Thanks to advocacy from community leaders, New Haven residents, particularly those of color, will soon participate in the third phase of a COVID-19 vaccine trial conducted by Pfizer and held at the Yale Center for Clinical Investigation, or YCCI.
Pharmaceutical giant Pfizer was in talks with the YCCI to bring the trial to New Haven, but it was ultimately the YCCI cultural ambassadors — pastors and community leaders working to increase the participation of the African American and Hispanic communities in clinical trials — that persuaded the company, said Yale New Haven Hospital Chief Medical Officer Thomas Balcezak.
YNHH is one of more than 100 sites participating in the Phase 3 trial of Pfizer’s COVID-19 vaccine. Principal investigator of the trial at Yale, Onyema Ogbuagu, enrolled the hospital’s first participant on Aug. 26. By then, nearly 400 people had applied to join the study at Yale, including healthcare workers, Yale faculty and members of the wider community. Recruitment is ongoing and the University and its community partners are particularly trying to recruit people of color to enroll in the trial.
“If a vaccine is tested and people of color do not participate we may not know how effective the vaccine will be on people of color. If communities of color try to wait out the results others may benefit while it will put us at a greater disadvantage,” Leroy Perry, pastor of St. Stephens American Methodist Episcopal Zion Church and a cultural ambassador, wrote in an email to the News. “To do nothing is not an option.”
Still, Perry said many members of the St. Stephens community are wary of clinical trials. Medical trials have historically mistreated or excluded people of color, and Black Americans often face discrimination when seeking medical care.
“People feel the medical establishment doesn’t value their lives, [it] is often willing to provide inferior or incomplete treatment,” he wrote. “This is new and people are apprehensive [of] being the first and becoming yet another guinea pig.”
Cultural ambassadors, including pastors at AME Zion churches and leaders with Junta, a Latino nonprofit in New Haven, are working to bring more people of color to the trial. Because COVID-19 has disproportionately impacted communities of color, the pandemic has made their efforts particularly pressing.
“We have not had anyone test positive from the church,” Perry wrote. “But every member knows a friend, a family member who has either tested positive, been hospitalized or died.”
Perry is working to overcome this distrust by educating the St. Stephens community on the vaccine and recruiting church members to participate in the trial. He said he is informing people about the vaccine by newsletter, radio and word-of-mouth.
The vaccine, developed by pharmaceutical companies Pfizer and BioNTech, contains modified RNA. This genetic code enters cells and instructs them to make a protein that resembles the one that allows the SARS-CoV-2 virus to infect cells. People can then generate antibodies against the protein without ever suffering from COVID-19.
In the first two phases of the trial, in which the vaccine was given to a small group of people, it was well-tolerated and generated the appropriate immune response: the development of antibodies. Now Phase 3 will enroll 30,000 people and will test-drive how the vaccine functions in the real-world.
“You can always assess the immune response to the vaccine, which is one thing, but it’s a whole different issue to test whether those antibodies that are produced are able to protect against COVID,” Ogbuagu said.
Phase 3 may also show rarer side effects that don’t show up in the earlier phases with smaller sectors of the population.
The trial will operate with a prime-boost strategy, which means that participants will receive two doses of the vaccine three weeks apart. The first dose primes the immune system, while the second one boosts the immune response and allows for “skyrocketing of the antibody levels,” Ogbuagu said.
Participants will have four scheduled follow-up visits and will be instructed to continually monitor themselves for signs and symptoms of COVID-19.
In the trial of healthy volunteers aged 18 and 85, a randomly-chosen half of participants will receive the vaccine and half will get placebo. If the vaccine proves effective, every participant will then receive it.
The biotech firms have already contracted with the U.S. government to supply 100 million doses by the close of 2020, and 1.3 billion doses the following year. After a Phase 3 trial, the Food and Drug Administration may grant a vaccine Emergency Use Authorization, which Pfizer has said it will seek as early as October.
The warp-speed search for a COVID-19 vaccine has already shattered precedents and raised concerns that safety will be sacrificed for speed.
In the earlier phases individuals have had mild effects including pain at the injection site and fatigue, Balcezak said. But the vaccine has not caused any serious complications. If problems should flare up, the responsibility falls to the FDA and people conducting the trial to immediately halt it, Balcezak explained.
“There’s a lot of regulation and oversight that goes into the conduct of these studies,” Ogbuagu said. “Even if the timelines of the studies have been accelerated, the necessary safeguards are still in place.”
There are currently nine ongoing Phase 3 trials worldwide.