Guidance for COVID-19 Vaccine Manufacturing Issued

The race among pharmaceutical companies to produce a vaccine for coronavirus disease 2019 (COVID-19) might have been going on for months, but the rules of the road were made more formal today. The US Food and Drug Administration issued guidance to manufacturers that the agency hopes will facilitate the creation of a vaccine while still ensuring any such product’s safety.

FDA officials describe the guidance as providing an outline of key considerations that the manufacturers must keep in mind when trying to develop the vaccine. They include requirements for manufacturing and control, chemistry, and the development and licensure of clinical and nonclinical data. It also details how the vaccine will be evaluated after its approved.

Peter Marks, MD, the director of the FDA’s Center for Biologics Evaluation and Research, said in a press release that “right now, neither the FDA nor the scientific community can predict how quickly data will be generated from vaccine clinical trials. 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 says that “it is critical that vaccine production processes for each vaccine are well defined and appropriately controlled to ensure consistency in manufacturing.”

In addition, it says: “A quality control system should be in place for all stages of manufacturing, including a well-defined testing program to ensure in process/intermediate product quality and product quality throughout the formulation and filling process.”

The size of the clinical trials for the vaccine need to be large enough to validate its safety and efficacy. The FDA guidance says that any vaccine would need to be able to either prevent COVID-19 or decrease the severity of its symptoms in at least 50% of those who are vaccinated.

“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 comorbidities,” the FDA said in its press release. “Sponsors are also 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.”

FDA Commissioner Stephen M. Hahn, MD, said in the statement that the agency is willing to work with the pharma industry and researchers and other federal or even international partners to accelerate the creation of a vaccine.

“While the FDA is committed to expediting this work, we will not cut corners in our decisions and are making clear through this guidance what data should be submitted to meet our regulatory standards,” Hahn said. “This is particularly important, as we know that some people are skeptical of vaccine development efforts.”

A vaccine that almost everybody takes would produce the herd immunity that health experts hope will finally defeat COVID. But Anthony Fauci, MD, a member of the White House Coronavirus Task Force, recently pointed out that many Americans say that they would refuse to get vaccinated even if a COVID-19 vaccine is manufactured.

In the FDA statement, 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. This is a commitment that the American public can have confidence in and one that I will continue to uphold.”