There’s business confidence—and then there’s Pfizer.
Last March, with the coronavirus enveloping the globe, Pfizer, the multinational pharmaceutical giant with a major Connecticut presence, decided to develop a vaccine with the German company BioNTech.
The companies were already working on an influenza vaccine.
“We were in partnership with BioNTech on another program and that’s what really enabled us to switch from flu over to COVID,” Angela Hwang, group president of Pfizer Biopharmaceuticals, said Jan. 22 at the 2021 Economic Summit + Outlook, hosted by CBIA and the MetroHartford Alliance with the support of Webster Bank.
As its scientists worked with four possible vaccine candidates, Pfizer did something many companies would think reckless: It began the manufacturing process, purchasing the materials needed to produce millions of vials of vaccine.
“It began with the assumption that we would get there,” Hwang told CBIA’s Paul Pescatello, senior counsel and executive director of the Connecticut Bioscience Growth Council.
“There was no time for us to make decisions in a sequential way.”
Pfizer executives assumed early on that its vaccine would be approved.
“We began purchasing the materials we believed we would need—glass vials, tubing, raw materials—before we even knew which [vaccine] candidate would get approval,” Hwang said.
“It was risk taking. We made decisions in our company that allowed us to manufacture the vaccine at such a rapid pace.
“It began with the assumption that we would have a vaccine.”
Hwang described the work of Pfizer’s scientists and researchers.
“This was really an all-out effort by so many in our different departments—research, manufacturing, commercial—all coming together so we could be ready for the day when the vaccine was potentially approved,” she said.
Pfizer’s robust clinical trials gave it confidence to move into the manufacturing phase.
“All of these things coming together enabled us to not only develop a vaccine, but to produce it, and enter into contracts with governments,” she said.
Traditionally, scientists develop vaccines by using a sample of a virus to elicit an immune response from the human body.
But Pfizer scientists used messenger RNA, which does not expose the body to the virus.
“Its basis is a genetic sequence housed in an RNA sequence,” Hwang explained.
The RNA attempts to replicate a genetic sequence that mimics the spike protein of the virus.
“Your body reads the genetic code and creates antibodies against that spike protein,” she said.
“Your antibodies recognize the spike proteins coming from the virus and react.”
Hwang said Pfizer is hoping to apply the messenger RNA to other diseases and viruses.
“A lesson learned from all of this is that fostering an environment where innovation can thrive, where science can thrive, is really important,” she said.
That research was already being done on messenger RNA and made it easier for Pfizer to proceed.
“It would have taken us a whole lot longer to come up with this solution,” Hwang said.
The U.S. Food and Drug Administration granted the Pfizer/BioTech vaccine emergency approval Dec. 18, the first COVID-19 vaccine approved for use in the U.S.
In nine tumultuous months, the partnership had done what normally takes 10 to 13 years—bring a vaccine all the way from concept to regulatory approval.
“This vaccine program has taught us a lot about where time is spent and where time can be shortened,” Hwang said.
“I definitely think we will all move forward from a development perspective and have a ... clearer sense as to where the points of acceleration might be.”