Photo: Arnold Gold / Hearst Connecticut Media
NEW HAVEN — Yale School of Medicine and Yale New Haven Hospital announced the start of Phase 3 of the Pfizer coronavirus vaccine trial at the hospital that will draw participants from across the country.
The hospital and medical school trial of Pfizer’s treatment vaccine candidate is part of a massive effort that will involve nearly 30,000 test subjects. Yale New Haven officials have launched an effort to find individuals willing to be involved in the testing, particularly Latino and Black participants, two communities the pandemic has hit hard.
Phase 3 is the final step before a drug candidate is submitted to the federal Food and Drug Administration for approval to be used. Normally, the drug approval process takes several years to play out. The fastest vaccine development that ever occurred, a vaccine to inoculate against the mumps, took four years, according to Yale officials.
But because of the worldwide death toll from the pandemic, the Pfizer drug is just one of several being investigated as a possible treatment. FDA officials were not immediately available Monday to provide details on how long the study might last or on other hospitals and universities that might be participating in the testing.
“We are just hoping for diverse participation, which is representative of the population of the State of Connecticut,” said Tesheia Johnson, director of the Yale Center For Clinical Investigation. “Some racial and ethnic minorities are disproportionally burdened by chronic diseases and are much more likely to succumb to certain illnesses, making the need for tailored communication and research significant.”
A decade ago, YCCI launched its Cultural Ambassadors program in an effort to recruit more Latino and Black people into health care clinical trials. Prior to the launch of the program, “people of color represented only 3 to 6 percent of the participants in clinical trials,” said the Rev. Elvin Clayton, pastor at Walter’s Memorial AME Zion Church in Bridgeport, which is part of the Cultural Ambassadors program. “Now we see between 30 percent to 50 percent participation, and in some trials, over 80 percent.”
Another church participating Yale’s efforts to reach out to people of color for the study is Branford’s St. Stephens AME Zion Church. The Rev. Leroy Perry, who is the pastor, said, “our community has been disproportionately impacted by COVID-19.”
“We will be working harder than ever to ensure that the underserved community has access to this clinical trial and when ready, the vaccine will be made affordable to those who are disproportionately affected,” Perry said.
Dr. Onyema Ogbuagu, a Yale New Haven infectious disease physician and associate professor of medicine at the university, said “earlier trial phases have been very encouraging, showing that when injected, the vaccine is tolerated well and generates the appropriate immune response that has the potential to protect humans from COVID-19.”
The Cultural Ambassadors now are sharing information about the Pfizer COVID-19 vaccine trial with the goal of ensuring that the final vaccine will be effective for everyone, regardless of their cultural or ethnic background.
Experts in public policy and health care say communities of color, particularly Black people, have long held a mistrust of clinical research in medicine. Some of that dates back to 1932, when 600 Black men from Macon County, Ala., were sought to take part in a scientific study on syphilis.
The goal of the infamous “Tuskegee Study” was to observe untreated syphilis. Those who participated in the study were unaware of its real purpose. Some never received any treatment.
U.S. lawmakers passed the National Research Act of 1974 amid growing growing concern about the ethics violations in research, particularly as they related to study subjects. As part of the passage of that legislation, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was created.
The goals of Yale’s Cultural Ambassadors program include increasing the amount and quality of clinical trial data available on racial and ethnic minorities to understand how minorities react to medical products. The program also seeks to promote health and safety communication to minority populations who may experience low health literacy and who may speak English as a second language, or not at all.
Angela Mattie, a professor in the Schools of Business & Medicine at Quinnipiac University, said the program recognizes that “people trust people that are in their own communities.”
“Ideas like this are key to doing a better job deliver health care and treating individuals in ethnic communities,” she said. Different ethnic groups and races have different reactions to pharmaceuticals, according to Mattie.
The COVID study is a collaboration between Pfizer and a German company BioNTech SE. Late last month, the two companies announced a $1.95 billion deal with the U.S. Department of Health and Human Services and the Department of Defense.
The goal is to meet the government’s Operation Warp Speed program goal to begin delivering 300 million doses of a vaccine for COVID-19 in 2021.
Under the agreement, the U.S. government will receive 100 million doses of BNT162, the COVID-19 vaccine candidate jointly developed by Pfizer and BioNTech, after Pfizer successfully manufactures and obtains approval or emergency use authorization from the FDA. The government will pay the companies the full amount upon the receipt of the first 100 million doses.
Half of the nearly 30,000 people enrolled in the study will receive the vaccine and half will receive a placebo. If success is seen early on in the trial, all participants will be given the vaccine and all who are enrolled in the study will be followed for two years, according to Yale.
There are about 120 clinical investigation sites around the world, including 39 states across the United States and countries including Argentina, Brazil and Germany, according to Pfizer officials. The sites where the studies are taking place are selected based on factors including scientific expertise and capabilities, the epidemiology of the disease and prior experience conducting clinical trials.