CDC recommends reformulated coronavirus booster shot for fall

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The Centers for Disease Control and Prevention on Thursday recommended that millions of eligible Americans, including those as young as 12, receive a booster shot targeting the updated omicron to boost defenses against disease. serious and death during a possible increase in covid-19 cases in the fall or winter. .

CDC Director Rochelle Walensky endorsed an advisory group recommendation, paving the way for some clinicians, pharmacies and other providers to begin administering the injections as early as this weekend. The Immunization Practices Advisory Committee voted 13 to 1 to recommend updated vaccines from Moderna, for ages 18 and older, and Pfizer-BioNTech, for ages 12 and older.

Thursday’s action, as well as permission to fire a day earlier by the Food and Drug Administration, marked another turning point in the pandemic and reflected the ongoing struggle to stem disease and death 2½ years since the pandemic began.

“The updated COVID-19 boosters are formulated to better protect against the most recent COVID-19 variant,” Walensky said in a statement. “They can help restore protection that has waned since previous vaccination and have been 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 strongly encourage you to get it.

Several members of the advisory committee expressed concern about the lack of clinical data on the reworded recalls, 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 roll out the updated recall could be 9,700 deaths and 137,000 additional hospitalizations, based on projections presented during the the one-day meeting.

“I think that’s the tension I feel for sure,” Daley said. But with the FDA decision, “we are now in a position where we have millions of doses of bivalent vaccines ready and available. And I think they’re going to be an effective tool for disease prevention this fall and into the end of winter.

The latest recommendation for reminders offers a new opportunity for the Biden administration and public health experts to launch a new series of messages to a pandemic-weary public about the importance of vaccination against a virus that still kills on average. more than 500 people a day in the United States.

Doses began shipping Wednesday to pharmacies, clinics and doctor’s offices after the FDA authorized updated plans of Moderna and Pfizer and its German partner BioNTech. Like previous coronavirus vaccines, updated boosters will be free.

The new recalls — the first changes since the mRNA vaccines rolled out in December 2020 — target the US-dominant BA.4 and BA.5 omicron subvariants. Officials say the new vaccines will help broaden immunity because they better match the circulating strain.

Vaccines so far have targeted the original version of the coronavirus, even as different variants have emerged. Half of the new booster, known as a bivalent vaccine, contains the original formulation, while the other half carries a recipe against BA.4 and BA.5, by far the most contagious versions of the virus since the coronavirus swept the globe in 2020. BA.5 count now for nearly 90% of cases in the United States, according to the CDC.

The updated booster is for people who have had their primary vaccinations, using the original vaccines, or those eligible for a booster at least two months after their last one. 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 aims to broaden immunity because doing it too soon reduces the effectiveness of the vaccine.

A longer interval between injections also reduces the risk, especially for young adults and older adolescents, of rare side effects such as myocarditis – inflammation of the heart muscle, health officials said.

The CDC estimates that about 200 million Americans ages 12 and older are eligible for the updated shot. While nearly 22 million adults aged 50 and over have received a second booster dose, most people aged 5 and over are at least six months away from their last dose of the coronavirus vaccine, said Thursday CDC official Sara Oliver on the advisory board.

Americans have been slow to get recalls, and experts say it’s unclear whether passing the reworded recall will be any different. The country may be moving from coronavirus to an emergency, “to becoming something we have to learn to manage on a more regular and routine basis, including through routines [coronavirus] vaccination,” said Jen Kates, senior vice president of the Kaiser Family Foundation.

“It’s hard to see how there will be an undertow, a rush of boost,” Kates said in an email. Some people — about 20% of people who have been vaccinated — are “waiting for updated vaccines that can target variants,” Kates said, referring to a recent Kaiser Family Foundation survey. “On the other hand, if people don’t perceive them as better or necessary, or have other reasons for not wanting to get a recall, it’s hard to see how that will change things.”

Albert Ko, an infectious disease physician and epidemiologist at the Yale School of Public Health, expressed concern about what Americans will face this winter, noting that the country is seeing more than 500 Covid-19 deaths per day. .

“Poor uptake of the new boosters is a real and pressing concern since 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 say could fuel skepticism about the effectiveness of boosters. The data used by the FDA to authorize the shot included human studies of previous experimental bivalent shots, including one that generated anti-virus antibodies against BA.1, the first omicron subvariant and the overall shot record since December 2020. .

Pablo J. Sanchez, professor of pediatrics at Ohio State University, said he voted no because “I really think we need the human data” on the new vaccine, which is only being collected now.

But Seattle and King County health officer Jeffrey Duchin said he was comfortable with the animal data supporting the reworded reminders. Panel members also noted that animal studies have been routinely used to adjust the composition of annual influenza vaccines.

Oliver of the CDC presented data showing how a booster vaccination program in September could prevent deaths, hospitalizations, infections and significant direct medical costs. Oliver noted that as the virus evolved, the effectiveness of vaccines waned faster. Inclusion of a variant in the vaccine broadens the antibody response.

Interest in earlier booster shots has been lukewarm at best.

Experts said it may reflect people lacking correct information about vaccines, partisan differences and practical challenges. In a recent Kaiser Family Foundation survey, nearly 6 in 10 people who are vaccinated but not boosted said they felt they had enough protection, “which we know from the data is not the case being given the decline and the new variants,” Kates said. Three in 10 said they were simply too busy and 15% worried about not having a job, the survey found. 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 injections — 72% of eligible respondents said they would definitely or probably receive an updated booster against omicron, Oliver said.

Only half of Americans eligible for recall – about 108 million people – received the first recommended booster dose, and only about a third of those 50 and over – around 22 million people – received a second booster. CDC surveys have shown that older adults, college graduates, and high-income people remain the most likely to be vaccinated and boosted.

Anyone who received the primary two-shot series of mRNA or Novavax vaccines or the single shot Johnson & Johnson vaccine will be eligible whether or not they have received booster shots.

FDA officials expect pediatric data on the new recalls in a month or two and may authorize injections for some children under 12 later this year.

What you need to know about the updated covid booster shots for fall

The change of booster is already confusing. Some people who signed up to receive the original booster formulation will need to reschedule their appointments to get the new version because the original formulations are no longer cleared by the FDA to be used as boosters.

“The last thing we need to do is tell people who signed up [for the original booster] and should get vaccinated this week that they have to wait,” said Michael Fraser, chief executive of the Association of State and Territory Health Officials. “We’ve seen lagging demand nationwide and that’s not building trust with the public and providers who are asking their health officer what to do now.”

The CDC recommends the coronavirus vaccination for anyone 6 months and older, and boosters for anyone 5 and older who is 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 reminder had a three times lower risk of death than people who had only one reminder.

Experts and officials disagree on the need for an updated booster because the original vaccines still provide strong protection against serious illness and death for generally healthy people, especially if they have received the first booster dose. Some experts said it was unclear how much additional benefit a reworded booster would provide.

People should check with local pharmacies and providers and visit vaccines.gov before coming in for injections, as only about 1.5 million doses are likely to be available initially, according to information provided to health officials in the state. ‘State. Ten million more doses are expected to be delivered next week.

Laurie McGinley contributed to this report.

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