WASHINGTON — The Biden administration has decided that most Americans should receive a coronavirus booster vaccination eight months after receiving their second shot, and could begin offering third injections as early as mid-September, according to government officials familiar with the virus. discussions.
Officials plan to announce the decision this week. Their goal is to let Americans who have received the Pfizer-BioNTech or Moderna vaccines now know that they need extra protection against the Delta variant that is causing the number of cases to rise in much of the country. The new policy will depend on Food and Drug Administration approval for additional shots.
Officials said they expect recipients of the Johnson & Johnson vaccine, which was approved as a single dose, will also need an additional dose. But they’re waiting for the results of that company’s two-dose clinical trial, which is expected later this month.
The first boosters are likely to go to nursing home residents, health professionals and care providers. They would likely be followed by other older people who were first in line when vaccinations started late last year, and then by the general population. Officials are imagining giving people the same vaccine they were originally given.
The decision comes as the Biden administration struggles to regain control of a pandemic it claimed had tamed just over a month ago. President Biden had stated that the country had reopened to normal living for the July 4 holiday, but the wildfire spread of the Delta variant has thwarted that. Covid-19 patients are once again overwhelming hospitals in some states, and federal officials are concerned about an increase in the number of children being hospitalized just as the school year begins.
For weeks, officials in the Biden administration have been analyzing the increase in Covid-19 cases to find out whether the Delta variant is better able to dodge the vaccines or if the vaccines have declined in strength over time. According to some government experts, both could be true, a disturbing combination that is breathing new life into a pandemic the nation fervently hoped had been contained.
dr. Francis S. Collins, the director of the National Institutes of Health, told “Fox News Sunday” that “there is a concern that the vaccine may be starting to decline.” That, coupled with the ferocity of the Delta variant, could dictate boosters, he said.
Federal health officials were particularly concerned about data from Israel suggesting that the protection of the Pfizer-BioNTech vaccine against serious illnesses has decreased significantly for elderly people who received their second injection in January or February.
Israel can in some ways be seen as a template for the United States, as it has vaccinated more of its population more quickly, using almost exclusively the Pfizer-BioNTech vaccine that made up much of the US supply. However, unlike the United States, Israel has a nationalized health care system that allows it to monitor patients systematically.
The latest Israeli data, posted on the government’s website on Monday, shows what some experts described as continued erosion of the effectiveness of the Pfizer vaccine against mild or asymptomatic Covid-19 infections in general and against serious illnesses. in elderly vaccinated early in the year. the year.
One slide suggests that for those 65 or older who received their second shot in January, the vaccine is now only about 55 percent effective against serious illness. But researchers noted that the data has a large margin of error, and some said other data from the Israeli government suggested the decline in efficacy was less severe.
“It shows a pretty strong decrease in effectiveness against infection, but it’s still a bit obscure about protection against serious disease,” said Dr. Peter J. Hotez, a vaccine expert at Baylor College of Medicine in Houston, who reviewed the data at the request of NewsMadura.
dr. Jesse L. Goodman, a former chief scientist at the Food and Drug Administration who also reviewed the data, said it suggests “troubling trends” that could indicate declining vaccine effectiveness. 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.
Understand the State of Vaccine and Mask Mandates in the US
- Mask Rules. The Centers for Disease Control and Prevention recommended in July that all Americans, regardless of vaccination status, wear masks in indoor public places in areas with outbreaks, a reversal of the guidance it offered in May. Find out where CDC guidelines apply and where states have their own masking policies. The battle over masks has become controversial in some states, with some local leaders defying state bans.
- Vaccine rules. . . and Buselessness. Private companies are increasingly mandating coronavirus vaccines for employees, taking different approaches. Such mandates are permitted by law and have been confirmed in court proceedings.
- College and universities. More than 400 colleges and universities are demanding that students be vaccinated against Covid-19. Nearly 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 should be vaccinated or tested regularly, the first state in the nation to do so. A survey published in August found that many U.S. parents of school-aged children are opposed to mandatory vaccines for students, but were more in favor of mask mandates for students, teachers and staff who have not received their injections.
- Hospitals and Medical Centers. Many hospitals and major health systems require workers to receive a Covid-19 vaccine, citing the increasing caseload fueled by the Delta variant and persistently low vaccination coverage in their communities, even within their workforce.
- New York. On August 3, New York City Mayor Bill de Blasio announced proof of vaccination would be required from employees and customers for indoor meals, gyms, performances and other indoor settings, becoming the first U.S. city to require vaccines for a wide variety of activities. . City hospital employees should also receive a vaccine or be tested weekly. Similar rules apply to employees in New York State.
- At the federal level. The Pentagon announced it would aim to make coronavirus vaccinations mandatory for the country’s 1.3 million active-duty troops “by mid-September.” President Biden announced that all civilian federal employees would be required to be vaccinated against the coronavirus or undergo regular testing, social distancing, mask requirements and restrictions on most travel.
Federal officials said the booster program will most likely follow the same scenario as the initial vaccination program. The first injections to the general public in the United States were administered on December 14, days after the FDA approved the Pfizer injection for emergency use. People got the Moderna vaccine a week later.
While primary care workers and nursing home residents were among the first to be vaccinated nationwide, states followed their own plans for who else was eligible for shots in the early weeks and months of the vaccination campaign.
But nearly everyone 65 and older was eligible for vaccination at the end of February, as were many police officers, teachers, grocery store workers and other people at risk of being exposed to the virus on the job.
The regulatory path for additional shots is not entirely clear. Pfizer-BioNTech submitted data to the FDA on Monday demonstrating the safety and effectiveness of a booster injection. But the data was preliminary, from phase 1 of a clinical trial. Moderna is on a similar track, investigating the safety and efficacy of both a half-dose and full-dose third injection.
The World Health Organization has called for a moratorium on booster shots until the end of September, saying the available doses should be used to help countries that are lagging far behind on vaccinations. But Israel is already offering third shots to people at least 50 years old. Germany and France have said they plan to offer additional shots to vulnerable sections of their populations next month. Britain has a plan to do this, but is holding it off for now.
Late last week, the FDA approved third doses of the Pfizer and Moderna vaccines for certain people with weakened immune systems, and the Centers for Disease Control and Prevention recommended them. Authorities decided that those individuals, who make up less than 3 percent of Americans, deserved additional injections because many failed to respond to the standard dosage. The agency has not yet approved any of the vaccines for children under the age of 12.
Noah Weiland reporting contributed.