Full Approval: What Does FDA Approval for the Pfizer COVID-19 Vaccine Mean for Mandates? Hesitancy? The Fall?

• Pfizer-BioNTech’s mRNA COVID-19 vaccine has now received full FDA approval for those aged 16 and over; it continues to have emergency use authorization for those aged 12 to 15.
• Full FDA approval has led some entities, including the U.S. Military, to mandate COVID-19 immunization.
• While the rate of immunization has increased following full FDA approval of Pfizer’s vaccine, we still need higher numbers of Americans to be immunized at a faster pace to get ahead of Delta and other emerging variants.

For those paying close attention to the rollout of COVID-19 vaccines, August 23, 2021 was a landmark day. The U.S. FDA granted what’s called a BLA (Biologics License Application) for the Pfizer-BioNTech mRNA COVID-19 vaccine, making this the first fully approved COVID-19 vaccine in the country. The vaccine was also given a brand name, Comirnaty, and was approved for those aged 16 and over. For those aged 12 to 15, the vaccine will still be available under the earlier emergency use authorization (EUA) though full approval for that age group is also being sought. For many physicians and other scientists, the full approval is useful, but not essential to their decision-making, since the vaccine has been shown in “real world” use to be highly effective, very safe, and continues to show robust protection against serious COVID-19 disease, hospitalization, and death, including protection against these severe outcomes with the Delta variant. But for many others – from the U.S. Military leadership to corporate boardrooms to school boards and event organizers – full authorization is a sea change. The U.S. Military, to use one example, was previously reluctant to mandate immunization with vaccines with EUA status, but the U.S. Department of Defense quickly moved after the full FDA approval to mandating vaccines for all armed services personnel. Many companies have made the same decision, including some of the largest health care employers in the nation. Johns Hopkins, where I teach, has mandated Covid-19 vaccines for all faculty, students, and staff who want to be on our campuses, with exemptions for medical conditions and religious objection, granted only on a case-by-case basis and with a formal process for review.

How important are these changes? Very. The U.S. immunization campaign by any measure has been a success. But coverage remains too low, still below 65% of eligible Americans, and too spotty, with significant parts of the country falling well below that national average. Predictably, but tragically, unvaccinated people – and the low coverage communities many reside in – are being ravaged by the Delta variant, and we are again seeing unacceptably high hospitalization and death rates among the unvaccinated. This current wave is all the more troubling and emotionally challenging for health care providers, since these are overwhelmingly preventable hospitalizations and needless losses of life.

Since the full approval of the vaccine, and the start of vaccine mandates across multiple sectors, immunization rates are increasing again, but the science shows clearly that we need higher numbers of Americans to be immunized. And, we need a faster rate of immunization to get ahead of Delta and other emerging variants. Both pace and coverage matter.

So, will full approval impact vaccine hesitancy? Surprisingly, only a small proportion of Americans are opposed to all vaccines and immunization. The American Academy of Pediatrics estimates that only about 1% of U.S. parents refuse all vaccines for their children and families. That small group is unlikely to be moved by full approval. But there are many millions more Americans who have waited, with vary degrees of uncertainty, to see if the vaccines are truly safe and worth the risk. At least some of these people may be more willing to be immunized with a fully approved vaccine.

But for many, the choice to remain unvaccinated against COVID-19 is going to be increasingly difficult now that one vaccine is fully approved – and likely in the coming few months, 2 more vaccines, as Moderna and Johnson and Johnson seek and attain full approval. And the change here is going to be mandates for many tied to employment, education, and access to venues and services. In addition to vaccine requirements, many entities, from corporations to public schools to college campuses, may allow some people to remain unvaccinated but will have such rigorous testing and reporting requirements for these people that many will find immunization preferable to such onerous requirements. Other employers have taken another step which may add pressure: refusal to cover COVID-19-related health costs, including hospitalization, for those who choose to remain unvaccinated. Since COVID-19 hospitalizations when one is not vaccinated can lead to catastrophic outcomes and long intensive care stays, these costs could be enormous.

Where does that leave us? The best protection against COVID-19 remains immunization, and full approval for Pfizer’s Comirnaty vaccine will almost certainly significantly increase our coverage, and hopefully our pace of immunization. We’ll have to continue with non-vaccine prevention, including mask-wearing indoors, for some time, since children under 12 remain ineligible for vaccines, and at risk. We can only hope – and work with – the remaining millions of Americans who have not been immunized to get their doses. This will protect them against disease and death, protect others around them, lessen the burden on our health systems, and help us get out of the epidemic. If we don’t succeed, it could be another long, cold winter with this unwelcome visitor.