CDC recommends reformulated coronavirus booster shot for fall


The Centers for Disease Control and Prevention recommended Thursday that millions of eligible Americans, including those as young as 12, receive an updated omicron-targeted booster shot to bolster defenses against serious illness and death during a potential fall or winter surge in covid- 19 cases.

CDC Director Rochelle Walensky supported a recommendation by an advisory panel, which cleared the way for some clinicians, pharmacies and other providers to begin administering the shots as early as this weekend. The Immunization Practices Advisory Committee voted 13-1 to recommend updated images from Moderna, for those 18 and older, and from Pfizer-BioNTech, for people 12 and older.

Thursday’s action, along with approval of the shots a day earlier by the Food and Drug Administration, marked another turning point in the pandemic and reflected the continuing struggle to curb disease and death 2½ years since the pandemic began.

“The updated COVID-19 boosters are formulated to better protect against the most recently circulating COVID-19 variant,” Walensky said in a statement. “They can help restore protection that has waned since the last 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 strongly encourage you to 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 later in November to roll out the updated booster shot could be an additional 9,700 deaths and 137,000 hospitalizations, based on estimates presented at the daylong meeting.

“I think it’s the excitement 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 that are ready and available. And I think they’re going to be an effective tool for disease prevention this fall and into late winter.”

The latest recommendation for boosters provides another opportunity for the Biden administration and public health experts to launch a new round of messages to a pandemic-weary public about the importance of vaccination against a virus that still kills an average of more than 500 people a day in the United states.

Doses began shipping Wednesday to pharmacies, clinics and doctors’ offices after the FDA approved the updated shots 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 rolled out in December 2020 – target the BA.4 and BA.5 omicron subvariants that are predominant in the United States. Officials say the new shots will help extend immunity because they are a better match to the strain that is circulating.

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 has a recipe against BA.4 and BA.5, by far the most infectious versions of the virus since the coronavirus swept the globe in 2020. BA. 5 now accounts for nearly 90 percent of cases in the United States, according to the CDC.

People can receive the updated shots if it has been at least two months since they completed the primary vaccine series or the last booster. Even if a person received boosters of the original formulation, they can receive the updated booster as long as two months have passed since the last shot. The interval of at least two months is intended to extend immunity because getting the shot too early 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 picture. While nearly 22 million adults 50 and older have received another booster dose, most people age 5 and older are at least six months away from their last coronavirus vaccine dose, CDC official Sara Oliver told the advisory panel 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 transition from the coronavirus as an emergency, “to becoming something we have to learn to deal with on a more regular, routine basis, including through routine [coronavirus] immunization, said Jen Kates, senior vice president at the Kaiser Family Foundation.

“It’s hard to see how there will be a swell, a rush to be reinforced,” 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 Kaiser Family Foundation survey. “On the other hand, if people don’t perceive these as better or necessary, or have other reasons for not wanting to get a booster, it’s hard to see how this will change things.”

Albert Ko, an infectious disease physician and epidemiologist at the Yale School of Public Health, said he was worried about what Americans will face this winter, noting that the country is experiencing more than 500 Covid-19 deaths 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 disappearing,” Ko said.

Panel members, echoing questions among some experts, raised concerns about the lack of human data on the shots’ effectiveness — the FDA relied heavily on mouse studies — which experts have said could cast doubt on 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 antiviral antibodies against BA.1 — the first omicron subvariant — and the overall record of the shots since December 2020.

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

But Jeffrey Duchin, chief of health for Seattle and King County, said he was comfortable with the animal data to support the reformulated boosters. Panel members also noted that animal studies have regularly been used to adjust the composition of annual flu vaccines.

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

Interest in past booster shots has proven lukewarm, at best.

In a recent Kaiser Family Foundation survey, 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 given waning and new variants,” Kates said. Three out of ten said they are simply too busy, and 15 percent are worried about a lack of work, 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 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 booster-eligible Americans — about 108 million people — received the first recommended booster dose, and only about a third of those 50 and older — about 22 million people — received a second booster. CDC research has shown that older adults, college graduates, and people with higher incomes remain the most likely to be vaccinated and boosted.

Anyone who has received the two-shot primary series of the mRNA or Novavax vaccines or single-shot Johnson & Johnson vaccine will be eligible, regardless of whether they received any booster shots.

FDA officials expect pediatric data on the new boosters in the next month or two and may approve the shots for some children younger than 12 later this year.

What you need to know about the updated covid booster photos for autumn

The booster change is already causing confusion. Some people who signed up to receive the original booster formulation have to reschedule appointments to get the new version because the original formulations are no longer approved by the FDA for use as boosters.

“The last thing we need to do is tell people who signed up [for the original booster] and expected to be vaccinated this week that they will have to wait, says Michael Fraser, executive director of the Association of State and Territorial Health Officials. “We have seen a delayed demand nationally, and this does not build confidence among the public and providers who are asking healthcare professionals what to do now.”

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

Experts and officials have disagreed about whether an updated booster is needed because the original vaccines still provide strong protection against serious illness and death for generally healthy people, especially if they received the first booster dose. Some experts have said it’s not clear how much additional benefit a reformulated booster would offer.

People should check with local pharmacies and providers and visit before showing up to receive shots, because only about 1.5 million doses are likely to be available initially, according to information provided to state health officials. A further 10 million doses are scheduled to be delivered next week.

Laurie McGinley contributed to this report.

Source link

Back to top button