U.S. to Advise Boosters for Most Americans 8 Months After Vaccination

WASHINGTON – The Biden government has decided that most Americans should have a coronavirus booster vaccination eight months after receiving their second vaccination and could start offering third vaccinations as early as mid-September, according to administrative officials familiar with the discussions.

Officials want to announce the decision later this week. Their goal is to let Americans who have received the Pfizer BioNTech or Moderna vaccines know now that they need additional protection against the Delta variant, which is causing case numbers to rise across much of the country. The new policy is subject to approval of additional syringes from the Food and Drug Administration.

Officials said they expect recipients of the Johnson & Johnson vaccine, which has been approved as a one-dose regimen, will also need an additional dose. But they are waiting for the results of the two-dose clinical trial from this company, which is expected later this month.

The first boosters should go to nursing home residents, health workers and rescue workers. They would likely be followed by other elderly people who were on the front lines at the start of vaccinations late last year, then the general population. Officials envision giving people the same vaccine they were originally given.

The decision is made as the Biden government struggles to regain control of a pandemic it allegedly tamed a little over a month ago. President Biden had declared the nation reopened to normal life for the July 4th holiday, but the spread of the Delta Variant wildfires has thwarted this. Covid-19 patients are again overwhelming hospitals in some states, and federal officials are concerned about an increase in the number of children being hospitalized at the beginning of the school year.

For weeks, officials in the Biden administration have been analyzing the rise in Covid-19 cases, trying to find out whether the Delta variant is better able to avoid vaccines or whether the vaccines have lost strength over time. According to some administrative experts, either could be true, a worrying combination that is resurrecting a pandemic the nation fervently hoped has been contained.

Dr. Francis S. Collins, director of the National Institutes of Health, told Fox News Sunday that “there is concern that the vaccine may wear off.” That, combined with the ferocity of the Delta variant, could dictate boosters, he said.

Federal health officials were particularly concerned about data from Israel suggesting the Pfizer BioNTech vaccine’s protection against serious illness has fallen significantly in older people who received their second vaccination in January or February.

Israel can in some ways be seen as a role model for the United States, having vaccinated a larger portion of its population faster and using almost exclusively the Pfizer BioNTech vaccine, which made up much of the US population. Unlike the United States, however, Israel has a nationalized health system that allows patients to be systematically tracked.

The latest Israeli data, released Monday on the government’s website, shows what some experts consider to be the ongoing erosion of the Pfizer vaccine’s effectiveness against mild or asymptomatic Covid-19 infections in general and against serious illnesses in the elderly who vaccinated early, have described the year.

Updated

Aug. 16, 2021, 10:32 p.m. ET

One slide suggests that for those over 65 who received their second vaccination in January, the vaccine is only about 55 percent effective against serious illnesses. However, the researchers found that the data had a large margin of error, and some said that other Israeli government data suggested that the decline in effectiveness was less severe.

“It’s showing a pretty big drop in effectiveness against infections, but it’s still a little unclear about protection against serious diseases,” said Dr. Peter J. Hotez, a vaccines expert at Baylor College of Medicine in Houston, who contributed the data. checked the New York Times request.

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

Understand the state of vaccination and masking requirements in the United States

    • Mask rules. The Centers for Disease Control and Prevention in July recommended that all Americans, regardless of vaccination status, wear masks in public places indoors in areas with outbreaks, reversing the guidelines offered in May. See where the CDC guidelines would apply and where states have implemented their own mask guidelines. The battle over masks is controversial in some states, with some local leaders defying state bans.
    • Vaccination regulations. . . and B.Factories. Private companies are increasingly demanding corona vaccines for employees with different approaches. Such mandates are legally permissible and have been confirmed in legal challenges.
    • College and Universities. More than 400 colleges and universities require a vaccination against Covid-19. Almost all of them are in states that voted for President Biden.
    • schools. On August 11, California announced that teachers and staff at both public and private schools would have to get vaccinated or have regular tests, the first state in the nation to do so. A survey published in August found that many American parents of school-age children are against mandatory vaccines for students but are more likely to support masking requirements for students, teachers and staff who are not vaccinated.
    • Hospitals and medical centers. Many hospitals and large health systems require their employees to have a Covid-19 vaccine, due to rising case numbers due to the Delta variant and persistently low vaccination rates in their communities, even within their workforce.
    • new York. On August 3, New York City Mayor Bill de Blasio announced that workers and customers would be required to provide proof of vaccination when dining indoors, gyms, performances, and other indoor situations. City hospital staff must also be vaccinated or have weekly tests. Similar rules apply to employees in New York State.
    • At the federal level. The Pentagon announced that it would make coronavirus vaccinations compulsory for the country’s 1.3 million active soldiers “by mid-September at the latest. President Biden announced that all civil federal employees would need to be vaccinated against the coronavirus or undergo regular tests, social distancing, mask requirements and travel restrictions.

Federal officials said the booster program will most likely follow the same scenario as the initial vaccination program. The first syringes for the general public in the United States were given on December 14, days after the FDA approved the Pfizer emergency shot. A week later, people received the Moderna vaccine.

While frontline health workers and nursing home residents were among the first to be vaccinated nationwide, states had their own plans for who else would be vaccinated during the first weeks and months of the vaccination campaign.

But almost everyone over 65 will have qualified for a vaccination by the end of February, as have many police officers, teachers, grocery store workers, and others exposed to the virus in the workplace.

The regulatory path for additional recordings is not entirely clear. Pfizer-BioNTech filed data with the FDA on Monday demonstrating the safety and effectiveness of a booster vaccination. But the data was preliminary, from a phase 1 clinical trial. Moderna is following a similar path, studying the safety and effectiveness of both half and full doses as a third shot.

The World Health Organization has called for a moratorium on booster vaccinations until the end of September, stating that the doses available should be used to help countries lagging far behind on vaccinations. But Israel is already offering third recordings to those who are at least 50 years old. Germany and France have announced that they will offer additional vaccinations to vulnerable populations next month. Britain has a plan to do so, but is holding back for the time being.

Late last week, the FDA approved third doses of the Pfizer and Moderna vaccines for certain people with compromised immune systems, and the Centers for Disease Control and Prevention recommended them. Authorities decided that these people, who make up less than 3 percent of Americans, deserve extra shots as many do not respond to the standard dose. The agency has not yet approved any of the vaccines for children under the age of 12.

Noah Weiland contributed the reporting.

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