Biden Officials Now Expect Vulnerable Americans to Need Support Shots


WASHINGTON — Biden administration health officials are increasingly considering that vulnerable populations will need booster vaccines, even as research continues into how long coronavirus vaccines will remain effective.

Senior officials now say they expect people aged 65 and older or those with compromised immune systems to need a third shot from Pfizer-BioNTech or Moderna, two vaccines based on the same technology the vast majority used to vaccinate. That’s a stark change from a few weeks ago, when the administration said it didn’t think there was enough evidence to support boosters yet.

On Thursday, a key official from the Centers for Disease Control and Prevention said the agency was exploring options for giving third doses to patients with compromised immune systems before regulators expand their emergency use mandate for coronavirus vaccines; This step may come soon for Pfizer. vaccine.

The CDC’s chief medical officer, Dr. Amanda Cohn immunization department, a advisory committee It reported to the agency that authorities are “actively looking for ways” to ensure certain people have access to supporting shots “before any possible change in regulatory decisions”.

“So stay tuned,” he added.

The growing consensus within the administration that at least some Americans will need a supplement is due in part to research suggesting that the Pfizer vaccine is less effective against coronavirus after about six months. More than half of those fully vaccinated so far in the United States received the Pfizer vaccine in two doses administered three weeks apart.

Pfizer’s ongoing global research on clinical trial participants shows that four to six months after the second dose, the vaccine’s effectiveness against symptomatic infection dropped from 95 percent to 84 percent, according to the company.

Data from the Israeli government, which has fully vaccinated more than half of its population with Pfizer doses since January, point to a downward trend in effectiveness over time, although administration officials are wary of this data due to the wide margin of error.

latest figures A report by the Israeli Ministry of Health, released late this week, suggested that Pfizer’s vaccine was only 39 percent effective in preventing infection in that country in late June and early July, compared to 95 percent in the January-April period.

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

Head of the infectious disease division of the National Institutes of Health, Dr. Anthony S. Fauci said he was surprised by the apparent sharp decline in the effectiveness of the Pfizer vaccine, as Israeli data suggest. He said he wanted to compare it with data the CDC had gathered from the community of thousands of people in the United States. “People raise their eyebrows a little bit,” he said.

While other questions abound, senior management officials said it seems increasingly clear that vaccines will not provide indefinite immunity against the virus, and that for at least some people, vaccines may be necessary nine months after their first vaccination. Management has purchased more vaccines than needed to deliver third doses of both Pfizer and Moderna and is quietly preparing to expand its distribution efforts if necessary.

With little publicly available data yet, many health officials and experts have spoken cautiously about booster vaccines. Dr. Paul A. Offit, member of the Food and Drug Administration external advisory committee Some of the vaccine experts said that the increase in mild or moderate Covid-19 cases among vaccinated people does not necessarily mean that a vaccine is necessary.

“The purpose of this vaccine is not to prevent mild or low to moderate infectious diseases,” he said. “The aim is to prevent death by being hospitalized. Right now this vaccine is based on that.”

Other health experts warn that early suspension of the possibility of a third dose may also act as a deterrent to the vaccine. They said that if Americans feel that immunity from vaccines is short-lived, they may be less likely to get their first shot.

Dr. Fauci testified at a congressional hearing on Tuesday: “We don’t want people to believe that when you talk about boosters, that means vaccines aren’t effective.” “They’re extremely effective.”

Among vaccine manufacturers, Pfizer has been particularly proactive in sharing its data with the government. But management was surprised to see that the company’s public announcement this month plans to seek emergency clearance from the FDA for a booster shot.

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

Fearing that the American public would get the wrong message, the FDA and CDC reacted with an unusual public statement saying, “Fully vaccinated Americans do not need a booster shot right now.” We’re ready for booster doses if science shows it’s necessary,” they added.

Typically, the FDA authorizes the use of a booster, perhaps after a meeting of the external advisory committee. Dr. The CDC, which then has its own advisory committee, would have to formally recommend it, Offit said.

But if the FDA fully licenses a vaccine, doctors will have much more freedom to prescribe a vaccine to their patients. Some healthcare professionals expect Pfizer to receive that approval this fall.

At Thursday’s meeting of the CDC advisory panel, the vaccine division’s paramedic, Dr. Cohn suggested that it might be possible to offer booster vaccines to those with compromised immune systems, whether through a research study or other means, without waiting for the FDA.

An infectious disease specialist at Massachusetts General Hospital, Dr. Camille Kotton told the panel that some patients, particularly those who were more educated or “authorized to take care of their own health,” were able to get a third dose on their own. Although there is no green light from the government.

“Many took matters into their own hands,” he said. “I’m worried they’re doing it in this kind of unsupervised way,” he said, while doctors’ hands were tied for lack of regulatory approval.

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

At Tuesday’s Senate health committee hearing, several senators questioned administration medics about how soon they would take action on boosters. Utah Republican Senator Mitt Romney said he was unhappy that officials were unable to provide a better timeline.

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

CDC’s director, Dr. Rochelle Walensky stated that scientists have examined the effectiveness of vaccines in tens of thousands of people, including those living in nursing homes and more than 5,000 essential workers.

“Fortunately, we anticipate that this will decrease and not drop,” he said. “When we see that decreasing, we — it’s going to be our time to act.”

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

Johnson & Johnson’s one-shot vaccine has so far played a minor role in the nation’s vaccination campaign. Clinical trial data on how this vaccine works with two shots is expected next month.

Noah Weiland contributing reporting.


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