Moderna and J&J Covid-19 Boosters, Mix and Match are FDA Approved

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A move announced Wednesday by the Food and Drug Administration will make boosters available to most adults who have been fully vaccinated and have passed the recommended waiting period.

Currently, all Covid-19 vaccines approved in the United States also have boosters. And people who got shots from one company for vaccination could choose to take a booster dose made by another company.

“Available data suggest weakened immunity in some fully vaccinated populations,” said FDA Deputy Commissioner Janet Woodcock. “The availability of these licensed boosters is critical to continued protection against Covid-19 disease.”

Who gets the booster and when depends on the original vaccine the person took.

Adults who have been vaccinated for Jammu and Kashmir can receive a booster from Pfizer. Ltd.

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Partner BioNTech SE, Moderna, or J&J for at least 2 months after a single dose.

The first person to receive Pfizer-BioEntech or Moderna vaccine may be extended for at least 6 months after the second dose, as long as they are elderly or at high risk due to underlying illness or workup. Growth.

The FDA has already begun considering whether to grant booster approval to more people. According to people familiar with the issue, the expansion will make an additional dose available to anyone over the age of 40 who has been vaccinated with Pfizer-BioNTech or Moderna Vaccine. He said a decision could be made in a few weeks, after which further approval would be given for the younger age.

According to health officials, allowing the use of a combination of vaccines and booster immunizers ensures that anyone who wants the vaccine can get the vaccine, as well as increasing options for those who are fully vaccinated. This will help.

Some studies have shown that mixed and matched people may have greater protection, especially if they were vaccinated against J&J for the first time. Health officials say the option could also provide relief to those who are concerned that side effects may occur if they are given the same vaccine again.

The shots may be available within a few days after the Centers for Disease Control and Prevention provides guidance to doctors, pharmacies and vaccination sites about how to use them and who should get them.

The FDA, which regulates various medical products, must approve or approve the vaccine before it can be used outside of clinical trials. Once a vaccine is approved, CDC policies determine whether people should be vaccinated, in which group, and at what time.

CDC will make a decision after a panel of experts has reviewed the issue and made recommendations. The CDC advisory board will meet on Thursday.

The United States needs enough vaccines to meet booster demand, according to people familiar with the matter. People can get them in clinics, pharmacies, and other vaccination sites.

The new authorization follows a debate among health professionals about whether many people really need to get boosters, or at least in the near future, whether two shots will provide enough protection. ..

The Biden administration has called for boosters, specifically to bolster the immune defenses of those vaccinated against the infectious Delta version of the coronavirus.

According to the CDC, more than 69 million people in the United States have been twice vaccinated with Moderna.

Moderna’s original vaccine therapy, which was approved for adults in the United States in December 2020, required two doses every 28 days. The Moderna booster dose will be half the dose for each of the first two shots.

About 15 million people in the United States have been vaccinated with the J&J vaccine since it was approved as a single shot in late February.

The dosage of the J&J booster shot is the same as the first dose.

The Biden administration has called for boosters, specifically to bolster the immune defenses of those vaccinated against the infectious Delta version of the coronavirus. After approving the original vaccine regime last winter, the FDA is evaluating applications to add additional doses.

In September, the FDA approved a booster dose of the Pfizer-BioEntech vaccine for seniors and adults at high risk for Covid-19 who have already been injected and vaccinated for at least 6 months. did.

The FDA also approves vaccination promotion of Pfizer-BioNTech and Moderna Vaccines for some people with weakened immunity.

Boosters are also available in Israel, the United Kingdom, and other countries.

Vaccine experts advising the FDA last week voted to recommend a third dose of Moderna shots to older people and others at risk of severe Covid-19. The panel also voted to recommend a second dose of J&J vaccine to all adults who received the first dose.

A problem seen in a small number of people receiving the Modana double-dose regimen, especially in young adult men, is inflammatory heart diseases called myocarditis and peritonitis. In some European countries, the use of modern vaccines is restricted to younger age groups because of potential risks.

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The FDA noted the risk of myocarditis in its approval of the Moderna booster shot, but did not specifically state whether the risk was similar after booster administration and after primary vaccination.

A study assessing booster doses is too small to adequately assess the risk of myocarditis, Doran Fink, deputy director of the FDA’s vaccine division, said last week in an advisory board. Pfizer’s Covid-19 vaccine is also associated with an increased risk of myocarditis.

So far, 11.2 million people in the United States, or about 5.9% of the fully vaccinated population, have had a boost, according to the CDC.

The mix-and-match decisions were communicated by a National Institutes of Health study showing that vaccination with a different vaccine than the original vaccine resulted in increased antibody levels in all three types of vaccines, particularly in Jammu and Kashmir. between recipients. Growth.

NIH studies show that booster-immunized J&J vaccine recipients at the Moderna dose increased antibody levels 76-fold, the Pfizer booster increased antibody levels 35-fold, and the J&J dose increased antibody levels 4-fold. He was done.

write in Peter Loftus ([email protected]) and Felicia Schwartz ([email protected])

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Source Link Moderna and J&J Covid-19 Boosters, Mix and Match are FDA Approved

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