Pfizer expands phase 3 COVID-19 vaccine trial, looks for end of year emergency authorization

Dr. Onyema E. Ogbuagu, an infectious disease specialist, virologist and principal investigator of the Pfizer trail at Yale New Haven Hospital

One of the lead doctors associated with Pfizer’s efforts to develop a COVID-19 vaccine said yesterday on WBLQ’s Morning Show that Pfizer is expanding its clinical trial to include participants as young as 12, with no upper age requirement, and that the vaccine could receive emergency authorization by the end of the year. 

Dr. Onyema E. Ogbuagu, an infectious disease specialist, virologist and principal investigator of the Pfizer trail at Yale New Haven Hospital, said Pfizer is expanding the trail pool from 30,000 and ages 18 to 85 to 44,000 individuals from12 to no upper age limit.

Dr. Ogbuagu was a guest on the Westerly’s station’s Morning Show, hosted by Frank Prosnitz. Dr. Ogbuagu is affiliated with Yale New Haven Hospital, which is the parent of Westerly Hospital and nearby Lawrence & Memorial in New London, Ct.

The Pfizer study is among more than 130 worldwide, five of which are in stage 3 trials, Dr. Ogbuagu said. 

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Stage 3 is the final stage before approval and distribution. Most studies are in phase 1 or 2, with a handful at stage 3 and two that are actually in limited distribution, although their efficacy in question. Those two are from China and Russia, rushed into production before reaching stage 3 trials, with experts concerned that the rushed process poses potential serious risks.

Dr. Ogbuagu said that Pfizer and Moderna are the two companies closest to approval. Moderna has received more than $2 billion in government support. Canada has already agreed to acquire 20 million doses from Moderna, once the vaccine is approved.

A vaccine goes through several stages:  Preclinical tests in which scientists give the vaccine to animals; phase 1 safety trials in which scientists administer the vaccine to a small number people; phase 2, in which the vaccine is given to hundreds of people, separately participants into groups; and phase 3 efficacy trials in which thousands of people receive the vaccine.

Typically, Dr. Ogbuagu said, trials are designed to last two years. The studies are data-driven, he said, with stops at various points for data review. The next “interim analysis,” Dr. Ogbuagu said, is scheduled for sometime in November.

He said, “things are going well,” but cautioned about the importance of following the science and adhering to FDA standards.

“The FDA has very reasonable standards,” Dr. Ogbuagu said. “The FDA should be ideally independent.” 

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Frank Prosnitz brings to WhatsUpNewp several years in journalism, including 10 as editor of the Providence (RI) Business News and 14 years as a reporter and bureau manager at the Providence (RI) Journal. Prosnitz began his journalism career as a sportswriter at the Asbury Park (NJ) Press, moving to The News Tribune (Woodbridge, NJ), before joining the Providence Journal. Prosnitz hosts the Morning Show on WLBQ radio (Westerly), 7 a.m. to 9 a.m. Monday through Friday, and It’s Your Business, also on WBLQ, Monday and Tuesday, 9 a.m. to 10 a.m. Prosnitz has twice won Best in Business Awards from the national Society of American Business Editors and Writers (SABEW), twice was named Media Advocate of the Year by the Small Business Administration, won an investigative reporter’s award from the New England Press Association, and newswriting award from the Rhode Island Press Association.