- Pfizer and BioNTech confirmed they will file with the FDA for emergency use authorization on Friday, after announcing the final Phase 3 coronavirus vaccine results a few days ago.
- The experimental drug proved to be highly effective in the final testing stage, and it had minimal side effects.
- The FDA will inspect the full data and should issue an Emergency Use Authorization quickly.
- Immunizations in the US could start within the next few weeks.
Pfizer and BioNTech shared the final efficacy results from their Phase 3 coronavirus vaccine trial a few days ago, revealing that the drug might be even better than what interim data showed. The two companies announced the vaccine is 95% effective and doesn’t have any severe side effects. They also said they would seek regulatory approval within days. It turns out they meant it, as Pfizer and BioNtech confirmed they plan to file with the FDA for Emergency Use Authorization (EUA) on Friday. If successful, the weeks-long process would allow them to start supplying vaccine doses to the US government to start emergency immunization campaigns.
As new coronavirus case numbers continue surging to record highs that are now approaching 200,000 cases per day, the end of the coronavirus pandemic is finally in sight.
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Once Pfizer and BioNTech submit their paperwork, scientists from the US Food and Drug Administration (FDA) will analyze the data and determine if the vaccine is safe and effective. When announcing the final results of the Phase 3 trial, Pfizer and BioNTech did not publish the study’s full scientific data. Of course, FDA officials will get to comb through the entire data set.
As The Washington Post notes, a vaccine EUA is typically a lower standard than full approval, but the FDA imposed higher standards for COVID-19 vaccines. The FDA requires that a vaccine be at least 50% effective, a threshold that the Pfizer/BioNtech and Moderna vaccines both cleared by a staggering margin.
The two companies will submit two months of follow-up data on 38,000 people, The Washington Post reports. That’s more than the minimum the FDA requires from each vaccine candidate. A few weeks ago, the agency released guidelines saying that it will need safety data for at least two months for at least half of the volunteers in coronavirus vaccine Phase 3 trials. The final stage of testing requires at least 30,000 volunteers, per FDA regulations. Pfizer and BioNTech’s Phase 3 trial had around 44,000 volunteers.
The submission will also include safety data on 100 children between 12 and 15 years old, a group added to the trial only recently.
Besides FDA regulators looking at the application, external scientists will meet during a full-day advisory committee meeting to make recommendations to the agency about the vaccine approval.
If emergency authorization is granted, high-risk people will have access to the vaccines as soon as next month. Government officials anticipate having enough vaccine for 20 million people in December between Pfizer and Moderna. Both vaccines require a two-dose regimen, with the shots administered a few weeks apart. Moncef Slaoui, the chief scientific adviser of Operation Warp Speed, estimates there will be enough vaccine doses for 25 million to 30 million people per month in early 2021.
It’s crucial to note that the availability of vaccines will not stop the current surge of new coronavirus cases. The US has reached new record highs, registering more than 185,000 cases on Thursday. Health and Human Services Secretary Alex Azar urged Americans to “hang in there,” as the end of the pandemic is in sight. “Take the simple steps that the doctors have talked about today because there is a light at the end of the tunnel. This isn’t forever,” he said during a briefing.