Novavax’s protein-based COVID-19 vaccine is still being reviewed by the U.S. Food and Drug Administration (FDA). The FDA has granted the vaccine full approval. Now, they’re requiring Novavax to run a new clinical trial to gather additional evidence of its effectiveness. U.S. government regulators want to know how well the vaccine protects people from getting sick. This development is a clear sign of their deep commitment to the issue.
More than ever, experts are looking at COVID-19 vaccines with a careful eye. Coincidentally, a new combination shot has come along just in time to guard against both influenza and COVID-19. This newfangled vaccine takes advantage of messenger RNA technology, which we’ve seen works really well in other COVID-19 vaccines. Early results from a company-funded study indicate that the two-pronged shot initially provoked an immune response in participants’ blood 29 days after vaccination. This indicates that it may provide short-term protective effects against disease.
Dr. Greg Poland, an expert in vaccine response at the Mayo Clinic, stressed the importance of efficacy data. He argues that this data is crucial in determining vaccine effectiveness. He stated,
“I agree in this case with FDA that efficacy data are important to see.”
The FDA is encouraging a more direct evaluation of the combination vaccine’s effect on disease risk. Due to this lack of guidance, Moderna has pushed back its timeline for pursuing approval for its own vaccine to 2026. This change is indicative of the increased public and stakeholder pressure for more transparent information about how effective these vaccines are at reducing your risk of getting sick.
The FDA’s desire for new clinical trials leaves much doubt about what the future state of COVID-19 vaccinations will be. In July, the U.S. This snap-shot method has led to confusion surrounding when existing vaccines would be updated.
Dr. Poland expressed doubt over consumer demand for the combination shot. He focused on several key challenges that will shape public acceptance.
