FDA Guidance Provides Safety, Quality Standards for COVID-19 Vaccine Development

Seeking to assure those who are concerned that an expedited coronavirus disease 2019 (COVID-19) vaccine may not be safe and effective, the FDA updated its guidance for developing and evaluating vaccine candidates to protect humans from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

“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,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a press release.¹ “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.”

Although neither the FDA nor the scientific community can predict how quickly data will be generated from vaccine clinical trials, Marks said, the FDA is committed to “thoroughly and expeditiously evaluating” all the data.

“But make no mistake: the FDA will only approve or make available a COVID-19 vaccine if we determine that it meets the high standards that people have come to expect of the agency,” Marks added.

FDA’s June 30 guidance, “Development and Licensure of Vaccines to Prevent COVID-19,” states these important requirements:²

1. The agency “strongly encourages the inclusion of diverse populations in all phases of clinical development, including populations most affected by COVID-19, specifically racial and ethnic minorities.”

2. Late phase trials should include adequate representation of elderly individuals and those with medical comorbidities. Older adult participants aged 55 and older may be enrolled in FIH and other early phase studies so long as they do not have medical comorbidities associated with an increased risk of severe COVID-19, FDA said.

3. Sponsors are encouraged to include studies in their development plans that would provide data to support use during pregnancy, as well as plan for pediatric assessments of safety and effectiveness. “Use of COVID-19 preventive vaccines in pregnancy and in women of childbearing potential will be an important consideration for vaccination programs. Therefore, FDA recommends that prior to enrolling pregnant women and women of childbearing potential who are not actively avoiding pregnancy in clinical trials, sponsors conduct developmental and reproductive toxicity (DART) studies with their respective COVID-19 vaccine candidate,” the agency said.

4. The sizes of clinical trials must be large enough to demonstrate the safety and effectiveness of a vaccine. “The FDA would expect that a COVID-19 vaccine would prevent disease or decrease its severity in at least 50% of people who are vaccinated,” the agency said. Late phase clinical trials will likely need to enroll many thousands of participants, including many with medical comorbidities for trials seeking to assess protection against severe COVID-19, according to the guidance.

References:

1. Coronavirus (COVID-19) update: FDA takes action to help facilitate timely development of safe, effective COVID-19 vaccines. Press release. FDA; June 30, 2020. Accessed June 30, 2020. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-action-help-facilitate-timely-development-safe-effective-covid?utm_campaign=063020_PR_FDA%20Helps%20Facilitate%20Development%20of%20Safe%2C%20Effective%20COVID-19%20Vaccines&utm_medium=email&utm_source=Eloqua

2. FDA. Development and licensure of vaccines to prevent COVID-19: Guidance for industry. Published June 30, 2020. Accessed June 30, 2020. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/development-and-licensure-vaccines-prevent-covid-19