FDA grants full approval to Pfizer COVID-19 vaccine for ages 16+💥


The U.S. Food and Drug Administration has granted full approval to the Pfizer vaccine for ages 16+, meaning it is a fully licensed vaccine and no longer under Emergency Use Authorization (EUA).

❓What does this mean in practice?

Full approval may tilt the balance for some “wait and see” people on the fence about the vaccine, but it is not expected to move the needle for those who are most hesitant.

The biggest impact of full approval on vaccine uptake could be through employers, who may feel more comfortable enforcing mandates with a fully approved rather than emergency use vaccine.

Full approval also gives clinicians flexibility for “off label use” of the vaccine, which is not permitted for products under emergency authorization. This may apply to boosters or other deviations from specific ACIP guidance. Does this mean kids under age 12? That will probably still be a tough sell for most clinicians, as trials for younger kids with different dosing are still underway.
(See related post: “Should I lie to get my not-yet-12-year-old vaccinated before school starts?” and American Academy of Pediatrics Cautions Against Off-Label Use of COVID-19 Vaccines in Children Under 12.

Update: Some new language from CDC on off-label use is not very encouraging for added flexibility.

❓What new information led to full approval?

Basically, the participants in the original clinical trial have now been followed up longer (average of 6 months vs. 2 months for the EUA), and the efficacy and safety data have remained consistent.
In addition to safety and efficacy, applications for full licensure require companies to submit much more detail about the manufacturing processes and quality control of the product, which will be subject to on-going inspections by the FDA. So, both the product itself AND the manufacturing processes are licensed by the FDA through this approval.

In addition to longer follow-up of the 44,000 original trial participants, the FDA also closely examined all of the real-world safety surveillance data from vaccines administered under the EUA. This included reports of myocarditis and pericarditis following the vaccine, with data suggesting an increased risk, particularly within the seven days of the second dose and for younger males.

The CDC’s Advisory Committee on Immunization Practice (ACIP) evaluated these risks and concluded the benefits of vaccination outweigh the risks even for younger age groups (see summary here.), but a warning about these risks will be now be included in the packaging information about the vaccine.

Because trials for <16s began later, use of the Pfizer vaccine in 12-15-year-olds remains under EUA while the full six months of required follow-up data is being collected.

Moderna submitted their application for full licensure in early June and is still under review–Pfizer started the process in early May.


Since the EUA approval last December (doesn’t that seem like 100 years ago?!) hundreds of millions of Pfizer doses have been given worldwide (over 200 million in the US alone), with safety and efficacy far beyond what any of us would have imagined 18 months ago.

Full FDA approval means the vaccine has been through the scrutiny of any other drug or vaccine that we routinely use. We hope this approval is reassuring to some “wait and see” folks and continues to build trust that no corners were cut in the vaccine process. Onwards and upwards, science!!

Those Nerdy Girls


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STAT News: FDA grants full approval to Covid-19 vaccine developed by Pfizer, BioNTech

Previous DP Post on EUA vs full FDA approval

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