FDA Grants Full Approval of COVID-19 Vaccine

On Monday, the U.S. Food and Drug Administration (FDA) approved the Pfizer-BioNTech COVID-19 vaccine. The approval replaces the emergency use authorization (EUA) granted by the agency on December 11, 2020 for use of the vaccine in individuals 16 years of age and older.

“The public is counting on safe and effective vaccines and we are thankful to the researchers and medical community that worked diligently to investigate, study, and inform the public throughout the vaccine trials,” said Rob Casalou, president and CEO of Trinity Health Michigan. Permanent approval means the vaccine passed numerous, required safety checks including study of all reported side effects and any adverse reactions. Several months of safety data showed the vaccine is safe and effective. This announcement should ease concerns from people who’ve been hesitant to receive the vaccine while still under emergency use authorization.” 

The U.S. has recorded over 37.7 million cases of COVID-19 and 628,000 deaths. More than 170.8 million Americans, or 51.5-percent of the population, have been fully vaccinated, according to the CDC.

“We are pleased to see the FDA’s approval as we continue to fight against the recent COVID-19 variants, knowing that we still have more work to do,” said Rosalie Tocco-Bradley, PhD, MD, Chief Clinical Officer, Trinity Health Michigan. We encourage all colleagues, patients, residents and people in the communities we serve to get vaccinated. Vaccination is an important step to end the COVID-19 pandemic.”

The U.S. Department of Health and Human Services recommends those who received the Moderna or Pfizer vaccine should receive a booster shot eight months after their first round of vaccination starting the week of Sept. 20, but they do not recommend crossing over which type of vaccine you receive. Therefore, if you received a Moderna vaccine, you should not get a booster shot of the Pfizer vaccine and vice versa. The Center for Disease Control and Prevention (CDC) and FDA will provide additional information in the coming days.

The Pfizer vaccine continues to be available under EUA for individuals 12 through 15 years of age, and for a third dose in certain immunocompromised individuals. The FDA is also reviewing Moderna’s application for permanent approval of its vaccine. Johnson and Johnson earned EUA for its vaccine later than Pfizer and Moderna, and has not applied for permanent approval from the FDA.

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