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FRIDAY, December 01, 2023

With federal sign-offs, all American adults now eligible for coronavirus vaccine boosters

With federal sign-offs, all American adults now eligible for coronavirus vaccine boosters
SATURDAY, November 20, 2021

WASHINGTON - All American adults became eligible for coronavirus vaccine boosters on Friday, ending months of confusion over complicated guidelines that had slowed their uptake and prompted unilateral moves by governors from Maine to California to make the shots available more broadly.

Federal health officials hope a straightforward boosters-for-all policy will prompt millions more people to get the shots before they travel or gather with friends and family over the holidays. Many are concerned about the worsening picture as winter approaches. After new cases dipped to almost 69,000 on Oct. 25 - their lowest point in months - they began climbing again, with the seven-day average rising 40% to more than 96,000 on Thursday.

The final piece of the booster-policy overhaul fell into place early Friday evening when Rochelle Walensky, director of the Centers for Disease Control and Prevention, accepted two unanimous recommendations from the agency's independent experts. The Advisory Committee on Immunization Practices said anyone 18 and older may get a booster and - to stress the urgency of increasing protection for the most vulnerable age group - anyone 50 and older should make sure they get one.

"Based on the compelling evidence, all adults over 18 should now have equitable access to a COVID-19 booster dose," Walensky said in a statement. "Booster shots have demonstrated the ability to safely increase people's protection against infection and severe outcomes and are an important public health tool to strengthen our defenses against the virus as we enter the winter holidays."

The more forceful recommendation for those 50 and older had not been on the CDC advisory panel's agenda and was added at the last minute. Panel members said it was important to convey that older adults have the clearest benefit versus risk, with far less chance than young people of developing the rare but serious cardiac side effects from the mRNA vaccines.

Grace Lee, a pediatrics professor at Stanford University and chair of the advisory panel, said she favored the callout to older people because many have a hard time keeping up with the guidelines. "That list keeps changing," she said. "I'm not even sure I could keep up with who's eligible and who's not eligible."

Earlier in the day, the Food and Drug Administration authorized Pfizer-BioNTech and Moderna boosters for people 18 and older who are at least six months past their second shot of the two-dose regimen.

"I have heard from I don't know how many states, 'everything is confusing here, can you make it simpler?'" Peter Marks, director of the FDA center that regulates vaccines, said in an interview. "I think this is pretty simple now: If you are over 18, and you have been vaccinated . . . it is time to go get a booster. Doesn't matter which one you get, go get a booster."

The new policy is an attempt to put into place a coherent federal position as about a dozen states moved ahead in recent days to give all adults access to boosters. Until Friday, federal guidelines said boosters were for people 65 or older as well as for others at high risk of covid-19 because of health problems or their job or living conditions. Any adult who received the single-dose Johnson & Johnson already has been eligible for a booster two months after vaccination.

Those categories covered a high proportion of vaccinated Americans, but experts said their complexity slowed the booster rollout because some people believed they didn't need the shots or didn't qualify for them. And some health-care providers were confused as well. Only about 38% of fully vaccinated people over 65, and 18% of all adults have gotten boosters, according to the CDC.

"Simplifying eligibility will allow staff across the states, territories and local health departments to focus on making vaccination - primarily the primary vaccination series - as easy and as accessible as possible," said Nirav Shah, director of Maine Center for Disease Control and Prevention, president of the Association of State and Territorial health Officials.

Still, individuals who wanted boosters, regardless of their eligibility, were able to get them by attesting they qualified, so the simplified policy largely reflects what has been taking place on the ground.

The action on booster shots means the Biden administration has come full circle since August, when President Joe Biden and his top health aides announced plans to make boosters available to all adults beginning in late September. The administration backed off after receiving sharp criticism from many scientists and public health experts who said there was little evidence that young, healthy people needed the extra shot, especially because of concerns about a rare side effect involving inflammation of the heart muscle seen mostly in young men.

Three months later, with cases spiking, there was also more data - both on waning immunity and on the vaccines' safety.

But data on side effects, presented for the first time Friday, provided reassurance: Of 26 million mRNA boosters given in the United States, there were a dozen confirmed reports of myocarditis, and another 38 pending investigation, said Tom Shimabukuro, a CDC vaccine safety official, citing preliminary data from one vaccine safety monitoring system. The median age of the dozen confirmed with myocarditis is 51. Ten were discharged from the hospital and six recovered from symptoms, he said.

And FDA's Marks said the agency also took a close look at the potential risk of heart-related side effects in older male teenagers and young men. Updated information and analyses showed that the risks posed by the boosters were very low, and were far outweighed by the potential benefits of preventing covid-19, he said.

Nevertheless, the agency noted in its Moderna booster fact sheet for health care providers that some studies show a potentially higher risk of the cardiac side effect after the second shot of Moderna, compared with Pfizer-BioNTech. The FDA also noted a lower risk from the Moderna booster shot than from the initial vaccination. Some countries have restricted or barred the use of the Moderna vaccine in younger men because of concerns about that side effect.

The FDA and CDC decisions were largely praised by experts Friday, although some questioned just how much firepower the booster shots might bring to the pandemic battle.

David Dowdy, an epidemiologist at Johns Hopkins, expressed skepticism that boosters would affect the course of the pandemic.

"Whether that is going to have a major impact in terms of transmission, probably not," he said. "A large fraction of transmission is still occurring from people who are not vaccinated." Getting those people inoculated, he argued, should be the No. 1 priority.

Still, Dowdy backed giving all adults the option of getting extra doses. "The risk-benefit ratio is sufficiently favorable that if you want a booster, this is the time to do it, with cases going up," he said.

Robert M. Wachter, professor and chairman of the department of medicine at the University of California at San Francisco, was more enthusiastic.

"The evidence is just crystal clear now that [vaccine] efficacy wanes for all infections" and that boosters can reduce breakthrough cases and vulnerability to long covid," he said.

CDC official Sara Oliver told panel members Friday that the impact of a vaccine booster dose on transmission is unknown. But even a temporary boosting effect, she said, "may factor into the benefit risk balance, especially as we approach the winter and holidays with increased traveling and indoor gatherings."

The American Medical Association applauded the agencies' decisions, saying, "The scientific evidence is clear that the vaccines against COVID-19 are safe and remain effective. We continue to strongly urge everyone who has not yet been vaccinated against COVID-19 and is eligible, including children aged 5 and older and pregnant people, to get vaccinated as soon as possible to protect themselves and their loved ones."

The new policy ends an awkward chapter for federal officials who have wrestled with the eligibility issue since summer and been leapfrogged by New York City and a growing number of states, including Louisiana, Maine and Colorado, that already endorsed widespread use of the extra shots to try to stave off a spike in cases.

"The states made the right decisions, but the optics are awful in appearing to go rogue and undermining the federal agencies," said Peter Hotez, a professor of pediatrics and molecular virology and microbiology at Baylor College of Medicine.

While many experts expressed relief at the simpler recommendations, Jay A. Winsten, director of strategic media initiatives at the Harvard School of Public Health, said that the conflicting messages over recent weeks have taken a toll that will have an ongoing impact on people's trust in public health.

"After months of confused and contradictory messaging, it's baked into the coverage now and into the public psyche," Winsten said. "The way they have handled this has done real damage to the agency's credibility with a lot of people."