FDA approves another Pfizer, Moderna COVID booster, with over 50 – Leading Eagle


US regulators approved another COVID-19 booster for people over the age of 50 on Tuesday. This is a step towards providing additional protection to the most vulnerable people in the event of a coronavirus rebound.

At the Food and Drug Administration’s decision, a fourth dose of Pfizer or Moderna vaccine will be opened to that age group at least 4 months after the last booster.

So far, the FDA has only allowed a fourth dose to people over the age of 12 who have a significantly weakened immune system. The agency said this particularly vulnerable group could also get an additional booster, the fifth shot.

The latest expansion allows millions of Americans to take additional shots, regardless of their health — one of the remaining issues when the Centers for Disease Control and Prevention considers its own recommendations. Whether all qualified people should hurry and ask for a dose immediately.

Dr. Peter Markes, FDA’s head of vaccines, said he needed everyone to be eligible for the first booster who hadn’t yet obtained a booster. However, the second booster is dedicated to these high-risk groups, as there is evidence that protection may be weakened and the FDA has decided on an option that “helps save lives and prevent serious consequences.” ..

This move occurs at a very uncertain time. Cases of COVID-19 declined to low levels after a winter surge in hyperinfectious Omicron mutants. According to CDC data, two doses of vaccination and booster immunization provide strong protection against serious illness and death.

However, Omicron’s brothers are causing a surge in infectious diseases of concern, spreading in Europe and in the United States, despite vaccination stalemate. About two-thirds of Americans are fully vaccinated, and half of those initially targeted for booster immunization are unvaccinated.

Pfizer has asked the FDA to clear the fourth shot for people over the age of 65, but Moderna has done everything “to provide flexibility” to determine what the government really needs. Requested another dose for adults.

According to the FDA’s Marks, regulators have set the age at 50. This is because chronic diseases such as heart disease and diabetes become more common and the risk of COVID-19 increases. Regarding weakened immunity, Marks said these patients are more likely to see their immune protection diminish faster and therefore can benefit more from additional protection. Only Pfizer vaccines can be used for children up to 12 years of age. Moderna’s is for adults.

There is limited evidence of how much profit another booster can currently offer. The FDA made the decision without input from an independent expert panel that has been working on the amount of data needed to magnify the shot.

E. John Welly, an immunoscientist at the University of Pennsylvania, said he was not involved in the government’s decision.

However, although he encourages older friends and relatives to follow the advice, the healthy, vaccinated and backed-up 50-year-old Cherry does not plan to receive a fourth vaccination immediately. Protection against severe illness is still strong, “I will wait until I think I need it.”

None of the COVID-19 vaccines are as potent against Omicron variants as they are against previous versions of the virus. Also, protection against mild infections naturally diminishes over time. However, the immune system builds multiple layers of defense, withholding types that prevent severe illness and death.

During the Omicron wave in the United States, two doses were nearly 80% effective against ventilator or mortality needs — and boosters boosted their protection to 94%, the CDC recently reported. did. Vaccine efficacy was lowest in people with weakened immunity, at 74%. The majority did not receive a third dose.

US health officials have also turned to Israel. Israel began a fourth dose to people over the age of 60 at least four months after the last shot during the Omicron surge. The FDA said no new safety concerns emerged in the review of the 700,000 fourth doses administered.

Preliminary data posted online last week suggested some benefits. Israeli researchers counted 92 deaths in those who received more than 328,000 additional shots, compared to 234,000 232 deaths who skipped the fourth dose.

Far from being clear is how long the additional profit from another booster will last, and therefore when to get it.

“When” is a really difficult part. Ideally, we’ll time the booster effect just before the surge, but we’re not always sure when that will happen, “said Dr. William Moss, a vaccine expert at the Johns Hopkins Bloomberg School of Public Health. increase.

In addition, increasing the spacing between shots helps the immune system initiate stronger, cross-reactive defenses.

“It doesn’t hurt to bring the boosters too close together. You just can’t get a lot of benefits from them,” Wheely said.

The latest booster expansion may not be the last. Next week, the government will hold a public meeting to discuss whether everyone will eventually need a fourth dose of the original vaccine or updated shots.

Even if high-risk Americans are now boosted, Marks said additional doses may be needed in the fall if regulators decide to fine-tune the vaccine.

For that effort, people’s research-shots targeting Omicron alone or in combination with the original vaccine-is underway. The National Institutes of Health recently tested monkeys and found that there were “no significant benefits” to using boosters targeting only Omicron.


The Associated Press’s Department of Health Sciences is supported by the Science Education Department of the Howard Hughes Medical Institute. AP is solely responsible for all content.

FDA approves another Pfizer, Moderna COVID booster, with over 50 – Leading Eagle

Source link FDA approves another Pfizer, Moderna COVID booster, with over 50 – Leading Eagle

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