The Food and Drug Administration (FDA) today followed the advice of its advisory committee and recommended booster shots of COVID-19 vaccines from Moderna and Johnson & Johnson-Janssen. The agency also approved mixing or matching booster doses, which means people can either get another dose of the same vaccine they originally received or get a booster shot with a different vaccine. More than 150 million doses of the Moderna vaccine and 15 million of the J&J Janssen vaccine have been given in the United States
In a briefing that discussed the agency’s decision, incumbent FDA director Dr. Janet Woodcock, the main reason for recommending boosters is because of the increasing evidence that the immunity provided by the original COVID-19 vaccinations is decreasing. “The availability of authorized boosters will be important in further protection against COVID-19 disease,” she said. “The measures taken today are helping to combat dwindling immunity.”
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The decision means anyone who has been vaccinated against COVID-19 – with any of the three vaccines available in the US – could at some point get a booster shot. To date, only people who were initially vaccinated with the Pfizer-BioNTech vaccine or those with compromised immune systems could receive an extra dose. The FDA made it clear that those eligible for a booster vaccination are initially those who are already vaccinated with Pfizer-BioNTech or Moderna and are over 65 years of age, or those between the ages of 18 and 64 who have undergone one Have a underlying health condition, or work or live in an environment that puts them at higher risk of exposure to COVID-19. This includes teachers, public transport workers, and key health care workers and frontline workers, as well as those living in homeless shelters or prisons. However, anyone who has previously been vaccinated with the J&J Janssen vaccine can receive a booster as this vaccine is less effective compared to the other two.
On September 22nd, the FDA approved booster syringes for individuals immunized with the Pfizer BioNTech syringe, and the Centers for Disease Control and Prevention (CDC) supported that decision with subtle reservations. While the CDC recommends Pfizer BioNTech boosters for people over 65 and those with health problems who might be at a higher risk of developing severe COVID-19, the agency hasn’t recommended them for younger people. CDC director Dr. Rochelle Walensky decided instead to give younger people in jobs or higher-risk environments an extra dose if they so wished.
With a few exceptions, the FDA’s recommendation for the Moderna and Johnson & Johnson-Janssen boosters follows the guidelines of the authorities for the Pfizer-BioNTech booster. The Pfizer BioNTech booster is another dose of the same dose people have already received twice, while the Moderna booster is half the original dose. Moderna scientists showed that the lower dose produced a sufficiently strong immune response and caused fewer potential side effects; They found that half the dose would also double the number of people who could get a booster dose.
J & J-Janssen’s vaccine is the only one that requires a single dose. Unlike Pfizer-BioNTech and Moderna, which are recommended at least six months after the initial vaccination, the J & J-Janssen booster is recommended two months after the first dose. It is also recommended without limitation for anyone who received the vaccination, as it is initially less effective in protecting against COVID-19 compared to the Pfizer-BioNTech and Moderna vaccines.
Woodcock and Dr. Peter Marks, director of the Center for Biologics Evaluation and Research, admitted that introducing boosters with their different dosage regimens and target populations will be complicated. Because of this, the agency has approved the mixing and matching of booster doses to give providers the flexibility to boost people with any COVID-19 vaccine if people cannot remember which one they were vaccinated with, or if this is not practical for mobile vaccination teams or pharmacies or hospitals to carry all three vaccines.
It is now up to the CDC Advisory Committee on Immunization Practices, which will meet on October 21, to clarify the details of how the booster will be given. Once the committee has reviewed and discussed the data and the FDA’s decision, Walensky will make a final recommendation. The White House has stated that the federal government, which will pay for booster vaccinations as it did with the original COVID-19 vaccinations, is ready to begin shipping cans so that eligible people can access them soon.
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Reference: time.com