US opens second COVID-19 boosters to 50 and up, others in jeopardy
US opens second COVID-19 boosters to 50 and up, others in jeopardy

US opens second COVID-19 boosters to 50 and up, others in jeopardy

Americans 50 years and older can get another COVID-19 booster, if at least four months have passed since their last vaccination, a chance for extra protection for the most vulnerable if the coronavirus returns.

The Food and Drug Administration on Tuesday approved an extra dose of the Pfizer or Moderna vaccine for that age group and for certain younger people with severely weakened immune systems.

The Centers for Disease Control and Prevention later recommended the extra shot as an option, but stopped urging those eligible to hurry out and get it right away. This decision extends the extra booster to millions of Americans.

Dr. Rochelle Walensky, director of the CDC, said it was especially important for older Americans – those 65 and older – and the 50-year-olds with chronic illnesses such as heart disease or diabetes to consider another shot.

“They are most likely to benefit from receiving an extra booster dose at this point,” Walensky said.

There is evidence that protection may decline, especially in higher-risk groups, and for them, another booster will “help save lives,” said FDA vaccine chief Dr. Peter Marks.

Despite all the attention to who should get a fourth dose of Pfizer and Moderna vaccines, only about half of Americans eligible for a third shot have received one – and the government urged them to stick up to date. Two shots plus a booster still provide strong protection against serious illness and death, even during the winter wave supersmitsom omicron variant.

The move toward additional boosters comes at a time of great uncertainty, with limited evidence of how much benefit an extra dose right now can provide. COVID-19 cases have dropped to low levels in the US, but all vaccines are less potent against newer mutants than previous versions of the virus – and health officials are keeping a close eye on an omicron sibling it causes worrying increases in infections in other countries.

Pfizer had asked the FDA to remove a fourth shot for people 65 and older, while Moderna requested a second dose for all adults “to provide flexibility” so the government can decide who really needs one.

The FDA’s Marks said regulators set the age at 50 because that’s when chronic conditions that increase the risks from COVID-19 become more common.

Until now, the FDA had only allowed a fourth dose of vaccine for immunocompromised people as young as 12. Vaccines have a harder time resuscitating severely weak immune systems, and Marks said their protection also tends to decline faster. Tuesday’s decision also gives them another booster – a fifth dose. Only the Pfizer vaccine can be used for those as young as 12 years of age; Moderna’s is for adults.

What about people who received Johnson & Johnson’s single-dose injection? They were already entitled to one booster of any kind. Of the 1.3 million who received another J&J shot, the CDC said they can now opt for a third dose – either Moderna or Pfizer. For the more than 4 million who got Moderna or Pfizer as their second shot, the CDC says an extra booster is only needed if they meet the latest criteria – a severely weakened immune system or are 50 or older.

This is because a CDC study that tracked which boosters J&J recipients originally chose concluded that a Moderna or Pfizer second shot was better than another J&J dose.

If the new recommendations sound confusing, external experts say it makes sense to consider extra protection for the most vulnerable.

“There may be a reason to fill the mind a little” for older people and those with other health conditions, said University of Pennsylvania immunologist E. John Wherry, who was not involved in the government decision.

But while urging older friends and relatives to follow the advice, 50-year-old Wherry – who is healthy, vaccinated and boosted – plans not to get a fourth shot right away. With protection against serious illness still strong, “I will wait until it seems there is a need.”

While protection against milder infections naturally diminishes over time, the immune system builds up several layers of defenses, and the type that prevents serious illness and death persists.

During the US omicron wave, two doses were nearly 80% effective against the need for a fan or death – and a booster pushed that protection to 94%, the CDC recently reported. Vaccine efficacy was lowest – 74% – in immunocompromised individuals, the vast majority of whom had not received a third dose.

To evaluate an additional booster, US officials looked to Israel, which opened a fourth dose for people 60 years and older during the omicron rise. The FDA said no new safety concerns emerged in a review of 700,000 administered fourth doses.

Preliminary data published online last week suggested some benefit: Israeli researchers counted 92 deaths among more than 328,000 people who received the extra shot, compared with 232 deaths among 234,000 people who skipped the fourth dose.

What is far from clear is how long an added benefit of another booster will last, and thus when to get it.

“When” is a really difficult part. Ideally, we would time booster doses just before increases, but we do not always know when that will be, ”said Dr. William Moss, a vaccine expert at 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 to each other, it does no harm – you just will not benefit much from it,” Wherry said.

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

Although higher-risk Americans are being boosted now, Marks said they may need another dose in the fall if regulators decide to adjust the vaccine.

For that effort, studies in humans – 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 benefit” from using an omicron-only booster.

Related story: The FDA recommends 2nd COVID-19 booster for millions of Americans

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