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A Necessity? FDA Approves New Pfizer And Moderna COVID Vaccines, Expected To Hit Pharmacies Soon

FDA

(USA Today)  The Food and Drug Administration on Monday authorized updated COVID-19 vaccines aimed at more recent viral variants.

The move has been expected since earlier this summer, when an advisory committee recommended the move.

 

A different advisory committee meets Tuesday to recommend how the vaccine should be used.

COVID-19 infections have been rising since early July, data from the Centers for Disease Control and Prevention shows. Hospitalizations are up nearly 16% and deaths nearly 17% in the week that ended Thursday, compared to the week before, though totals remain well below previous peaks.

There’s still some debate within the medical community about whether everyone stands to benefit substantially from another booster shot.

It’s clear, experts say, that people who have multiple health problems or whose immune systems are weakened by age, illness or medications, should get boosted at least once a year and possibly more.

For young healthy people, getting an annual shot provides less obvious benefit, as they are already at low risk for severe disease from COVID-19 and already have some protection from previous vaccinations and infections.

“People who are immune compromised, people who have obesity and diabetes, chronic heart, liver, kidney, neurologic disease ‒ those are people who really do benefit,” said Dr. Paul Offit, who directs the Vaccine Education Center at the Children’s Hospital of Philadelphia. “If you’re not vaccinated, you should be vaccinated.”

But Offit does not think young, otherwise healthy people need to get annual shots. Vaccines will not protect against all infections with COVID-19 and the immune system’s T cells have learned through previous vaccinations and infections how to block severe infections.

Luckily, said Dr. Jesse Goodman, a professor of medicine and infectious diseases at Georgetown University, the virus that causes COVID-19 has not mutated as much as the influenza virus that causes annual flu outbreaks, so most healthy people retain some protection. Both Goodman and Offit spoke to reporters Monday as part of the COVID-19 Vaccine Analysis Team, an informal group of vaccine experts.

Syringes with COVID-19 vaccines are prepared at the L.A. Care and Blue Shield of California Promise Health Plans' Community Resource Center last year in Lynwood, Calif.

“People who are older and people with chronic diseases should clearly get revaccinated,” said Goodman, who chairs the COVAT group and is a former FDA chief scientist. “I’m still seeing older and immunocompromised people get severe disease. Much less than before, which is wonderful, but … for people who need it, it has definite value.”

What happened with COVID vaccines Monday

The FDA’s actions Monday related just to the vaccines manufactured by Moderna and Pfizer-BioNTech.

Both of their vaccines will be updated to target the omicron variant XBB.1.5, which was the dominant variant this spring and early summer.

It has since been replaced by other variants, but early research suggests the new vaccines will be protective against those variants, as well.

The FDA officially:

  • Approved use of the updated version of Comirnaty, Pfizer-BioNTech’s vaccine, for people 12 and older.
  • Approved use of the updated version of Spikevax, Moderna’s vaccine, for people 18 and older.
  • Authorized use of the updated versions of both Pfizer-BioNTech and Moderna’s vaccines for emergency use in children ages 6 months through 11 years.

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