Pfizer’s facility in Groton has a history of developing some of the most popular drugs ingested by Americans, including Zoloft, which treats anxiety, and Zithromax, able to kill the toughest bacteria.
But the pharmaceutical company’s work on a COVID-19 vaccine may give the Connecticut facility its greatest fame — birthplace of a drug to shield humanity from a lethal virus that has so far taken the lives of more than 189,000 Americans and 894,000 people worldwide.
John Burkhardt, a Pfizer senior vice president and director of the Groton site, is proud of the role his facility is playing in the high-stakes race for a coronavirus vaccine.
“The Connecticut site is Pfizer’s largest research and development facility in the world,” he said. “And the contribution of the Connecticut scientists are unique to the development of the vaccine.”
Pfizer and rival Moderna are ahead of all other U.S. efforts to produce a COVID-19 vaccine. Last week, at a conference of international pharmaceutical executives, Pfizer CEO Albert Bourla created a stir when he said his company could have results from its late-stage coronavirus vaccine trial as early as October.
“We expect by the end of October, we should have enough … to say whether the product works or not,” Bourla said.
The stakes are high. Analysts have predicted the total market for COVID-19 vaccines would be worth $100 billion in sales –with Pfizer having a substantial share.
First, of course, Pfizer must prove the vaccine it has developed — largely though the work of 200 employees in Groton — is an effective shield from the coronavirus.
Because the Food and Drug Administration said it would consider Pfizer’s request to fast-track approval of the drug by giving it an “emergency use” designation, a vaccine could be on the market before the first day of winter, or even before Thanksgiving– if Pfizer’s effort, or any of the other pharmaceutical late-stage trials, prove effective.
But there are a lot of “ifs” and doubts that a COVID vaccine can be developed so quickly – in a fraction of the time it has taken other vaccines to be developed, tested and approved for use.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, is among the doubters, saying recently that approval of a vaccine by October remains “unlikely,” though possible. And a leading vaccine expert took to Twitter to warn against “emergency use” designation of the vaccine to speed it to market.
“How can you justify a substandard or lesser review for something that would be injected in tens of millions, maybe hundreds of millions of Americans?” asked Dr. Peter Hotez, the dean of Tropical Medicine at Baylor College of Medicine.
But Burkhardt is optimistic. As of last week, he said, Pfizer’s clinical trials had enrolled 23,000 people in 39 states, including Connecticut, at a total of 120 sites around the world. The target is 30,000 enrollees, he said, with half receiving a placebo. In Connecticut, Yale New Haven Health has been enrolling people in the Pfizer trial.
The vaccine Pfizer is testing on those individuals is one of four it developed with German partner BioNTech. The winning candidate, known as BNT162b2, was found to develop antibodies at or about the levels found in patients who have recovered from COVID-19, with “moderate” and “transient” side effects, the drug company says.
To declare its vaccine a success, Burkhardt said Pfizer must prove that those who received doses during the trial are at least 50% less likely to have contracted the coronavirus than those in the control group. He’s hopeful the numbers exceed the 50% benchmark and are “really high.”
“We think that science will win,” Burkhardt said. “But it is science.”
President Donald Trump has pressed to have a vaccine ready quickly, before the Nov.3 general elections.
On Tuesday, Bourla and the CEOs from eight other pharmaceuticals — AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, and Sanofi — signed a pledge to produce a vaccine ethically. The CEOs said they “want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles.”
The reassurance from the pharmaceutical companies appears to be well-timed. Citing a new study Tuesday, Gov. Ned Lamont said that 20% percent of Connecticut respondents who were surveyed by DataHaven said they were not planning on getting vaccinated for COVID-19. Those who say they will refuse a vaccine may sense “that maybe these things have been rushed … (that) they’re not going through the necessary protocols,” Lamont observed.
He also said there are those who say they don’t have enough time to get immunized and others who suffer from “a general anxiety about vaccines.”
The governor vowed COVID-19 vaccine distribution in Connecticut would be safe.
“We’re not going let anything happen unless we’re convinced ourselves that this is the safest thing that we can do,” he said. State officials “are looking for a lot of verification on that,” Lamont said at a Yale School of Public Health panel discussion earlier on Tuesday.
Never tested on humans
Vaccines can take many different forms, but most in use today contain inactivated viruses, weakened live viruses, or pieces of proteins. Pfizer and Moderna are testing a new kind of vaccine that has never before been approved for use by people. It contains genetic molecules called messenger RNA.
The RNA is injected into muscle cells and prompts those cells to create a protein like the one found on the surface of the coronavirus. The theory is that these proteins will stimulate the immune system and result in long-lasting protection against COVID-19. But without the results of the final clinical trials, this is only a theory.
While Pfizer’s Groton office was a main player in research and development of the vaccine, the actual vaccine will be produced in four stages at four different sites. Production starts in Chesterfield, Mo., then the vaccine travels to Holland, Mich., Andover, Mass. and overseas to a site in Belgium.
“Each facility is producing their part,” Burkhardt said.
The vaccine will require two doses, injected nearly a month apart. And it will have to be stored at very cold temperatures — minus 80 degrees Celsius.
Pfizer says its distribution system is built “on a flexible just-in-time system which will ship the frozen vials to the point of vaccination.”
The company plans to use special freezer trucks and temperature-controlled containers that would keep the vials of vaccine frozen at the proper temperature for up to 10 days.
It will be up to the Centers for Disease Control and Prevention to decide how much of the first doses of any vaccine — which initially will be rationed — will go to Connecticut and who will first be inoculated in the state.
Those first to receive the vaccine are expected to be doctors and hospital personnel, other front-line workers, and staff and residents of elderly long-term care facilities.
The Trump administration announced in July it had awarded Pfizer and BioNTech a $1.95 billion contract to produce 100 million doses of the vaccine. Pfizer said it could potentially produce more than 1.3 billion doses by the end of 2021.
Burkhardt said the first version of the vaccine is the “pandemic version.” Workers at the Groton site and other Pfizer locales have returned to the lab to work on a more refined, and hopefully improved, “post-pandemic” version, Burkhardt said, because there’s an expectation that there will be high demand for a COVID-19 vaccine for years.
The federal government will initially cover the cost of immunizations, but some patients may have to pay administrative costs for their injections, such as the cost of a doctor’s visit.
Connecticut and all states are required to provide the CDC with its recommendations on distribution sites in the state, which besides doctors offices could include hospitals, community health centers and pharmacies.