a little easier".

The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee, a group of outside experts, for December 8, 9 and 10, a source familiar with the process told CNN this week.

"We would expect to see Moderna filing soon also", Azar said at the press conference.

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