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The Centers for Disease Control and Prevention recommended on Thursday that millions of eligible Americans, including those up to 12 years old, receive an updated omicron targeting booster injection to bolster defenses against serious illness and death during a potential fall or winter spike in covid-19 cases. .
CDC Director Rochelle Walensky approved a recommendation from an advisory panel, clearing the way for some doctors, pharmacies and other providers to begin administering the shots as soon as this weekend. The Advisory Committee on Immunization Practices voted 13 to 1 to recommend updated vaccinations from Moderna, for those 18 and older, and from Pfizer-BioNTech, for those 12 and older.
Thursday’s action, along with the Food and Drug Administration’s authorization of the shots a day earlier, marked another turning point in the pandemic and reflected the persistent struggle to combat disease and death over 2 and a half years since the pandemic began.
“The updated COVID-19 boosters are formulated to better protect against the most recently circulating variant of COVID-19,” Walensky said in a statement. “They can help restore protection that has waned since the previous vaccination and were designed to provide broader protection against newer variants. … If you’re eligible, there’s no bad time to get your COVID-19 booster and I highly encourage you to receive it.”
Several members of the advisory panel expressed concern about the lack of clinical data on the reformulated boosters, but also noted the potential harm of waiting for clinical data until November.
Matthew Daley, a physician at Kaiser Permanente Colorado, said the cost of waiting until the end of November to implement the updated booster vaccine could be 9,700 deaths and 137,000 additional hospitalizations, according to projections presented at the one-day meeting .
“I think that’s the tension I feel for sure,” Daley said. But with the FDA’s decision, “we are now in the position where we have millions of doses of bivalent vaccines that are ready and available. And I think they will be an effective tool for disease prevention this fall and through the end of the “winter”.
The latest booster recommendation offers a new opportunity for the Biden administration and public health experts to push another round of messages to a pandemic-weary public about the importance of vaccination against a virus that still kills a average of more than 500 people a day in the United States.
Doses began shipping to pharmacies, clinics and doctors’ offices on Wednesday after the FDA approved the updated injections from Moderna and from Pfizer and its German partner, BioNTech. Like previous coronavirus vaccines, the updated boosters will be free.
The new boosters, the first changes since the mRNA vaccines were launched in December 2020, target the omicron BA.4 and BA.5 subvariants dominant in the United States. Officials say the new traits will help broaden immunity because they more closely match the circulating strain.
Until now, vaccines have targeted the original version of the coronavirus, although different variants emerged. Half of the new booster, known as a bivalent vaccine, contains the original formulation, while the other half carries a prescription against BA.4 and BA.5, by far the most contagious versions of the virus since the coronavirus swept the world in 2020. BA.5 now accounts for nearly 90 percent of cases in the United States, according to the CDC.
People can receive up-to-date vaccinations if it has been at least two months since they completed their primary vaccination series or their most recent booster. Even if a person received boosters of the original formulation, they can get the updated booster as long as two months have passed since their last injection. The interval of at least two months is intended to extend immunity because getting vaccinated too soon reduces the effectiveness of the vaccine.
A longer interval between shots also reduces the risk, especially for young adults and older teenagers, of rare side effects such as myocarditis, inflammation of the heart muscle, health officials have said.
The CDC estimates that about 200 million Americans age 12 and older are eligible for the updated vaccination. While nearly 22 million adults age 50 and older have received a second booster dose, most people age 5 and older are at least six months out from their last dose of the coronavirus vaccine, he said CDC official Sara Oliver on the advisory panel on Thursday.
Americans have been slow to get boosters, and experts say it’s unclear whether uptake of the reformulated booster will be any different. The country may be moving from the coronavirus as an emergency, “to becoming something that we have to learn to manage more regularly and routinely, even through routine. [coronavirus] immunization,” said Jen Kates, senior vice president of the Kaiser Family Foundation.
