CDC proposes reformulated coronavirus booster vaccine for decline

CDC proposes reformulated coronavirus booster vaccine for decline
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The Centers for Disease Control and Prevention on Thursday recommended that millions of eligible Americans, including those under the age of 12, receive an updated omicron-targeting booster vaccine to support defense against serious illness and death during a possible fall in covid-19 cases or a winter rise. .

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

Along with Thursday’s action shooting authorization The day before by the Food and Drug Administration marked another turning point in the pandemic, reflecting the persistent struggle to suppress disease and death over the 2½ years since the pandemic began.

“Updated COVID-19 boosters are formulated to provide better protection against the latest circulating COVID-19 variant,” Walensky said in a statement. Said. “They can help restore protection that has decreased since previous vaccination and are 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 recommend getting it.”

Several advisory panel members expressed concern about the lack of clinical data on 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 late November to make the updated booster vaccine could be an additional 9,700 deaths and 137,000 hospitalizations, based on projections presented at the day-long meeting.

“I think that’s definitely the tension I felt,” Daley said. But with the FDA decision, “We are now in a position where millions of doses of bivalent vaccines are readily available and available. And I think they will be an effective tool for disease prevention this fall and by the end of winter.”

The latest advice for supporters offers a new opportunity for the Biden administration and public health experts to launch a new round of messages to a public weary of the epidemic about the importance of vaccinating against a virus that still kills an average of more than 500 people a day in the country. United States of America.

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

The new enhancers – the first changes since mRNA vaccines became available in December 2020 – target the BA.4 and BA.5 omicron subvariants that are dominant in the United States. Officials say the new vaccines will help expand immunity, as it’s a closer match to the circulating strain.

So far, vaccines have targeted the original version of the coronavirus, even though different variants have 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, which are by far the most contagious versions of the virus since the coronavirus ravaged the world in 2020. BA.5 now accounts about 90 percent of cases In the United States, according to the CDC.

People can receive updated vaccines if it has been at least two months since they completed their primary vaccine series or their last supplement. Even if a person has taken boosters from the original formulation, they can still receive the updated booster two months after their last shot. A gap of at least two months aims to boost immunity because giving vaccines too early reduces the effectiveness of the vaccine.

A longer interval between shots also reduces the risk of rare side effects such as the following, especially for younger adults and older teenagers. heart muscle inflammationheart muscle inflammation, health officials said.

The CDC estimates that approximately 200 million Americans ages 12 and older are eligible for the updated shot. Nearly 22 million adults aged 50 and over receive a second booster dose, while most people aged 5 and older have at least six months of their last dose of coronavirus vaccine, CDC executive Sara Oliver told the advisory board on Thursday.

Americans have been slow to take the booster, and experts say it’s unclear whether uptake of the reformulated booster will differ. The country may be becoming something we must learn to manage on a more regular, routine basis, including “routines” from the coronavirus as an emergency. [coronavirus] vaccination,” said Jen Kates, senior vice president of the Kaiser Family Foundation.

“It’s hard to see what fundamental volatility will be, a rush to accelerate,” Kates said in an email. Citing a recent Kaiser Family Foundation survey, some people — about 20 percent of people who have been vaccinated — are “anticipating updated vaccines that can target variants,” Kates said. “On the other hand, it’s hard to see how that will change things if people don’t see them as better or necessary, or if they have other reasons for not wanting to take a booster.”

Albert Ko, an infectious disease doctor and epidemiologist at the Yale School of Public Health, said the country is experiencing more than 500 covid-19 deaths a day, saying he is worried about what Americans will face this winter.

“The inadequate uptake of new boosters is a real and urgent concern, especially as we rely on vaccines to protect our communities, especially now that social distancing and the use of face masks are disappearing,” Ko said. Said.

Panel members echoed questions among some experts, raising concerns about the lack of human data on the efficacy of the shots — the FDA relied heavily on mouse studies — that experts said could fuel skepticism about the efficacy of the boosters. Data used by the FDA to approve the vaccine included human studies of previous experimental bivalent vaccines, including those that produced virus-fighting antibodies against its first omicron sub-variant, BA.1, and the overall registry of vaccines since December 2020.

Pablo J. Sanchez, professor of pediatrics at Ohio State University, said he voted no because he thought “we need human data” on the new vaccine, which is just beginning to be collected.

But Seattle and King County health officer Jeffrey Duchin said he’s comfortable with animal data to support reformulated boosters. Panel members also noted the regular use of animal studies to adjust the composition of annual influenza vaccines.

In September, CDC’s Oliver presented data showing how a booster vaccination program can prevent significant deaths, hospitalizations, infections, and direct medical costs. Oliver noted that the effectiveness of vaccines decreases faster as the virus develops. Including a variant in the vaccine broadens the antibody response.

Interest in earlier booster shots has performed lukewarm at best.

in and soon Kaiser Family Foundation researchAlmost 6 out of 10 people who were vaccinated but not supplemented said they felt they had adequate protection, and “as we know from the data, this is not the case given the declining and new variants,” Kates said. In the survey, three out of 10 people said they were too busy, and 15 percent were worried about missing work, she said. Democrats are more likely to be vaccinated and reinforced than Republicans.

A CDC survey with the University of Iowa in August suggests that more people will want shots — 72 percent of eligible respondents said they would definitely or likely receive an updated booster versus omicron, Oliver said.

Only half of Americans eligible for sponsors — about 108 million people – took the first recommended dose of booster, and only a third of those aged 50 and over – about 22 million people – took a second boost. CDC surveys have shown that older adults, college graduates, and people with higher incomes are more likely to be vaccinated and supplemented.

Anyone who receives a two-beat primary sequence of mRNA or Novavax vaccines or one shot Johnson & Johnson vaccine will be eligible regardless of whether or not they receive any supporting shots.

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

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

The booster change is already causing confusion. Some people who signed up to receive the original booster formulation will need to reschedule their appointment to receive the newer version because the original formulations are no longer authorized by the FDA to be used as boosters.

“The last thing we have to do is to people who sign up. [for the original booster] “They’re expected to get vaccinated this week because they have to wait,” said Michael Fraser, president of the Association of State and Regional Health Officials. “We’ve seen lagging demand nationally, and that doesn’t build trust among the public and providers asking health officials what to do now.”

The CDC recommends a coronavirus vaccine for everyone 6 months of age and older, and boosters for anyone 5 years and older who are eligible.

CDC data from Thursday’s meeting showed that adults with 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 reinforcer had a three times lower risk of death than those who had a single reinforcer.

Experts and officials disagree on whether an updated vaccine is necessary 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 wasn’t clear how much additional benefit a reformulated booster would provide.

People should check with and visit local pharmacies and providers. According to information given to state health officials, initially only about 1.5 million doses are likely to be available before they show up to get vaccinated. Another 10 million doses are scheduled for next week.

Laurie McGinley contributed to this report.

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