Original COVID shots no longer authorized — but newer ones are, FDA says. What to know
UPDATE: This article was updated to include additional information regarding the Novavax COVID-19 vaccine, which is still available in the U.S.
The original COVID-19 vaccines made by Pfizer and Moderna no longer are authorized in the U.S., the Food and Drug Administration announced on Tuesday, April 18.
Now, both companies’ newer COVID-19 vaccines, which include a component of the original vaccine and a second component targeting the omicron variant, are authorized as the main dose for people 6 months and older, the FDA said in a news release.
Anyone unvaccinated against the virus looking to get either company’s shot would get a single “bivalent” dose instead of two shots of the original “monovalent” vaccines, according to the agency.
For most people who’ve received one dose of the newer shots, they aren’t eligible for an extra shot, the FDA said. Certain individuals, however, such as those 65 and older, are eligible for an extra dose.
The majority of people vaccinated with an original COVID-19 vaccine dose can get a single shot targeting omicron, according to the agency.
The FDA plans to decide on what’s next for COVID-19 vaccines after receiving recommendations on a “fall strain” vaccine composition in June at an advisory committee meeting, the agency said.
The current, newer vaccines were updated to target omicron BA.4 and BA.5 strains, according to the FDA.
“Evidence is now available that most of the U.S. population 5 years of age and older has antibodies to SARS-CoV-2, the virus that causes COVID-19, either from vaccination or infection that can serve as a foundation for the protection provided by the bivalent vaccines,” Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
A prior COVID-19 infection and vaccination, also known as hybrid immunity, is “the best protection you get,” Dr. Diego Hijano, an infectious disease specialist at St. Jude Children’s Research Hospital’s Department of Infectious Diseases, previously told McClatchy News.
Separately from the FDA authorization changes related to Pfizer and Moderna’s mRNA vaccines, Novavax confirmed its protein-based COVID-19 vaccine, which is formulated differently, is still available in the U.S., the company said in a news release. People 12 and older can get the shot as their primary series and vaccinated adults can get the shot as a third dose.
In the U.S., over 55 million people, nearly 17% of the population, have received an updated COVID-19 shot, according to Centers for Disease Control and Prevention data.
More on who can get a newer, extra COVID dose — and when
People 65 and older may get an extra dose of the bivalent at least four months after their first dose, according to the FDA.
Most people who are immunocompromised can get an extra dose at least two months after their prior dose of an updated vaccine, the FDA says.
Then, these individuals can continue to get extra doses in consultation with their health care provider.
When it comes to immunocompromised babies 6 months and older through children 4 years of age, “eligibility for additional doses will depend on the vaccine previously received,” the FDA said.
Dr. Matthew Laurens, of the University of Maryland School of Medicine, told the Associated Press he agrees with the FDA’s decision to make extra booster doses available to “eligible, high-risk groups.”
“We do have vaccines that are available to protect against these severe consequences, so why not use them?” he told the outlet. “They don’t do any good just sitting on a shelf. So let’s give them to individuals who are at the highest risk who can benefit the most.”
More on children and the vaccines
For healthy children 6 months through 5 years old who haven’t gotten a COVID-19 vaccine, there are two options, the FDA said.
Parents can opt for two doses of Moderna’s newer COVID-19 vaccine or three doses of Pfizer’s newer vaccine, according to the agency.
For healthy children 6 months through 5 years of age who have gotten at least one original COVID-19 vaccine dose, they can get a newer shot, the FDA said.
However, the amount of doses they can get depends on the prior vaccine they’ve gotten, according to the agency.
“COVID-19 continues to be a very real risk for many people, and we encourage individuals to consider staying current with vaccination, including with a bivalent COVID-19 vaccine,” Marks said.
As of April 12, COVID-19 cases in the U.S. are trending downward compared to the previous week, according to CDC data.
This story was originally published April 18, 2023 at 9:51 AM with the headline "Original COVID shots no longer authorized — but newer ones are, FDA says. What to know."
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