FDA on Monday issued its full approval for the Pfizer-BioNTech vaccine, making it the first Covid-19 vaccine to receive approval from the agency.
Up until now, the vaccine—which FDA said will be marketed under the brand name Comirnaty—was authorized for use under an emergency use authorization (EUA). Now, however, the vaccine is fully approved for the prevention of Covid-19 in individuals ages 16 and older.
FDA said the vaccine will remain available under an EUA for individuals ages 12 to 15. A third dose of the vaccine is also still available under the EUA for certain immunocompromised individuals.
Peter Marks, director of FDA's Center for Biologics Evaluation and Research, said FDA "evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty's safety and effectiveness, and performed a detailed assessment of the manufacturing process, including inspections of the manufacturing facilities."
"The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.," Marks added.
What does FDA's approval mean for you?
This new FDA approval, new guidance from the federal government, and new regulations from schools and private business have the potential to shift the posture of the currently unvaccinated. Today, just over 70% of American adults have had at least one dose Covid-19 vaccines. The question now is, how far can we get? The answer is up to you.
It may feel like decisions about the treatment and prevention of Covid-19 are out of your control. And while federal agencies and private businesses are making decisions quickly, every one of you has a vital role to play in this next phase of the pandemic. But there are three constituencies I want to speak to directly.
Many employers have been hesitant to come down hard on vaccine mandates or implementing clear consequences for the unvaccinated (such as submitting to weekly tests). Much of that fear had to do with the fact that vaccines were only approved for emergency use. Today’s announcement of the full approval of the Pfizer-BioNTech vaccine should offer many employers enough comfort to move forward with vaccine mandates. In fact, on the heels of announcing full approval, New York City announced that it would require all education staff to be vaccinated. I expect to see more employers inside and outside of health care following suit. If you are still questioning whether a vaccine mandate is appropriate, we recommend asking yourselves these five questions:
- Are you complying with federal and state guidance?
- Is a Covid-19 vaccine mandate the best way to achieve your goals?
- How will you manage individuals who have legitimate exemptions if you impose a Covid-19 vaccine mandate?
- How will you collect 'proof of vaccination'?
- How will you address workforce retention concerns?
Since the start of the Covid-19 crisis, we’ve recommended that providers adopt a single source of truth mentality to combat misinformation associated with the virus, it’s treatment, and concerns over vaccination. Today, vaccine skepticism is largely why adults continue to pass on their shot, and while the FDA’s full approval of the Pfizer-BioNTech vaccine isn’t going to appease all of their fears, full approval really does matter to some vaccine hesitant patients, at least according to polling from the Kaiser Family Foundation.
Your job is to identify those patients, offer custom outreach that shares the good news of full approval, and direct patients to the right next steps. The more customized the communication can be, the better. But there are some common principles everyone can take when developing strong Covid-19 vaccine communication strategies. In fact, we’ve built a readiness assessment for this purpose. And while this readiness assessment was built for initial rollout, the questions within should continue to guide your organization in addressing key factors such as patient navigation, equity in vaccine access, public health messaging, and vaccine hesitancy and mistrust.
The best communication strategy generates action—action for the patient (e.g., making an appointment for their first dose) but also action steps for frontline providers. Leaders must make sure that their staff is equipped to recognize vaccine hesitancy vs. skepticism, which is rooted in misinformation. Leaders must train staff to listen to personal narratives and not merely default to scientific facts, and leaders must make sure clinicians feel equipped to ease potential patient concerns.
Doctors must also be equipped to handle individual conversations with patients and discuss what this full approval means. Since patients typically turn to their doctors as a top, trusted source of insight, frontline clinicians are more important than ever in driving vaccine confidence. Yet in a recent poll from SymphonyRM, 41% of patients lost trust in their doctors amid the pandemic—and among those individuals, just over half noted it was because their provider rarely or never communicated with them about Covid-19. To regain trust and communicate the importance of the full approval, frontline clinicians should be prepared to proactively communicate and answer the following questions:
- How does full approval differ from an emergency use authorization? Under what conditions is a full approval granted?
- Why did the FDA decide to grant this approval? What data or evidence led to their increased confidence in the vaccine?
- How should patients view this approval? What concerns, fears, or questions about the vaccine should this approval counter?
- How might this full approval lead to increased mandates or pushes for vaccination, and what does that mean for patients?
Doctors should also continue to be prepared to answer any skepticism or misinformation about the full approval, which may come up during these discussions. In a July poll from KFF, 34% of unvaccinated adults were not at all confident about the safety of Covid vaccines, and 31% were not too confident. Today's full approval should be used as an opportunity to help increase patient confidence in the safety of the vaccine.
The best defense we have against this virus is vaccination, and full approval of the Pfizer-BioNTech vaccine gives employers, providers, and frontline clinicians the shot in the arm they need to keep motivating Americans to get vaccinated (pun intended). It’s up to you to capitalize on the momentum of the FDA announcement, whether through your own vaccine regulations or through direct communication to the "watchful waiters" who have been waiting for this moment to get vaccinated.
Advisory Board's Pamela Divack contributed to this article. Andrew Mohama helped contribute additional research.