FDA Issues Guidance on Development of a Safe and Effective COVID-19 Vaccine

WASHINGTON – The U.S. Food and Drug Administration released a series of recommendations Tuesday that it say should help facilitate the timely development of a safe and effective COVID-19 vaccine.

The agency said the guidance reflects advice it has been providing over the “past several months” to companies, researchers and others, regarding the clinical development, manufacturing and ultimate approval of a COVID-19 vaccine.

The release of the FDA guidance came hours after White House Health Advisor Dr. Anthoyn Fauci told a senate panel that the U.S. is “not in total control” of the country’s coronavirus outbreak.

“I can’t make an accurate prediction, but it’s going to be very disturbing,” Fauci told senators in a hearing held by the Senate Health, Education, Labor and Pensions Committee. “We are now having 40-plus-thousand new cases a day. I would not be surprised if we go up to 100,000 a day if this does not turn around, and so I am very concerned.”

In rolling out the guidance, FDA Commissioner Dr. Stephen Hahn said the agency recognized the “urgent need” for a COVID-19 vaccine, but added that it would not “cut corners” to get there.

He said the agency is “making clear through this guidance what data should be submitted to meet our regulatory standards.

“This is particularly important, as we know that some people are skeptical of vaccine development efforts,” Hahn said.

“We have not lost sight of our responsibility to the American people to maintain our regulatory independence and ensure our decisions related to all medical products, including COVID-19 vaccines, are based on science and the available data,” he continued. “This is a commitment that the American public can have confidence in and one that I will continue to uphold.”

The FDA also emphasized Tuesday that it has the scientific expertise to evaluate any potential COVID-19 vaccine candidate regardless of the technology used to produce or administer it.

This includes the different technologies such as DNA, RNA, protein and viral vectored vaccines being developed by commercial vaccine manufacturers and other entities.

“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 Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

“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,” he said.

“Right now, neither the FDA nor the scientific community can predict how quickly data will be generated from vaccine clinical trials,” Marks continued. “Once data are generated, the agency is committed to thoroughly and expeditiously evaluating it all. 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.”

The guidance, “Development and Licensure of Vaccines to Prevent COVID-19,” provides an overview of key considerations to satisfy requirements for chemistry, manufacturing and control, non-clinical and clinical data through development and licensure, and for post-licensure safety evaluation.

The FDA 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, as well as adequate representation in late phase trials of elderly individuals and those with medical issues.

Sponsors are also encouraged to include studies in their development plans that would provide data to support use during pregnancy, as well as plans for pediatric assessments of safety and effectiveness.

The guidance also discusses the importance of ensuring that the sizes of clinical trials are large enough to demonstrate the safety and effectiveness of a vaccine. It conveys that 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.

Additionally, after approval by the FDA, the safety of all vaccines, including a COVID-19 vaccine, continues to be closely monitored using various existing surveillance systems. The FDA may also require post-marketing studies to further assess known or potential serious risks.

Among those welcoming the release of the guidance Tuesday was House Speaker Nancy Pelosi, who said, “The whole world is praying for a coronavirus vaccine, but it must be effective and safe to be the answer to our prayers.”

She also underscored its importance in ensuring Americans have confidence in any vaccine the agency approves “in light of the immense political pressure on the FDA to deliver a vaccine as soon as possible.”

Toward this end, she reiterated how important it is that vaccines have a trial size of at least 30,000, including diverse populations in all phases of clinical development, especially racial and ethnic minorities.

That it be found to be at least 50% more effective than a placebo.

And that there must be full transparency throughout the vaccine approval process, including public advisory committee review by the FDA before an emergency use authorization for a new vaccine is approved.

The FDA should also track the health of those vaccinated for at least a year after vaccination, to ensure we understand the long-term safety of the vaccine, Pelosi said.

“Anything less than the FDA’s ‘Development and Licensure of Vaccines to Prevent COVID-19’ guidance would jeopardize the confidence the American people have in the vaccine. We are grateful for this guidance, which gives us hope,” she concluded.