US prepares to vaccinate vulnerable people with booster dose

Health officials in the administration of Joe biden considers it increasingly likely that vulnerable populations will need booster vaccines, even while investigating how long coronavirus vaccines remain effective.

Officials now say they expect people over 65 or with weakened immune systems will probably need a third injection of Pfizer–BioNTech O Modern, two vaccines based on the same technology that have so far been used to inoculate the vast majority of Americans. This is a dramatic change from a few weeks ago when management said they believed there was not enough evidence to support the reinforcements.

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

Dr. Amanda Cohn, chief medical officer of the CDC’s immunization division, told an agency advisory committee that those responsible were “In active search for resources” allow certain people to have access to booster vaccines “before any potential change in regulatory decisions”. “So stay tuned”he added.

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

Pfizer’s ongoing global study of participants in its clinical trials shows that, four to six months after the second dose, the efficacy of the vaccine against symptomatic infection decreases from a maximum of 95% to 84%, according to the company.

Government data Israeli, which has fully immunized more than half of its population with doses of Pfizer since January, they also indicate to thea declining trend in efficiency over time, although administration officials treat these data with caution due to the wide margins of error.

Latest figures from Israel’s Health Ministry, released later this week, suggest Pfizer’s vaccine was just one 39% effectiveness in preventing infection in this country in late June and early July, against 95% from January to April.

The vaccine remained over 90% effective in preventing serious disease, and almost as effective in preventing hospitalization. Israel has started offering citizens a third dose of Pfizer with a severely weakened immune system, the July 12.

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

Although there are other questions, Senior administration officials said it seemed increasingly clear that vaccines would not grant indefinite immunity to the virus., and it might be necessary booster dose for at least some people maybe new month later of your first injection. The administration has already purchased more than enough vaccine to provide the third doses of Pfizer and Moderna, and has quietly prepared to expand the distribution effort, if necessary.

With so little data still public, many health officials and experts have spoken with caution about booster shots. Dr Paul Offit, a member of the Food and Drug Administration (FDA) External Advisory Committee on Vaccines, said an increase in mild to moderate cases of COVID-19 in people vaccinated. this did not necessarily mean that strengthening was necessary.

“The aim of this vaccine is not to prevent mild or moderate infectious diseases”, He said. “The objective is avoid hospitalization until death. At the moment, this vaccine has fulfilled that ”.

Other health experts warn that prematurely offering the possibility of a third dose could also discourage vaccination. If Americans think immunity to vaccines is short-lived, they may be less likely to get the vaccine for the first time.

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

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

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

Fearing that the American public would receive the wrong message, the FDA and CDC responded with a unusual public statement in which they said: “Americans who have been fully vaccinated they don’t need a reminder at the moment “. They added: “We are ready for the booster doses. if science shows that they are necessary ”.

Normally, the FDA would allow the use of a booster dose, perhaps after a meeting of its external advisory committee. Then the CDC, which has its own advisory committee, I should recommend it formally, said Dr Offit.

But if the FDA fully clears a vaccine, physicians would have much more leeway to prescribe a booster to their patients. Some health experts are hoping Pfizer can receive this approval by the fall.

At the CDC’s advisory committee meeting on Thursday, Dr Cohn, chief medical officer of the vaccine division, suggested that it might be possible to offer booster vaccines to people with weakened immune systems through research study or other avenues, without waiting for the FDA.

Dr Camille Kotton, Expert in Infectious diseases Massachusetts General Hospital, told the panel that some patients, especially those who are more educated or “The power to take care of your own health”, they manage to get a third dose on their own, despite the lack of a green light from the government.

“Many have taken matters into their own hands”, He said. “I’m afraid they are doing it in an unsupervised manner,” he said, as doctors have the hands tied due to lack of regulatory approval.

People with weakened immune systems represent 2.7% of the population, according to the CDC, and include those who have Cancer, grafts organ or stem cells, or Infectious diseases, among others.

At Tuesday’s hearing of the Senate Committee on Health, several senators asked health officials in the administration about how quickly they would act on the reinforcers issue. Utah Republican Senator Mitt Romney was not satisfied that officials were unable to provide a more appropriate timeline.

North Carolina Republican Senator Richard Burr noted that Israel is already offering a third injection to some of its most vulnerable citizens. “Why don’t we make the same decisions? I ask.

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

“Fortunately, we expect it to decrease and not drop”said about its effectiveness. “When we see this decrease, we … this will be our time to act ”.

Pfizer is expected to publish its research on immunity reduction clinical trials soon. and the benefits of a booster injection in peer-reviewed journal articles. Moderna has yet to release data from recall studies.

The single injection vaccine of Johnson & johnson it 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.

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