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FDA Announces New Covid-19 Vaccine Approval Process, Limiting Eligibility
The FDA is changing how it approves Covid-19 vaccines, focusing future vaccinations on older Americans and those at higher risk of severe illness. This shift, announced in a New England Journal of Medicine editorial by FDA officials, means Covid-19 shots this fall will likely be available to adults 65 and older and those with underlying health conditions, but not necessarily for everyone previously eligible.
This change aligns the US with vaccination strategies in countries like the UK, Canada, and Australia. While supported by some experts, it raises concerns about access for healthy adults and children, particularly those under 2 who face higher hospitalization risks from Covid-19.
The new framework prioritizes “immunobridging studies” for those 65 and older and those with high-risk conditions. These studies, similar to those used for annual flu shots, focus on antibody responses and allow for quicker vaccine development and rollout.
However, for other groups, the FDA now requires placebo-controlled trials demonstrating the vaccines’ effectiveness in preventing symptomatic Covid-19, along with data on severe illness, hospitalizations, and deaths. This higher standard of evidence aims to address concerns about the clinical benefits for healthy individuals.
This change has sparked debate within the medical community. Some experts, like Dr.
Paul Offit of the Children’s Hospital of Philadelphia, disagree with the FDA’s assertion that previous vaccine recommendations lacked robust evidence. He emphasizes the safety and efficacy of existing mRNA vaccines and the data supporting past decisions.
The FDA acknowledges that this new policy will restrict vaccine access for millions, but emphasizes that a significant portion of the population – an estimated 100 to 200 million Americans – will still qualify due to underlying health conditions. The agency believes this targeted approach will rebuild public trust in vaccines, citing declining vaccination rates in recent years and potential negative impacts on other vaccine programs.