First COVID-19 vaccine goes to FDA today for emergency authorization

[Karlston]

First COVID-19 vaccine goes to FDA today for emergency authorization

If Pfizer and BioNTech get authorization, they'll start distribution within hours.

Enlarge / Pfizer headquarters in Manhattan, New York City, United States on November 19, 2020.

Getty | Anadolu Agency

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Today the US Food and Drug Administration will receive its first submission of a candidate vaccine to fight the pandemic coronavirus.

 

Pharmaceutical giant Pfizer and German biotech firm BioNTech announced early this morning that they are submitting the formal request to obtain an Emergency Use Authorization (EUA) from the FDA for the companies’ mRNA vaccine, BNT162b2.

 

The submission follows the celebrated news just Wednesday that the companies had wrapped up their Phase III trial and found the vaccine to be 95-percent effective at preventing symptomatic COVID-19, the disease caused by the coronavirus, SARS-CoV-2.

 

Though full data on the trial has not been published, the companies announced by press release that the vaccine appeared consistently effective across racial and ethnic backgrounds and was 94-percent effective in people over age 65—an age group at highest risk of severe disease. Trial data also indicated that the vaccine was protective against severe disease as well as mild cases.

 

The trial reached an end point when 170 cases occurred among the 43,661 participants, who were enrolled at one of 150 trial sites in the United States, Germany, Turkey, South Africa, Brazil, and Argentina. Of the 170 cases, 162 were in the placebo group and just eight occurred in the group receiving the experimental two-dose vaccine. Among all the cases, 10 were severe, nine of which were in the placebo group.

Urgency

In addition to the impressive efficacy numbers, the companies will also submit to the FDA detailed safety reports on 8,000 randomly selected adult participants and data on about 38,000 adult participants who were passively monitored for a median of two months following the second dose of vaccine. Additionally, the companies have safety data on 100 children ages 12 to 15. The companies reported no severe reactions to the vaccine, with the most bothersome side effects including bad headaches and fatigue.

 

It’s unclear how long the FDA will take to review the EUA request. However, the FDA has repeatedly said it is committed to speedy action to address the dire health crisis, which is only growing worse by the day.

In the filing announcement, Pfizer Chairman and CEO Dr. Albert Bourla said:

Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of COVID-19 globally. Filing in the US represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential.

The companies said they are also preparing submission to other regulatory agencies around the world, including a rolling submission with the European Medicines Agency.

Pfizer and BioNTech “will be ready to distribute the vaccine candidate within hours after authorization,” they stated in the announcement.

 

The pair have the manufacturing capacity to produce up to 50 million vaccine doses globally in 2020 and up to 1.3 billion doses by the end of 2021. The companies have a deal with the US government to deliver 100 million doses—enough to vaccinate 50 million people—with an option for the US to buy an additional 500 million.

 

 

First COVID-19 vaccine goes to FDA today for emergency authorization