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August 25, 2020

Local COVID-19 vaccine trial to get underway soon 

IMAGE | stock.adobe.com
By Michelle Tuccitto Sullo

Hundreds of area residents have signed up to participate in a study which will test the effectiveness of a potential vaccine against COVID-19.

Yale New Haven Health officials are partnering with New York-based pharmaceutical company Pfizer Inc. for the late-stage trial. 

On Monday, Thomas Balcezak, MD, executive vice president and chief clinical officer for Yale New Haven Health, said about 300 individuals from the region have signed up to participate so far. 

Yale officials hope to enlist up to 2,000 people from the region. Anyone interested in participating can do so by visiting yalecovidvaccine.org.

As of Monday, Yale had not yet received the vaccines to administer, as the product was being shipped in cold storage from Germany.

“We hope to be able to start administering it later this week,” Balcezak said.

According to Balcezak, prevention is the best weapon against the virus. 

“The cornerstone of stopping this pandemic will be widespread mask-wearing and widespread vaccination,” Balcezak said.

If researchers determine the vaccine works at preventing illness, the next stage would be seeking regulatory approvals. Pfizer plans to enroll up to 30,000 participants for the study overall, according to Sally Beatty, a Pfizer media spokesperson. Half of the volunteers will get the vaccine, and the rest will get a placebo. 

Earlier this summer, Pfizer, which has a large Connecticut presence, and BioNTech SE announced the planned safety and efficacy clinical study.

According to the companies, this vaccine candidate takes a different approach. Instead of using inactive virus to create immunity, it uses a genetic code (modified RNA) to make the body generate proteins that resemble the SARS-CoV-2 virus spike protein, so the body develops antibodies against it. In initial testing, the vaccine has proven to be safe and effective in generating an immune response. Now, researchers are trying to determine if it prevents infection.

All participants must be healthy, willing to comply with scheduled visits and be between the ages of 18 and 85. Researchers will follow the enrollees via six follow-up visits over a two year period.

The U.S. Food and Drug Administration has granted fast track status for the potential vaccine. If trials are successful, the companies expect to seek emergency use authorization or regulatory approval as early as October. If they can secure all required approvals, they aim to supply up to 100 million doses globally by the end of 2020 and approximately 1.3 billion doses by the end of 2021.

Marna P. Borgstrom, CEO of Yale New Haven Health, said Monday the health system had 24 inpatients with COVID-19. This included 17 at Yale New Haven Hospital, four at Bridgeport Hospital, and one each at Greenwich Hospital, Lawrence + Memorial Hospital in New London, and Westerly Hospital in Rhode Island. The numbers are a slight increase from earlier this month, when there were just 15 COVID-19 patients across the system.

“We haven’t seen anything to indicate we are poised for another wave, but we can’t let our guard down,” Borgstrom said. 

Contact Michelle Tuccitto Sullo at msullo@newhavenbiz.com. 

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