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The FDA has authorized a second booster vaccine against COVID at the age of 50


More than 34 million Americans age 50 and older may soon be eligible for revaccination after the Office of Food and Drug Administration said On Tuesday, he approved a new round of vaccines against COVID-19 Moderna or Pfizer and BioNTech for those who want them.

Centers for Disease Control and Prevention should also sign updated guidelines before providers can begin providing additional accelerators.

“Current data suggest some reduction in protection over time from the serious effects of COVID-19 in the elderly and immunocompromised,” said FDA Dr. Peter Marx. statement.

So far, only Americans out weakened immune systems were entitled to receive a fourth vaccination when they were first vaccinated with Pfizer-BioNTech or Moderna vaccines, or a third vaccination if they were originally given Johnson & Johnson.

Americans who are old enough to be eligible will be able to get a second booster as early as four months after the first booster. Americans with weakened immune systems aged 12 and older who have been backed up will also be able to get another vaccine.

The FDA said their decision was based on data from health authorities in Israel that did not show that “there are no new safety concerns” with the fourth dose of Pfizer and BioNTech vaccines. The regulator also said data from an “independent study” showed that the fourth dose of Moderna found no safety issues “up to three weeks of follow-up after the second booster dose”.

Pfizer and BioNTech had announced the request On March 15, the second boosters for the elderly over 65 will be launched. The companies said they presented “two real data sets from Israel” where the fourth images were deployed for adults 60 years and older. Moderna later said it is too filed a request for fourth shotsbut for all adults, hoping to “provide flexibility” for federal health authorities.

Both Moderna, Pfizer and BioNTech are also looking for new versions of their vaccines, which could be introduced later this year. The companies hope the revised drugs will surpass current formulations that were developed to target the original “ancestral strain” of the virus.

But for now, the current round of vaccinations will build on the same stock of vaccinations that is currently being deployed for primary vaccinations and vaccinations.

Federal officials for weeks sought to split their discussions of the “emergency situation” to push the most vulnerable Americans against a new potential wave of COVID-19 cases, and to discuss longer-term solutions to accelerators for the general population.

The move was announced Tuesday without public disclosure to either the CDC or external FDA vaccine consultants. FDA plans to convene a meeting of the Advisory Committee on Vaccines and Related Biological Products Next week on the topic.

“On April 6, the FDA will hold an important meeting – and the CDC will be involved – on what the fall of the amp looks like? How will we decide on this fall? CDC Director Dr. Rachel Valensky told about the event organized by Columbia University on Monday.

Although the CDC has advertised data Believing that mRNA vaccines “continue to be very effective” for preventing severe results from COVID-19 during the Omicron wave, the agency also acknowledged a significant increase – and differences – in severe Omicron infections.

CDC data also suggest Recipients of Johnson & Johnson Died more often during the Omicron wave than other vaccinated Americans, even among those who received recovery.

“I think we are in a relatively weak position on the political front as to what exactly the data are convincing decisions about the fourth dose,” said Dr. Kate O’Brien, the World Health Organization’s chief vaccine official. at an event in Colombia.

“The gap between the evidence needed for regulatory vaccine approval and the truly sound policy decisions to optimize vaccine programs has always been a gap. It continues to remain,” O’Brien said.

Supply of second boosters

The transition to extending the right to receive a second booster occurs when the campaign to deploy the first boosters has slowed for several months, up to less than 75,000 additional doses per day.

Overall, the White House estimates that about two-thirds of eligible adults have been vaccinated. More than 34 million Americans aged 50 and older received advanced training four months ago to CDC data.

The Biden administration says it has enough reserves to support a fourth dose “for our most vulnerable, including the elderly” this spring.

However, White House officials have also publicly warned for weeks that it has run out of money to buy enough extra boosters for all Americans later this year or replace current batches if vaccine manufacturers release updated formulations modified for new options.

Chapters Moderna told investors last week that the firm is “actively preparing” for the fact that it will need to sell its vaccine on the private market in the United States

“We just want to be ready because we don’t want to be in a world obviously where Americans don’t have access to vaccines in the fall,” Moderna CEO Stefan Bansel said.

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