Pfizer to Apply for Emergency Use of COVID Vaccine, High-Risk Populations May Get Shot Before Christmas

Pfizer and BioNTech will apply to the U.S. Food and Drug Administration on Friday to roll out its vaccine against COVID-19, hoping that it will be available to high-risk individuals in the U.S. in December.

The American pharmaceutical and German biotechnology companies said in a press release on Friday that they will submit a request to the FDA for what is known as an emergency use authorization for their vaccine named BNT162b2. This is the first such application to the FDA for a COVID vaccine.

If given the green light, the vaccine could be distributed "within hours" and made available to populations at high risk of health complications from COVID-19 by the middle to end of December, 2020, the news release said. That means it may be in people's arms before Christmas.

A source close to the situation told Reuters an FDA advisory committee may meet to discuss the vaccine between December 8 to 10, however the dates are subject to change.

The companies plan to submit applications to other regulatory agencies around the world "immediately." They forecast 50 million doses will be available globally in 2020, and 1.3 billion by the end of next year. But that is dependent on a number of factors, including whether bodies authorize its use, as well as manufacturing capabilities, the news release said.

The announcement comes in a fortnight of positive vaccine news amid a pandemic that has killed over 1.3 million people globally. On Monday, November 9, Pfizer claimed its vaccine was 90 percent on, later updating the figure to 95 percent.

A week later on Monday, November 16, biotechnology firm Moderna reported phase 3 trials suggest its vaccine was 94.5 percent effective. And on Thursday, a scientists at Oxford University published a study indicating their COVID vaccine was safe and triggered an immune response in older people—a population at serious risk of COVID. Neither Pfizer nor Moderna have published their phase 3 trial results data in peer-reviewed journals, prompting experts not involved in the research to urge caution.

Both Pfizer and Moderna's vaccines contain genetic material known as mRNA. This approach has not yet been used in commercially available vaccines for humans.

Dr. Ugur Sahin, CEO and co-founder of BioNTech, said in a statement: "Filing for Emergency Use Authorization in the U.S. is a critical step in making our vaccine candidate available to the global population as quickly as possible.

This is a developing story and will be updated as more information becomes available.

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A stock image shows a vaccination being prepared against a background of an illustration of the coronavirus. Pfizer is due to apply to the FDA for an EUA. Getty