Yale School of Medicine and Yale New Haven Hospital today announced the start of Phase 3 of the Pfizer vaccine trial at the hospital. This groundbreaking study is intended to be one of several vaccine trials to be undertaken in the hopes of finding the most scientifically validated vaccine in the shortest amount of time.
The study is a collaboration between BioNTech SE and Pfizer using modified RNA. This is a novel way to create a vaccine for use in humans. Rather than using the part or whole of the actual virus in an inactive form to create immunity, this vaccine candidate uses a genetic code (modified RNA) to make the body generate proteins that resemble the SARS CoV-2 virus spike protein, thereby causing development of antibodies against it. Antibodies against the spike protein, a projection from the COVID virus that allows it to attack cells and infect a person, may block the infection from taking hold if the body comes in contact with the virus. In Phases 1 and 2 of the trial, this novel vaccine has proven safe and effective in generating an appropriate immune response. This third phase hopes to show that it can prevent infection.
“I am very excited that Yale New Haven Hospital and the Yale Center for Clinical Investigation (YCCI) are undertaking this novel vaccine trial,” said Principal Investigator Dr. Onyema E. Ogbuagu, YNHH Infectious Disease physician and associate professor of Medicine at Yale School of Medicine. “The 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 YCCI Cultural Ambassadors program is playing a large role in educating the public on clinical trials, building on past success to address cultural and operational issues to encourage a diverse and underserved patient population to participate. The Cultural Ambassador program is a partnership between YCCI, the Connecticut AME Zion Churches, and Junta for Progressive Action. Created 10 years ago, this group has had great success in engaging populations of color in clinical research. “When we started talking about clinical trials in our community, people of color represented only 3%–6% of the participants in clinical trials,” said the Rev. Elvin Clayton, pastor, Walter’s Memorial AME Zion Church. “Now we see between 30%-50% participation, and in some trials, over 80%.”
The Cultural Ambassadors are now sharing information about the Pfizer COVID vaccine trial with the goal of ensuring that the final vaccine will be effective for everyone, regardless of their cultural or ethnic background. “Our community has been disproportionately impacted by COVID-19,” said the Rev. Dr. Leroy Perry, pastor of St. Stephens AME Zion Church. “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.”
The trial is a randomized placebo-controlled trial which means that of the planned nearly 30,000 enrollees, half 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 enrollees will be followed for two years. All participants must be healthy, willing to comply with scheduled visits and be between the ages of 18 and 85 years. To learn more about the trial or to sign up to participate, visit the Clinical Trials at Yale website.
“This vaccine trial is yet another example of the importance of academic medical centers,” said Dr. Thomas Balcezak, executive vice president and chief clinical officer, Yale New Haven Health. “Our partnership with the Yale School of Medicine and YCCI creates opportunity to bring cutting-edge care and therapeutics to our community.”
This vaccine is being developed at a record rate due to the rapid proliferation of COVID-19 around the globe. But despite the pace, there will be no sacrifice to safety, which is forefront in the minds of the research team, YNHH and YCCI. Prior to COVID-19, the fastest development of a vaccine was to inoculate against the mumps, which took four years.