WASHINGTON -- U.S. regulators on Wednesday signed off on extending covid-19 boosters to Americans who got the Moderna or Johnson & Johnson vaccines and said people eligible for an extra dose can get a brand different from the one they received initially.
The Food and Drug Administration's decisions mark a big step toward expanding the U.S. booster campaign, which began with extra doses of the Pfizer vaccine last month. But before more people roll up their sleeves, the Centers for Disease Control and Prevention will consult an expert panel today, then finalize official recommendations for who should get boosters and when.
The latest moves would expand by tens of millions the number of Americans eligible for boosters and would formally allow "mixing and matching" of shots -- making it simpler to get another dose, especially for people who had a side effect from one brand but still want the proven protection of vaccination.
Specifically, the FDA authorized a third Moderna shot for senior citizens and others at high risk from covid-19 because of their health problems, jobs or living conditions. They can receive the boosters six months after their last shot. One big change is that Moderna's booster will be half the dose that's used for the first two shots, based on company data showing that was plenty to rev up immunity again.
For Johnson & Johnson's single-shot vaccine, the FDA said all U.S. recipients, no matter their age, could get a second dose at least two months after their initial vaccination.
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The FDA rulings differ because the vaccines are made differently, with different dosing schedules -- and the Johnson & Johnson vaccine has consistently shown a lower level of effectiveness than either of the two-shot Moderna and Pfizer vaccines.
As for mixing and matching, the FDA said it's OK to use any brand for the booster regardless of which vaccine people got first. The interchangeability of the shots is expected to speed the booster campaign, particularly in nursing homes and other institutional settings where residents have received different shots over time.
The FDA's acting commissioner, Dr. Janet Woodcock, said the agency wanted to make its booster guidance as flexible as possible, given that many people don't remember which brand they first received. In other cases, some people may want to try a different vaccine if they previously experienced common side effects like muscle aches or chills.
Still, regulators said it's likely many people will stick with the same vaccine brand.
The decision was based on preliminary results from a government study of different booster combinations that showed an extra dose of any type revs up levels of virus-fighting antibodies. That study also showed that recipients of the single-dose Johnson & Johnson vaccine had a far bigger response if they got a full-strength Moderna booster or a Pfizer booster rather than a second Johnson & Johnson shot. The study didn't test the half-dose Moderna booster.
Health authorities stress that the priority still is getting first shots to about 65 million eligible Americans who remain unvaccinated. But the booster campaign is meant to shore up protection amid signs that vaccine effectiveness is waning against mild infections, even though all three brands continue to protect against hospitalization and death.
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"Today the currently available data suggest waning immunity in some populations of fully vaccinated people," Woodcock told reporters. "The availability of these authorized boosters is important for continued protection against covid-19 disease."
The Moderna booster decision essentially matches the FDA's ruling that high-risk groups are eligible for the Pfizer vaccine, which is made with the same technology.
The FDA recommended that everyone who'd gotten the Johnson & Johnson vaccine get a booster since it has consistently shown lower protection than its two-shot rivals. And several independent FDA advisers who backed the booster decision suggested Johnson & Johnson's vaccine should have originally been designed to require two doses.
Experts continue to debate the rationale of the booster campaign. Some warn that the U.S. government hasn't clearly articulated the goals of boosters given that the shots continue to head off the worst effects of covid-19, and they wonder if the aim is to tamp down the virus's spread by curbing milder infections, at least temporarily.
Nirav Shah, president of the Association of State and Territorial Health Officials, said the ability to use boosters regardless of what shot a person initially received would aid in the outreach effort.
"If the FDA were to authorize mixing and matching, the ability to provide boosters on the ground at the state and local level would be greatly enhanced," Shah, who is also director of Maine's Center for Disease Control and Prevention, said ahead of the FDA decision. "We have advocated for such a policy, and we would uniformly support a policy move by the FDA."
The FDA's top vaccine official suggested that regulators would move quickly to expand boosters to lower age groups, such as people in their 40s and 50s, if warranted.
"We are watching this very closely and will take action as appropriate to make sure that the maximum protection is provided to the population," said the FDA's Dr. Peter Marks.
In August, the Biden administration announced plans for an across-the-board booster campaign aimed at all U.S. adults, but outside experts have repeatedly argued against such an effort.
Today, a panel convened by the CDC is expected to offer more specifics on who should get boosters and when. Their recommendations are subject to approval by the CDC director.
The vast majority of the nearly 190 million Americans who are fully vaccinated against covid-19 have received the Pfizer or Moderna options, while about 15 million have received the Johnson & Johnson vaccine.
VACCINATING KIDS
Meanwhile, the White House on Wednesday announced plans to distribute vaccines to 28 million children age 5 to 11. The operation is set to begin as soon as federal health officials sign off on a reduced dose of the Pfizer-BioNTech vaccine, which the Biden administration anticipates as soon as the first week of November.
"We're completing the operational planning to ensure vaccinations for kids ages 5 to 11 are available, easy and convenient," White House covid-19 coordinator Jeff Zients said. "We're going to be ready, pending the FDA and CDC decision."
White House officials said they have already acquired enough doses to vaccinate every child in that group and plan to make the specially packaged vaccine available at more than 25,000 pediatrician and doctor offices, hospitals, pharmacies, community health centers, and school- and community-based clinics. They also will undertake a campaign to educate parents more fully about the vaccines.
That strategy is key to reducing the impact of the virus across the United States, said Dr. Anthony Fauci, the nation's top infectious-disease specialist, during a White House briefing. The delta variant has changed the game, he said, describing a recent study showing children are getting infected and transmitting the virus as readily as adults, even though 50% of them are asymptomatic.
"If we can get the overwhelming majority of those 28 million children vaccinated, I think that would play a major role in diminishing the spread of infection in the community," Fauci said. "That's one of the reasons why we want to do as best as we can to get those children 5 to 11 vaccinated."
The rollout will rely on familiar approaches, such as identifying trusted messengers to overcome vaccine hesitancy. But this one will be tailored to children and families, officials said. Among the changes will be a focus on administering the vaccines in small-group settings and the creation of a Parent Leadership Corps of scientists and other experts who are parents themselves, and who will be a resource for other parents.
Dr. Sterling Ransone said his rural Deltaville, Va., office is already getting calls from people asking for appointments for their children and saying, "I want my shot now."
"Judging by the number of calls, I think we're going to be slammed for the first several weeks," said Ransone, president of the American Academy of Family Physicians.
Justin Shady, a film and TV writer in Chicago, said his 6-year-old daughter, Grey, got nervous when he told her that she would be getting the shots soon. But he said he is bribing her with a trip to Disney World, and "she's all in."
The family likes to travel, and "we really just want to get back in the swing of seeing the world," Shady said.
As for children under 5, Pfizer and Moderna are studying their vaccines in children down to 6 months old, with results expected later in the year.
Information for this article was contributed by Matthew Perrone, Lauran Neergaard, Mike Stobbe, Zeke Miller, Lindsey Tanner and Jim Anderson of The Associated Press; and by Lena H. Sun, Frances Stead Sellers, Amy B. Wang, Carolyn Y. Johnson and Laurie McGinley of The Washington Post.