The Food and Drug Administration would first need to decide that third doses are safe and effective for Pfizer-BioNTech and Moderna, the two vaccines that were rolled out first and have been most used.,
The U.S. will advise most Americans to get booster shots eight months after vaccination.
The Food and Drug Administration would first need to decide that third doses are safe and effective for Pfizer-BioNTech and Moderna, the two vaccines that were rolled out first and have been most used.
Preparing doses in New York. Clinical trials are underway to determine whether booster shots of Covid-19 vaccines will be necessary in the coming months.Credit…Mary Altaffer/Associated Press
More than five million Americans could be eligible for booster shots of Covid-19 vaccine by late September under a Biden administration plan to combat the Delta variant by giving extra doses eight months after initial vaccinations.
Officials are expected to announce the strategy at a White House briefing on Wednesday. Nursing home residents, health care workers and emergency workers would probably be first in line. Other older people would be next, followed by the rest of the general population.
But the plan depends on several crucial steps taking place in the next few weeks. Most important, the Food and Drug Administration would need to decide that third shots are safe and effective for Pfizer-BioNTech and Moderna, the two vaccines that were rolled out first and have been most used.
Pfizer is farther along in submitting data to the F.D.A. that it says supports the use of boosters. Moderna and the National Institutes of Health are still studying whether a half-dose or a full dose would work better for a third shot, but they expect results soon. Moderna’s chief executive, Stephane Bancel, has said the firm plans to submit its data to the F.D.A. next month.
Officials envision giving people the same vaccine they originally received, using pharmacies as key distribution points.
Administration officials are discouraging people from seeking booster doses on their own, noting that the F.D.A. has yet to rule on their safety and efficacy. Nonetheless, the C.D.C. says that more than a million Americans have already obtained them, apparently by pretending they were unvaccinated. The officials hope to roll out extra shots in an orderly way, so that people get a booster shot when it is recommended, not simply based on their own fears.
Dr. Danny Avula, the vaccine coordinator for the state of Virginia, said that his state had thousands of vaccine providers already in place and could most likely manage boosters without much change. “What caused so much of the urgency and frenzy of January through April was the limitations in supply,” he said.
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The government has more than 100 million doses stockpiled that could be used for boosters, along with tens of millions more doses that have already been delivered to pharmacies and other locations. Even more supply is scheduled for delivery this fall.
In interviews on Tuesday, hospital officials and doctors were supportive of the push for booster shots.
“I think we’re running out of second chances,” said Dr. Matthew Harris, the medical director of the coronavirus vaccination program at Northwell Health, New York’s largest hospital system. “What keeps me up at night is the inevitability of a variant that is not responsive to the vaccine, so if this is how we stay ahead of it, I fully support it.”
Understand the State of Vaccine and Mask Mandates in the U.S.
Mask rules. The Centers for Disease Control and Prevention in July recommended that all Americans, regardless of vaccination status, wear masks in indoor public places within areas experiencing outbreaks, a reversal of the guidance it offered in May. See where the C.D.C. guidance would apply, and where states have instituted their own mask policies. The battle over masks has become contentious in some states, with some local leaders defying state bans.Vaccine rules . . . and businesses. Private companies are increasingly mandating coronavirus vaccines for employees, with varying approaches. Such mandates are legally allowed and have been upheld in court challenges.College and universities. More than 400 colleges and universities are requiring students to be vaccinated against Covid-19. Almost all are in states that voted for President Biden.Schools. On Aug. 11, California announced that it would require teachers and staff of both public and private schools to be vaccinated or face regular testing, the first state in the nation to do so. A survey released in August found that many American parents of school-age children are opposed to mandated vaccines for students, but were more supportive of mask mandates for students, teachers and staff members who do not have their shots. Hospitals and medical centers. Many hospitals and major health systems are requiring employees to get a Covid-19 vaccine, citing rising caseloads fueled by the Delta variant and stubbornly low vaccination rates in their communities, even within their work force.New York. On Aug. 3, Mayor Bill de Blasio of New York announced that proof of vaccination would be required of workers and customers for indoor dining, gyms, performances and other indoor situations, becoming the first U.S. city to require vaccines for a broad range of activities. City hospital workers must also get a vaccine or be subjected to weekly testing. Similar rules are in place for New York State employees.At the federal level. The Pentagon announced that it would seek to make coronavirus vaccinations mandatory for the country’s 1.3 million active-duty troops “no later” than the middle of September. President Biden announced that all civilian federal employees would have to be vaccinated against the coronavirus or submit to regular testing, social distancing, mask requirements and restrictions on most travel.
Federal officials envision offering additional shots to recipients of the single-dose Johnson & Johnson vaccine, as well as those who got Moderna or Pfizer. But the government began offering the Johnson & Johnson vaccine in March, months later than the others, and only 14 million people have gotten it. By comparison, 155 million people have been fully vaccinated with either Pfizer or Moderna.
Data from a Johnson & Johnson clinical trial in which participants were given two doses is likely to be submitted to the F.D.A. later this month and will guide the government’s recommendation on that vaccine.
At Wednesday’s briefing, administration officials plan to make the case that a booster strategy is essential, even if it must be amended as more data comes in. They are expected to present data showing that vaccine efficacy is declining even though unvaccinated people still make up the vast majority of those who become seriously ill or are hospitalized.