(CNN) — Dr. Rochelle Walensky, director of the US Centers for Disease Control and Prevention (CDC), signed Thursday the recommendation of the agency’s independent vaccine advisers to Please update booster doses of covid-19 vaccines from Pfizer/BioNTech and Moderna.
The Advisory Committee on Immunization Practices (ACIP) voted 13-1 earlier in the day to recommend updated mRNA boosters for Americans this fall.
Walensky’s decision means the vaccines could be available on Friday, according to pharmaceutical manufacturers, who began shipping the new doses after the US Food and Drug Administration (FDA) authorized on Wednesday.
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“The updated COVID-19 vaccine boosters are formulated to provide better protection against the most recently circulating variant of COVID-19,” Walensky said in a statement. “They can help restore protection that has diminished since previous vaccination and were designed to provide broader protection against newer variants. This recommendation followed a comprehensive scientific evaluation and sound scientific discussion. If you are eligible, there is no bad time to get your COVID-19 vaccine and we strongly encourage you to get it.”
The updated boosters have instructions that tell our cells to make antibodies against two variants of the virus that causes covid-19: the original variant and subvariants BA.4 and BA.5 omicron, which share the same spike.
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Pfizer’s updated vaccine is a 30-microgram dose licensed for people 12 years and older. Moderna’s updated vaccine is a 50-microgram dose licensed for ages 18 and older.
The CDC said in the statement that they “also expect to recommend boosters of updated COVID-19 vaccines for other pediatric groups” in the coming weeks.
People are eligible for catch-up boosters as long as they have completed all of the primary doses in their vaccine series. The committee recommended that new boosters be given at least two months after the last dose of any COVID-19 vaccine and up to three months after an infection.
The new vaccines do not replace the doses of the primary series.
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The boosters were approved based on studies in mice bred to have human ACE-2 receptors, which are the gates the coronavirus uses to enter our cells, but clinical trial data showing how well they may work in humans will not be available. Available for another month or two.
This is similar to the way annual flu shots are studied and approved, but it is the first time it has been done for COVID-19 vaccines.
In approving the vaccines, regulators also reviewed the data behind different two-variant boosters. Those carry instructions to combat the original omicron variant, BA.1, along with the original virus. Those boosters have been studied in about 1,400 people. They have been licensed for use in the United Kingdom and Canada, but will not be available in the United States.
Several committee members said they were uncomfortable recommending a vaccine without supporting human performance data.
“We have been extrapolating the data that has been seen with the bivalent BA.1 and hopefully we will have similar data for BA.4 and BA.5,” said Dr. Pablo Sánchez, a pediatrician at Ohio State University and a member of the committee. .
“So I’m just worried about that extrapolation. And because, ultimately, I really don’t want to set a precedent of recommending a vaccine for which we don’t have clinical data,” says Sánchez.
That drew a swift rebuttal from government experts working with the committee.
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“I’d like to remind the committee that every year we use flu vaccines that are based on new strains without clinical trials,” said Dr. Melinda Wharton, associate director for vaccine policy at the National Center for Immunization and Diseases. CDC Respiratory.
Dr. Doran Fink, deputy director of the US Food and Drug Administration (FDA) Division of Vaccine Applications and Related Products added: “I appreciate the amount of discomfort I hear from committee members being asked to take this step with covid-19 vaccines that they have not previously been asked to do with covid vaccines.”
“The FDA was very comfortable with the approach of extrapolating safety and efficacy, or rather known and potential benefits,” Fink said. “We recognize that we have taken a different path than the regulatory authorities in Europe and Canada,” he added.
Fink said the United States chose to go down this path based on feedback from its independent advisory group and projections of viruses that may be circulating in the country through the fall and winter.
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On Thursday, the committee saw new modeling data that suggested there were substantial risks in waiting to roll out new booster doses.
According to CDC projections, booster doses given to American adults in September could prevent 137,000 more hospitalizations and 9,700 deaths than if booster doses were continued through November.
New analysis of the cost-effectiveness of boosters suggests the United States could save at least $63 billion in medical costs between August and March 31 if as many people get these boosters as they do flu shots during the 2021-22 season.
In studies looking at BA.1-targeted injection alongside the original, the boosters amplified immunity against many variants and were shown to be better than the older single-strain boosters because they produced higher levels of antibodies.
Moderna presented tantalizing data suggesting that injections of two strains it developed against the Beta variant could extend the duration of protection people get from their shots, which currently tapers off significantly after about four months. She said a study on these results was being prepared for publication.
In mice bred to have human ACE-2 receptors, the two-strain vaccines against BA.4 and BA.5 protected better against infections in their lungs, compared with the original vaccine.
About two-thirds of the total US population is vaccinated against Covid-19 with an initial series, according to data from the CDC. But less than half of those who have their initial series, and less than a third of the total population, have also received a booster.
CNN’s Naomi Thomas and Deidre McPhillips contributed to this report.
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