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The U.S. Food and Drug Administration on Monday approved and authorized for emergency use updated COVID-19 vaccines formulated to target currently circulating variants and provide better protection against serious consequences of COVID-19, including hospitalization and death. The action relates to updated mRNA vaccines for 2023-24 manufactured by Moderna and Pfizer.
"Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death," said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research. "The public can be assured that these updated vaccines have met the agency's rigorous scientific standards for safety, effectiveness and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated."
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The FDA made these recommendations for specific age groups:
- Individuals 5 years of age and older regardless of previous vaccination are eligible to receive a single dose of an updated mRNA COVID-19 vaccine at least two months since the last dose of any COVID-19 vaccine.
- Individuals 6 months through 4 years of age who previously have been vaccinated against COVID-19 are eligible to receive one or two doses of an updated mRNA COVID-19 vaccine (timing and number of doses to administer depends on the previous COVID-19 vaccine received).
- Unvaccinated individuals 6 months through 4 years of age are eligible to receive three doses of the updated authorized Pfizer-BioNTech COVID-19 vaccine or two doses of the updated authorized Moderna COVID-19 vaccine.
The updated vaccines first must be recommended by an expert panel that advises the Centers for Disease Control and Prevention on how vaccines should be used. After the Advisory Committee on Immunization Practices votes on whether to recommend the boosters on Tuesday — it is expected to recommend them — CDC Director Mandy Cohen must sign off on the recommendations before the shots can be put into use.
Related: CDC's big COVID dilemma: Whether to recommend the new boosters for all ages
These vaccines also are the first COVID shots in this country that were not purchased by the federal government, although most health insurance policies and Medicare are expected to cover the cost of the vaccines. CDC's Advisory Committee on Immunization Practices, which will vote on Tuesday, sets U.S. vaccination policy and helps determine insurance coverage for vaccines.
The federal government has put in place a bridge program administered by the CDC to provide COVID vaccines this fall to roughly 25 million to 30 million adults, ages 18 to 64, who either do not have health insurance or whose insurance doesn't cover COVID shots.
Pfizer said it would start distributing the shots now that they are approved and that the vaccines could be available as soon as the CDC clears their usage. This means it is possible shots could be available for some people by the end of this week. Moderna also said the shots would be available in the coming days.
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Alan Goforth
Alan Goforth is a freelance writer in suburban Kansas City. In addition to freelancing for several publications, he has written a dozen books about sports and other topics.
