Covid Live Updates: FDA decision on boosters expected in days

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ImageA woman who received the Pfizer-BioNTech vaccine this month in San Antonio, Texas.  The FDA is expected to decide this week who should receive a third dose of Pfizer.
Credit…Matthew Busch for The New York Times

The Food and Drug Administration is likely to authorize Pfizer booster shots this week for many Americans at high risk of becoming seriously ill from the coronavirus, now that a major advisory committee has voted to recommend the measure.

On Friday, a panel of experts approved the provision of Pfizer booster shots to people over 65 and people 16 and older who are at high risk of contracting severe Covid-19 or who work in environments where they are more likely to be infected. hit, good.

The bureau, which often follows the advice of the committee but is not obliged to, is expected to make a decision early this week. An advisory committee from the Centers for Disease Control and Prevention is scheduled to meet Wednesday and Thursday to discuss booster shots before that agency — which determines vaccine policy — issues its recommendations.

The decision on Pfizer booster injections is just one of a series of key questions the agency is expected to consider in the coming weeks. Officials have said they expect data soon on whether boosters are needed for people who have received the Moderna and Johnson & Johnson vaccines.

A decision is also expected this fall on an injection for children aged 5 to 11, a subject that is being closely watched as some 48 million children are not yet eligible for a vaccine, but have largely returned to the classrooms. Pfizer has said it plans to release results of the child trial by the end of this month, and officials have said they expect results from Moderna’s child trial later this fall.

dr. Anthony S. Fauci, the nation’s top infectious disease physician and adviser to President Biden, was interviewed on Sunday morning news programs asking Americans to be patient and not get booster vaccinations until they qualified. That includes people 65 and older who have received the Moderna and Johnson & Johnson vaccines.

“We’re working on that now to get the data to the FDA so they can investigate and make a decision on the boosters for those people,” he said on NBC’s “Meet the Press.” “They are not left behind in any way.”

Last month, the Biden administration proposed a plan that would make all vaccinated Americans eligible for a booster shot eight months after their second shot, or their first in the case of the one-time Johnson & Johnson vaccine.

But the expert panel concluded that boosters weren’t necessary for most younger, healthier Americans unless their jobs put them at special risk of infection.

Jobs in that category include health professionals, counselors and teachers, according to Dr. Peter Marks, who oversees the FDA’s vaccine division.

Whatever the FDA decides on boosters this week, Dr. Fauci predicted it will likely be revised as more data comes in. “More and more data is accumulating in real time,” he said on ABC’s “This Week.” “There will be an ongoing re-examination of that data and possible amendment of recommendations.”

dr. Francis S. Collins, the director of the National Institutes of Health, echoed those comments on CBS’s “Face the Nation,” saying the category of who will be eligible for an additional injection is likely to expand in the coming weeks. ”

FDA officials will also spend the coming weeks and months evaluating vaccines for children under 12. On Sunday, Dr. Fauci told ABC that a decision on childhood vaccines would definitely come “this fall”, adding, “sometime in the middle to late fall, we’ll see enough data from the kids ages 11 to 5 to be able to make a decision.” to vaccinate them.” After that, a decision would be made about vaccines for children under the age of 5.

The flurry of decisions comes as public health officials hope to prevent a repeat of last fall and winter, when a spate of infections led to peak levels of hospitalizations and deaths in the United States.

The extremely transmissible Delta variant now accounts for more than 99 percent of cases tracked in the country, according to the CDC. 1, according to a New York Times database. Vaccinations have been shown to protect against serious diseases caused by the variant.

dr. Fauci said on Sunday the key to avoiding a fall and winter surge would be for adults who were eligible but had not yet been vaccinated to change their mind.

“I believe if we get that overwhelming majority of people vaccinated as we go into the fall and winter, we can have good control over this and not have a really bad winter at all,” he said on “Meet the Press.”

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