Cooperation of scientists, residents, speed of work ‘nothing short of miraculous,’ Yale researcher says

If the Pfizer-involved COVID-19 vaccine is successful in slowing the spread of the pandemic that has gripped the nation for nearly 10 months, it will to some extent be due to the efforts of myriad Connecticutbased scientists and clinical trial volunteers.

A New Haven research center is among the 150 clinical testing locations around the world that are in the third and final phase of testing the COVID-19 vaccine being developed by a German company and pharmaceutical giant Pfizer, which has a research and development center in Groton.

The Yale Center for Clinical Investigation in New Haven, which is part of the university’s medical school, has about 266 people enrolled in testing the vaccine, said center Director Tesheia Johnson. Phase 3 testing of the vaccine, the final step in the research process before a drug candidate is submitted to the U.S. Food and Drug Administration, began in late August, according to Johnson.

“We have participants from all across Connecticut,” Johnson said.

The Connecticut-based participants are among 43,538 people enrolled in the testing, according to data from Pfizer. Study participants working with the Yale Center For Clinical Investigation were paid $100 per visit and were required to make six visits, Johnson said.

The center worked with Yale New Haven Hospital and the Yale School of Medicine in performing the testing.

The first visit for participants was devoted to screening test subjects and obtaining their informed consent, Johnson said. The first injection of the vaccine — two shots are required, several weeks apart — is administered on the second visit, she said.

“The rest of the visits are basically follow-ups assessing patient safety,” Johnson said. “Participants were asked to keep journals and to call researchers if they feel any side effects between visits.”

Worldwide, 38,955 participants in the study have received the second dose of the vaccine.

Testing protocol calls for half of the study participants to be given the vaccine candidate while the other half received a placebo, Johnson said.

Enrollment for the Phase 3 trial filled up quickly, she said. The vaccine trial had broad parameters in terms of what researchers were looking for. The age for participants ranged from 18 to 85, although a pediatric study of the vaccine was done on children as young as 12 at some testing sites, according to Johnson.

One concern researchers had to overcome with participants, she said, was how the development of the COVID-19 vaccine differs from the flu vaccine. Unlike flu vaccines, which are developed with influenza viruses that have been grown in cells, “this compound being developed by Pfizer does not come from an inactive virus.”

“People were worried that by taking the vaccine, they were going to be infected by COVID-19,” Johnson said.

One of the participants in the study was the Rev. Leroy Perry, pastor of Branford’s St. Stephens AME Zion Church. Perry is part of the Yale Center for Clinical Investigation’s Cultural Ambassadors program, which was founded a decade ago to recruit more Black people and Latinos into health care clinical trials.

COVID-19 has hit members of the Black and Latino communities hard and Perry said he felt he could more adequately address any fears individuals in those communities had about the vaccine if he participated in the testing himself.

“Sometimes, it’s not enough to tell people they need to do something,” Perry said. “Sometimes you have to show them.”

Perry’s 28-year-old daughter also participated in the testing. He said neither of them experienced any side effects, outside of soreness in the arm near the injection site.

“My daughter and I have been trying to figure out the best way to reach young people to help them understand that taking the vaccine can save your life,” Perry said. “You’ve got to take responsibility for health. Nobody’s going to knock on your door and tell you that you’ve got to do it.”

Close to 50 percent of the participants in the Yale Center for Clinical Investigation portion of the study were people of color, said Dr. Onyema Ogbuagu, an infectious disease specialist and associate professor of medicine at Yale School of Medicine. Ogbuagu is the principal investigator in the research being done on the vaccine.

Ogbuagu said he has led clinical drug trials for years, but has never seen a singular focus to achieve a goal quite like this.

“It’s a shared goal with many players,” Ogbuagu said. “The amount of cooperation and the acceleration of the process is nothing short of miraculous. It never happens like this.”

The COVID-19 vaccine candidate was developed by German company BioNTech, Ogbuagu said.

“It takes a huge investment to advance drugs in the approval process,” he said. “So, Pfizer sponsored the clinical trial and we got involved in the Phase 2/3 studies.”

Ogbuagu said the FDA requires two months of data be submitted following the second shot of the vaccine. That data is expected to be submitted at end of this month, he said.

Once FDA officials have all of the information from the drug trials, it will be reviewed by an independent committee for a period of two to four weeks, Ogbuagu said. Given the importance of the vaccine, “it is not unreasonable to expect” that emergency approval to begin marketing the drug could be given by the end of December, he said.

“After that, it’s a mad rush to get the vaccine out,” Ogbuagu said.

File photo Ogbuagu