Covid Vaccine Study Coming To New Haven

Pfizer will be bringing to New Haven a Phase 3 trial study of a potential Covid-19 vaccine, through a new partnership with the pharmaceutical giant announced by Yale New Haven Hospital.

Top Yale New Haven Health Systems (YNHHS) administrators and clinicians shared that news Tuesday at noon during the regional hospital system’s latest Covid-19-related virtual press conference.

They also announced that Chris O’Connor, the former president and CEO of the late Hospital of Saint Raphael, will become the new president of YNHHS starting in October. See more below.)

The question-and-answer session with reporters was held online via the Zoom videoconferencing platform and on Facebook Live.

YNHHS Chief Clinical Officer Thomas Balcezak said that last week the New York-based pharmaceutical company Pfizer officially signed on with the Yale Center for Clinical Investigation and Yale New Haven Hospital to conduct a Phase 3 trial study in New Haven for a potential Covid-19 vaccine.

The study will provide the potential vaccine to half of its participants, and a saline placebo to the other half.

“No one knows who’s getting which shot,” Balcezak said. Then, at the end of the trial, Pfizer will see if those who received the vaccine proved to be any more immune to contracting Covid-19 than those in the control group.

Balcezak said that Pfizer — which received a nearly $2 billion contract from the federal government in late July in exchange for providing 100 million doses of a Covid-19 vaccine by December — will be conducting this Phase 3 trial study nationwide.

He said the pharmaceutical company is looking to enroll roughly 30,000 people across the country in the trial: 15,000 people as part of the treatment group who will receive the vaccine, and 15,000 as part of the control group who will receive the placebo.

“We should be able to get 1,000 or a couple thousand in New Haven,” Balcezak said about how many people should be able to enroll in the New Haven-based Phase 3 trial. ​“We’re still working on the details of how we’re going to do that.”

Balcezak said that the he did not yet have any details on when the trial will start in New Haven or how long it will run.

“It’s for people who are asymptomatic, and it’s to prevent the disease. It’s not a test; it’s a prevention,” he said.

Pfizer spokesperson Sally Beatty told the Independent that Pfizer and the German firm BioNTech kicked off ​“a large-global Phase 2/3 study for a potential vaccine candidate against SARS-CoV2” on July 27.

“The design of the study is to enroll up to 30,000 non-pregnant participants between 18 – 85 and we expect to include approximately 120 sites globally,” she wrote. ​“The trial regions include areas with significant expected SARS-CoV‑2 transmission to assess whether investigational vaccine candidate, BNT162b2, is effective in preventing COVID-19.” She deferred to YNHHS on any information about the locally conducted trial.

“A Single Death In 10 Days”

Balcezak and YNHHS President and CEO Marna Borgstrom also said during Tuesday’s press conference that the regional hospital system, which includes New Haven’s York Street and St. Raphael’s campuses as well as five other campuses throughout the state and Rhode Island, now has only 15 Covid-positive in-patients systemwide. YNHHS also has only three Covid patients currently in intensive care units.

Seven of the current patients are in New Haven, five are at Bridgeport Hospital, two are at Greenwich Hospital, and one is at Lawrence and Memorial Hospital.

Balcezak said that YNHHS has conducted over 140,000 Covid-19 tests to date systemwide.

“We have discharged healthy more than 3,600 patients,” he said. ​“There have been 581 deaths within the health system. We’ve only had a single death in the last 10 days.”

Balcezak said that YNHHS first put into place its Code D emergency operations plan in anticipation of a surge of Covid-19 cases on Feb. 9. The hospital system had its first Covid in-patient on March 8, and experienced its peak of hospitalizations on April 21 with roughly 1,970 Covid patients in hospital beds systemwide.

“There is no going back to the way it was,” he cautioned. Going forward, the hospital system is expecting more of a ​“transformation” than a ​“recovery.”

“It really is in the hands of our citizens to continue the great work of social distancing, mask wearing, hand hygiene, and avoiding large gatherings,” he said. ​“We can get through this. There is a light at the end of the tunnel.” But that light won’t be reached until the country, and the world, has a Covid-19 vaccine that works.

YNHHS Announces New President

Following up on last week’s announcement of Keith Churchwell becoming the next president of Yale New Haven Hospital, Borgstrom shared on Tuesday another major leadership change — this time involving a native New Havener.

Borgstrom said that Chris O’Connor (pictured), who was born and raised in New Haven and who currently serves as a senior vice president and the chief operating officer for YNHHS, will become the hospital system’s new president starting in October. Borgstrom will be stepping down as YNHHS president, though she will remain as the hospital system’s CEO.

O’Connor previously served as president and CEO of the former Hospital of Saint Raphael.

“The work that we have ahead of us and the economic challenges that Covid has presented is something that we’re diligently working to mitigate and turn the tide,” O’Connor said Tuesday,” in terms of our financial performance and building the program and services that Yale New Haven is known for.”

O’Connor said he began his healthcare career as an emergency room tech at the former Hospital of Saint Raphael. After working in the St. Raphael’s emergency room throughout his undergraduate and graduate studies, O’Connor rose to the ranks of vice president of clinical operations at the Ochsner Clinic Foundation in New Orleans and later as the president of Caritas St. Elizabeth’s Medical Center in Boston.

In 2009, O’Connor returned to New Haven to lead the Hospital of Saint Raphael and eventually help it merge with YNHHS in 2012.

“Chris is an extraordinary person who is widely recognized for his leadership skills and strategic insights,” Borgstrom is quoted as saying in an email press release sent out Tuesday afternoon. ​“Chris truly is a courageous leader who effectively worked himself out of a job at Saint Raphael’s doing what was right for that organization, its staff and its patients. It was a privilege to be able to attract him to Yale New Haven when the acquisition was complete.”