Sept. 11, 2023 – The FDA today authorized the newest COVID-19 vaccine, the first not to target the initial or “ancestral” strain of the virus.
Last year, the FDA authorized a bivalent vaccine aimed at both the old and the new. This time, it’s a “monovalent” or single-strain vaccine with one main objective: to minimize health risks, hospitalizations, and deaths associated with newer variants like the XBB.1.5 Omicron subvariant. It is also expected to provide some protection against related variants currently in circulation.
The FDA emergency authorization applies to vaccines made by both Pfizer and Moderna.
Two steps remain before you can get the booster at your doctor’s office or local pharmacy, however. The CDC’s Advisory Committee on Immunization Practices, or ACIP, is expected to vote on approving the new vaccine this week. Then the new director of the CDC, Mandy Cohen, MD, MPH, will have to sign off.
The FDA said the vaccine is authorized for anyone age 5 and older regardless of previous vaccination status as long as it’s been more than 2 months since you’ve received a COVID shot.
Children 6 months through age 4 who have received at least one earlier COVID vaccine are eligible for one or two doses of the new vaccine. You’ll need to speak to your pediatrician to confirm dosage.
Children in the same age group who have never received a COVID vaccine are eligible for three doses of the new Pfizer vaccine or two doses of the new Moderna formula.
“The FDA is confident in the safety and effectiveness of these updated vaccines and the agency’s benefit-risk assessment demonstrates that the benefits of these vaccines for individuals 6 months of age and older outweigh their risks,” the agency said in a statement.
The number of people who got the previous booster fell short of expectations. In most places throughout the United States, 20% or less of the population received the updated bivalent vaccine since its approval Sept. 1, 2022, for example. Only in seven states and the District of Columbia does the percentage go above 25%, according to a CDC map.
A major unknown is how the cost of the new boosters, no longer free of charge, could affect their uptake. The manufacturers estimate that without health insurance they will cost $110 to $130 for each dose.