Yale to assist with Pfizer COVID-19 vaccine human trial

Photo | Pfizer Scientists at Pfizer's lab in Groton.

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By Michelle Tuccitto Sullo

New Haven area residents will have an opportunity to participate in a study of the effectiveness of a potential vaccine against COVID-19.

Yale New Haven Health officials are partnering with New York-based pharmaceutical giant Pfizer Inc. in the coming weeks for a late stage trial of its vaccine candidate. If researchers determine the vaccine is successful, the next stage would be seeking regulatory approvals.

Thomas Balcezak, MD, executive vice president and chief clinical officer for Yale New Haven Health, spoke about the partnership in a press conference with area media outlets Tuesday afternoon.

The Yale Center for Clinical Investigation will be shepherding the vaccine trial in the region to determine if it works to prevent COVID-19 infection.

Half of the participants will get the vaccine, while the remainder will get a placebo. Researchers hope to determine if the vaccinated group has a lower rate of infection, Balcezak said.

Thomas Balcezak

Sally Beatty, media spokesperson for Pfizer, said the overall study will enroll up to 30,000 participants.

Yale officials indicated this number will include roughly 2,000 people from the region. Participants should be asymptomatic people who haven’t been infected previously.

Details are still being finalized, and Balcezak couldn’t comment on exactly when the local trial will start or how long it will take.

In July, Pfizer, which has a large Connecticut presence, and BioNTech SE announced their planned safety and efficacy clinical study to evaluate a “single nucleoside-modified messenger RNA (modRNA) candidate from their BNT162 mRNA-based vaccine program against SARS-CoV-2.”

The U.S. Food and Drug Administration has granted fast track designation status.

If trials are successful, the companies hope to seek emergency use authorization or regulatory approval as early as October. Then, if the companies secure all necessary 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.