Similar to the annual updates made to the flu vaccine, the COVID-19 vaccine is also being revised to ensure its continued effectiveness. The U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) convened on June 15th to discuss and make recommendations for the updated COVID-19 vaccines for use in the United States starting in the fall of 2023. The new vaccine will be focused on protecting against the latest omicron mutation.
World Still Dealing With Covid
From 15th May to 11th June 2023, the world witnessed approximately 1.5 million new COVID-19 cases and 7300 fatalities. This data from a 28-day period, indicates a decrease in both cases and deaths across all six regions monitored by the World Health Organization (WHO). As of June 11th 2023, the global tally stands at over 767 million confirmed cases and more than 6.9 million deaths.
The New Formulation
For the 2023-2024 formulation of the COVID-19 vaccines, the committee unanimously voted to update the vaccine composition to a monovalent COVID-19 vaccine with an XBB-lineage of the Omicron variant. The committee expressed a preference for XBB.1.5 after reviewing the available data.
The Decision-Making Process
The advisory committee reviewed several factors during their meeting. These included the manufacturing timelines, the circulation of SARS-CoV-2 virus variants, current vaccine effectiveness, human immunogenicity data of current vaccines against recently circulating virus variants, the antigenic characterization of circulating virus variants, and preliminary human immunogenicity data generated by one XBB.1.5 candidate vaccine.
Immunogenicity is the measure of the immune response by the body to a vaccine. In vaccine development, a high level of immunogenicity is usually desirable as it indicates that the vaccine is effective at stimulating an immune response that can protect against the targeted disease.
Based on the totality of the evidence, the FDA has advised manufacturers updating their COVID-19 vaccines to develop vaccines with a monovalent XBB 1.5 composition. This decision follows the January 26, 2023, VRBPAC meeting where the FDA discussed the process for determining the need for recommending updates to the composition of COVID-19 vaccines.
According to the Centers for Disease Control and Prevention (CDC), everyone aged 6 years and older is recommended to get an updated COVID-19 vaccine, regardless of whether they’ve received any original COVID-19 vaccines. This includes Pfizer-BioNTech or Moderna COVID-19 vaccines.
For people aged 65 years and older, an additional dose of the COVID-19 vaccine is recommended 4 or more months after the first updated COVID-19 vaccine. People who are moderately or severely immunocompromised may get an additional dose of the updated COVID-19 vaccine 2 or more months after the last updated vaccine.
For children aged 6 months to 5 years, the recommendations vary based on the type of vaccine they received initially.
The FDA will continue to monitor the safety and effectiveness of the COVID-19 vaccines and the evolution of the SARS-CoV-2 virus.