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CDC panel recommends new omicron Covid booster set to launch next week

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The Centers for Disease Control and Prevention’s Independent Committee on Vaccines recommended a reformulated booster shot targeting the latest Omicron subspecies.

The panel voted 13 to 1 in favor of the injection on Thursday after reviewing available safety and efficacy data in a nearly seven-hour meeting. CDC Director Rochelle Walensky, PhD, needs final approval before pharmacies can begin administering the boosters, but her approval is expected to follow soon.

Pfizer’s Omicron Booster is for ages 12+ and Moderna’s latest shot is for ages 18+. Eligible age groups will receive their booster at least two months after completing the primary series or most recent booster with older shots.

Millions of Americans could be eligible for new Covid boosters

Pfizer plans to ask the Food and Drug Administration to also approve a new booster for children ages 5 to 11 in early October, company officials told the committee on Thursday.

The original vaccine will no longer be used as a booster for people over the age of 12 now that re-prescribed shots are online.

Public health officials expect another wave of Covd infections this fall. This is because immunity from older vaccines weakens, the more contagious Omicron subspecies spreads, and people spend more time indoors as the weather gets colder and families gather for vacations.

The CDC and FDA hope the new boosters will provide more durable protection against infections, minor illnesses and severe illnesses. The reconstructed shots target Omicron BA.5, the dominant variant of Covid that emerged in China over two years ago.

So far, the US has secured 171 million new boosters from Pfizer and Moderna. According to the CDC, more than 200 million people are eligible for vaccination. CDC official Dr. Sarah Oliver told the committee on Thursday that there should be enough supplies of the vaccine to meet demand this fall.

Omicron BA.5 No human data available

With no human trial data on the new BA.5 booster, it’s unclear how it will perform in the real world. CDC and FDA used human data from a clinical trial of SCHOTT targeting the original version of Omicron BA.1. BA.1 elicited a stronger immune response than older vaccines.

Pfizer and Moderna initially developed an omicron booster targeting the BA.1, but after the subvariant became dominant, the FDA switched gears in June and developed the BA.5 shot instead. I have asked both companies to do so. The decision to focus on BA.5 did not leave enough time to await data from human trials prior to the fall vaccine rollout.

The lack of human data for the BA.5 shot has caused some controversy, but senior FDA official Dr. I said I was following the same process. Marks said Wednesday that flu vaccine strains have also been altered without human clinical data.

Dr. Pablo Sanchez, the only committee member to vote against the shot, called the recommendation premature and said the US should have waited for human data before proceeding with the booster.

“There’s already a lot of hesitation about vaccines. We need human data,” said Sanchez, a professor of pediatrics at Ohio State University. I believe.

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Panel member Dr. Oliver Brooks, chief medical officer of Watts HealthCare Corporation in Los Angeles, explained why, given the availability of clinical data for the vaccine maker’s first BA. 5 I wondered why they decided to adopt the vaccine. Brooks ultimately voted in favor of the shot.

But Dr. Sarah Long, also a member of the committee, said the BA.5 booster also contains the original Covid strain, so there’s no reason to expect it to be inferior to the old shot, and could reduce hospitalizations and deaths. Said that there is a nature.Autumn and winter. Long also voted in favor.

mouse research

FDA and CDC officials believe that the Omicron BA.1 and Omicron BA.5 boosters are sufficiently similar that the immune response data for BA.1 injections are highly indicative of the efficacy of BA.5 injections. says. According to Dr. Jacqueline Miller, who is working on vaccine development at Moderna, Omicron BA.1 and He BA.5 are closely related with he four mutational differences.

Moderna completed enrollment in a clinical trial of the BA.5 shot last week and should have results by the end of the year, Miller told the CDC committee on Thursday. It did not disclose when the results would be expected.

The health agency also reviewed data on BA.5 shots from mouse studies. Moderna presented data showing that BA.5 shots increased antibody in mice more than 4-fold compared to old shots. Mice express the same cellular proteins that humans catch viruses on. His BA.5 booster from Pfizer increased antibodies in mice 2.6-fold compared to the original vaccine.

safety

According to the FDA, the most common side effects in human trials of BA.1 shots were pain, redness, injection site swelling, fatigue, headache, muscle and joint pain, chills, nausea, vomiting, and fever.

CDC official Oliver told the panel that health officials believe there is no difference in the safety profile of injections of BA.1 and BA.5.

However, Oliver said the risk of myocarditis following BA.5 booster injections is unknown. According to the CDC, there is a higher risk of myocarditis among young men and adolescent boys who have received a second dose of Pfizer and Moderna, but a higher risk of myocarditis from Covid infection.

“We know the risk of myocarditis is unknown, but we would expect a risk similar to that seen after a monovalent vaccine,” Oliver said. It’s an old injection administered to millions of people in

Older Vaccines Lose Effectiveness

The original vaccine, first approved in December 2020, no longer provides meaningful protection against infection as the virus has mutated so much over the past two years. Shot was developed against the first strain to emerge in China, so it is no longer a match for targeting the ubiquitous omicron subspecies.

Infections, hospitalizations, and deaths have dropped dramatically since last winter’s massive wave of Omicron infections, but leveled off at stubbornly high levels this summer. BA.5 is the most contagious and immune-evading variant to date, resulting in breakthrough infections becoming increasingly common.

After Omicron BA.5 became dominant, the efficacy of older vaccines for hospitalization also declined. CDC data showed that on the third dose, four months after receiving the injection, he was 77% effective in preventing hospitalization, but after 120 days, he was down to 34%. On his 4th dose over 50 years old, he was 56% effective in preventing hospitalization 4 months later.

Covid deaths and hospitalizations in people over the age of 65 have increased since April, according to CDC epidemiologist Heather Scobie, who presented data at a conference Thursday. It is increasing among people with

CDC has moved to a more targeted public health response focused on protecting the most vulnerable, including the elderly, those with serious medical conditions, and those with weakened immune systems. There is no data on the actual effectiveness of the new boosters, but the US is moving rapidly to deploy them in hopes of protecting people this fall.

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