FDA Coronavirus (COVID-19) Update:
Independent experts from the U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee met to publicly discuss whether a change to the current strain composition of COVID-19 vaccines is necessary for booster dose for the fall and winter 2022 seasons.
The COVID-19 vaccines that the FDA has approved and authorized for emergency use have made a huge difference in public health and saved countless lives in the US and around the world. However, SARS-CoV-2, the virus that causes COVID-19, has evolved significantly, with recent surges around the world associated with the rapid spread of highly transmissible variants like Omicron.
Currently available vaccines have helped reduce the most serious outcomes (hospitalization and death) caused by COVID-19, but results from post-licensure observational studies have shown that the effectiveness of primary vaccination declines over time against certain variants, including Omicron . And although the initial booster doses helped restore protection against serious illness and hospitalization associated with Omicron, studies have also indicated a decline in the effectiveness of the first booster doses over time.
The American public can be assured that any COVID-19 vaccine authorized or approved by the FDA will meet our standards for safety and effectiveness. In the meantime, we encourage those who are currently eligible for a booster to get one.
As we move into fall and winter, it is critical that we have safe and effective vaccine boosters that can provide protection against circulating and emerging variants to prevent the most serious consequences of COVID-19. After extensive discussion on June 28, 2022, an overwhelming majority of the advisory committee voted to include an Omicron component of SARS-CoV-2 in COVID-19 vaccines that would be used as a booster in the US. .starting fall 2022.
Following the vote, and striving to use the best available scientific evidence, we have advised manufacturers seeking to update their COVID-19 vaccines that they should develop modified vaccines that add an omicron BA.4/5 spike protein component to the current vaccine composition to create a two-component (bivalent) booster vaccine, so that modified vaccines can potentially be used from early to mid-autumn 2022.
As we expect next year to be a transition period in which this modified booster vaccine can be introduced, we have not advised manufacturers to switch to primary vaccination, as a primary series with the authorized COVID-19 vaccines and FDA-approved vaccines provide a foundation of protection against severe COVID-19 outcomes caused by circulating strains of SARS-CoV-2.
Vaccine manufacturers have already reported clinical trial data with modified vaccines containing an Omicron BA.1 component and we have advised them to submit this data to the FDA for our evaluation prior to any potential authorization of a modified vaccine containing an Omicron component. BA. Manufacturers will also be asked to begin clinical trials with modified vaccines containing an Omicron BA 4/5 component, as this data will be useful as the pandemic evolves.
The FDA has been planning for the possibility that vaccines will need to be modified to address circulating variants and previously provided guidance to the industry on how to do so efficiently. As has been the case with all COVID-19 vaccines during the pandemic, the agency will evaluate all relevant data to inform the safety, efficacy and manufacturing quality of modified vaccines being considered for authorization or approval to ensure they meet FDA standards.
Consistent with our commitment to transparency, the FDA will communicate future plans related to the potential authorization or approval of booster doses of the COVID-19 vaccine with an Omicron component.
