As COVID-19 vaccine technology and learning advances, the FDA is adjusting its guidance (which is a good thing).
Since the FDA press release with the new guidance is a bit hard to read, I have summarized it for you below.
The FDA announced that some people can now get a second dose of the bivalent COVID-19 vaccine and that the updated biovalent shots have now completely replaced the original type of vaccine.
The agency took away the emergency use authorizations for the monovalent Moderna and Pfizer-BioNTech mRNA vaccines and approved the bivalent boosters (original plus Omicron BA.4/BA.5 strains) for all doses starting at 6 months of age.
People 65 Years Old and Older
People who are 65 or older can now get a second bivalent dose at least 4 months after their first bivalent dose. The FDA said that a second bivalent dose for this group is supported by data showing that this group’s immunity goes down over time, but that an extra dose brings it back up.
Weak Immune Systems
The FDA also said that people with weak immune systems can get a second dose at least two months after their first bivalent shot. They can get more doses if prescribed by their healthcare provider, who can also decide how often they get doses, the agency said.
The agency said that for young children with weak immune systems (ages 6 months to 4 years), getting more doses is dependent on the vaccine they already got.
Children from 6 months to 5 years old who have had one, two, or three doses of a monovalent vaccine can get a bivalent shot, but the number of doses will depend on the vaccine and the child’s vaccination history, according to the FDA.
The Moderna bivalent vaccine is a two-dose series for children ages 6 months to 5 years who have never been vaccinated OR a three-dose series of the Pfizer-BioNTech bivalent vaccine. Children who are 5 years of age or older may receive a single dose of the Pfizer-BioNTech bivalent shot.
Also, the agency said that for people who have never been vaccinated, a single dose of the bivalent vaccine will now be enough instead of multiple doses of monovalent vaccines.
Most people who used to only get monovalent shots can now get a bivalent booster dose in a single shot. After an FDA advisory committee meeting in June to evaluate data regarding the fall 2023 COVID strains, the agency plans to make decisions about future vaccination recommendations.
Peter Marks, MD, Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said in a statement that there is now evidence that most people 5 years old and older in the U.S. have antibodies to SARS-CoV-2, the virus that causes COVID-19, either from vaccination or infection. This can serve as a foundation for the protection that the bivalent vaccines provide. “COVID-19 is still a very real risk for a lot of people, and we encourage people to think about getting vaccinated, even with a COVID-19 vaccine with two parts.”
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