Michigan Medicine will partner with pharmaceutical company AstraZeneca for a Phase 3 trial of a COVID-19 vaccine, the University of Michigan announced Tuesday.
The trial will examine “how well the investigational vaccine works and how safe it is,” according to a press release.
The University is one of several sites participating in the trial, which is expected to last about two years and aims to test a total of 30,000 people across the country, and will begin recruiting hundreds of volunteers immediately.
Marschall Runge, the University of Michigan’s executive vice president for medical affairs and Michigan Medicine CEO, expressed his support for the partnership and said the vaccine could save lives.
“The importance of a safe and effective vaccine against COVID-19 cannot be overstated,” Runge said. “The AstraZeneca Phase III trial will bring answers as to the effectiveness of this vaccine. At the end of the day, this kind of rigorous clinical trial with the commitment of Michigan Medicine and other study sites to safety will be a key step in realizing a vaccine that will save lives when one is developed.”
Participants in the Phase I/II trial of the vaccine, led by Oxford University, demonstrated “robust immune responses.” More than 1,000 adults ages 18 to 55 in the United Kingdom took part in the trial. A study published in The Lancet showed the vaccine to be relatively safe, though side effects such as fever or headaches and injection site reactions occurred in more than half of participants. Some patients also reported muscle aches and injection site reactions.
In a statement, University President Mark Schlissel said Michigan Medicine’s role in the trials built on the University’s history of medical research.
“We are proud to advance the University of Michigan’s outstanding legacy of excellence in vaccine trials with this important clinical trial partnership,” Schlissel said. “We hope one day soon to be able to announce a successful vaccine against COVID-19 and save lives.”
The University has previously played a role in the development of a major vaccine. In 1955, Dr. Thomas Francis Jr., chair of the School of Public Health Department of Epidemiology, announced to a crowd of scientists and reporters at Rackham Auditorium that a vaccine developed by his former student, Jonas Salk, was effective in preventing polio.
More than 1.8 million children took part in the field trials, which at the time were “unprecedented in magnitude.”
The AstraZeneca trial — officially known as the AZD1222 COVID-19 VACCINE Study — looks to do something similar. Funding for the effort comes from Operation Warp Speed, a public-private partnership with the U.S. Department of Health and Human Services with the goal of fast-tracking the creation of a COVID-19 vaccine.
Operation Warp Speed aims to “deliver 300 million doses of a safe, effective vaccine for COVID-19 by January 2021,” according to HHS.
In exchange for $1.2 billion in federal funding, AstraZeneca is working to administer 300 million vaccine doses. The company has also promised to forgo any profits it makes during the pandemic from vaccine development, a claim that has spurred some doubts from members of Congress.
The AZD1222 COVID-19 VACCINE Study is in the market for participants. Eligible candidates must be at least 18 years old and be “in good or stable health.” They must also not have previously contracted COVID-19.
Those interested in enrolling can do so online or by emailing AZVaccineTrial@med.umich.edu.
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