Groton scientists played a critical role in new pill
Team at Pfizer facility were key part of effort to design Paxlovid
In the race among pharmaceutical giants to create the first pill to ward off the COVID-19 virus, a team of researchers at Pfizer in Groton played a critical role.
The Pfizer scientists helped bring the new drug, Paxlovid, to market, from initial discovery efforts to the submission to the U.S. Food & Drug Administration for emergency use authorization.
“Our colleagues in Groton were part of the team who designed nirmatrelvir [one of the drugs in
Paxlovid]. … They then performed the necessary chemistry, drug metabolism, formulation, and safety assessment work to transform the molecule into a novel investigational oral antiviral,’’ said Steve Danehy, director of Global Media Relations for Pfizer, in a statement.
“The scientists first made the molecule and analyzed the initial studies to determine its potency and how the compound is processed by the human body,” Danehy said.
“We also manufactured the first tablets for clinical trial supply in the solid dose clinical manufacturing facility in Groton, Connecticut. The clinical research unit in New Haven conducted the first-in-human studies for the candidate and all drug interaction studies.”
Pfizer has nearly 5,300 employees at its Groton facility.
On Thursday, the FDA authorized a second pill against COVID19, providing another easy-to-use medication to battle the rising tide of omicron infections.
The Food and Drug Administration authorization of Merck’s molnupiravir comes one day after the agency cleared the new Pfizer pill.
Both treatments will be free to patients in the U.S. after being purchased by the federal government.
Federal health officials are expected to ration early shipments to the hardest-hit parts of the country. Pfizer said the small supply is due to the manufacturing time — currently about nine months. The company says it can halve production time next year.
The U.S. government has agreed to purchase enough Paxlovid to treat 10 million people. Pfizer says it’s on track to produce 80 million courses globally next year, under contracts with the U.K., Australia and other nations.
Pfizer’s Paxlovid is likely to become the first-choice treatment against the virus, thanks to its superior benefits and milder side effects.
The new Pfizer pill is the “first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic,” said Patrizia Cavazzoni, M.D., director of the FDA’S
Center for Drug Evaluation and Research. “This authorization provides a new tool to combat COVID19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for
progression to severe COVID-19.”
Pfizer CEO Albert Bourla said the new drug is more evidence of how science if fighting the pandemic.
“This breakthrough therapy, which has been shown to significantly reduce hospitalizations and deaths and can be taken at home, will change the way we treat COVID-19, and hopefully help reduce some
of the significant pressures facing our health care and hospital systems,” Bourla said in a news release. “Pfizer stands ready to begin delivery in the U.S. immediately to help get Paxlovid into the hands of appropriate patients as quickly as possible.”