US to recommend boosters to most Americans 8 months after vaccination



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WASHINGTON – The Biden administration has decided that most Americans should receive a coronavirus booster shot eight months after receiving their second injection, and could begin offering a third injection as early as mid-September, according to officials from the administration familiar with the discussions.

Authorities plan to announce the decision as early as this week. Their goal is to let Americans who have received the Pfizer-BioNTech or Moderna vaccines know that they will need additional protection against the Delta variant which is causing an increase in the number of cases in much of the country. The new policy will depend on the Food and Drug Administration’s approval for additional shots.

Officials said they expected recipients of the Johnson & Johnson vaccine, which was cleared as a single-dose regimen, would also need an additional dose. But they are awaiting the results of the company’s two-dose clinical trial, due later this month.

The first recalls will likely go to residents of nursing homes, healthcare workers and first aid workers. They would likely be followed by other seniors who were near the front line when vaccinations started late last year, and then by the general population. Authorities are considering giving people the same vaccine they originally received.

The move comes as the Biden administration struggles to regain control of a pandemic it claimed to have tamed just over a month ago. President Biden had declared the nation reopened to normal life for the July 4 vacation, but the spread of the Delta variant wildfire thwarted that. Covid-19 patients are once again overwhelming hospitals in some states, and federal officials worry about an increase in the number of children hospitalized just as the school year begins.

For weeks, officials in the Biden administration have analyzed the increase in Covid-19 cases, trying to determine if the Delta variant is better able to evade vaccines or if vaccines have lost strength over time. time. According to some administration experts, the two could be true, a distressing combination that reignites a pandemic the nation fervently hoped was stemmed.

Dr Francis S. Collins, director of the National Institutes of Health, told “Fox News Sunday” that “there are concerns that the vaccine is starting to decline.” That, combined with the ferocity of the Delta variant, could dictate the boosters, he said.

Federal health officials have been particularly concerned about data from Israel suggesting that the protection of the Pfizer-BioNTech vaccine against serious illness has declined significantly for older people who received their second injection in January or February.

Israel can in some ways be seen as a model for the United States as it vaccinated more of its population faster and almost exclusively used the Pfizer-BioNTech vaccine which made up a large part of the US stockpile. Unlike the United States, however, Israel has a nationalized healthcare system that allows it to systematically track patients.

The latest Israeli data, released on the government website on Monday, shows what some experts have described as continued erosion of the effectiveness of the Pfizer vaccine against mild or asymptomatic Covid-19 infections in general and serious illnesses in general. elderly people who were vaccinated at the start of the year.

One slide suggests that for those 65 or older who received their second injection in January, the vaccine is now only about 55% effective against serious illness. But the researchers noted that the data has a large margin of error, and some said other Israeli government data suggested the drop in efficiency was less severe.

“This shows a pretty big drop in efficacy against infections, but protection against serious disease remains a bit unclear,” said Dr Peter J. Hotez, vaccine expert at Baylor College of Medicine in Houston, who has reviewed data at the request of the New York Times.

Dr Jesse L. Goodman, a former chief scientist with the Food and Drug Administration who also reviewed the data, said it suggested “worrying trends” that could signal a decline in the vaccine’s effectiveness. But he said he would like to see more details from Israel and, more importantly, data showing whether the United States is moving in the same direction.

Federal officials have said the booster program will most likely follow much the same scenario as the original vaccination schedule. The first shots intended for the general public in the United States were administered on December 14, days after the FDA cleared the Pfizer vaccine for emergency use. People started getting the Moderna vaccine a week later.

While frontline health workers and nursing home residents were among the first to be vaccinated nationally, states followed their own plans to determine who else was eligible for vaccines at the national level. during the first weeks and months of the vaccination campaign.

But almost everyone 65 and over qualified for the vaccination in late February, as did many police officers, teachers, grocery store workers and others at risk of exposure to the virus at work.

The regulatory path for additional shots is not entirely clear. Pfizer-BioNTech on Monday filed data with the FDA that it said showed the safety and effectiveness of a booster. But the data was preliminary, from phase 1 of a clinical trial. Moderna is on a similar path, exploring the safety and effectiveness of a half dose and a full dose as a third injection.

The World Health Organization has called for a moratorium on booster injections until the end of September, saying the available doses should be used to help countries far behind in immunization. But Israel is already offering third blows to those who are at least 50 years old. Germany and France have said they plan to offer additional injections to vulnerable segments of their population next month. Britain has a plan to do it, but is waiting for now.

At the end of last week, the FDA cleared third doses of the Pfizer and Moderna vaccines for some people with weakened immune systems, and the Centers for Disease Control and Prevention recommended them. Authorities have decided that these individuals, who make up less than 3% of Americans, deserve additional injections because many do not respond to the standard dose. The agency has yet to authorize any vaccines for children under 12.

Noah Weiland contributed report.

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