Beaumont Hospital, Royal Oak, is seeking participants for a COVID-19 vaccine study.

Beaumont Hospital, Royal Oak, is seeking participants for a COVID-19 vaccine study.

File photo by Deb Jacques


Beaumont seeks participants for COVID-19 vaccine study

By: Sarah Wojcik | Royal Oak Review | Published November 13, 2020

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ROYAL OAK — Beaumont Hospital, Royal Oak, has been selected as one of approximately 100 hospitals across the country to participate in an investigational COVID-19 vaccine study.

The AZD1222 COVID-19 vaccine study is part of the national Operation Warp Speed endeavor to find a vaccine for COVID-19. According to the U.S Department of Health and Human Services, Operation Warp Speed’s goal is to produce and deliver 300 million doses of safe and effective vaccines with initial doses available by January 2021.

According to the U.S. Department of Health and Human Services, Congress has directed almost $10 billion to Operation Warp Speed through supplemental funding, including the CARES Act.

Dr. Christopher Carpenter, infectious disease specialist and chair of internal medicine at Beaumont Health, said the hospital is hopeful the study will attract a diverse group of participants who have not contracted COVID-19, particularly those most at-risk for infection, such as frontline workers and African Americans.

“Because there is currently no (U.S. Food and Drug Administration)-approved vaccine to prevent COVID-19, we’re eager to have Beaumont participate as one of the trial sites. Beaumont Health cared for the most COVID-19 patients in Michigan during the surge in March and April,” Carpenter said.

The AZD1222 COVID-19 investigational vaccine, developed by AstraZeneca in conjunction with the University of Oxford, is in Phase 3 trial research and seeks approximately 40,000 participants nationwide.

Those who meet the study criteria will receive two injections four weeks apart. Participants will not be told whether they received the vaccine or a placebo. Two-thirds of study volunteers will receive the investigational vaccine, and the other one-third will receive a placebo, according to Beaumont Health.

“There are about five or six (investigational vaccines) at the top of the list in terms of how far along they are,” Carpenter said. “Once we have data, we’ll submit it to the FDA to be evaluated.”

In order to determine data points, Carpenter said, researchers will look at the number of people in each arm of the study who develop COVID-19 and then compare the ratios of those in the placebo group versus the investigational vaccine group.

To be a positive study, among those who contracted COVID-19, the ratio of those who received a placebo should be much greater than those who received the investigational vaccine.

“(Enrollment for the AZD1222 COVID-19 vaccine study will be) open until we get to 40,000 participants,” Carpenter said. “We follow people for two years.”

He said the study follows participants for two years because it is important in determining the safety and efficacy of the vaccine, as well as the durability of immunity. While some vaccines only need to be administered once, others, such as the influenza vaccine, need to be administered annually.

“This vaccine may end up being an annual vaccine. We have to wait and see,” Carpenter said.

The National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority, a part of the U.S. Health and Human Services’ Office of the Assistant Secretary and Preparedness and Response, are providing funding for the research study, according to Beaumont Health.

“This large-scale study definitely has the potential to save lives across our state, the nation and across the globe,” Dr. Matthew Sims, director of infectious disease research at Beaumont Health, said in a prepared statement.

Researchers are seeking people 18 years of age or older in good or stable health — they may have an underlying medical condition and still participate, if their disease is stable; individuals with an increased risk of getting COVID-19 or those at greater risk of developing complications from COVID-19; and those who do not have a previously confirmed diagnosis of COVID-19.

All clinic visits will take place at Beaumont Hospital, Royal Oak. Tests will be provided at no cost, and participants will be reimbursed for their time and travel.

Visit beaumont.org/covid-trial or call (248) 898-5000 to learn more about the study.

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