August 24, 2021

Expert: What FDA approval means for COVID-19 vaccines

The COVID-19 vaccine from Pfizer and BioNTech has now received full approval from the U.S. Food and Drug Administration for those 16 years and older. Aaron Lottes, a Purdue University expert on FDA regulatory processes, explains what this means going forward.

Expertise: Lottes worked with the FDA on the approval of drug-device combination products for 13 years. Now, as an associate professor of engineering practice in Purdue’s Weldon School of Biomedical Engineering, he continues to collaborate with the FDA and industry experts to educate the next generation of biomedical engineers and regulatory leaders.

Q: Does FDA approval mean the Pfizer vaccine is officially considered safe and effective?

A: FDA approval means that the Pfizer vaccine has now gone through the FDA’s full standard review process and the FDA has determined, based on extensive data with longer follow-up, that the vaccine is safe and effective for preventing COVID-19. An emergency-use authorization had just indicated that the vaccine may be safe and effective and that the known and potential benefits outweighed the known and potential risks.

Q: Why has the Pfizer vaccine just received FDA approval for people age 16 and up?

A: Studies for ages 12-15 were started later than for those 16 and older. While there are enough data to support emergency use in this younger age group, it was not part of the submission for approval. A supplement is planned for this age group once the required six-month data are available.

Q: Are there still risks involved with getting the Pfizer vaccine?

A: The FDA has identified an increased risk of myocarditis and pericarditis, especially for males under 40. But this is being followed up in multiple required postmarket studies. The approved labeling includes a warning for this risk.

Q: How fast was the FDA approval timeline for the Pfizer vaccine relative to other vaccines approved by the FDA in the past?

A: The submission was accepted by FDA and received priority review status in July. A normal submission has a target 10-month review timeline, whereas a priority submission is targeted at six months, which would have been January 2022. The actual review and approval time was just over one month, representing a tremendous effort by the FDA review team. This does not mean that FDA only spent one month reviewing all the data. Rather, this submission was provided over time to FDA for review. As different parts of the application were completed, FDA was able to review in near-real-time. It was just the final pieces that were not submitted until more recently. Additionally, based on the urgent need, the FDA diverted extensive resources to focus on this review and ensure that safety and effectiveness were thoroughly evaluated.

Q: Why has the Moderna COVID-19 vaccine not yet been approved by the FDA?

A: Moderna’s submission was about a month behind Pfizer’s submission, so it remains under review.

Q: Does FDA approval for the Pfizer vaccine also include a booster shot?

A: The booster shot is not yet approved. At this time, there is only an FDA emergency use authorization in place for certain immunocompromised individuals to receive a booster shot.

Media contact: Kayla Wiles, 765-494-2432,

Source: Aaron Lottes, 765-496-6024,

Note to journalists: Journalists visiting campus should follow visitor health guidelines.

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