How Pfizer and BioNTech made history with their vaccine

How Pfizer and BioNTech made history with their vaccine
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Wondering how Pfizer and partner BioNTech developed a COVID-19 vaccine in record time without compromising safety? Dr Bill Gruber, SVP of Pfizer Vaccine Clinical Research and Development, explains the process from start to finish.

“I told my team, at first we were inspired by hope and now we’re inspired by reality,” Dr Gruber said. “If you bring critical science together, talented team members together, government, academia, industry, public health officials—you can achieve what was previously the unachievable.”

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent COVID-19 for use in individuals 12 years of age and older. The emergency use of this product is only authorized for the duration of the emergency declaration unless ended sooner. See Fact Sheet: cvdvaccine-us.com/recipients.
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BILL GRUBER:

Dr. Bill Gruber is senior vice president of Pfizer Vaccine Clinical Research and Development, and is responsible for global clinical development of vaccines. Dr. Gruber was previously an associate professor of pediatrics at Vanderbilt University School of Medicine and also served as the director of the Diagnostic Virology Laboratory at Vanderbilt University Hospital. Dr. Gruber received his bachelor degree in mathematical sciences from Rice University, Houston, Texas, and his medical degree from Baylor College of Medicine, Houston, Texas. He is board-certified in pediatrics and pediatric infectious diseases and has authored or co-authored 140 original research articles and numerous invited articles and book chapters.
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TRANSCRIPT:
DR. BILL GRUBER: Historically, vaccines have been one of the most important medical intervention for public health. Diseases like smallpox that used to have a 30% mortality rate, that are completely wiped from the face of the Earth. When it looked like there was the potential for us to engage in moving forward a COVID-19 vaccine, there was the daunting challenge to do something that had never been done before. And that was to try to get a vaccine out within less than a year. That, I can tell you, is unprecedented in history.

My name is Bill Gruber. I head vaccine clinical research and development for Pfizer and I’ve been involved in vaccine development for over 35 years. If you had asked me at the time, “what did I think the chances of our success were at the very beginning of this?” I would say well less than 50% because the fastest way any other vaccine had ever been developed, to my knowledge, prior to COVID-19 was 4 years. And so, as we were looking at this with our partners at BioNTech, we had to say, “well, can this be done? Is it possible to really take something that takes decades and do it in less than a year?” And we decided, “well yes, it probably can be done, but here’s what has to happen.”

One of the key elements to the success for delivering a vaccine in record time is we have a platform for developing vaccines and it’s the mRNA platform developed with our colleagues at BioNTech. mRNA is the material that codes for translation to proteins, so what we’re doing is we’re exploiting that very fundamental part of nature to make a vaccine by inserting mRNA that codes for the protein of interest, in this case, the spike protein that’s responsible for that virus attaching to human cells, gaining entry, replicating itself and producing disease. And so at the beginning, it was unclear whether or not, should we focus our energy really on that very tiny part of the spike protein, the receptor binding domain, the business end, if you will, of the spike or is it more important to take the entire spike protein? Once we had those candidates in hand and once we’d proven that it was safe to move into human clinical trials, we then looked at them in parallel so that we had more than one shot on goal.

To read the full transcript, please visit https://bigthink.com/videos/pfizer-covid-vaccine