August 24, 2021

FDA Approval: What This Means for Your Business

By
Stephen Massey
Managing Director, Health Action Alliance

Many more employers are expected to require COVID-19 vaccinations following yesterday's announcement. Our resources can help you boost vaccine confidence & strengthen your policy.

Yesterday’s announcement that the Food and Drug Administration (FDA) has fully approved Pfizer-BioNTech’s COVID-19 vaccine for people ages 16 and older is an important milestone that should reassure anyone who has concerns about getting vaccinated. It also creates an opportunity for businesses to build confidence in COVID-19 vaccines and strengthen workplace policies. 

Here are three ways your business may respond:

  1. Reinforce Vaccine Safety: In recent polling, 3 in 10 unvaccinated adults said they would be more likely to get a vaccine once it receives full FDA approval. By sharing yesterday’s announcement, you can help your employees feel even more confident that the COVID-19 vaccines work and are safe. Review our key messages below and use our sample email to employees.
  1. Consider Nudges: FDA approval provides additional justification for “nudges” that some businesses may adopt to increase vaccination and promote a safer work environment. Think “stick” as well as “carrot” — in addition to offering incentives for vaccination, you might consider a monthly paycheck deduction for unvaccinated workers to cover anticipated increases in healthcare costs, much like the deduction already charged to many workers who smoke. Consider your approach using our updated Quick Start Guide.
  1. Require Vaccinations: Although the Justice Department, EEOC and OSHA all agree that businesses are legally allowed to require vaccines under emergency use authorization, many private employers have chosen to wait until full FDA approval to issue vaccination requirements. Use our updated Decision Tool to develop your policy.

Key Messages for Employees

FDA approval is an important opportunity to reach unvaccinated workers with effective messaging that can break through hesitancy and misinformation. Here are tested messages that can help boost confidence in COVID-19 vaccines:

  • On August 23, the Food and Drug Administration (FDA) issued full approval for the Pfizer-BioNTech COVID-19 vaccine for people ages 16 and older. The vaccine will now be marketed as Comirnaty. 
  • Full approval by the FDA means that the Pfizer-BioNTech vaccine (Comirnaty) now has the same level of approval as other vaccines routinely used in the U.S., such as vaccines for hepatitis, measles, chicken pox and polio. Full approval represents the FDA’s highest level of confidence in a drug’s safety and effectiveness.
  • FDA’s full approval of the first COVID-19 vaccine is an important milestone that should reassure anyone who has concerns about getting vaccinated.
  • On top of the rigorous testing and trials that went into Emergency Use Authorization of the Pfizer-BioNTech vaccine, the FDA has now completed additional analysis of the effectiveness and safety data from tens of thousands of clinical trial participants, as well as analysis of real-world safety data.  
  • All three COVID-19 vaccines currently authorized or approved in the U.S. are extremely safe and effective, based on extensive clinical trials and the fact that nearly 200 million Americans have received at least one shot. The vast majority of COVID-19 hospitalizations and deaths in recent months have been among the unvaccinated. 
  • With increasing rates of COVID-19 infection, hospitalization, and deaths across the country, it is more important than ever that everyone ages 12 and older get vaccinated to protect themselves and prevent the spread. All three vaccines work. They reduce the risk of getting COVID-19 and greatly reduce your risk of being hospitalized or dying.
  • Vaccines are free and widely available at more than 80,000 locations across the country, including at over 40,000 retail pharmacies. Ninety percent of Americans live within five miles of a vaccine site.
  • Search vaccines.gov, text your ZIP code to 438829, or call 1-800-232-0233 to find locations near you.

Answers To Tough Questions

What’s the difference between Emergency Use Authorization and full approval?

Full FDA approval takes longer than Emergency Use Authorization because more data needs to be processed and reviewed over a longer period of time. When a product is fully approved by the FDA, patients can be assured that its recommendation is grounded in large amounts of scientific data. Full approval represents the FDA’s highest level of confidence in a drug’s safety and effectiveness.

What went into full approval?

Additional analysis of the effectiveness and safety data from tens of thousands of clinical trial participants, as well as the analysis of real-world safety data. According to Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, “Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We 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 processes, including inspections of the manufacturing facilities.”

Why is Pfizer-BioNTech’s COVID-19 vaccine not yet fully approved for adolescents ages 12 through 15?

Pfizer’s application for FDA approval was for use in individuals ages 16 and older. Pfizer plans to request full approval for adolescents ages 12 to 15 once it has collected and analyzed six months of safety data from clinical trial participants. Emergency Use Authorization for the Pfizer-BioNTech COVID-19 vaccine remains in place for adolescents ages 12 through 15, and the CDC continues to recommend that everyone ages 12 and older get vaccinated against COVID-19.

Are the Moderna and Johnson & Johnson COVID-19 vaccines safe?

Yes. The FDA’s approval of the Pfizer-BioNTech vaccine doesn’t make any of the other vaccines currently authorized by the FDA any less safe or effective. In fact, all three COVID-19 vaccines currently authorized or approved in the U.S. are extremely safe and effective, based on extensive clinical trials and the fact that nearly 200 million Americans have received at least one shot. The vast majority of COVID-19 hospitalizations and deaths in recent months have been among the unvaccinated. 

The Moderna and Johnson & Johnson COVID-19 vaccines will continue to be safely administered through emergency use authorization as the FDA reviews data about their real-world use. Moderna has also submitted an application for full approval of its COVID-19 vaccine, and the FDA is currently reviewing that data.

More answers to frequently asked questions can be found here.

Up-to-Date Resources

  • Our sample email to employees will help you share facts about FDA’s announcement.
  • Our newly updated Decision Tool, created in partnership with the National Safety Council, offers the latest public health and legal analysis for companies considering vaccination requirements. 
  • Our tracker will help you stay informed about companies requiring vaccinations.
  • Our updated Quick Start Guide can help your business strengthen vaccination policies and workplace safety in response to the Delta variant.
  • The de Beaumont Foundation offers a one-pager with tested messages about the FDA’s approval of the Pfizer-BioNTech COVID-19 vaccine. 


Special thanks to the Public Health Communications Collaborative and the de Beaumont Foundation for providing messaging guidance and content support for this resource.