The United States advises on boosters for most Americans 8 months after vaccination


WASHINGTON — The Biden administration has decided that most Americans will get a booster vaccine for the coronavirus eight months after they receive the second one, and they could begin offering the third vaccinations as early as mid-September, according to administration officials familiar with the discussions.

Officials plan to announce the decision early this week. Their goal is to let Americans who have received the Pfizer-BioNTech or Moderna vaccines know now that they will need additional protection against the delta variant that 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 authorization of additional doses.

Officials said they expect recipients of the Johnson & Johnson vaccine, which is authorized as a single-dose regimen, will also need an extra dose. But they are waiting for the results of this company’s two-dose clinical trial, expected later this month.

The first reinforcements are likely to go to nursing home residents, health care workers and emergency workers. They will likely be followed by other seniors who were near the front of the line when vaccinations began late last year, and then by the general population. Officials envision giving people the same vaccine they originally received.

The decision comes as the Biden administration struggles to regain control of a pandemic it claimed was tamed just over a month ago. President Biden announced that the nation reopened to normal for the July 4 holiday, but the spread of wildfires in the Delta variant thwarted that. Once again, Covid-19 patients are overcrowded in hospitals in some states, and federal officials are concerned that more children will be hospitalized altogether as the school year begins.

For weeks, Biden administration officials have been analyzing the spike in Covid-19 cases, trying to figure out whether the delta variant was more likely to evade vaccines or whether vaccines have waned aggressively over time. According to some management experts, both could be true, a sad combination that is reinvigorating a pandemic that the nation so desperately hoped would be curbed.

Dr. Francis Collins, Director of the National Institutes of Health, For “Fox News Sunday” That “there are concerns that the vaccine may start to wear off.” That, combined with the ferocity of the delta variable, could dictate the reinforcements, he said.

Federal health officials have been particularly concerned about data from Israel indicating that the Pfizer-BioNTech vaccine’s protection against severe disease has fallen dramatically for older adults who got their second vaccine in January or February.

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

The latest Israeli data, published on the government’s website on Monday, shows what some experts have described as the continued erosion of the effectiveness of the Pfizer vaccine against mild or asymptomatic Covid-19 infections in general and against severe disease among older vaccinated early. the year.

One slide indicates that for those 65 and older who got their second vaccine in January, the vaccine is now only 55 percent effective against severe disease. But the researchers noted that the data had a wide margin of error, and some said other Israeli government data suggested the decline in effectiveness was less severe.

Dr. Peter J. said: Hotez, a vaccine expert at Baylor College of Medicine in Houston, who reviewed the data in the New York Times request.

Dr. Jesse L. Goodman, a former chief scientist at the Food and Drug Administration who also reviewed the data, said it points to “worrying trends” that could indicate a declining efficacy of the vaccine. But he said he would like to see more details from Israel and, more importantly, data indicating whether the United States is heading in the same direction.

Federal officials said the boosted program will likely follow the same scenario as the initial vaccination program. First shots of the general public in the United States It was administered on December 14th, days after the US Food and Drug Administration authorized the Pfizer syringe for emergency use. People started receiving the Moderna vaccine a week later.

While frontline health care workers and nursing home residents were among the first to get vaccinated nationwide, states followed their own plans for who else was eligible for injections in the early weeks and months of the vaccination campaign.

But all people 65 and older have qualified for the vaccination by late February, as have many police officers, teachers, grocery staff and other people at risk of contracting the virus on the job.

The regulatory path of additional snapshots is not entirely clear. Pfizer-BioNTech submitted data to the Food and Drug Administration on Monday that it said showed the safety and efficacy of a booster dose. But the data was preliminary, from a phase I clinical trial. Moderna is on a similar path, exploring the safety and efficacy of both a half-dose and a full-dose as a third injection.

The World Health Organization has called for a moratorium on the use of booster doses until the end of September, saying that available doses should be used to help countries behind in vaccinations. But Israel does provide third doses to those at least 50 years old. Germany and France said they plan to provide additional doses to vulnerable segments of their population next month. Britain has a plan to do so, but for now it is delaying.

Late last week, the US Food and Drug Administration (FDA) The authorized third doses of Pfizer and Moderna vaccines For some people with weakened immune systems, The Centers for Disease Control and Prevention recommended. The authorities decided that these individuals, who make up less than 3 percent of Americans, deserve additional doses because many do not respond to the standard dose. The agency has not yet authorized any vaccines for children under 12 years of age.

Noah Welland Contribute to the preparation of reports.

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