“It’s hard to see how there will be a wave of funds, a rush to increase,” Kates said in an email. Some people, about 20 percent of people who have been vaccinated, “are waiting for updated vaccines that can target variants,” Kates said, citing a recent survey by the Kaiser Family Foundation. “On the other hand, if people don’t perceive them as better or necessary, or have other reasons for not wanting to receive a booster, it’s hard to see how that’s going to change things.”
Albert Ko, an infectious disease physician and epidemiologist at the Yale School of Public Health, said he was concerned about what Americans will face this winter, noting that the country is experiencing more than 500 deaths from covid -19 a day.
“Poor uptake of the new boosters is a real and pressing concern as we rely on vaccination to protect our communities, especially now that the use of social distancing and face masks is waning,” Ko said.
Panel members, echoing questions from some experts, raised concerns about the lack of human data on the injections’ effectiveness (the FDA relied heavily on mouse studies), which experts have said it could fuel skepticism about the boosters’ effectiveness. The data used by the FDA to authorize the shot included human studies of previous experimental bivalent shots, including one that generated virus-fighting antibodies against BA.1, the first omicron subvariant, and the general registry of shots from of December 2020.
Pablo J. Sanchez, a professor of pediatrics at Ohio State University, said he voted no because “I really feel we need the human data” on the new vaccine, which is only now being collected.
But Jeffrey Duchin, the health officer for Seattle and King County, said he was comfortable with the animal data supporting the reformulated boosters. The panel members also noted that animal studies have regularly been used to adjust the composition of annual flu shots.
The CDC’s Oliver presented data showing how a booster vaccination program in September could prevent major deaths, hospitalizations, infections and direct medical costs. Oliver noted that as the virus has evolved, the effectiveness of vaccines has waned more quickly. Including a variant in the vaccine broadens the antibody response.
Interest in previous booster shots has been lukewarm at best.
In a recent survey by the Kaiser Family Foundation, nearly 6 in 10 people who are vaccinated but not boosted said they feel they have enough protection, “which we know from the data is not the case because of the new variants and the decline,” Kates said. The survey found that three in 10 said they are too busy and 15% are concerned about a lack of work. Democrats are more likely to have been vaccinated and boosted than Republicans.
A CDC survey conducted in August with the University of Iowa suggests more people will want the shots: 72 percent of eligible respondents said they would definitely or probably get an updated booster against omicron, Oliver said.
Only half of Americans eligible for a booster (about 108 million people) received the first recommended booster dose, and only about a third of those over age 50 (about 22 million people) received a second booster. CDC surveys have shown that older adults, college graduates, and people with higher incomes remain more likely to be vaccinated and boosted.
Anyone who has received the primary series of two mRNA vaccines or Novavax or the Johnson & Johnson one-shot vaccine will be eligible regardless of whether they have received any booster shots.
FDA officials expect pediatric data on the new boosters in the next month or two and could authorize the injections for some children younger than 12 later this year.
What you need to know about the updated covid booster shots for autumn
The reinforcement change is already causing confusion. Some people who signed up for the original booster formulation will need to reschedule appointments to get the new version because the original formulations are no longer FDA-cleared for use as a booster.
“The last thing we need to do is tell people they’ve signed up [for the original booster] and expected to get vaccinated this week they will have to wait,” said Michael Fraser, executive director of the Association of State and Territorial Health Officials. “We’ve seen delayed demand nationally, and that doesn’t inspire confidence between the public and providers asking their health care provider what to do now.”
The CDC recommends the coronavirus vaccine for everyone 6 months of age and older, and boosters for everyone 5 years of age and older who are eligible.
CDC data at Thursday’s meeting showed that adults who had a primary series and two boosters had a 14 times lower risk of death from covid-19 than unvaccinated people. People who had a second booster had a three times lower risk of death than people who had only one.
Experts and officials have disagreed on whether an updated booster is needed because the original vaccines still offer strong protection against serious illness and death from…