Biden officials are now hoping that vulnerable Americans need booster shots

Health officials in the Washington-Biden administration believe that vulnerable populations need boosters, despite ongoing research into the shelf life of the coronavirus vaccine.

Currently, senior officials predict that people over the age of 65, or those with a weakened immune system, are likely to need a third shot from Pfizer-BioNTech or Moderna, the majority. Two vaccines based on the same technique used for inoculation Americans so far. This is a radical change from just a few weeks ago when the government thought there wasn’t enough evidence to support boosters yet.

On Thursday, key officials at the US Centers for Disease Control and Prevention sought an option to give patients with a weakened immune system a third dose, even before regulators expanded their emergency use authorization for the coronavirus vaccine. I said there is. vaccination.

Dr. Amanda Corn, Chief Medical Officer of the CDC Immunization department,Said Advisory Committee Authorities told the agency that they were “actively considering ways” to provide certain people with access to booster shots “earlier than potential changes in regulatory decisions.”

“So look forward to it,” she added.

The growing consensus within the administration that at least some Americans need boosters is partly linked to studies suggesting that the Pfizer vaccine is less effective against the coronavirus after about six months. To date, more than half of all fully vaccinated people in the United States have been vaccinated with Pfizer twice every three weeks.

According to a continuous global study of Pfizer clinical trial participants, the effectiveness of the vaccine against symptomatic infections drops from 95% to 84% 4-6 months after the second dose.

Data from the Israeli government, which has fully vaccinated Pfizer in more than half of its population since January, also show a tendency to become less effective over time, but due to the wide error margins of government officials. I’m looking carefully at that data.

Latest numbers Pfizer’s vaccine was only 39% effective in preventing infections in late June and early July, compared to 95% in January-April, according to a report released later this week by the Israeli Ministry of Health.

The vaccine was more than 90% effective in preventing serious illness and was about as effective in preventing hospitalization. On July 12, Israel began offering a third dose of Pfizer to citizens with significantly weakened immunity.

Dr. Anthony S. Forch, head of the National Institutes of Health’s Infectious Diseases Division, said he was surprised at the apparent sharp decline in the effectiveness of the Pfizer vaccine, as Israeli data suggest. He said he wanted to compare it to the data that the CDC had collected from a cohort of thousands of people across the United States. “People are like raising their eyebrows a little,” he said.

There are many other questions, but senior government officials say that the vaccine does not give indefinite immunity to the virus, and that at least some people may need a booster, perhaps nine months after the first injection. Said it seemed to be more and more apparent. The government has already purchased enough vaccine to give both Pfizer and Modana a third dose and is quietly preparing to expand its distribution efforts as needed.

Many health officials and experts have spoken carefully about booster shots, as there is very little data available yet.Dr. Paul A. Ofit, a member of the Food and Drug Administration External advisory board According to the proportion of vaccination specialists, an increase in mild or moderate cases of Covid-19 among vaccinated people does not necessarily mean that booster immunization is required.

“The purpose of this vaccine is not to prevent mild or moderate moderate infections,” he said. “The goal is to prevent death from hospitalization. Currently, this vaccine is tolerant.”

Other health experts have warned that prematurely hanging the prospect of a third dose may also act as a deterrent to vaccination. If Americans consider immunity from the vaccine to be short-lived, they said they may be unlikely to get their first shot.

“When talking about boosters, I don’t want people to believe that it means vaccines aren’t effective,” Dr. Forch testified at a parliamentary hearing on Tuesday. “They are very effective.”

Among vaccine manufacturers, Pfizer has been particularly active in sharing data with the government. But this month, the government was surprised by the company’s official announcement that it plans to seek emergency permission from the FDA for booster shots.

According to the company, early data from the Booster study showed that clinical trial participants who received the third dose 6 months after the second dose had levels of neutralizing antibody of 5 to 5 of the recipients of the second dose. It was 10 times.

Fearing that Americans would receive the wrong message, the FDA and CDC responded to a rare official statement that “fully vaccinated Americans do not need booster shots at this time.” They added, “If science shows that a booster effect is needed, then the booster effect is ready.”

The FDA usually approves the use of boosters, perhaps after a meeting of an external advisory board. Later, the CDC, which has its own advisory board, needs to formally recommend it, Dr. Ofit said.

However, if the FDA fully approves the vaccine, physicians have much more room to prescribe booster immunity to patients. Some health professionals expect Pfizer to be approved by this fall.

At a CDC advisory board meeting on Thursday, Dr. Korn, head of medical care for the vaccine department, may be able to provide booster shots to people with weakened immune systems through research or other means without waiting for the FDA. I suggested that it wasn’t.

Dr. Camille Cotton, an infectious disease specialist at Massachusetts General Hospital, said that some patients, especially those who were more educated or “authorized to manage their own health,” were the third on their own. He told the panel that he was able to receive the dose. , Despite the lack of green light from the government.

“Many people solved the problem with their own hands,” she said. “I’m worried they’re doing this kind of thing in an unsupervised way,” she said.

People with weakened immunity make up 2.7% of the population. According to the CDC, And, among other conditions, include patients with cancer, organ or stem cell transplantation or HIV.

At a Senate Health Commission Tuesday hearing, some senators burned government health officials on how quickly they would act on booster issues. Utah Republican Senator Mitt Romney said he was dissatisfied with the authorities’ inability to provide a better schedule.

North Carolina Republican Senator Richard M. Barr said Israel has already provided third shots to some of its most vulnerable citizens. “Why don’t we make the same decision?” He asked.

Dr. Rochelle Walensky, director of the CDC, testified that scientists are studying the effectiveness of vaccines in tens of thousands of people, including nursing home residents and more than 5,000 key workers.

“Fortunately, we don’t expect this to decline and plunge,” she said of its effectiveness. “When we see that decline, we-it will be the time of our actions.”

Pfizer will soon publish a clinical trial study on the benefits of booster shoots in a journal article on weakened immunity and peer review. Moderna has not yet released data on booster research, officials said.

Johnson & Johnson’s one-shot vaccine has so far played a small role in national vaccination campaigns. Clinical trial data on how the vaccine works two-shot is expected next month.

Noah Wayland Contribution report.