The CDC’s Immunization Advisory Board voted 13 to 1 earlier in the day to recommend an updated mRNA booster for Americans this fall.
Warenski’s decision means the shot could be available by Friday, according to the drug maker, which began shipping the new dose after the U.S. Food and Drug Administration approved it on Wednesday.
“Our latest COVID-19 booster is formulated to provide enhanced protection against the recently circulating COVID-19 variant,” Walensky said in a statement. “This recommendation is designed to help restore protection that has weakened since previous vaccinations and to provide broader protection against new subspecies. This recommendation is based on a comprehensive scientific evaluation and robust scientific based on public debate.If you are eligible, we strongly encourage you to receive a COVID-19 booster.”
The updated booster contains instructions that tell cells to make antibodies against the two strains of the virus that cause Covid-19. The original strain and the BA.4 and BA.5 Omicron subvariants that share the same spike.
Pfizer/BioNTech’s latest vaccine is a 30 microgram dose licensed for people 12 years and older. Moderna’s updated vaccine is a dose of 50 micrograms licensed for people 18 years and older.
In a statement, the CDC said it “will be recommending the latest COVID-19 booster to other pediatric groups in the coming weeks.”
As long as you have completed all first doses of the vaccine series, you are eligible for renewed boosters. The committee recommended that new boosters be administered at least two months after the last dose of Covid-19 vaccine and up to three months after infection.
New formulations do not replace primary series shots.
The booster was approved based on a study of mice bred to have human ACE-2 receptors (the doors the coronavirus uses to enter cells), but how well it works in humans. No clinical trial data showing another .month or two.
This is similar to how annual flu vaccinations are researched and approved, but is a first for a Covid-19 vaccine.
When approving the vaccine, regulators also looked at the data behind various two-strain boosters. They contain the original virus along with instructions to combat the original strain of BA.1, a subspecies of Omicron. These boosters are being studied in about 1,400 people. Approved for use in the UK and Canada, but not for use in the US.
Several panel members said Thursday they were reluctant to recommend a vaccine for which there is no human data to support it.
Dr. Pablo Sanchez, a pediatrician at Ohio State University, said: and a member of the committee.
“So I’m just worried about that extrapolation. And ultimately, I don’t want to set a precedent for recommending a vaccine that we don’t have clinical data for.
It prompted swift counterarguments from government experts working with the commission.
“Each year, we want to remind the committee that we use influenza vaccines based on new strains that have not been tested clinically,” said the associate director of vaccine policy at the CDC’s National Center for Immunization and Respiratory Medicine. said Dr Melinda Wharton. illness.
Dr. Doran Fink, Deputy Director of the FDA’s Office of Vaccines and Related Products Submissions, said: I have never been asked to make one before with a Covid vaccine.
“The FDA was very pleased with the approach to estimating safety and efficacy, or rather known potential benefits. I am aware that I have walked through
Fink said the US chose this route based on feedback from an independent advisory group and forecasts of the virus that may be circulating in the country over the fall and winter.
On Thursday, the commission confirmed new modeling data that suggests there is considerable risk in waiting for the deployment of new boosters.
The CDC predicts that administering a booster to US adults in September could prevent 137,000 hospitalizations and 9,700 deaths compared to administering the booster through November.
A new analysis of the cost-effectiveness of boosters shows that if the same number of people who received these boosters as were vaccinated against the flu during the 2021-22 season, the United States would lose between August and March 31. could save at least $63 billion in health care costs.
A study examining shots targeting BA.1 alongside the original found that the booster was superior to the old single-strain booster because it broadened immunity to many variants and produced higher levels of antibodies. Proven.
Moderna presented interesting data suggesting that two lines of shots developed against the beta variant may extend the protection that people get from vaccines. This now drops significantly after about 4 months.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 pulmonary infection compared to the original vaccine.
About two-thirds of the total US population has been vaccinated against Covid-19 in the first series, according to CDC data. But less than half of those with the first series, and less than a third of the total population, got boosters.
CNN’s Naomi Thomas and Deidre McPhillips contributed to this report.