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Omicron-specific vaccine boosters receive FDA sign-off

COVID-19 vaccines designed to target the omicron variant have just been authorized by the Food and Drug Administration. Both Pfizer/BioNTech and Moderna have received the FDA’s sign-off for booster doses of their reformulated shot. This is the first update to the approved COVID-19 vaccines in the United States.

The Pfizer/BioNTech booster is available for people 12 and older, and the Moderna shot is available for people 18 and older. They are only boosters — people who haven’t already taken the first doses can’t use them.

The new booster shots target both the originals The BA.4 and BA.5 lineages of the strain and omicron variant of the coronavirus — these are the main versions of the virus currently circulating.

The original vaccines still protect people from getting seriously ill or dying from Covid-19, but with BA.4 and BA.5 everywhere, those vaccines don’t offer much protection against getting sick or getting sick. Research shows that omicron-targeted vaccines boost the immune response against that version of the virus, so experts believe it can better protect against omicron infection.

Pfizer / BioNTech and Moderna have run clinical trials in humans with a booster version that targets the BA.1 lineage, an earlier form of the Omicron variant. They also tested BA.4 and BA.5-specific shots in animals. The FDA said in June that it wanted to look at BA.4 and BA.5-specific shots and would review them based on the BA.1 data. Both companies are still running clinical trials of their new boosters.

Both vaccines are constructed using mRNA – they introduce small snippets of the virus’s genetic material to create antibodies against the body. One of the promised advantages of this type of vaccine is that the genetic sequence is relatively easy to adjust, so it is not difficult to update shots in response to changes in the virus. It still took a long time for the regulatory process to kick into gear to actually bring the updated vaccines to market. But this update puts the COVID-19 vaccines on par with the flu shot, which changes each year in response to circulating strains of the influenza virus.

Moderna announced last week that it is suing Pfizer and BioNTech for infringing its vaccine patents.


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