Pfizer COVID vaccine researched in Groton proves 90% effective
Pfizer reported a COVID-19 vaccine it is developing with a German company showed more than 90 percent effectiveness in late-stage trials, but with plans to further investigate the safety of the vaccine prior to seeking U.S. Food & Drug Administration approval.
Pfizer’s Groton research center has drug safety and effectiveness as its primary mission, with the company based in New York City and having its research headquarters in Cambridge, Mass.
Pfizer is working with Germany-based BioNTech on a coronavirus vaccine, citing the possibility of obtaining the required two months of safety data by the third week of November. Pfizer and BioNTech enrolled more than 43,500 people in the trials, with 94 patients contracting COVID-19 and “no serious safety concerns” observed, in the words of Pfizer.
In tandem with the patient trials, Pfizer is working on procedures to be able to manufacture the drug to consistently meet quality standards. The Trump administration put in a $2 billion order for vaccines when they become available, with Pfizer having footed the research on its own dime.
On a conference call late last month, Pfizer CEO Albert Bourla said the company is proceeding with the goal of producing between 30 million and 40 million vaccine doses for U.S. distribution this year and 100 million by March, if it can secure speedy FDA approvals.
The United States has seen a renewed surge of COVID-19 cases in recent weeks, including in Connecticut with more than 400 people hospitalized as of last week and Gov. Ned Lamont’s administration reporting last Friday 1,065 new cases, of more than 29,500 people tested for a daily test positivity rate of 3.6 percent.
“Let’s all be very patient — I know how much the stress levels are growing, I know how much a vaccine is needed for the world,” Bourla said in late October. “We are seeing right now the worst fears that we had before ... becoming true — the COVID is coming back in Europe and the U.S. and globally. And we are working very diligently and very carefully to make sure that we will bring this project through the finish line.”
The Pfizer and BioNTech vaccine is designed to deliver to genetic strands called messenger RNA the instructions to create cells that mimic COVID-19, inducing the body to produce an immune response to help people ward off infection in future exposures. That is a departure from flu vaccines and others that inject protein-based antigens in the body to produce a response.
Pfizer is one of several companies developing a vaccine candidate. Others include Janssen Pharmaceutical in partnership with Johnson & Johnson; Cambridge-based Moderna Therapeutics, which is scheduled to release late-stage trial results in December for its own mRNA technique; and the United Kingdom-based AstraZeneca in partnership with Oxford University, with Iqvia providing support in the effort.
With dual headquarters in Danbury and Charlotte, N.C., Iqvia provides a range of pharmaceutical research services, including the enrollment of patients in clinical trials and monitoring their progress. Last month, Iqvia announced it is working with the FDA to provide better information on how people in communities are affected by exposure to coronavirus, including whether any medications or supplements they are taking affect the severity of their symptoms. More than 20,000 people have enrolled in an Iqvia registry for the purpose.
The head of the BioCT life sciences industry trade group noted several more Connecticut companies and research labs are working on COVID-19, including Yale University and the University of Connecticut.
On Monday, President-elect Joe Biden named Yale University health care expert Dr. Marcella Nunez-Smith as one of three people to lead a coronavirus advisory board, along with former Surgeon General Dr. Vivek Murthy and Dr. David Kessler, who served as Food & Drug Administration commissioner from 1990 to 1997. Nunez-Smith focuses her research on the delivery of health care to “structurally marginalized populations” in the words of a Biden transition team press release.
Bourla tempered expectations on when vaccines will become available, but with an underlying tone of optimism.
“You never know before you have the final analysis,” he said in October. “We have reached the last mile here, right? So we expect that these things will start coming soon, so let’s all have the patience that’s required for something so important for public health and the global economy.”
Includes prior reporting by Peter Yankowski.
Alex.Soule@scni.com; 203-842-2545; @casoulman