Top FDA Brass Weigh in on Regulatory Safeguards in COVID-19 Vaccine Trials
Three top FDA officials, including Commissioner Stephen Hahn, last week shared with their medical peers the agency’s primary considerations when reviewing COVID-19 vaccine trials, reassuring them that these vaccine candidates would face the same level of scrutiny as all other FDA-approved products.
Hahn, along with Center for Biologics Evaluation and Research Director Peter Marks and Deputy Commissioner for Medical and Scientific Affairs Anand Shah, wrote in an opinion piece published on the Journal of the American Medical Association website that the physician leaders of the agency “unequivocally state that candidate COVID-19 vaccines will be reviewed according to the established legal and regulatory standards for medical products.”
In the case of COVID-19 vaccine candidates specifically, the FDA will focus on three factors, the officials say. First, it will ensure that any vaccine is manufactured in accordance with all of FDA’s quality standards and that its safety and effectiveness are verified.
Second, to be effective in a widespread population, the agency is stressing the need for COVID-19 vaccine sponsors to focus on populations disproportionately affected by the pandemic, including racial and ethnic minorities, older adults and people with medical comorbidities. “Inclusion of diverse populations, including older individuals, in trials is necessary for a comprehensive assessment of product safety and effectiveness and to properly inform clinical decision-making,” the officials wrote.
Sponsors also should consider additional trial safeguards for special populations, such as children and pregnant women, to guarantee they can be included safely in trials, they say.
Third, the FDA will discuss with sponsors their plans for postmarket surveillance of vaccines that are approved before a large volume of safety evidence is available.
The authors also note that current vaccine trial enrollments of 15,000 to 20,000 far exceed the FDA benchmark of more than 3,000 patients needed to build a reliable safety database.
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