Georgetown Professor Comments on FDA Authorization of Vaccine to Prevent COVID-19

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Karen Teber

WASHINGTON (December 11, 2020) — This evening, the U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) for the BioNTech/Pfizer vaccine.

Former FDA Chief Scientist and infectious disease physician Jesse Goodman, MD, MPH, professor of medicine at Georgetown University Medical Center, celebrates and provides a brief perspective on this historic moment:

“The first emergency use authorization of a COVID-19 vaccine by FDA marks an exciting and hopeful moment. It builds on investments over many years in science and technology that have provided new platforms to accelerate the vaccine development needed to respond to this, and future pandemics. 

“It is also a testament to collaboration across the scientific community, industry and government. And it impacts all of us: As a health care provider who treats people with COVID-19, I’m looking forward to being vaccinated and protected.

Jesse Goodman
Jesse Goodman, MD, MPH

“Important in my decision to be vaccinated and to recommend vaccination to others at risk is that FDA scientists, despite tremendous pressure from the highest levels of government, have protected the integrity of their vaccine review process, promoting transparency and incorporating external expert input in its deliberations.

“But, as new vaccines bring hope, we still have a long way to go.

“First, while safe and effective vaccines can finally help end this pandemic, supply is severely limited at the current time and the pandemic is still raging, so we must double down on public health measures such as masks and social distancing, to save lives and get us to the point where vaccines can reach and protect most people both in the U.S. and globally.

“Second, while studies support the vaccine’s safety and efficacy, the data are from a short time period and, as the vaccine is rolled out,  we need careful monitoring of its safety and of the duration of protection to ensure it performs as anticipated.

“While this and other forthcoming new vaccines and therapeutics are wonderful achievements, we need to invest to shore up our more basic defenses as well, including modernizing and supporting our neglected public health infrastructure and its leadership. Let’s build on what has been accomplished to start preparing for the next public health emergency, because this pandemic isn’t going to be the last one, and we must do even better next time.”

Goodman is co-chair of COVAT, the COVID-19 Vaccine Analysis Team, and is director of Georgetown’s Center on Medical Product Access, Safety and Stewardship.