Covid-19 and Annual Vaccinations is the New Normal: FDA
As FDA begins to move into the next phase of the Covid-19 public health emergency, it is positioning the agency and public to accept that Covid infections will be with us for the foreseeable future and will likely become an annual concern like seasonal influenza. Writing in a 5/2 online JAMA viewpoint, FDA commissioner Robert Califf, principal deputy commissioner Janet Woodcock and CBER director Peter Marks acknowledge that it is time to “accept that the presence of SARS-CoV-2, the virus that causes COVID-19, is the new normal” and “(w)idespread vaccine- and infection-induced immunity, combined with the availability of effective therapeutics, could blunt the effects of future outbreaks.”
Because the current Covid-19 vaccine composition is based on the original Wuhan virus make-up, which has resulted in waning immunity and a decrease in effectiveness as variants have circulated across the globe, the agency and its Vaccines and Related Biological Products Advisory Committee (VRBPAC) will need to recommend a new Covid-19 vaccine composition in June so that it can be used during the 2022-2023 influenza season beginning in October, according to the FDA officials. They write that the composition will be “based on the available evidence and predictive modeling, with the understanding that there will be some inherent residual uncertainty about the further evolution of SARS-CoV-2. 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.”
Already FDA has scheduled a tentative 6/28 advisory committee meeting to discuss whether the Covid-19 strain composition should be modified, and if so, which strain(s) should be selected for fall 2022. Also this summer, the officials say decisions will need to be made for the 2022-2023 season about who should be eligible for vaccination with additional boosters.
“Those at greatest risk who might benefit most from vaccination include immunocompromised individuals and people older than 50 years, given the prevalence of comorbidities that increase the risk of severe disease and death in this latter group,” they explain. “Additional groups that might benefit include those who are unvaccinated (including children) or not up-to-date with vaccination (e.g., those who have received only one dose of a Covid-19 vaccine or have not received a booster dose). The benefit of giving additional Covid-19 booster vaccines to otherwise healthy individuals 18 to 50 years of age who have already received primary vaccination and a first booster dose is not likely to have as marked an effect on hospitalization or death as in the other populations at higher risk…”