FDA Takes First Step to Simplify Procedures for COVID-19 Vaccines Boosters

Deployment of bivalent COVID-19 boosters has been extremely complex, and one of the key reasons uptake has been low is confusion about who should get them. Find out about how the Food and Drug Administration hopes to simplify the process, possibly by creating an annual COVID-19 vaccine similar to the current influenza vaccine.

SILVER SPRING, MD – Confusion about eligibility or awareness was the most common reason why uptake of the bivalent COVID-19 booster vaccine has been so low, according to a recent articlein the Morbidity & Mortality Weekly Report.


That is one of the reasons the Food and Drug Administration is so anxious to simplify the process. “The complexities associated with the differences in composition and regimens of the currently authorized and approved COVID-19 vaccines in the United States (U.S.), the still incomplete understanding of SARS-CoV-2 immunology, and the absence of an established framework to inform periodic vaccine composition updates, leave open scientific and policy questions regarding recommendations for simplifying the immunization schedule and updating the current COVID-19 vaccines for future vaccination campaigns,” according to a recent FDA briefing document.


The document was created in advance of the Jan. 26 meeting of the agency’s key science advisory panel, the Vaccines and Related Biological Products Advisory Committee.

“Although the beneficial effect associated with a reduction in hospitalization and death in these studies is most apparent in older individuals, younger individuals appear to also benefit with a reduction in symptomatic disease and health care utilization,” the FDA writes. “Though perhaps not identical, this pattern of response is analogous to that observed with annual influenza vaccination, a well-accepted intervention in individuals 6 months of age and older.”

This raises the possibility that pharmacists would offer a single COVID-19 vaccine each year, much as they now conduct vaccination drives during the annual influenza season.

The briefing document adds, “Although the use of the bivalent mRNA boosters is supported by the available evidence, their deployment has been associated with significant implementation complexities. Given these complexities, and the available data, a move to a single vaccine composition for primary and booster vaccinations should be considered. 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 only formal vote during the all-day meeting was on the question of whether one COVID-19 vaccine consisting of a single composition for nearly everyone – whether currently vaccinated or not – should be offered. That would be in contrast to the present system where one formulation is used as a primary series and another is administered as a booster. The 21-member panel voted to endorse that concept, but it will have to be approved by the national Centers for Disease Control and Prevention to go into effect.

“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,” the FDA notes. “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.”

It adds that two doses of an approved or authorized COVID-19 vaccine might be necessary for those who have a low likelihood of prior exposure, such as the very young, or those who may not generate a protective immune response, those who are older and/or immunocompromised.

As with influenza, the change in vaccine compositions should be determined globally and coordinated by the World Health Organization, according to the recommendations, (older and immunocompromised individuals). 5 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,” the document adds.

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