FDA approves COVID-19 booster shots for all adults – Community News

FDA approves COVID-19 booster shots for all adults

FILE – A pharmacist fills a syringe with the Pfizer COVID-19 booster vaccine at a vaccine booster vaccination clinic on Oct. 1, 2021 in San Rafael, California. (Photo by Justin Sullivan/Getty Images)

US regulators on Friday opened COVID-19 booster shots to all adults, expanding the government’s campaign to bolster protections and stay ahead of the rising coronavirus cases that could worsen with the holidays.

Pfizer and Moderna announced the Food and Drug Administration’s decision after at least 10 states had already started offering boosters to all adults. The latest move simplifies what has been a confusing list of eligibility by allowing anyone 18 or older to choose a booster from both companies six months after their last dose — regardless of which vaccine they had first.

But there’s one more step: The Centers for Disease Control and Prevention must agree to extend Pfizer and Moderna boosters to even healthy young adults. The scientific advisers would debate later Friday.

If the CDC agrees, tens of millions more Americans could receive three doses of protection before the new year. Anyone who has received the Johnson & Johnson single-dose vaccine can already receive a booster.

All three COVID-19 vaccines used in the US still provide strong protection against serious illness, including hospitalization and death, but protection against infection may diminish over time. Previously, the government had approved boosters of the vaccine from Pfizer and BioNTech, as well as the comparable Moderna vaccine, only for vulnerable groups, including older Americans and those with chronic health conditions.

The move to expand comes as new cases of COVID-19 have risen steadily over the past two weeks, especially in states where colder weather is driving people indoors.

Fueled by those troubling trends, some states did not wait for federal officials to intervene. Utah and Massachusetts were the last states to announce last week that they are opening boosters to all adults.

Boosters for all was the original goal of the Biden administration. But in September, a panel of FDA advisors voted overwhelmingly against that idea based on the vaccines’ continued effectiveness in most age groups. Instead, they approved an extra dose of Pfizer only for the most vulnerable.

Since then, government officials, including Dr. Anthony Fauci, continue to advocate for the wider use of boosters, noting that even milder infections in younger people can cause “long-term COVID” and other complications.

“I don’t know of any other vaccine where we’re just concerned about keeping people out of the hospital,” Fauci said at a briefing on Wednesday.

Last week, Pfizer and its German partner BioNTech submitted new data to prove that broader boosters can help suppress infections in a critical period.

“We have absolutely no chance in the current situation of getting the pandemic under control without giving everyone a boost,” BioNTech CEO Ugur Sahin told reporters during a visit to Washington last week.

The companies studied 10,000 adults of all ages and found that a booster restored protection against symptomatic infections to about 95%, even while the extra-infectious delta variant was on the rise. It’s too early to know if that high level of protection lasts longer after a third shot than after the second, something Sahin said the companies will monitor carefully.

To back up that evidence, Britain released real-world data this week showing the same leap in protection when it began offering boosters to middle-aged and older adults. Israel has credited widespread boosters with helping to curb another wave of the virus in that country.

More than 195 million Americans are fully vaccinated, defined as two doses of either the Pfizer or Moderna vaccines or the Johnson & Johnson single-dose vaccine. More than 30 million have already received a booster.

Before the expansion, people who received the Pfizer or Moderna vaccination were eligible for a third dose if they are older or at high risk for COVID-19 due to health problems or their job or living conditions. Because a single J&J injection has not been shown to be as effective as its two-dose competitors, any J&J recipient can receive a booster at least two months later.

But people who don’t meet the criteria often score an extra chance because many vaccine sites don’t check the qualifications.

The FDA previously ruled that people who receive a booster may be given a different brand than the vaccine they initially received.

Some experts worry that all the focus on boosters could hurt efforts to reach the 60 million Americans who qualify for vaccinations but haven’t received the injections. There is also a growing concern that rich countries are offering widespread boosters when poor countries have been unable to vaccinate more than a small fraction of their populations.

“In terms of the No. 1 priority for reducing transmission in this country and around the world, this continues to give people their first vaccine series,” said Dr. David Dowdy of the Johns Hopkins Bloomberg School of Public Health.