US Food and Drug Administration (FDA) officials are “very carefully” considering second booster doses of the mRNA COVID-19 vaccines, while Anthony Fauci, the US president’s chief medical advisor, said the “potential future requirement was being "very carefully monitored”, reports The Wall Street Journal.
FDA spokesperson Alison Hunt confirmed to CNN that the FDA “is indeed continually looking at the emerging data on the pandemic and variants in the United States and overseas to evaluate the potential utility and composition of booster doses”.
She said although there was much uncertainty, the FDA was evaluating whether another booster dose would be needed when the country moves into autumn 2022, which would coincide with the typical administration of annual flu shots, CNN noted.
“As more data become available about the safety and effectiveness of COVID-19 vaccines, including the use of a booster dose, we will continue to evaluate the rapidly changing science and keep the public informed,” Hunt said.
Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases (NIAID), said the “potential future requirement” for an additional booster was being "very carefully monitored in real time, and recommendations, if needed, will be updated according to the data”.
He said the timing of when the second booster would be administered was critical and that it “doesn’t make much sense” to administer the fourth dose now as Omicron begins to fade.
It would be best to administer a second booster, if needed, in the fall or winter, he added, or when a new variant was more likely to emerge.
If the FDA approves another booster dose, it would then face approval by the Centers for Disease Control and Prevention (CDC), reports The Hill.
Both Pfizer-BioNTech and Moderna are currently developing Omicron-specific vaccines, and both companies believe a fourth dose will eventually be necessary to keep protection levels high.
However, the CEO of BioNTech said last week that stalls in data evaluation had led to a weeks-long delay in the development, as it was still unclear whether or not these altered vaccines would be needed.
Israel was the first country to approve a second booster shot for certain citizens in December, while last week (Monday 21 February), Sweden approved another booster for residents over 80.
The Hill article – FDA considering second COVID-19 booster in coming months (Open access)
Wall Street Journal article – FDA Eyes Second Covid-19 Booster Shot (Restricted access)
See more from MedicalBrief archives:
Booster mRNA vaccines wane in effectiveness at 4 months – CDC
Warning from WHO and EU regulator against repeat COVID boosters
UK vaccination committee says 4th booster not necessary
Boosters significantly strengthen immunity — Cov-Boost trial