The Middletown Press (Middletown, CT)
FOCUS ON VIRUS FIGHT
Pfizer: Vaccine researched in Groton 90 percent effective
Pfizer reported a COVID- 19 vaccine with ties to Connecticut it is developing with a German company showed more than 90 percent effectiveness in latestage trials, but with plans to further investigate the safety of the vaccine prior to seeking U. S. Food & Drug Administration approval.
The United States has seen a renewed surge of COVID- 19 cases in recent weeks, including in Connecticut with more than 500 people hospitalized, including nearly 100 of them admitted over the weekend. Gov. Ned Lamont’s administration reported Monday that the state has counted more than 3,300 fresh cases since last Friday, of nearly 90,000 people tested for a daily test positivity rate of 3.7 percent.
A vaccine is seen as critical not just in saving lives but in restoring the economy to normalcy, by giving people the confidence to resume frequenting favorite establishments like restaurants without fear of contracting coronavirus. Stocks jumped Monday on the announcement, with Pfizer’s shares up 8 percent on the day to $ 39.20, and travel companies like Norwalk- based Booking Holdings getting an even bigger boost.
Last week, the U. S. Department of Labor estimated October unemployment at 6.9 percent of the workforce, compared to 3.6 percent in January. More than 147,000 Connecticut residents
“Pfizer has been in the vaccine business for quite a number of years. No corners were cut — we followed this tried-and-true methodology that worked so well for us in the past.”
John Burkhardt, Pfizer’s global head of drug safety research and development
were claiming unemployment benefits as of the third week of October, with more than a third of that group having been out of work at least six months . Another 37,600 independent contractors were getting jobless aid due to reduced income during the pandemic.
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. John Burkhardt, Pfizer’s global head of drug safety research and development and site director in Groton, fielded questions Monday during a press confer
ence with Gov. Ned Lamont.
“The efficacy is very strong — the safety component is still reading out ... [and] we need a couple more weeks to reach that milestone,” Burkhardt said Monday. “The manufacturability, quality — those are ongoing [and] looking very good, ... and some of that is occurring right here in our laboratories in Groton.”
On a conference call late last month, Pfizer CEO Albert Bourla said the company is proceeding with the goal of producing 100 million vaccine doses by next March, if it can secure speedy FDA approvals; with the possibility of up to half those doses this year.
Lamont said Connecticut typically gets 1 percent of the U. S. allotment of
vaccines, which would equate to Connecticut getting sufficient quantities of the two- dose Pfizer regimen for about 250,000 people. Vaccinations will be prioritized for health care workers and others on the “front lines” fighting the virus; as well as nursing home residents and other elderly people considered at high risk.
“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.”
Genetic instructions to cells
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 even as it continues amassing data on the drug’s effectiveness. Pfizer and BioNTech began enrolling people in late July in the trials, with the tests divided between people who received the vaccine candidate and those who received a placebo to provide a comparison.
Pfizer’s Groton lab led early animal trials to determine drug safety among other duties, Burkhardt said Monday.
“Pfizer has been in the vaccine business for quite a number of years,” Burkhardt said. “No corners were cut — we followed this tried- and- true methodology that worked so well for us in the past.”
Pfizer’s update on Monday suggested that the vast majority of 94 people who contracted coronavirus in the initial trial results took the placebo drug, giving hope that the vaccine candidate is proving effective. Through Sunday, nearly 39,000 people had taken the two vaccine doses required in the regiment, or placebos in the control group.
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.
In tandem with the patient trials, Pfizer is working on procedures to be able to manufacture the drug to consistently meet quality standards. The vaccine candidate’s active ingredients require it to be kept stored at temperatures below minus 70 degrees Celsius. Connecticut hospitals have added freezer capacity to do so in the past few months, but the sheer volumes of the vaccine will pose a major test in Connecticut and nationally as boxes of vials pass through the “cold chain” to hospitals and clinics.
“We have to keep the product very cold,” Burkhardt said. “That’s going to be a logistical challenge.”
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 proteinbased 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.
‘ We have reached the last mile’
The head of the BioCT life sciences industry trade group noted several more Connecticut companies and research labs are working on COVID- 19 vaccines or therapies, including Yale University and the University of Connecticut. Others include Shelton- based Nanoviricides; Sanofi and its Protein Sciences division, which has a research lab in Meriden; and Boehringer Ingelheim Pharmaceuticals in Ridgefield.
“We do have a lot of companies in Connecticut — in our small state — that are making a difference,” said BioCT CEO Dawn Hocevar said. “One of the reasons that Pfizer and the others were able to work on this so quickly was the amount of money that poured in. ... The government obviously showed that they can step up and move things fairly quickly.”
On Monday, Presidentelect 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, with NunezSmith described as “very influential” by a Lamont administration official in Connecticut’s efforts to formulate policies to limit the spread of COVID- 19.
“Her thinking is woven throughout our COVID response,” said Josh Geballe, chief operating officer in the Lamont administration, speaking Monday. “She’s going to do an amazing job leading us forward advising the president- elect.”
Bourla said last month that last week’s presidential election played no part in the timing of the announcement.
“This is [ not] going to be ... a Republican vaccine or a Democratic vaccine,” Bourla said. “It will be a vaccine for the citizens of the world, and this is how we see it.”
In New Haven on Monday, U. S. Sen. Richard Blumenthal ( D- Conn.) addressed the timing of the announcement in response to a query.
“They announced it as soon as they knew,” Blumenthal said Monday. “I believe they are listening to the scientists who are developing this vaccine and talking straight to the FDA and the American people. They certainly never contradicted the president when he made some of this statements about the timing, but they developed the vaccine as soon as they could. Pfizer has insisted they have played it straight.”
In a Sunday op- ed in the Wall Street Journal, former FDA chief Scott Gottlieb highlighted Connecticut — he lives in Westport — among the states he believes are getting results in restricting business activities and asking people to limit the size of gatherings, while waiting for vaccines and therapies under development.
“Like Massachusetts, Connecticut rolled out an enormous amount of testing,” Gottlieb wrote. “Against the backdrop of rising infection, the governor introduced targeted mitigation measures this week, like asking restaurants to close by 9: 30 p. m.”
In late October, 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,” Bourla said. “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.”