WASHINGTON -- All American adults became eligible for coronavirus vaccine boosters Friday, ending months of confusion over complicated guidelines that had slowed their uptake and prompted unilateral moves by some governors to make the shots available more broadly.
"We heard loud and clear that people needed something simpler -- and this, I think, is simple," said Peter Marks, Food and Drug Administration vaccinations chief. "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."
Federal health officials hope a straightforward policy will prompt millions more people to get the shots before they travel or gather with friends and relatives 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 direction is not a good one," Marks said. "People are going inside more and, oops, next week happens to be the largest travel week of the year, so it probably makes sense to do whatever we can here to try to turn the tide."
The final piece of the booster-policy overhaul fell into place Friday 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 or older may get a booster and -- to stress the urgency of increasing protection for the most vulnerable age group -- everyone 50 or older should make sure they get one.
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"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."
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 rare but serious cardiac side effects.
Grace Lee, a pediatrics professor at Stanford University and chair of the advisory panel, said she favored the call-out 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.
The new policy is an attempt to put into place a coherent federal position as about a dozen states -- including Arkansas -- moved ahead in recent days to give all adults access to boosters. A host of other countries have taken the same approach, including Australia, Brazil, Canada, Germany, Hungary, Israel, Japan, Norway and Saudi Arabia.
Until Friday, U.S. guidelines said boosters were for people 65 or older and others at high risk because of health problems or their job or living conditions. Any adult who received the single-dose Johnson & Johnson has also 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.
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"Simplifying eligibility will allow staff across the states, territories and local health departments to focus on making vaccination ... as easy and as accessible as possible," said Nirav Shah, director of the Maine Center for Disease Control and Prevention and president of the Association of State and Territorial Health Officials.
Individuals who wanted boosters, regardless of their eligibility, were already able to get them by attesting they qualified, so the simplified policy largely reflects what has been taking place on the ground.
POTENTIAL RISKS
The action means the 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 getting 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.
Data on side effects presented 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 their 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 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 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 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 efficacy wanes" 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."
Dr. Anthony Fauci, the government's top infectious-disease expert, has argued relentlessly over the past month for booster shots for all adults. Public health experts who argue that healthy younger adults do not need them, he said, are ignoring the risks of symptomatic covid-19.
"Enough is enough. Let's get moving on here," he said at an event Wednesday night. "We know what the data are."
Other public health experts have argued that data from Israel, which rolled out an aggressive booster campaign over the summer, suggests boosters can cut transmission rates. They say the extra shots are needed both to counteract waning protection and to limit confusion.
In other developments Friday:
• Canada's health regulator approved Pfizer's kid-size shot and announced it will allow people returning from short trips abroad to use a quicker, less-expensive test for the coronavirus.
Health Canada authorized the shots for children 5 to 11. But the National Advisory Committee on Immunization has suggested the country's provinces offer the two doses at least eight weeks apart; in the U.S., 5- to 11-year-olds receive two low doses three weeks apart, the same schedule as everyone else in the U.S.
Canada had problems getting vaccines into the country early this year and delayed a second dose for adults until more supply came in, but Canadian officials now say delaying a second dose provides better protection.
• The European Medicines Agency issued emergency-use advice for Merck's covid-19 pill, even though it has not yet been authorized.
The regulator said the pill can be used to treat adults infected with the coronavirus who don't yet need extra oxygen and are at increased risk of developing severe disease. It said the drug should be given as soon as possible after covid-19 has been diagnosed and within five days of symptoms starting.
The agency said it was issuing this advice "to support national authorities who may decide on possible early use of the medicine prior to marketing authorization, for example in emergency use settings, in light of rising rates of infection and deaths due to COVID-19 across the EU."
Europe is currently the epicenter of the pandemic, with numerous countries facing surges amid lagging vaccination rates.
• The European agency also said it has started evaluating the pill made by Pfizer to see if it might be used in emergency situations before it is officially authorized.
It said it is looking at data on the effectiveness of Pfizer's pill when given to people infected with covid-19 who are not yet hospitalized but are at risk of developing severe disease.
Early results suggest Pfizer's pill reduces the risk of hospitalization or death, compared with people who received a dummy pill, when they were treated within three to five days of developing covid-19 symptoms, the agency said.
"This current review will provide EU-wide recommendations in the shortest possible time frame so they can be used by national authorities who wish to take evidence-based decisions on the early use of the medicine," the regulator said.
Information for this article was contributed by Lena H. Sun, Laurie McGinley and Frances Stead Sellers of The Washington Post; by Lauran Neergaard, Matthew Perrone, Mike Stobbe, Rob Gillies and additional staff members of The Associated Press; and by Apoorva Mandavilli of The New York Times.
Gallery: Coronavirus scenes, 11-19-2021
