FDA panel to consider annual COVID-19 vaccine shots

The Food and Drug Administration’s (FDA) advisory panel on vaccines is set to consider an annual schedule for the coronavirus vaccine, akin to how flu vaccines are administered, when it meets this week.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet Thursday to discuss how to simplify and streamline the COVID-19 vaccination process, including the composition of coronavirus vaccines and the recommended scheduling for these shots.

The rapid evolution of the SARS-CoV-2 virus, resulting in variants with an improved ability to escape immune protection, means that “periodically updating the composition of COVID-19 vaccines as needed,” as was done with the updated bivalent booster, requires consideration, according to panel documents posted Monday.

The panel said it anticipates evaluating the composition of the COVID-19 vaccine annually in June and make a recommendation for the following year — though it acknowledged the difficulties of mounting a globally coordinated vaccine recommendation.

“FDA anticipates conducting an assessment of SARS-CoV-2 strains at least annually and to engage VRBPAC in about early June of each year regarding strain selection for the fall season,” the VRBPAC documents said.

While acknowledging that COVID-19 and and the flu are not identical, VRBPAC said the deployment of the bivalent COVID-19 boosters, created to target both the ancestral strain of the virus as well as the BA.4 and BA.5 omicron subvariants, was “analogous” to annual flu vaccinations.

The committee will also consider transitioning to a simplified immunization schedule in which a two dose series of vaccines is given to young children, older adults and immunocompromised individuals while everyone else is given a single dose.

And it will look at whether to move to using the same vaccine composition for all vaccine shots in a series. Under current FDA guidance, the updated bivalent boosters are authorized for individuals who have completed their primary COVID-19 vaccinations, which are geared towards the ancestral strain of the virus.

“This simplification of vaccine composition should reduce complexity, decrease vaccine administration errors due to the complexity of the number of different vial presentations, and potentially increase vaccine compliance by allowing clearer communication,” the panel said.