WASHINGTON – The Biden administration plans to provide next-generation coronavirus booster shots to Americans 12 and older as soon as Labor Day, a campaign that federal officials hope will reduce deaths due to Covid-19 and protection from the expected winter spike.
Dr Peter Marks, the Food and Drug Administration’s top vaccine regulator, said in an interview on Tuesday that his team was close to authorizing updated doses that would target version of the virus currently circulating.
Although these formulations have not been tested in humans, the agency has “extremely good” data showing that the injections are safe and will be effective, he said. “How confident am I?” he say. “I’m extremely confident.”
This week, both Moderna and Pfizer-BioNTech completed their submissions to the FDA for urgent authorization for booster shots aimed at BA.5 and another sub-variant of Omicron that together cause most of the illnesses. coronavirus cases in the United States.
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 received the two primary vaccinations, and far fewer have received additional doses.
Some outside scientists say the government is moving too quickly to remove the redesigned shots, saying 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 protection the new injections provide against infection may 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 from 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.
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Other scientists say the government’s plan makes sense given how the virus has changed. 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.
Officials plan to make the new Pfizer energy drink available to everyone 12 and older while restricting firing of the new Moderna 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 said the FDA may want people who have recently received a dose of the Covid vaccine to wait “several months” before getting a new shot. 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 outlined a blueprint for delivering the shots, warning that supplies would be “sufficient but limited” and saying doses should be “directed to those 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 are too preliminary and that regulators should wait for the results of human trials.
But Dr Fauci said using such data “is no different than we do” to update the flu vaccine each year. And Dr Marks said evidence includes an extensive track record of existing vaccines and a series of earlier human trials with specific variant 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. Last week, the UK approved that version of Moderna’s vaccine, but US regulators have requested formulations aimed at newer sub-variants.
Researchers are still working to answer key questions about the protection the new vaccine offers, including the level of antibodies the shot produces in people and how those antibodies protect children. 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 outbreaks that defy new recipes, potentially reducing confidence. General belief in a Covid-19 vaccine.
“My issue 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-containing booster is some kind of magic bullet that will give them super powerful protection from infection, are they at risk of changing their behavior to increase the possibility of contact?”
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 managers have overlooked the board at key steps.
Dr Marks defended the decision, saying an advisory board meeting in late June on the need to update vaccines gave regulators “everything we needed”. The committee then voted overwhelmingly to recommend that the vaccine be updated for Omicron, but it did not consider specific formulations.
