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Pfizer site leader cites ongoing COVID-19 work

Groton — The site leader at the Pfizer Inc. labs here says about 200 colleagues locally have been so focused on developing a vaccine to battle COVID-19, it's only now sinking in that they were part of a historic effort over the past year that likely saved millions of lives.

"I think we're only now starting to reflect," said John Burkhardt, a senior vice president at Pfizer who runs the company's largest research and development center in Groton, in a phone interview March 5. "When you're going through this, you get this laser-like focus on delivery."

Albert Bourla, chairman and chief executive officer of Pfizer, in a note to company employees that coincided with the one-year anniversary of the World Health Organization declaring the COVID-19 outbreak a pandemic, praised the effort of everyone involved in delivering the world's first vaccine to protect against a disease that has claimed the lives of more than 2 million worldwide and over 500,000 in the United States.

"We found new ways to use digital technology, to partner with regulators and to perform tasks in parallel rather than sequentially — all of which allowed our scientists and clinicians to advance the clinical trials for our COVID-19 vaccine with unprecedented speed, without compromising safety or quality," he said in the note sent Thursday. "We watched as human ingenuity solved problems that we hadn't even pondered just 12 months ago."

As Burkhardt reviewed the whirlwind year at the Groton labs, which employ about 2,600 direct workers locally as well as hundreds of contractors, he said there were several key inflection points: the partnership between drug discoverer BioNTech and Pfizer, setting up clinical trials to test the vaccine's effectiveness and safety, an agreement that the U.S. government would buy up to 600 million Pfizer doses, and then the big one: the discovery that the vaccine was 95% effective at keeping the disease at bay.

"We were all speechless; it was almost too much to process," Burkhardt said when recounting his incredulity at the drug-trial results. "We couldn't have hoped for anything that good."

Burkhardt said he was particularly proud to have helped bring the world its first COVID-19 vaccine, though others from Moderna and Johnson & Johnson have since followed.

"As a scientist, you're either first or you're not first," he said. "We got to be first."

Burkhardt said the local Pfizer labs have been involved in virtually every step of the process of ensuring the COVID-19 vaccine is safe and effective. This includes studying the vaccine at nearly the molecular level through the use of special technology as well as planning, designing and executing drug trials, analyzing the results and submitting to regulators.

More trials underway 

He added that Groton also is overseeing ongoing trials of the vaccine to see if booster shots provide enhanced protection against new coronavirus variants. The study will involve giving previous subjects an extra dose of the vaccine six to 12 months after their initial two-dose regimen, according to the company.

"While we have not seen any evidence that the circulating variants result in a loss of protection provided by our vaccine, we are taking multiple steps to act decisively and be ready in case a strain becomes resistant to the protection afforded by the vaccine," Bourla, Pfizer's CEO, said in a release.

Other upcoming trial results will be examining the vaccine's effects on adolescents and pregnant women, Burkhardt said.

Burkhardt noted that a recent update of storage protocols for the Pfizer vaccine allows up to two-week storage of the drug in regular drugstore freezers. Previous requirements were for the doses to be kept in super-cold, specialized freezers that were not typically available at CVS or Walgreens, among other outlets.

"The alternative temperature for transportation and storage will help ease the burden of procuring ultra-low cold storage equipment for vaccination sites and should help to get vaccine to more sites," Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a release.

Pfizer had to invent new thermal-shipping technology along with the vaccine to be able to ensure doses would hold up while being transported over long distances.

"I first saw these machines with my own eyes when we hosted President (Joe) Biden at our facility in Kalamazoo, Michigan, three weeks ago, and it was a moment of great pride, wonder and joy," Bourla said in his note to Pfizer colleagues.

A boost for science

In addition, recent manufacturing enhancements have boosted production of the Pfizer vaccine from up to 5 million doses a week at the beginning of February to more than 13 million a week by mid-March. Some of the increased manufacturing capacity has been the result of a boost in lipid production capabilities in Groton. Lipids are used in the delivery of the vaccine doses.

"Across the industry we learned just how powerful collaboration can be," Bourla said in his note this past week. "Collaborations between Pfizer and BioNTech, and between Moderna and the National Institutes of Health helped deliver the world’s first two mRNA vaccines. ... And now the manufacturing collaboration between Johnson & Johnson and Merck will further accelerate the number of vaccine doses delivered to the world." 

Burkhardt said Pfizer has been hit with a "crush of media attention" since the pandemic hit, and especially now that vaccines are being rolled out nationwide. He wouldn't talk about any comparison among the three vaccines being administered locally as part of an FDA emergency use authorization, but he said he's been impressed at the number of people who have developed a surprising depth of interest in science in the wake of the pandemic.

"I'm hoping it's going to spawn a new generation of people who want to be scientists," he said. "I'm hoping it's a watershed moment."

And when the history of Pfizer's role in stemming the pandemic gets written, the Groton labs' contribution will no doubt be a big part of it.

"We've had amazing dedication from our colleagues," Burkhardt said. "In the end, there was execution when it was time to stand and deliver for humanity."

l.howard@theday.com

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