Biden Officials Now Expect Vulnerable Americans to Need Booster Shots

Biden Officials Now Expect Vulnerable Americans to Need Booster Shots
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Biden Officials Now Expect Vulnerable Americans to Need Booster Shots

Biden Officials Now Expect Vulnerable Americans to Need Booster Shots

WASHINGTON – Health officials in the Biden administration increasingly believe vulnerable populations will need boosters even as research continues on how long coronavirus vaccines remain effective.

Senior officials now say they expect people aged 65 and over or with weakened immune systems will likely need a third injection of Pfizer-BioNTech or Moderna, two vaccines based on the same technology that has been used to inoculate the vast majority of Americans until now. It’s a dramatic change from just a few weeks ago, when the administration said it believed there wasn’t enough evidence to support the boosters yet.

On Thursday, a key Center for Disease Control and Prevention official said the agency is exploring options to give patients with weakened immune systems a third dose before regulators even expand authorization for the use of emergency for coronavirus vaccines, a step that could soon happen for the Pfizer vaccine.

Dr Amanda Cohn, chief medical officer of the CDC’s immunization division, told an agency advisory committee officials are “actively looking for ways” to provide certain people with access to booster shots “above all else. potential change in regulatory decisions “.

“So stay tuned,” she added.

The growing consensus within the administration that at least some Americans will need a booster is in part linked to research suggesting that the Pfizer vaccine is less effective against the coronavirus after about six months. More than half of those fully vaccinated in the United States to date have received Pfizer’s vaccine, in two doses given three weeks apart.

Pfizer’s continuing global study of its clinical trial participants shows that four to six months after the second dose, the vaccine’s effectiveness against symptomatic infections drops from 95 to 84 percent, according to the company.

Data from the Israeli government, which has fully vaccinated more than half of its population with doses of Pfizer since January, also indicates a declining trend in effectiveness over time, although administration officials are examining these data with caution due to the large margins of error.

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The most recent figures from the Israeli Ministry of Health, released at the end of the week, suggest that Pfizer’s vaccine was only 39% effective in preventing infection in that country in late June and early July, up from 95 % from January to April.

The vaccine remained over 90 percent effective in preventing serious illness and almost as effective in preventing hospitalizations. Israel began offering a third dose of Pfizer to citizens with severely weakened immune systems on July 12.

Dr Anthony S. Fauci, who heads the division of infectious diseases at the National Institutes of Health, said he was surprised by the apparent sharp drop in the effectiveness of the Pfizer vaccine that Israeli data seems to suggest. He said he wanted to compare it with data the CDC had collected from cohorts of thousands of people across the United States. “People are raising their eyebrows a bit,” he said.

As other questions abound, senior administration officials said it seemed increasingly clear that the vaccines would not grant indefinite immunity to the virus, and that boosters might be needed for at least some people maybe nine months after their first injection. The administration has already purchased more than enough vaccine to deliver the third doses of Pfizer and Moderna, and has quietly prepared to expand the distribution effort, should it become necessary.

With so little data yet public, many health officials and experts have spoken with caution about booster shots. Dr Paul A. Offit, a member of the Food and Drug Administration’s External Advisory Committee on Vaccines, said that an increase in mild or moderate cases of Covid-19 among those vaccinated does not necessarily mean that a reminder was necessary.

“The goal of this vaccine is not to prevent mild or mild, moderate infectious diseases,” he said. “The goal is to avoid hospitalization to death. At present, this vaccine has resisted that. “

Prematurely dangling the prospect of a third dose could also have a chilling effect on vaccination, other health experts warn. If Americans think immunity to vaccines is short-lived, they said, they might be less likely to receive their initial injection.

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“We don’t want people to believe that when you talk about boosters it means the vaccines aren’t working,” Dr Fauci said during a congressional hearing on Tuesday. “They are very effective.

Among vaccine makers, Pfizer has been particularly proactive in sharing its data with the government. But the administration was taken aback by the company’s public announcement this month that it planned to seek emergency clearance from the FDA for a recall.

The company said the first data from its booster study showed that the level of neutralizing antibodies in clinical trial participants who received a third dose six months after the second was five to 10 times higher than in recipients. of two doses.

Fearing the American public would get the wrong message, the FDA and CDC responded with an unusual public statement saying, “Americans who have been fully vaccinated do not need a booster just yet.” They added, “We are ready for booster doses if and when science shows they are needed. “

Typically, the FDA will allow the use of a booster, perhaps after a meeting of its external advisory committee. Then the CDC, which has its own advisory committee, should officially recommend it, Dr Offit said.

But if the FDA fully cleared a vaccine, doctors would have a lot more leeway to prescribe a booster for their patients. Some health experts expect Pfizer to receive this approval by the fall.

At the CDC’s advisory committee meeting on Thursday, Dr Cohn, the medical officer for the vaccine division, suggested that it would be possible to offer booster shots to people with weakened immune systems through experimental study or other means, without waiting for the FDA.

Dr Camille Kotton, an infectious disease expert at Massachusetts General Hospital, told the panel that some patients, especially those who are more educated or “allowed to take care of their own health care,” manage to get a third dose by themselves. , despite the lack of a green light from the government.

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“Many have taken matters into their own hands,” she said. “I’m worried they’re doing this stuff without supervision,” she said, as doctors’ hands are tied due to lack of regulatory approval.

People with weakened immune systems make up 2.7 percent of the population, according to the CDC, and include people with cancer, organ or stem cell transplants, or HIV, among other conditions.

During the hearing of the Senate Health Committee on Tuesday, several senators questioned the health officials of the administration on the deadline within which they would act on the issue of boosters. Senator Mitt Romney, a Republican from Utah, said he was unhappy officials couldn’t come up with a better timeline.

Senator Richard M. Burr, a Republican from North Carolina, noted that Israel is already offering some of its most vulnerable citizens a third chance. “Why don’t we make the same decisions? ” He asked.

CDC director Dr Rochelle Walensky said scientists were studying the effectiveness of vaccines in tens of thousands of people, including nursing home residents and more than 5,000 essential workers.

“Fortunately, we expect it to go down and not go down,” she said of their effectiveness. “As we see this decline, we – this will be our time to act. “

Pfizer is expected to publish its clinical trial research on declining immunity and the benefits of a booster soon in peer-reviewed journal articles. Moderna has yet to release data on the booster studies, officials said.

Johnson & Johnson’s single-dose vaccine has so far played a minor role in the country’s vaccination campaign. Data from clinical trials on how this vaccine works with two injections is expected next month.

Noah Weiland contributed reports.

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