On September 11, US drug regulators, including the FDA, authorized new COVID-19 vaccines developed by Pfizer and Moderna. These vaccines are cleared for Americans as young as 6 months old and aim to address the declining effectiveness of current vaccines against the XBB.1.5 subvariant of the Omicron virus.
While Dr. Peter Marks, a top FDA official, stressed the importance of vaccination for public health, concerns have arisen regarding the lack of clinical trial data supporting the new shots’ efficacy. Moderna claims its new shot induces immune responses against the EG.5 variant, and Pfizer suggests preclinical data shows the antibodies from its vaccine can neutralize EG.5. These authorizations are based on neutralizing antibody studies suggesting effectiveness against the currently circulating COVID-19 variants.
The CDC is set to discuss which populations should receive these new vaccines. If recommended, the federal government will cover the costs. However, many countries have advised against vaccinating younger, healthy individuals as COVID-19 cases decline.
The FDA also plans to update these vaccines annually, following a similar approach to influenza vaccines. Novavax, another vaccine manufacturer, is awaiting FDA clearance for its updated vaccine.
Critics, including Florida Surgeon General Dr. Joseph Ladapo, have voiced concerns about the lack of data supporting these new shots. Some studies suggest waning vaccine effectiveness over time and potential side effects, such as heart inflammation. Dr. Paul Offit, an FDA adviser, believes that younger, healthy individuals who have already been vaccinated may not need the new doses, and resources should be focused on those at higher risk.
Conclusively, the FDA’s authorization of Pfizer and Moderna’s new COVID-19 vaccines aims to address the evolving virus landscape, but concerns persist regarding the lack of robust clinical data and potential overreach in recommending these shots to the broader population.
