FDA panel backs move to single-dose COVID

January 26, 2023 — A panel of FDA advisers unanimously backed an effort today to simplify COVID-19 vaccinations, with the goal of developing a single-dose — possibly annual — approach to general population.

The FDA is seeking to give clearer guidance to vaccine makers on future development of COVID-19 vaccines. The plan is to reduce the current complex landscape of vaccination options, and thus help increase the use of these injections.

COVID remains a threat, causing around 4,000 deaths per week recently, according to the CDC.

The 21 members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously “yes” on a single question posed by the FDA:

“Does the committee recommend harmonizing the composition of the vaccine strain of the primary series and booster doses in the United States into a single composition, for example, the composition of all vaccines currently administered would be a bivalent vaccine ( Original plus Omicron BA.4/BA.5)?”

In other words, would it be better to have one vaccine that potentially combines multiple strains of the virus, instead of multiple vaccines — like a two-shot primary series and then a booster containing different combinations of virus strains.

The FDA will heed the panel’s advice as it outlines new strategies to stay ahead of the evolving virus.

In explaining their support for the FDA’s plan, panel members said they hoped a simpler diet would help persuade more people to get the COVID shot.

Pamela McInnes, DDS, MSc, noted that it’s hard to explain to many people that the vaccine worked to protect them from more serious illness if they get COVID after being vaccinated.

“It’s a real challenge,” said McInness, retired deputy director of the National Center for Advancing Translational Sciences at the National Institutes of Health.

“The message that you would have gotten sicker and landed in the hospital resonates with me, but I don’t know if it resonates with ‘many people who are infected,’ she said.

The plan

In the meeting backgrounder, the FDA outlined a plan to transition the current complex landscape of COVID-19 vaccines to a single vaccine composition for the primary series and booster vaccination.

This would require:

• Harmonize the composition of the strains of all COVID-19 vaccines;

• Simplify the vaccination schedule for future vaccination campaigns to administer a series of two doses in some young children and in the elderly and immunocompromised, and a single dose in all other individuals;

• Establish a process for vaccine strain selection recommendations, similar in many respects to that used for seasonal influenza vaccines, based on the predominant and predicted variants that would take place by June to enable the production of vaccines. September.

During the discussion, however, questions were raised about the June target date. Given the production schedule for some vaccines, that date may need to be changed, said Jerry Weir, PhD, director of the viral products division at the FDA’s Center for Biologics Evaluation and Research.

“We’re all going to have to maintain some flexibility,” Weir said, adding that there isn’t a “good model” established yet for updating these vaccines.