Pfizer could seek emergency use authorization for its COVID vaccine by the end of this month
Pfizer Inc., one of the pharmaceutical companies that’s been racing to develop and test a vaccine for COVID-19, has announced some of the early data to come out of its large-scale clinical trial. According to the company, its vaccine has shown to be safe and more than 90 percent effective against the virus.
Out of 440,000 participants, 94 came down with COVID-19. Pfizer didn’t release an exact breakdown of how many of them had received the experimental vaccine versus a placebo, but in order for the effectiveness rate to be above 90 percent, eight or fewer people who were vaccinated would have contracted the virus. The FDA requires 50 percent effectiveness or higher to approve a vaccine.
UPDATE: We are proud to announce, along with @BioNTech_Group, that our mRNA-based #vaccine candidate has, at an interim analysis, demonstrated initial evidence of efficacy against #COVID19 in participants without prior evidence of SARS-CoV-2 infection.
— Pfizer Inc. (@pfizer) November 9, 2020
The news comes just one day after Dr. Anthony Fauci said he is “cautiously optimistic” about vaccine research that’s happening so far.
This makes Pfizer (and its partner company BioNTech) the first drug company to be able to show successful data from a large-scale clinical trial testing the safety and efficacy of a COVID vaccine. According to Reuters, the companies said that in addition to the high rate of effectiveness, they also found no major safety concerns with their vaccine. They expect to seek emergency use authorization in the U.S. before the end of this month.
Pfizer said it expects to seek authorization for the vaccine to be administered to anyone ages 16-85. Before seeking emergency authorization, the company needs to have collected two months of safety data for its study’s 440,000 participants. That data should be available in late November, Pfizer said.
That doesn’t mean there are no questions remaining about this and other potential vaccines. We don’t know how long protection against COVID-19 would last for anyone who is vaccinated. And even if approved, this vaccine would be available only in very limited quantities at first, and would likely be given only to the highest risk groups: Frontline healthcare workers, other essential workers, and the sick or elderly. It further complicates the logistics of rolling out a vaccine that the Pfizer vaccine was administered to trial participants in two doses, about three weeks apart.
But President-Elect Joe Biden has already announced the members of his COVID-19 task force, and has outlined vaccine distribution plans on his transition website. He also released a statement on the new vaccine development that sounded blessedly presidential. He reminds America that even with this great news, it’s still crucial to maintain social distance, wear masks, and stay vigilant with hand-washing. He’s realistic and steady, which is exactly what we need right now.
Here's the president-elect's statement on the Pfizer vaccine news: pic.twitter.com/SFGwIpy2vN
— Daniel Dale (@ddale8) November 9, 2020
With a competent leader in the White House, we’ll be far better prepared for whatever setbacks come with rolling out this or any other effective vaccine, once approval is granted.