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What FDA Approval of Pfizer’s COVID-19 Vaccine Means for Employers

Emily Hartman /

On August 23, 2021, the U.S. Food and Drug Administration gave full approval of the Pfizer COVID-19 vaccine for people ages 16 and older. This approval is the highest level of government clearance for a medical drug. Children and teenagers aged 12 – 15 can still receive the vaccine under the FDA’s emergency use authorization. 

With full approval, the vaccine has an official name, Comirnaty.

For employers who were considering or hesitant to implement vaccine mandates, the FDA’s approval of Comirnaty provides a more straightforward legal and regulatory path for mandates and mandate enforcement to help decrease the spread of the COVID-19 delta variant.

What to Consider With an Employer Vaccine Mandate

As an employer, there are several considerations to take into account with a vaccine mandate:

  • How will your employees, visitors, or customers respond to a mandate and what would your response be to resistance or refusals? Have you talked to your employees about a mandate?
  • What are the details in your policy for the amount of time to comply with a mandate? How will you keep confidential proof of vaccination, and who will access that information?
  • How will you communicate your policies to your employees?
  • Do you need to provide paid time off for vaccination and any related side effects of the vaccination? Do you need to pay employees for the time it takes for getting vaccinated? What are your state and local policies?
  • Does your accommodation policy cover requests based on religion and disability in a thoughtful way?
  • Are your vaccination screening questions compliant with Americans with Disabilities Act requirements?
  • Do you have a vaccine team to help with implementing your policy and any necessary updates or changes?

What to Consider If You’re Not Imposing A Mandate

If your business doesn’t plan to implement an employer-driven vaccine mandate, other options help promote COVID-19 health and safety:

  • An education campaign, using CDC and FDA information about the benefits and use of vaccines.
  • Employee incentives for proof of vaccination provided that it complies with the EEOC guidance from earlier this summer.
  • Require regular COVID-19 testing for employees that aren’t vaccinated. Make sure to check local and state regulations regarding whether employers must pay for the tests and the time it takes for the testing, including travel time.
  • Require additional health and safety precautions for unvaccinated employees, including anything from social distancing, mask mandates, travel restrictions, etc.

The full approval of the vaccine opens the door for employers to mandate the vaccine in more states. For example, Defense Secretary Lloyd Austin announced that all U.S. Armed Forces personnel will be required to receive the COVID-19 vaccine by mid-September. Additionally, several universities, large employers, and states also have begun to mandate vaccinations.

Booster Shots Are Coming This Fall

Additionally, on August 18, 2021, the U.S. Department of Health and Human Services and other federal agencies made a joint announcement that people who received the Pfizer and Moderna vaccines are eligible for a booster shot eight months after their second vaccine. As the COVID-19 delta variant continues to spread, the booster shots are meant to help improve immunity rates against the virus.

The boosters are expected to roll out the week of September 20, 2021. The booster shots will be prioritized for the immunocompromised, health care workers, first responders, and nursing home residents.

As booster shots roll out, employers should consider how they will handle booster shots and tracking proof of vaccination in the workplace. This process should include seeking advice of legal counsel when creating vaccine-related workplace policies.  

Additional Resources

Comirnaty and Pfizer-BioNTech COVID-19 Vaccine

Letter of Authorization (August 23, 2021)

Joint Statement from HHS Public Health and Medical Experts on COVID-19 Booster Shots (Press Release)

Joint Statement from HHS Public Health and Medical Experts on COVID-19 Booster Shots

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