FDA officials: ‘New normal’ may include annual COVID vaccination

Regulatory NewsRegulatory News
| 03 May 2022 | By Mary Ellen Schneider 

In a new editorial, top officials at the US Food and Drug Administration (FDA) outlined some of the key considerations for an annual COVID-19 vaccination strategy that could occur alongside seasonal influenza vaccination.

“Administering additional COVID-19 vaccine doses to appropriate individuals this fall around the time of the usual influenza vaccine campaign has the potential to protect susceptible individuals against hospitalization and death, and therefore will be a topic for FDA consideration,” Commissioner Robert Califf, Principal Deputy Commissioner Janet Woodcock, and Center for Biologics Evaluation and Research (CBER) Director Peter Marks, wrote in a JAMA Viewpoint article published 02 May 2022.

Waning immunity from prior vaccination or infection, additional evolution of the SARS-CoV-2 virus, and the seasonality of respiratory virus infections that can be more severe in the fall and winter months are all factors that could place the US at risk from COVID-19 later this year, they explained.  

To prepare for a potential annual COVID-19 vaccination strategy, FDA will work with the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on vaccine composition updates. A meeting of VRBPAC in April 2022 produced some initial consensus, including that it is preferred to have a single vaccine composition that is used by all manufacturers; that data is needed to decide whether such a vaccine should be a monovalent, bivalent, or multivalent; and that if a new vaccine composition is recommended, it could be used as both a primary vaccination and a booster.

A decision on vaccine composition would need to be made by June 2022 in order to be ready for a potential October rollout of a COVID-19 vaccine for the 2022-2023 season, the FDA officials said, using available evidence and predictive modeling.

“To date, the original, or prototype, vaccine composition deployed has been reasonably good at protecting against severe outcomes from COVID-19. However, a greater depth and duration of protection might be achieved with a vaccine covering currently circulating variants,” Califf, Woodcock, and Marks wrote.  

In terms of eligibility, FDA leaders said those at greatest risk – immunocompromised individuals and people older than 50 years – are most likely to benefit from vaccination this fall. Otherwise healthy adults ages 18-50 years are not likely to see the same level of benefits in reduction of hospitalization and death, but fall boosters could reduce health care utilization, the FDA leaders wrote.

“During the 2022-2023 COVID-19 vaccine planning and selection process, it is important to recognize that the fall season will present a major opportunity to improve COVID-19 vaccination coverage with the goal of minimizing future societal disruption and saving lives,” they wrote. “With the plan for implementation of year’s vaccine selection process, society is moving toward a new normal that may well include annual COVID-19 vaccination alongside seasonal influenza vaccination.”

JAMA Viewpoint article

 

© 2022 Regulatory Affairs Professionals Society.

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