Biden’s Management Plans for Operation Boosted Shot in September

WASHINGTON – The Biden administration plans to give the next-generation coronavirus booster vaccine to Americans 12 and older as soon as Labor Day, a campaign that federal officials hope will reduce deaths from coronavirus. Covid-19 and protection from the expected winter spike.

Peter Marks, the Food and Drug Administration’s top vaccine regulator, said in an interview on Tuesday that although he could not discuss the timing, his team had close to allowing updated doses that will target versions of the virus currently circulating.

Although those formulations have not been tested in humans, he said, the agency has “extremely good” data showing that the injections are safe and will work. “How confident am I?” he say. “I’m extremely confident.”

This week, both Moderna and Pfizer-BioNTech completed FDA filings requesting urgent authorization for additional injections aimed at BA.5 and another sub-variant of Omicron. most cases of coronavirus in U.S.A.

Federal health officials have said they are eager to provide updated boosters as quickly as possible, pointing to the death toll currently averages around 450 Americans a day and could rise in the coming months. as people spend more time indoors.

“We really have to do better to protect the American public,” Dr. Anthony S. Fauci, President Biden’s chief medical adviser, said in an interview Tuesday. “We’re in the middle of a BA.5 outbreak here and we’re close to where we want to be.”

The Biden administration has struggled to convince Americans of the need for successive immunizations. Only about two-thirds of the population has been immunized with the two primary immunizations, and much less received the booster dose.

Some outside scientists say the government is moving too quickly to remove the redesigned shots, arguing that existing vaccines offer strong protection against serious illness.

“Deaths are concentrated among the unvaccinated and those with serious health conditions,” said John P. Moore, a virologist at Weill Cornell Medicine. He said the additional protection the new shots would provide against infection could be “so weak as to be non-existent”.

Jeremy Kamil, a virologist at Louisiana State University Health Shreveport, says that although he favors the new boosters, many people have acquired immunity because of recent infections. “Even if we remove this in the next 10 days, how many people are left who haven’t received Omicron yet?” he say.

Other scientists say the government’s plan makes sense given how the virus has changed and evidence that immunity declines over time. Dr Marks said that if regulators waited for additional data or recommendations from outside experts, the virus could evolve further and “we could have lost a bunch of individuals who could have sat around dining together.”

In a sign of impending action from the FDA, the Centers for Disease Control and Prevention scheduled a two-day advisory board meeting of experts on the matter for September 1 and 2. CDC Director, Rochelle P. Walensky, will then make the final decision on whether to develop new doses. Shipments to the states could begin as early as next week, according to officials familiar with the plan.

The government plans to make the new Pfizer booster available to everyone 12 and older while limiting the new Moderna gun to adults. People who have received two initial shots of either vaccine will be eligible. So did those who received the initial shots plus one or two additional shots. The new booster campaign may be extended to younger children later.

Dr Marks says the biggest obstacle to this effort is the level of complacency that has been achieved, even as the pandemic continues to pinpoint what he calls “unacceptable” death tolls. .

He said the FDA may recommend that people who have recently received a dose of the Covid vaccine wait “several months” before getting a new shot, even if they are eligible. He said the CDC may consider whether people newly infected with the virus should wait.

As of mid-August, the federal government has purchased more than 170 million doses of the updated version of the vaccine. This month, the CDC released detailed plan to deliver the injections, warned that supplies would be “sufficient but limited” and said dosages should be “directed to providers with an expected need among eligible patients.”

The new injections combine the original vaccine with components that target BA.4 and BA.5, recent sub-variants of Omicron. Officials say the new formulations will provide stronger immune-boosting effects than existing vaccines.

Unlike previous photographs, the redesigned formulations have not been extensively tested in humans; Instead, the companies submitted data from tests on mice. Some vaccine experts have complained that the animal data is too preliminary and that regulators should wait for the results of human clinical trials.

But Dr Fauci said using animal data was “no different than we do” in updating flu vaccines each year. Dr Marks said other evidence included an extensive track record with existing vaccines and a series of earlier human trials with variant-specific formulations.

“I’m very interested in people who say, ‘Oh, you only approve of this with mouse data,’ he said. “We allow this with all the evidence we have.”

Moderna and Pfizer have both submitted clinical data from human studies of redesigned footage targeting the original version of the Omicron variant. I last week allow Moderna’s version of the vaccinebut US regulators have required formulas aimed at the newer subvariables of Omicron.

Researchers are still working to answer important questions about the protection the new vaccine offers, including the level of antibodies the shot produces in people and how those antibodies protect. People. Moderna began human trials of the new vaccine this month, and Pfizer plans to do the same by the end of the month. Initial data from those tests is expected later this year.

Dr. Moore, a virologist at Weill Cornell Medicine, said the administration’s plan could backfire if fall or winter brings a wave of epidemics despite new boosters, potentially reducing overall confidence in a Covid-19 vaccine.

“My question so far has been: Is there enough data to really justify the effort?” Dr. Moore said. “The potential downside is, if the public thinks this Omicron booster is some kind of magic bullet that will give them absolute protection from infection, are they at risk of changing their behavior to avoid infection? increased exposure?”

The FDA will decide whether to allow the doses to be retrofitted without seeking recommendations from an outside advisory panel of experts, a step the agency typically takes before providing a new vaccine. Critics have complained that regulators have overlooked the board at key steps.

Dr Marks defended the decision, saying a meeting in late June of an advisory board on the need for a vaccine revision gave regulators “everything we needed”. The committee then overwhelmingly voted in favor of updating the vaccine to work better against Omicron or its sub-variants, but it did not consider specific formulations.

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