Big news to end the week: Pfizer and BioNTech are submitting their coronavirus vaccine to the FDA, requesting emergency use authorization. That doesn’t necessarily mean our families will be able to get vaccinated next month, but it is a huge step to getting there.
It’s the first vaccine candidate to be submitted to the regulatory process in the United States, where over 250,000 Americans have died from COVID-19 and more than 1 million kids have tested positive.
“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,” said Dr. Albert Bourla, Pfizer Chairman and CEO, in a statement. “Filing in the U.S. 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.”
#COVID19 UPDATE: We will submit a request today to the @US_FDA for Emergency Use Authorization (EUA) of our mRNA va… https://t.co/KtVPj6fxkp
— Pfizer Inc. (@pfizer)
The final analysis of the vaccine found it to be 95% effective, even in older adults.
Based on those results, the company is seeking emergency use authorization, or EUA, from the FDA. An EUA will allow the vaccine to be used before all the evidence is available for approval. The FDA will evaluate whether the vaccine’s “known and potential benefits outweigh its known and potential risks.”
Pfizer says that pending approval, their vaccine will potentially be available for use in the United States by the middle to end of December. The vaccine, known as BNT162b2, requires two doses a few weeks apart. Protection is achieved 28 days after the first shot.
What happens next?
The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee for December 8, 9 and 10, according to CNN. The agency could make a decision then as to whether to approve the EUA.
If the EUA is granted, then the CDC’s Advisory Committee on Immunization Practices will meet within 24 to 48 hours. The independent panel of experts will discuss who should receive the vaccine first, if at all.
Pfizer CEO Albert Bourla told NPR’s All Things Considered that once their vaccine candidate receives full federal clearance, “we will be ready to start distributing our vaccine within hours.”
More good news
Pfizer and BioNTech are not alone in developing promising vaccine candidates. The pharmaceutical company Moderna announced earlier this week that they have also developed a vaccine candidate. Early clinical trials show their vaccine is 94.5% effective. It also requires two shots.
Johnson & Johnson is developing a single shot vaccine. They expect to request a EUA for their candidate by next February.
COVID-19 is not over
News about vaccines is exciting. It offers hope during a time when it’s desperately needed. Still, even if a vaccine is approved for use next month, it won’t end the pandemic overnight. It will take months to distribute enough doses to turn the tide against COVID-19.
You can take hope from this news, mamas, but don’t forget to practice vigilance during this pandemic. Continue wearing your masks, as well as practicing social distancing and good hygiene.