Yale to test COVID-19 vaccine
Yale School of Medicine and Yale New Haven Hospital are to start Phase 3 of the Pfizer coronavirus vaccine trial at the hospital.
The 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,” according to Yale.
“The study is a collaboration between BioNTech SE and Pfizer using modified RNA,” Yale said in a release. “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.”
“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,” According to Yale.
The U.S. government recently announced that it will pay $1.95 billion deal for 100 million does of Pfizer’s vaccine, if it is effective.
“I am very excited that Yale New Haven Hospital and the Yale Center for Clinical Investigation (YCCI) are undertaking this novel vaccine trial,” said Dr. Onyema E. Ogbuagu, principal investigator, 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 trial is a randomized placebo-controlled trial, meaning that of the planned nearly 30,000 enrollees, half will receive the vaccine and half will receive a placebo, according to Yale. “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 www.yalestudies.org.
“This vaccine trial is yet another example of the importance of Academic Medical Centers,” said Thomas Balcezak, MD, EVP and chief clinical officer, Yale New Haven Health, said in the release. “Our partnership with the Yale School of Medicine and YCCI creates opportunity to bring cutting-edge care and therapeutics to our community.”