US proposes once-a-year COVID shots for most Americans

(snip)

Given the evolution of SARS-CoV-2 variants and associated changes in the epidemiology,
susceptibility to reinfection, and waning of vaccine-induced immunity, barring development of a
significantly improved vaccine, periodic future updates to the S protein sequence(s) contained
or encoded in COVID-19 vaccines and revaccination will likely be needed to induce and
maintain vaccine effectiveness (VE), respectively. Therefore, an approach to both simplifying
the immunization schedule, and periodically updating the composition of COVID-19 vaccines as
needed, requires consideration.

Review of the totality of the available evidence on prior exposure to and vaccination against
SARS-CoV-2 suggests that, moving forward, most individuals may only need to receive one
dose of an approved or authorized COVID-19 vaccine to restore protective immunity for a period
of time. Two doses of an approved or authorized COVID-19 vaccine may be needed to induce
the expected protective immunity for those who have a low likelihood of prior exposure (the very
young) or those who may not generate a protective immune response (older and
immunocompromised individuals).

Similar to the approach with influenza, the global nature of SARS-CoV-2 strain evolution
warrants a global response when evaluating and recommending vaccine strain composition
changes. Ideally, any change in vaccine composition, when appropriate, would be implemented
broadly and would be coordinated by the World Health Organization (WHO) with national
regulatory authorities. However, unlike influenza, a well-established, highly coordinated
infrastructure and governance of global semi-annual vaccine composition evaluation and
recommendations do not currently exist for SARS-CoV-2. Furthermore, at this time the current
diversity of vaccine manufacturers and complexities in global supply of COVID-19 vaccines
would make a globally coordinated, simultaneous vaccine composition evaluation and
recommendation quite challenging.

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.
Subsequently, a decision on the recommended vaccine composition would be made in time for
any updated vaccine to be in production in time to be deployed for use no later than September
of each calendar year. Of note, circulation of a more pathogenic vaccine-escape variant of
SARS-CoV-2 would likely prompt, on an as needed and emergent basis, an ad-hoc strain
selection meeting of VRBPAC.

(snip)

WASHINGTON (AP) — U.S. health officials want to make COVID-19 vaccinations more like the annual flu shot. The Food and Drug Administration on Monday proposed a simplified approach for future vaccination efforts, allowing most adults and children to get a once-a-year shot to protect against the mutating virus.

This means Americans would no longer have to keep track of how many shots they’ve received or how many months it’s been since their last booster. The proposal comes as boosters have become a hard sell. While more than 80% of the U.S. population has had at least one vaccine dose, only 16% of those eligible have received the latest boosters authorized in August.

The FDA will ask its panel of outside vaccine experts to weigh in at a meeting Thursday. The agency is expected to take their advice into consideration while deciding future vaccine requirements for vaccine makers.

In documents posted online, FDA scientists say many Americans now have “sufficient preexisting immunity” against the coronavirus because of vaccination, infection or a combination of the two. That baseline of protection should be enough to move to an annual booster against the latest strains in circulation and make COVID-19 vaccinations more like the yearly flu shot, according to the agency.