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Wake Forest Baptist plays key role with Moderna COVID-19 vaccine
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Wake Forest Baptist plays key role with Moderna COVID-19 vaccine

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Wake Forest Baptist Medical Center played a significant role in the development of Moderna's COVID-19 vaccine, serving as an early testing site for the effort.

Moderna, a biotechnology company headquartered in Cambridge, Mass., said Monday a preliminary report found its vaccine had an effective rate of 94.5% in its Phase Three clinical trial in a small initial review of volunteers.

The Moderna announcement comes eight days after Pfizer said its COVID-19 vaccine appeared similarly effective at about 90%.

Healthcare analysts quoted by The Associated Press said it is possible that both companies are on track to seek Food and Drug Administration permission within weeks for emergency use in the U.S.

Wake Forest Baptist was among the first 10 participants in the U.S Moderna trial, which began July 27. Wake partnered with Javara Research on the trial.

"Wake Forest Baptist has had more than 300 volunteers at our site," said Dr. John Sanders, chief of infectious diseases at Wake Forest Baptist and principal investigator of the local trial.

"We are very excited about these results and proud of our volunteers, institution and Javara for having contributed to such an important finding."

The clinical trials are evaluating whether the Moderna vaccine boosts the immune system to produce enough antibodies against SARS-CoV-2, the virus that causes COVID-19, so it does not cause illness in case of infection.

Participants get two vaccine or placebo shots about a month apart. They are asked to keep an electronic diary documenting any potential COVID-19 symptoms.

Monday's announcement was prompted by the first interim analysis based on 95 cases. Ninety cases of COVID-19 were observed in the placebo group vs. five cases observed in the vaccinated group.

A secondary element of the clinical trial analyzed volunteers who developed severe cases of COVID-19. There were 11 severe cases, all of which occurred in the placebo group and none in the vaccinated group.

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The 95 cases included 15 older adults (ages 65 and up) and 20 participants identifying as being from diverse communities (including 12 Hispanics, four Black or African Americans, three Asian Americans and one multiracial).

The Phase Three study applies the "adaptive platform trial design," which allows for several possible drug treatments to be tested at the same time, "with the most promising potentially moving forward for further exploration, and the least promising being removed from the study," Wake Forest Baptist said in September.

Known as the COVE study, more than 30,000 participants have enrolled in the U.S. since July 27, including a projected 10,000 at UNC Hospitals sites in the Triangle.

The study was projected to last 25 months and involve up to 89 clinical trial sites. The vaccine does not use a live virus.

The main side effects were fatigue, muscle aches and injection-site pain after the vaccine's second dose.

Moderna is a participant in the Trump administration's Operation Warp Speed, through which it received nearly $1 billion in federal funding.

Moderna said it remains on track to manufacture 500 million to 1 billion doses globally in 2021.

If the FDA allows emergency use of Moderna's or Pfizer's candidates, there will be limited, rationed supplies before the end of the year.

Moderna expects to have about 20 million doses, earmarked for the U.S., by the end of 2020. Pfizer and its German partner BioNTech expect to have about 50 million doses globally by year's end.

On Oct. 18, the N.C. Department of Health and Human Services submitted the first version of its vaccine distribution plan to the federal Centers for Disease Control and Prevention.

Dr. Mandy Cohen, the state's health secretary, said at that time the "goal of the plan is to immunize everyone who is eligible for and wants a COVID-19 vaccine."

As expected, those at the top of the priority list include health-care providers and emergency responders who are at high risk for exposure, those who are vital to the initial COVID vaccine administration efforts, and staff in long term care facilities.

DHHS estimated that up to 951,000 individuals could receive vaccine doses in Phase One, which could come from Moderna, Pfizer or another vaccine manufacturer.

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@rcraverWSJ

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