Pfizer leader optimistic about COVID efforts

Company hoping it can have treatment ready in less than a year

Groton — Nearly a third of employees working at the Pfizer Inc. labs off Eastern Point Road are working toward a remedy related to COVID-19, Site Leader John Burkhardt said late last week.

“We’re really charged up by this,” Burkhardt said in a phone interview Friday. “We’re humbled to be on the front lines.”

Pfizer is taking a multipronged approach in the fight against the novel coronavirus that has led to a worldwide pandemic. The first approach has been to seek out a new antiviral treatment to be able to knock back symptoms before they grow severe; the second has been to turn to a new generation of JAK inhibitors similar to Pfizer’s autoimmune-disease fighter Xeljanz, focusing on patients whose symptoms have become more severe, and the third “Holy Grail” area of research has targeted a new vaccine to help everyone.

Asked whether Pfizer will need a year or more to develop the vaccine as others have suggested, Burkhardt said, “We think we can beat that.”

He added that expectations now would see a vaccine approved and millions of doses ready for distribu

tion with emergency-use authorization by the end of the year upon regulatory approval, a timeline that matches up with what President Donald Trump has been suggesting in recent news conferences. By sometime in 2021, he added, vaccine dosage numbers could be ramped up into the hundreds of millions required to put the pandemic in our rearview mirror.

“We believe science will win,” said Burkhardt, whose Groton R&D site is Pfizer’s largest worldwide.

Burkhardt noted that Pfizer already has been able to shave off between three and six months of the arduous vaccine-approval process because of fast-tracking efforts by the U.S. Food and Drug Administration. Also allowing for quicker delivery time of the still-experimental drug is Pfizer’s use of an advanced technology using messenger RNA that allows for synthetic processing of vaccines, he added.

Before the pandemic, Pfizer on any given day would have about 5,000 people working on the company’s Groton campus, including more than 2,600 direct employees. Burkhardt said only about 600 to 700 employees have been on site since Gov. Ned Lamont issued his “stay safe, stay at home” orders in March, and about 200 of those are working on remedies related to COVID-19.

He added that those who remain on-site in Groton have been issued personal protective equipment and have been maintaining social distancing, working and interacting in “tribes” at various areas on campus to reduce interactions with others.

“They’re doing a great job,” Burkhardt said of on-site employees.

The workers include about 200 support staff, he added, who are serving food, conducting frequent on-site cleanings, providing security and otherwise helping ensure continuing operations.

“They’re courageous people,” Burkhardt said. “They’ve really come through for us.”

Other employees, he said, continue to work remotely, mainly from home using videoconferencing and WebX technology to collaborate with colleagues. He added that employees concerned with working on site have been asked to consult with health and wellness specialists who can discuss the issues confidentially.

Burkhardt said Pfizer’s first approach to finding drugs that will beat back the coronavirus involves a “promising new molecule” discovered by company scientists in California that should be ready for clinical studies beginning in the third quarter of this year, somewhere between July and September. The experimental antiviral treatment aimed at preventing full-blown infection after diagnosis of COVID-19 “has to be formulated very carefully,” he added, as it must be administered intravenously in a hospital setting.

Candidates for a next-generation oral version of the drug are currently being screened at the labs in Groton, he added. The drug works as a protease inhibitor, meaning it blocks the virus from being able to replicate itself.

“It’s a very targeted approach,” Burkhardt said.

Clinical trials for the antiviral treatment, once they are underway, will involve healthy male volunteers for up to two weeks. If it is safe and seems to be working, Burkhardt said the drug would “probably quickly go to patients” who have contracted COVID-19.

Pfizer’s second approach to winning the war against COVID-19 grows out of the success of the locally discovered and developed drug Xeljanz, already FDA-approved for a variety of autoimmune diseases such as rheumatoid arthritis. A new-generation variant of the so-called JAK inhibitor theoretically might help coronavirus patients in the hospital who are having trouble breathing because of an “exuberant” immune response to the virus that can lead to acute respiratory distress, Burkhardt said.

“There are a franchise of variants,” he said. “We think that one of these in particular would be interesting.”

Of course, the “Holy Grail” of treatments remains a vaccine because it would mean that society could largely go back to life before COVID-19. Pfizer’s vaccine research is centered at its Pearl River site in New York, but Burkhardt said Groton scientists will be working on important aspects of the development program, including efficacy and safety studies, formulation and regulatory submissions.

He added that the FDA has worked hard to expedite development of the drug program, which is currently looking at four vaccine candidates, and early studies are already underway in both the United States and Germany with Pfizer’s partner BioNTech. The first doses of the vaccine, which are currently being studied for effectiveness and safety, will be given to healthy volunteers between 18 and 55 from a variety of ethnic backgrounds, and once safety is established would be prioritized to patients at greater risk of dying of coronavirus, principally those 65 and over, Burkhardt said.

“The science is complex,” he said. “The work is very precise.”

And while Burkhardt is amped up about the chance for Pfizer’s vaccine to hit the market fast, he doesn’t see the alacrity of the response to COVID-19 as any sort of competition among pharmaceutical firms.

“We need multiple vaccines,” he said, “because we have to get enough doses for the world’s population.”