President Donald Trump has repeatedly pressed the notion that a coronavirus vaccine will be available before the November election. Pfizer, one of the world’s largest pharmaceutical companies, may have just erased any possibility of that becoming a reality, however. CEO Albert Bourla announced on Oct. 16 that the company will not seek emergency authorization for a Pfizer vaccine until after the election has passed.
Vaccine developers have been under mounting pressure from the Trump administration to unveil a vaccine before Nov. 3. Bourla noted, in his remarks, that the company could know if a Pfizer vaccine is effective by the end of October. To compile the safety data required by the Food and Drug Administration, however, any release will be delayed until the end of November at the earliest.
The FDA recently released guidance on emergency authorizations. This guidance requires vaccine developers to provide a minimum of two months worth of safety data on half of its trial participants following their final vaccine dose.
Pfizer still intends to apply for emergency authorization but will not do so until it has met the FDA guidelines. “Let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the U.S. soon after the safety milestone is achieved in the third week of November,” Bourla wrote in an open letter posted on the Pfizer site.
There are other companies in late-stage trials for a coronavirus vaccine, but we won’t be seeing any emergency authorizations from them prior to the election either. The Pfizer vaccine appears to be on the fastest timeline, as Moderna—another company in the late-stages of development with more than 20,000 participants enrolled—is also looking to apply for emergency authorization several weeks following the election.
Other vaccine companies are months away, with many aiming to produce FDA-approved vaccines by the end of the year or in early 2021. British company AstraZeneca is in the race to develop a vaccine, but put its U.S. trials on hold in September.
Trump’s push for a prompt vaccine has sparked concern among experts and civilians alike, many of whom fear that a fast-tracked vaccine may not meet the necessary safety requirements laid out by the FDA. The FDA’s requirements were put down, in part, out of concern that a lack of faith in the vaccine would lead to hesitation from American citizens.
If not enough people take the vaccine when it is available—and it’s iffy if they will at this point—it will do little to slow the pandemic.
Read more on the coronavirus vaccine:
- Fauci says life won’t return to normal after a COVID-19 vaccine is developed
- Even if a vaccine is approved before the election, voters might not reward Trump
- Here’s how a lack of dry ice could stymie coronavirus vaccine distribution
- Could a nasal COVID-19 vaccine actually work?
- Would the U.S. approve a COVID-19 vaccine before we know if it’s safe?
- How the anti-vax movement could ruin the chances for a successful coronavirus vaccine
- Will the coronavirus vaccine be free for Americans?
- The coronavirus vaccine will cost hundreds of millions of dollars to make—here’s why
- Until now, what’s the quickest a vaccine has ever been developed?