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

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…