FDA and CDC authorize COVID-19 booster for omicron variant

The FDA and CDC have given emergency use authorization (EUA) to COVID-19 booster shots that have both the original formula of the mRNA vaccines that were based on the original 2019 coronavirus strain and an added component that addresses the BA.4 and BA.5 variants of omicron. Those are the variants that have been widely circulating this summer.

The CDC approved the vaccines on Thursday.

How will the new omicron booster be used?

  • The updated boosters will replace the original vaccines as a booster. They will not replace the original vaccine for the initial two doses in the primary series.
  • This new updated booster can be given to people two months after their primary series or their last booster. It is thought that would include anyone ages 12 and older, but doctors are awaiting specific recommendations from the CDC.
  • The Pfizer updated booster is for people ages 12 and older. The Moderna booster is for people ages 18 and older. Kids 12 and younger will have to wait for this booster to be approved for their age group. The FDA has said that approval could come in the next few months.

Why a different COVID booster shot?

These updated boosters "are really meant to match in a better way the virus that's circulating," said Manish M. Naik, MD, Chief Medical Officer of ARC in this recent article in the Austin American-Statesman. COVID-19 is still circulating; about 20% of the tests at ARC are coming back positive, said Dr. Naik.

Do you need this omicron booster?

Dr. Naik compares the new vaccines to vaccines for the flu. Some years the flu vaccine is a good match against the flu strain that's circulating, other years it's not as good a match. "It's still effective against hospitalization and dying ...," Dr. Naik said.

This booster will have a spike protein to recognize the original COVID-19 as well as a spike protein to recognize the BA.4 and BA.5 omicron variants. "There is value in boosting antibody response," Dr, Naik said.

If I've already had omicron, do I need this booster shot?

In general vaccination is still recommended after infection, even if you have been infected more recently. However, the CDC generally recommends to wait three months after infection for the most effective response to the vaccine. Please consult with your doctor for your individual situation.

When will these boosters become available at ARC?

ARC already has put in its order. Typically, the vaccines will show up within a few weeks of the CDC approval, Dr. Naik said.

Stay up to date on the latest booster information

ARC will announce on our website and on our social media as soon as we are ready to administer the new boosters. Follow us on our social media pages or check back here on our website. If you have other questions about COVID-19, use our COVID-19 Care page or call our 24/7 COVID-19 Hotline at 866-453-4525.

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