CDC advisors endorse booster shots that target Omicron for Americans 12 and up

The United States should replace most of its COVID-19 booster shots with updated versions that target the dominant omicron strains, an influential group of vaccine experts advising the Centers for Disease Control and Prevention said Thursday.

In a vote of 13 to 1, the panel recommended that Americans ages 12 and older who had been away for at least two months since their last shot rolled up their sleeves for the reformulated boosters designed to combat BA.4 and BA. 5 subvariants along with the original coronavirus that arrived in the US in early 2020.

When CDC director Dr. Rochelle Walensky agrees with the Advisory Committee on Immunization Practices, the “bivalent” boosters could go up in arms within days. She should make a decision by the end of the week.

The two offerings — one from Pfizer and BioNTech for people ages 12 and older, and one from Moderna for adults ages 18 and older — mark the first major change in the COVID-19 vaccine recipe since the country’s immunization campaign began almost two years ago.

If Walensky opts out, about 209 million Americans would be immediately eligible for the new vaccines. Most of them have not received a booster dose for more than six months.

Individuals would be considered “up to date” with their COVID-19 immunizations after receiving the bivalent booster, regardless of the total number of boosters they received. The original non-BA.4 and BA.5 boosters would no longer be available for those aged 12 and over.

Those who have recently had a coronavirus infection are advised to wait at least three months after they have tested positive for coronavirus or started showing their COVID-19 symptoms before receiving the new vaccine.

President Biden and members of his COVID-19 response team have been promoting a fall refresher campaign focused on the bivalent vaccine. The administration has already bought 171 million doses.

“It’s going to be really important that people get the new shots this fall and winter,” said Dr. Ashish Jha, White House COVID-19 Coordinator, last month. “It’s made for the virus out there.”

And since the updated boosters will train the immune system to recognize the dominant BA.4 and BA.5 strains, he added, they are expected to improve the vaccines’ “ability to prevent infection, prevent transmission and certainly prevent serious illness and death.”

A team of disease modeling experts from across the country believes that making the new booster vaccine available to adults in September, rather than waiting until November, could prevent 137,000 hospitalizations due to COVID-19 and 9,700 deaths. They also predict that rolling out the new booster shot to all adults, rather than restricting it to those over 50, would reduce hospitalizations by 20% and deaths by 15%.

A separate study by the Commonwealth Fund estimated that launching a top-up campaign in early fall could save between $63 billion and $109 billion, mostly in hospital bills.

The US Food and Drug Administration approved the two bivalent boosters on Wednesday after animal studies showed “a very good immune response,” said Dr. Peter Marks, the agency’s vaccine chief.

In a move reflecting annual flu vaccine formulation updates, the FDA did not require additional testing on humans before acting. Both companies said human trials of the new boosters were underway, but the lack of data made some panel members concerned.

“I understand that we need better vaccines,” said Dr. Pablo Sanchez, a pediatric infectious diseases specialist at Nationwide Children’s Hospital in Columbus, Ohio. “But I’m struggling with making a recommendation for a vaccine, a bivalent vaccine. . . this has not been studied in humans.”

Another of Moderna’s bivalent vaccines, targeting the original Omicron strain, known as BA.1, was approved by the UK Medicines and Health Agency last month. When tested on humans, side effects were similar to those of the original vaccine and were typically “mild and self-healing,” according to the agency.

Pfizer also developed a bivalent vaccine that targeted BA.1. But the FDA said in June that the only optimized boosters it was interested in were those targeting BA.4 and BA.5. Together, the two subvariants account for about 92% of the COVID-causing viruses currently circulating in the United States, according to CDC estimates. They have identical spike proteins, which is the part of the virus that the vaccine is trained to recognize.

While the original vaccines and boosters have proven effective in preventing serious illness and death, there is hope that the new vaccines will be more effective in fighting off infection. There’s reason to believe it will: Both Pfizer and Moderna said their BA.1 boosters caused recipients to commit higher levels of Omicron-fighting antibodies compared to booster doses of their original vaccines to produce.

In addition, representatives from Moderna presented data showing that those who received their BA.1 vaccine produced slightly higher levels of antibodies against the alpha, beta, delta and gamma variants compared to those who received a traditional second booster shot. This is consistent with experiments showing that exposure to a broader spectrum of coronaviruses makes the immune system better equipped to deal with coronaviruses than it has ever seen before.

Walensky’s decision will be the last federal obstacle to getting the new recordings public. But before they can be made available in California, they need the blessing of the Western States Scientific Safety Review Workgroup, an independent panel of public health experts that reviews COVID-19 vaccines. Officials expect the shots will be available here soon after Labor Day.

Los Angeles County has placed an order for 170,000 doses of the boosters, the maximum currently allowed. These are expected to arrive between September 6 and 9 and will be distributed to around 300 different healthcare providers by the middle of the month, according to Health Director Barbara Ferrer.

Both companies are still developing bivalent recordings for children, which could be ready within a few months. In the meantime, children under 11 must stick to the original booster formulations, as must teens who choose Moderna’s booster over Pfizer’s.

Ultimately, the shots’ ability to prevent the next wave depends on how many people choose to get them. Although more than two-thirds of all Americans have completed their first series of COVID-19 vaccinations, only 48.5% of those eligible for an initial booster have received them. And only 33.7% of Americans age 50 and older who are able to get a second booster shot have done so, according to the CDC.

In a survey conducted by the CDC, 72% of respondents said they would get the new refresher. CDC advisors endorse booster shots that target Omicron for Americans 12 and up

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