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Aug 31 (Portal) – The U.S. Food and Drug Administration on Wednesday approved updated COVID-19 booster vaccines from Pfizer (PFE.N)/BioNTech (22UAy.DE) and Moderna based on the dominant BA.4 and BA.5 omicron subvariants as the government prepares for a broad-case vaccination campaign that could begin within days.
The new vaccines also contain the original version of the virus that all previous COVID vaccinations targeted.
The FDA approved vaccinations for anyone 12 years and older who has had a primary series and is at least two months away from a previous booster shot at shorter than previously recommended intervals.
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dr Peter Marks, a senior FDA official who oversees vaccines, said he hopes the shots will restore the very good protection against symptomatic disease that the original vaccines provided when they were introduced in late 2020 and early 2021.
“We’re not sure yet if we’re going to reach the same level, but that’s the goal here,” said Marks.
The government has begun work on the fall rollout, which could begin soon, after the US Centers for Disease Control and Prevention (CDC) external panel of experts met on Thursday and the agency’s director, Rochelle Walensky, made a final recommendation.
The United States has secured more than 170 million doses of the two shots to stave off the worst effects of a potential spike in infections as schools reconvene and people spend more time indoors due to the colder weather.
This could be the last COVID vaccine made available to all Americans for free as the government plans to move it to the commercial insurance market next year. Continue reading
Moderna’s upgraded vaccine has been approved for people ages 18 and older, while the Pfizer/BioNTech vaccine will be available for people ages 12 and older, the FDA said.
Pfizer said it has some doses ready to ship immediately and could ship up to 15 million doses by Sept. 9. Moderna said it expects its new dose to be available “in the coming days.”
People pose with syringe with needle in front of Moderna logo displayed in this illustration December 11, 2021. Portal/Dado Ruvic/Illustration/Files
Experts have said the updated vaccines will be important for the elderly and immunocompromised, but noted there is limited data to support the level of protection the government is hoping for.
“For people who haven’t been infected and whose last dose was a year ago, yes it will benefit them. I can’t tell you how much,” said Dr. Gregory Poland, a vaccines expert at the Mayo Clinic. He said the new shots are unlikely to help those who have recently been infected.
This fall’s booster campaign is expected to target many more people than the previous boosters approved by the FDA earlier this year. Concerns about long COVID were one reason younger and healthier Americans should get the shot, officials said.
“If anything is going to prevent transmission and long COVID, it’s going to be a variant-specific vaccine for the variant that’s currently in circulation,” FDA Commissioner Robert Califf said.
DIFFERENT VACCINES IN OTHER COUNTRIES
About 50% of people in the United States over the age of 12 — approximately 107 million people — have received at least one COVID-19 booster dose to date.
Some scientists criticized the recommendation, which would allow a new booster shot just two months after a previous shot, saying a longer break would improve immune responses. FDA officials said the vast majority of Americans are well over two months from their last vaccination.
Other countries, including Canada and the United Kingdom, have also ordered updated Omicron vaccine boosters for autumn campaigns, although some vaccinations are tailored to the Omicron subvariant BA.1, which caused the record spike in COVID cases last winter.
The FDA in June urged vaccine makers to target vaccines against the BA.4/BA.5 subvariants of the virus, which are responsible for the recent global spike in infections. The BA.5 subvariant accounts for more than 88% of US infections.
Vaccine manufacturers have not yet completed human testing of the updated BA.4/BA.5-based boosters. The FDA bases its decision on safety and efficacy data from the original syringes as well as from clinical trials conducted with booster doses using the subvariant BA.1 Omicron.
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Reporting by Mrinalika Roy in Bengaluru, Julie Steenhuysen in Chicago and Michael Erman in Maplewood, New Jersey; Additional reporting by Ahmed Aboulenein in Washington; Edited by Caroline Humer and Bill Berkrot
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