On Monday, August 23, 2021, the U.S. Food and Drug Administration (FDA) fully approved Pfizer-BioNTech’s COVID-19 vaccine for people ages 16 and older. It 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. This FDA Approval Toolkit will help your business take action.
Three business responses to consider:
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:
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.
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.”
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.
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.
Today, we're at a very different place in the pandemic than we were a few months — or even days — ago. As you likely heard in the news, the Food and Drug Administration (FDA) has granted full approval of the first COVID-19 vaccine for people ages 16 and over. This is an important milestone that should reassure anyone who has concerns about getting vaccinated. With full FDA approval, we can all be even more confident that the COVID-19 vaccines work and are safe.
This news comes at a time when the Delta variant is driving a rapid surge in new COVID-19 cases across the country. Today, the vast majority of COVID-19 hospitalizations and deaths are among the unvaccinated. In order to protect yourself and prevent the spread, it’s important that everyone ages 12 and older get vaccinated against COVID-19 as soon as possible.
A fully vaccinated workforce creates the safest possible workplace environment for you and for our customers. That’s why I am committed to helping you get the facts about vaccines and making it as easy as possible to get yourselves and your eligible children vaccinated. Simply let your manager know what you need, and we will do our best to accommodate you. [Add here COMPANY-specific information about paid time off or other incentives for vaccination and recovery from possible side effects.]
You may be wondering whether vaccines will be required at our company. Your health and safety are our top priorities, and we have developed/are developing a policy that’s aligned with our company values and puts the needs of our people first. [Add here COMPANY-specific details.]
In the meantime, if you have specific questions about the vaccines and your health, I encourage you to get answers from your doctor or healthcare provider or visit GetVaccineAnswers.org. Here at [COMPANY], I remain committed to making sure you feel safe and supported. Please don’t hesitate to reach out with questions about our healthcare benefits, workplace safety policies, or ideas of your own.
As always, please continue to prioritize the health and safety of yourselves and each other.
President/CEO, Chief Medical Officer, or other trusted leader
To find a free vaccine near you, search vaccines.gov, text your ZIP code to 438829, or call 1-800-232-0233.