April 18, 2023: The FDA on Tuesday approved a momentary bivalent COVID-19 booster for high-risk Americans, hoping to increase public coverage and inspire more people to get vaccinated, which targets the original SARS-CoV-2 virus strain and two variants of Omicron.
The monovalent (single strain) mRNA COVID vaccines from Moderna and Pfizer-BioNTech will no longer be available, as it has withdrawn emergency use authorizations for both.
FDA recalls another bivalent to:
The FDA said unvaccinated children ages 6 months to 5 years can get a two-dose series of the bivalent Moderna vaccine; or they could get a three-dose series of the bivalent Pfizer-BioNTech vaccine (up to four years of age). Unvaccinated five-year-olds would likely receive two boosters of bivalent Moderna or one booster of single Pfizer.
The expected resolution
Support for a momentary booster was expected, especially as the CDC’s Advisory Committee on Immunization Practices (ACIP) meets Wednesday to officially present who gets the bivalent booster.
In February, the panel opposed any further withdrawal, saying the country instead moved to an annual injection in the fall. At the same time, the CDC released information that appeared to have an up-to-date reminder reduced the risk of death.
The CDC reports that only 17% of Americans have received a bivalent booster; Only 43% of other people over 65 won the two-strain vaccine. Meanwhile, there are about 100,000 COVID cases and more than 1,300 deaths in the U. S. week. The U. S. government, according to the agency. While most of those deaths involve other people over the age of 65, the FDA still urges others to get a booster.
“Americans under the age of 65 didn’t get much advantage from receiving a bivalent booster,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a briefing with reporters. He estimated that 75 percent of the remaining 12- to 65-year-olds “could get a bivalent booster at this level and haven’t taken it. “
These other people “could pass out and get bivalent retirement now for protection,” he said.
People under 65 who have already earned a single bivalent dose are still not getting another dose, the firm said.
Simplify the process
The company said it wants to simplify the COVID vaccination schedule to end confusion and better prepare for emerging variants. To that end, the FDA’s advisory committee will meet in June to discuss which strains and variants of SARS-CoV-2 are most likely. to circulate in autumn and winter 2023-24.
The committee will propose which of them will be included in a vaccine, and drug brands will then prepare the new vaccine to be administered in the fall, Marks said.
It’s similar to the procedure used by the FDA and drug brands for the composition of the flu vaccine each year, he said.
As with the flu vaccine, the company and fitness officials will urge others to get the latest vaccines. “It’s important for all Americans to get an up-to-date vaccine to provide coverage against the long-term variants that emerge,” Marks said.
The FDA judged how safe an individual bivalent vaccine would be, based on the prior knowledge of the age teams that won the monovalent and bivalent vaccines from Moderna and Pfizer.
“We’re easy to extrapolate here, based on our vaccines, given the loads of millions of doses administered and what we’ve seen with genuine evidence, both with both monovalent and bivalent vaccines,” Marks.
Neither the Moderna nor Pfizer monovalent or bivalent vaccines have been officially approved, but they have emergency use authorization. But Marks said the FDA still needs to put the products through a longer and more comprehensive approval process.
“We know that other people are more comfortable with authorized products,” he said. But “we guarantee their safety, efficacy and quality in the same way we do with authorized products. “
SOURCES:
FDA: “Coronavirus (COVID-19) Update: FDA Authorizes Changes to Simplify Use of COVID-19 Bivalent mRNA Vaccines. “
CDC: “Advisory Committee on Immunization Practices (ACIP)”, “Incidence and Mortality of COVID-19 Among Unvaccinated and Vaccinated Elderly ≥ 12 Years to Receipt of Bivalent Booster Doses and Time From Vaccination – 24 U. S. JurisdictionsU. S. Vaccine, October 3, 2021-December 24, 2022,” “COVID-19 Vaccines in the United States,” “COVID Data Tracker. “
Peter Marks, MD, PhD, Director, FDA’s Center for Biologics Evaluation and Research.
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