Obstacles to Immunization in Children with Juvenile Idiopathic Arthritis

FDA Approves Second Booster For People 50 And Older - PBS

U.S. Regulators on Tuesday authorized another COVID-19 booster for people age 50 and older, a step to offer extra protection for the most vulnerable in case the coronavirus rebounds.

The Food and Drug Administration's decision opens a fourth dose of the Pfizer or Moderna vaccines to those people at least four months after their previous booster.

READ MORE: Pfizer vaccine effective against severe COVID-19 for children between 5 and 11, CDC says

Until now, the FDA had cleared fourth doses only for people 12 and older who have severely weakened immune systems. The agency said this especially fragile group also can get an additional booster, a fifth shot.

The latest expansion, regardless of people's health, allows an extra shot to millions more Americans — and the question is whether everyone who's eligible should rush out and get it. The Centers for Disease Control and Prevention is expected to weigh in.

The move comes at a time of great uncertainty. COVID-19 cases have dropped to low levels after the winter surge of the super-contagious omicron variant. Two vaccine doses plus a booster still provide strong protection against severe disease and death, CDC data show.

But an omicron sibling is causing causing a worrisome jump in infections in Europe — and spreading in the U.S. — even as vaccination has stalled. About two-thirds of Americans are fully vaccinated, and half of those eligible for a first booster haven't gotten one.

Pfizer had asked the FDA to clear a fourth shot for people 65 and older, while Moderna requested another dose for all adults "to provide flexibility" for the government to decide who really needs one.

There's limited evidence to tell how much benefit another booster could offer right now. FDA made the decision without input from its independent panel of experts that has wrestled with how much data is required to expand shots.

"There might be a reason to top off the tanks a little bit" for older people and those with other health conditions, said University of Pennsylvania immunologist E. John Wherry, who wasn't involved in the government's decision.

But while he encourages older friends and relatives to follow the advice, the 50-year-old Wherry — who is healthy, vaccinated and boosted — doesn't plan on getting a fourth shot right away. With protection against severe illness still strong, "I'm going to wait until it seems like there's a need."

None of the COVID-19 vaccines are as strong against the omicron mutant as they were against earlier versions of the virus. Also, protection against milder infections naturally wanes over time. But the immune system builds multiple layers of defense and the type that prevents severe illness and death is holding up.

READ MORE: How businesses are handling vaccine rules with no federal mandates

During the U.S. Omicron wave, two doses were nearly 80% effective against needing a ventilator or death — and a booster pushed that protection to 94%, the CDC recently reported. Vaccine effectiveness was lowest — 74% — in immune-compromised people, the vast majority of whom hadn't gotten a third dose.

U.S. Health officials also looked to Israel, which during the omicron surge opened a fourth dose to people 60 and older at least four months after their last shot. Preliminary data posted online last week suggested some benefit: Israeli researchers counted 92 deaths among more than 328,000 people who got the extra shot, compared to 232 deaths among 234,000 people who skipped the fourth dose.

What's far from clear is how long any extra benefit from another booster would last, and thus when to get it.

"The 'when' is a really difficult part. Ideally we would time booster doses right before surges but we don't always know when that's going to be," said Dr. William Moss of the Johns Hopkins Bloomberg School of Public Health.

Plus, a longer interval between shots helps the immune system mount a stronger, more cross-reactive defense.

"If you get a booster too close together, it's not doing any harm — you're just not going to get much benefit from it," said Wherry.

The newest booster expansion may not be the last: Next week, the government will hold a public meeting to debate if everyone eventually needs a fourth dose, possibly in the fall, of the original vaccine or an updated shot.

As for updating vaccines, studies in people — of omicron-targeted shots alone or in combination with the original vaccine — are underway. The National Institutes of Health recently tested monkeys and found "no significant advantage" to using a booster that targets just omicron.

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Moderna Seeks FDA Approval To Authorize Booster Shots

Last month, the FDA approved a third Moderna shot for seniors and others at high risk from COVID-19. Arnd Wiegmann/REUTERS

A panel of Centers for Disease Control and Prevention experts is set to convene Friday to discuss data regarding Pfizer's request for the booster shots to be doled out to all Americans rather than just those at high risk.

The FDA, meanwhile, is aiming to authorize booster doses of the Pfizer-BioNTech vaccine as early as Thursday,

the New York Times reported, citing sources familiar with the agency's plans.

At least 30 to 40 percent of vaccinated adults remain excluded from booster eligibility, while more than 30 million people have received them, according to estimates cited by the newspaper.

At least 30 to 40 percent of vaccinated adults remain excluded from booster eligibility. Arnd Wiegmann/REUTERS

Health officials in New York City

announced Monday that all adults who got a Moderna or Pfizer booster at least six months earlier were eligible for boosters. Those who got the single-shot Johnson & Johnson vaccine should wait at least two months.

FDA Approves COVID Booster Shots For All Americans Age 18 And Up

The Food and Drug Administration approved COVID-19 vaccine booster shots for all Americans age 18 and up on Friday, which would expand eligibility for boosters of Pfizer and Moderna's vaccines ahead of the holiday season.

The Centers for Disease Control is expected to make a final decision later Friday, and if they agree Americans could start getting boosters immediately.

Previously, the FDA had only authorized booster shots of Pfizer and Moderna's vaccines for people aged 65 or older and people who were at high risk of contracting COVID-19, either due to preexisting conditions or their job. They had also approved anyone who had received the single-dose Johnson & Johnson vaccine to get a booster of their choice to increase their waning protection against the virus.

Under the new guidelines, anyone who is six months past the date that they reached full efficacy from their vaccination — two weeks after their second dose of Pfizer or Moderna — can get a booster shot of any of the vaccines.

People can elect to get a booster of any type, regardless of which vaccine they originally received. Studies have shown that mixing vaccine types can improve the body's immune response.

Several states and New York City had already expanded booster eligibility to anyone 18 or up, ahead of the FDA's recommendation. Residents of Arkansas, California, Colorado and New Mexico were all able to get a booster before Friday.

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The booster approval comes as the weather in most of the U.S. Grows colder and the holiday season, when people will be traveling and gathering indoors, nears.

New COVID-19 cases have also been on the rise over the last two weeks. After the summer surge, when cases rose to around 170,000 a day, they had started to dip down to around 70,000 in late October. But colder states and areas with fewer vaccinated people have led to another increase, and cases are now back up to an average of 85,000 a day as of Nov. 18, according to The New York Times.

Dr. Anthony Fauci, the nation's top infectious disease expert, urged people to get their booster shot.

"Always the primary thing is to get the unvaccinated vaccinated," Fauci said in an interview on CNBC Monday night. "But for those who are eligible to be boosted, by all means, go and get boosted."

As information about the coronavirus pandemic rapidly changes, PEOPLE is committed to providing the most recent data in our coverage. Some of the information in this story may have changed after publication. For the latest on COVID-19, readers are encouraged to use online resources from the CDC, WHO and local public health departments. PEOPLE has partnered with GoFundMe to raise money for the COVID-19 Relief Fund, a GoFundMe.Org fundraiser to support everything from frontline responders to families in need, as well as organizations helping communities. For more information or to donate, click here.

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