FDA guidance encourages diverse study pools at all phases of development.
The FDA has issued guidance with recommendations in order to help facilitate the development of a coronavirus disease 2019 (COVID-19) vaccine, according to a press release.
COVID-19, which is caused by severe acute respiratory syndrome coronavirus 2, has infected more than 10 million people and killed more than 500,000, according to the World Health Organization. The FDA has stated that they are committed to expediting the vaccine process, according to the press release. The FDA expects that any COVID-19 vaccine would prevent a disease or decrease severity in at least half of the people vaccinated.
The guidelines issued by the FDA include safety requirements, key considerations for manufacturing and control, and nonclinical and clinical data. Additionally, the FDA is encouraging that study groups at each phase are diverse and reflect the populations who are most at risk for contracting the virus. According to the press release, this includes ethnic and racial minorities as well as late phase trials of elderly individuals and patients with comorbidities.
“In this particular crisis in which there is so much at stake, we need to help expedite vaccine development as much as we can without sacrificing our standards for quality, safety, and efficacy. We firmly believe that transparency regarding the FDA’s current thinking about the scientific data needed to support approval of safe and effective COVID-19 vaccines will help build public confidence in the FDA’s evaluation process, which will be critical in ensuring their use,” Director of the FDA’s Center for Biologics Evaluation and Research Peter Marks, MD, PhD, said in the press release.
According to the press release, due to the public health emergency caused by COVID-19, consideration may be given to the FDA’s Accelerated Approval Program for vaccine licensure. Additionally, the guidance addresses considerations around the emergency use authorization for an investigational vaccine.
Coronavirus (COVID-19) Update: FDA Takes Action to Help Facilitate Timely Development of Safe, Effective COVID-19 Vaccines (News Release); White Oak, Maryland, June 30, 2020, FDA, accessed July 1, 2020.