Wisconsin Department of Health Services
Press Release

DHS Urges Vaccination as Pfizer COVID-19 Vaccine Gains Full FDA Approval

Vaccination also encouraged under EUA for children ages 12 to 15, and for an additional dose in people who are immunocompromised

By - Aug 26th, 2021 09:47 am

The U.S. Food and Drug Administration (FDA) granted its full approval of the Pfizer-BioNTech COVID-19 vaccine. The vaccine will now be marketed under the name Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in people 16 years of age and older. The Pfizer vaccine is also still available under the Emergency Use Authorization (EUA) for people ages 12 to 15 and for an additional dose for people who are immunocompromised.

“Nearly 3 million Wisconsinites have received their safe and effective COVID-19 vaccine, but we know that many folks across our state have been waiting to get their shot until the FDA provided full approval of a COVID-19 vaccine,” said Gov. Tony Evers. “The results are in. Now that they’ve issued full approval to the Pfizer COVID-19 vaccine, we can all be even more confident that these vaccines work and are safe. There has never been a better time to get vaccinated.”

The vaccine that received the FDA’s full approval is the same vaccine people have been getting for months. For full approval of new drugs or vaccines, the FDA requires extensive data on safety and effectiveness, inspection of manufacturing facilities, and a comprehensive review of all clinical and “real-world” use. The full approval means that even more data were used to further confirm that the vaccine works and is safe. The COVID-19 vaccines are extremely effective at preventing serious illness, hospitalization, and death – even from the Delta variant.

The Pfizer vaccine was the first COVID-19 vaccine to receive Emergency Use Authorization (EUA) in the United States back in December 2020. The EUA was expanded in May of 2021 to include people ages 12 to 15 and again in August for a third dose for people who are immunocompromised. This authorization came after the Pfizer product underwent rigorous clinical trials and an expedited review process to ensure the safety and efficacy of the vaccine. FDA granted the application for full approval through a Priority Review(link is external) designation, and reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population. As time passes and more data becomes available for the 12-15 year-old and immunocompromised populations, Pfizer will apply for full licensure for these uses as well.

“The FDA’s decision to issue full approval to the Pfizer vaccine reinforces what we have known since they issued the initial emergency use authorization – the Pfizer vaccine is safe and effective,” said DHS Secretary-designee Karen Timberlake. “This is an important milestone. It builds on evidence from across the country that the Pfizer vaccine is safe and effective for everyone ages 12 and up. It’s more important than ever that everyone who is eligible to get vaccinated get vaccinated so we can keep ourselves, our kids, our friends, family, and neighbors safe.”

People who are unvaccinated are encouraged to get vaccinated as soon as they can, and everyone should continue following local public health guidance. To find a vaccination location near you, visit Vaccines.gov(link is external) (https://vacunas.gov/(link is external)) or call 211. As part of the $100 COVID-19 Vaccine Reward Program(link is external), anyone who receives their first dose of COVID-19 vaccine between August 20 and September 6 is eligible for a $100 U.S Bank Rewards card. Anyone who has symptoms of COVID-19 or believes they have been exposed to COVID-19 should get tested.

For up-to-date information about Wisconsin’s COVID-19 response, visit the DHS COVID-19 webpage. You can also follow @DHSWI on Facebook(link is external)Twitter(link is external), or dhs.wi on Instagram(link is external) for more information on COVID-19.

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