First COVID-19 vaccine receives FDA approval based on safety and effectiveness

August 23, 2021

New guidance for adults to receive booster shot

By Regence

The Food and Drug Administration (FDA) has approved the first COVID-19 vaccine, developed by Pfizer-BioNTech, for people ages 16 and older. In December 2020 the Pfizer vaccine was made available under emergency use authorization (EUA). This formal approval now is based on continued research and monitoring of data showing the vaccine is safe and effective.

“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated,” said Acting FDA Commissioner Dr. Janet Woodcock. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

The Pfizer vaccine is available under EUA approval for people ages 12 through 15, as is a third shot for some immunocompromised people. The Moderna and Johnson & Johnson vaccines also continue to be available under EUA for people 18 and older. You can visit the Centers for Disease Control and Prevention (CDC) website for information about available vaccines.

All people eligible to receive a COVID-19 vaccine are encouraged to get their shots. While no vaccine is 100% effective, the COVID-19 vaccine significantly reduces severe illness and hospitalization. In the U.S. nearly all cases of severe COVID-19 illness, hospitalization and death have occurred with people not yet vaccinated.

Guidance on vaccine third shot

On Aug. 18, 2021, top U.S. medical and public health experts announced new guidance encouraging fully vaccinated adult Americans who received the Pfizer or Moderna vaccine to get a third COVID-19 booster shot, pending FDA approval and CDC recommendation. People who received the Pfizer or Moderna mRNA vaccine are encouraged to get a third dose eight months after they received their second shot. Health officials note that people who received the Johnson & Johnson vaccine may need a booster shot as well, however more research is being done. People are considered fully vaccinated two weeks after receiving the single shot of the Johnson and Johnson vaccine or the second shot of Pfizer or Moderna vaccine.

Studies show that the COVID-19 vaccines’ protection against infection lowers over time. The guidance for a booster shot was made as COVID-19 cases rise due to the highly contagious Delta variant, which is primarily infecting unvaccinated people.

The CDC provides additional information about COVID-19 booster shots online. Visit your state’s health department website or the CDC’s Vaccine Finder site to find out where all eligible people ages 12 and older can get a COVID-19 vaccine.

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