The Centers for Disease Control and Prevention reiterated its FDA mandate on Tuesday afternoon, signing instructions for a second booster dose of the Pfizer-BioNTech vaccine or the Moderna COVID-19 vaccine for eligible individuals who wish to increase their protection”.
The CDC also went one step further, clearing out a second booster dose for all adults “who received a main vaccine and a booster dose of Johnson & Johnson’s Janssen COVID-19 vaccine at least 4 months ago”.
“We hope that by taking this action, we will help people take action to protect themselves if we have another wave to cross this country,” FDA top vaccine official Dr told reporters on Tuesday. Peter Marks.
Americans who are old enough to be eligible will be able to receive their second souvenir four months after their first boost. Immunocompromised Americans 12 years of age and older who received the aid may also be vaccinated.
So far, only Americans with a weakened immune system have been eligible for a fourth vaccine if they were first vaccinated with the Pfizer-BioNTech or Moderna vaccine or a third vaccine if they first had Johnson & Johnson.
The FDA said Tuesday’s decision was based on data from health authorities in Israel that showed “no new safety concerns” with the fourth dose of the Pfizer and BioNTech vaccine being released to residents aged 60 and over. The regulator also said data from “an independent study” showed that the fourth dose of Moderna did not identify safety concerns “for up to three weeks after the second booster dose”.
Marks said the regulator had decided to extend its suitability beyond the Israeli border to the age of 50 to meet the challenges of previous efforts to “function” the federal recommendations. About a third of people between the ages of 50 and 65 “have significant medical comorbidities,” Marks said, and other vaccine policies are based on the age of 50 to define those at “high risk.”
Both Moderna and Pfizer and BioNTech are also looking for new versions of their vaccines that could be released later this year. The companies hope that the revised downloads will surpass the current compositions designed to target the original “original virus”.
But for now, the new round of boosters will be based on the same supply currently used for initial vaccinations and boosters. Marx said taking a second souvenir now “will not exclude people” from getting another set of vaccines in the fall if a new version of the vaccine is released.
“People may need to get an extra boost in the fall along with a more general boost campaign, if that happens, because we may need to switch to a different coverage variant,” Marks said.
Federal officials have been trying for weeks to split their discussions on the “immediate situation” to bolster the most vulnerable Americans to a possible new wave of COVID-19 cases and to discuss long-term solutions for falling amplifiers for the wider population.
Tuesday’s move was announced without public disclosure of the data to outside vaccine consultants either the CDC or the FDA. Marx said the move was “a relatively simple decision” that did not need to be enforced by the commission.
The FDA plans to convene a meeting of the Advisory Committee on Vaccines and Related Organic Products next week on the subject.
“On April 6, the FDA will have an important meeting – and the CDC will be involved – on what an autumn booster looks like. How do we make decisions about this fall booster? Do we need this fall booster?” CDC Director Dr. Rochelle Walensky said at an event hosted by Columbia University on Monday.
Although the CDC has advertised data suggesting that mRNA vaccines “continued to be extremely effective” in preventing severe COVID-19 outbreaks during the Omicron wave, the agency also acknowledged the significant increase – and differences – in severe Omicron infections.
CDC data also suggest that Johnson & Johnson recipients died at higher rates during the Omicron wave compared to other vaccinated Americans, even among those who had received a booster, and were at higher risk of hospitalization.
“I think we are in a relatively weak position on the kind of policy front on what exactly is the data that is binding on the fourth installments,” said Dr Kate O’Brien, a leading vaccine official at the World Health Organization. at the Columbia event.
“The gap between the evidence needed to regulate vaccine uses and the really sound policy decisions about optimizing vaccine programs has always been a gap. It remains a gap,” O’Brien said.
Supply of second amplifiers
The drive to expand the suitability for a second booster comes as the campaign to release the first boosters has slowed for months, to less than 75,000 additional doses a day. Overall, the White House estimates that approximately two-thirds of eligible adults have received a booster dose. More than 34 million Americans aged 50 and over were supported four months ago, according to the CDC. The Biden government claims it has enough reserves to support fourth installments “for our most vulnerable, including the elderly” this spring. However, White House officials have also publicly warned for weeks that they had run out of money to buy enough extra boosters for all Americans later this year or to replace current batches if vaccine makers release updated formulations tailored for new variants. . Moderna executives told investors last week that the company was “actively preparing” for the possibility that it would need to sell its vaccine on the US private market. “We just want to be ready because we do not want to be in a world where Americans obviously do not have access to vaccines in the fall,” said Stéphane Bancel, CEO of Moderna. Marks suggested that the new vaccines for COVID-19 could be released in the annual flu vaccination campaign in the coming years, citing the possibility of “operational effectiveness” in pairing the two circuits. “At some point we need to realize that this is a virus that will be with us and that we need to be able to tackle it on a regular basis,” Marx said. More Alexander Tin CBS News reporter covering public health and pandemic.
