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Yale doc and vaccine trial principal investigator Onyema Ogbuagu.
Roughly 300 locals are currently enrolled in a 44,000-participant, international Covid-19 vaccine trial that Yale New Haven Hospital’s principal investigator anticipates might lead to a final, approved vaccine by late December or early January at the soonest.
YNHH infectious disease doctor Onyema Ogbuagu gave that update at noon Tuesday during the hospital’s latest Covid-19 virtual press briefing, held online on Zoom and Facebook Live (click on the Facebook Live video at the bottom of this article to watch the full presser.)
Ogbuagu is the principal investigator for the local arm of the Phase 3 trial study, which is a partnership among the Yale School of Medicine, YNHH, the pharmaceutical giant Pfizer, and the German biotech company BioNTech SE.
Tuesday afternoon’s YNHH presser.
The New Haven-based study formally started in mid-August and is testing out “three BNT163 RNA-based Covid-19 vaccine candidates against Covid-19 in healthy adults,” according to the trial’s official description on the Clinical Trials at Yale website.
Ogbuagu said Tuesday that the Yale-YNHH-Pfizer study is one of six Phase 3 Covid-19 vaccine trials currently taking place across the country. While Phase 1 looked at the safety of a potential vaccine and Phase 2 at whether or not a vaccine candidate created the right kind of immune response against Covid-19, Phase 3 is evaluating the efficacy of such a candidate in preventing Covid-19 in people who receive the vaccine.
“These are randomized trials,” he said, meaning that roughly half of the enrollees get the vaccine, while the other half get a placebo.
“It’s one of the more inclusive study protocols out there,” Ogbuagu said about the Yale-YNHH-Pfizer trial.
Initially, he said, the project was capped at 30,000 enrollees, aged 18 to 85. The lower age limit is now 12 years old, he said, there is no longer an upper age limit, and the total enrollee goal is now 44,000 worldwide. He said that the trial also includes immunocompromised patients who have such diseases as HIV and Hepatitis C, and that over 33 percent of participants nationwide are minorities.
Ogbuagu said that a total of roughly 300 participants are currently involved in the New Haven-based study.
Phase 3 trial participants receive two doses of vaccine — or the placebo — over the course of a 21-day period. Ogbuagu said that roughly 70 percent of the trial study’s enrollees have already received their second vaccine dose.
“The safety profile so far has been great,” he said. “We haven’t had any serious adverse event that would have warranted a” stoppage of the study.
Ogbuagu said that, once the trial study has a total of 32 cases of Covid-19 among its roughly 44,000 participants, the companies and researchers involved will conduct a review to determine the efficacy of the vaccine vs. the placebo. A 75 percent difference between the impact of the vaccine and the placebo, he said, would be considered a “signal of efficacy.” (According to Stat News, Pfizer revealed Tuesday that its researchers have not yet conducted an analysis of the efficacy of its vaccine candidate — meaning that the trial’s progress is a bit slower than expected.)
Ogbuagu also said that he anticipates the trial study yielding an initial review by November. The federal Food and Drug Administration will then need another two to four weeks to review the data submitted. And the feds have required the trial study’s managers to follow up with participants for at least two months after the administering of the second vaccine, at a minumim.
“I think the earliest a vaccine would receive approval is the end of December or early January,” he said.
Yale New Haven Health Systems (YNHHS) Chief Clinical Officer Thomas Balcezak (pictured) said that, even after a vaccine is approved, widely distributed, and administered, people will likely still need to wear masks and keep social distances for a while to come.
That’s because a vaccine likely won’t prevent infection, he said, but rather will prevent symptoms by stopping the virus from replicating once it has entered a body.
“There will be a time when people will still be contagious,” he said. And, because the FDA is requesting that an approved vaccine be only 50 percent effective (that is, “prevent disease or decrease its severity in at least 50 people of people who are vaccinated”), there will likely be many people still susceptible.
“Even if you got the vaccine, you’ll still be infections,” he said. “So mask wearing will still need to be the standard.”
90 Inpatients Systemwide; Up From 26 Last Month
Balcezak and YNHHS CEO Marna Borgstrom (pictured) also said that the regional health system has seen an increase in Covid-related hospitalizations consistent with increases throughout the region and the country.
Borgstrom said that the hospital system — which includes seven hospital campuses in Connecticut and Rhode Island, including the York Street and St. Raphael’s campuses in New Haven — currently has a total of 90 Covid-positive inpatients . That’s up from 26 such patients hospitalized at the end of September.
The hospital system also currently has 22 Covid-positive patients in intensive care units (ICUs), with eight on ventilators. She said YNHHS had only two ICU Covid patients a month ago.
“It is still below are peak last spring of 800 cases,” she said. “But it doesn’t feel very good. People are tired. They’re tired of the pandemic. They’re tired of social distancing. They’re tired of wear masks.”
And yet, social distancing and mask-wearing “are among the only things that we can rely on right now” to keep infections down and communities safe.
Balcezak agreed. “There is now scientific certainty that mask wearing and social distancing work.”
Borgstrom said that the hospital system has discharged over 4,100 Covid-positive patients who have recovered from their illness, while 606 Covid patients under YNHHS care have died.
“That’s 606 too many people,” she said.
The hospital system is currently conducting roughly 3,000 Covid-19 tests per day. Balcezak said that the system still hopes to increase that daily testing average to 10,000, but that YNHHS has struggled to get the supplies and equipment it needs to conduct and process so many tests. He said the hospital system is also currently hiring new med techs and lab techs in a push to increase its daily testing capacity.
A YNHH spokesperson told the Independent by email after the presser that the hospital system has averaged 3,114 tests per day for the month of October, with an overall positivity rate of 2.26 percent and an average turnaround time for results between 24 and 48 hours.
He added that YNHH’s two local testing sites are located at 1380 Chapel St. and 130 Orchard St., and that patients with or without symptoms can schedule a testing appointment here.
And see below for a recent interview with Dr. Ogbuagu by Tom Ficklin on WNHH’s “The Tome Ficklin Show.”
Thank you to all the brave volunteers who are participating in the vaccine trials. You are our heroes and we will owe you a debt of gratitude for participating regardless of the risks involved. I wish you health and safety and success in becoming the people who help the world in developing a cure or vaccine for this deadly virus.