The University of Maryland School of Medicine and about 30 other U.S. centers have begun recruiting thousands of volunteers living in COVID-19 hot spots to join the nation’s most advanced trial for a vaccine against the disease.
The vaccine was developed by the Massachusetts biotech company Moderna along with the National Institutes of Health. It is among several vaccines to reach a Phase 3 trial globally but was the first one announced under Operation Warp Speed, the federal program to quickly identify, produce and distribute 300 million doses of a COVID-19 vaccine.
The trial of 30,000 people, including 500 in Maryland, follows promising smaller studies that demonstrated the vaccine’s safety and effectiveness in smaller groups of people. It aims to show definitively that the vaccine prevents infections and makes cases less severe.
“We hope it stops 100% of transmissions,” said Dr. Matthew B. Laurens, lead investigator at the University of Maryland.
“But if it decreases the severity of disease, that’s important for public health,” he said. “At the end of the day, if it saves lives, that’s what’s most important.”
The hunt for vaccines and therapies for COVID-19, the illness caused by the coronavirus, has been a massive undertaking by governments, academic institutions and industry, which have invested billions of dollars. Currently, there are no approved vaccines, though 27 human trials are underway worldwide, including five in Phase 3, according to a report from IHS Markit, a London-based research firm.
Others are in the pipeline, including those being developed by Johns Hopkins University and the Maryland biotech firm Novavax. Many preventive therapies and treatments also are being tested — including some that could beat vaccines to formal approval.
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If the Moderna vaccine shows it can prevent enough infections, officials believe federal regulators could approve it by year’s end and inoculations could begin by mid-2021, remarkably swift for a process launched only months ago.
The vaccine uses so-called messenger RNA, which has shown promise in past studies in preventing infectious diseases.
It works by conveying genetic instructions to a person’s cells to make specific proteins that can induce production of antibodies that defend against the virus. That differs from traditional vaccines that inject weakened virus into the body to induce antibody production.
“Although face coverings, physical distancing and proper isolation and quarantine of infected individuals and contacts can help us mitigate [coronavirus] spread, we urgently need a safe and effective preventive vaccine to ultimately control this pandemic,” Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, said when the Moderna study was announced.
Public health officials warn, however, that there’s no guarantee any vaccine will work. A big push also will be needed to manufacture enough doses and figure out how to dole them out fairly. Cost may be an issue. Moderna just said it would charge $32 to $37 a dose despite heavy public investment in the vaccine’s development.
Public buy-in also could be an issue, particularly from people often left out of research and at times exploited: Blacks, Latinos and Native Americans. The same communities have been hard hit by the virus.
Dr. Susan Bailey, president of the American Medical Association, said in a news conference Friday that there have been “centuries of inequities” in health care, contributing to fears.
She said allaying concerns in minority communities will be crucial to gaining a necessary mix of people in vaccine trials, as well as getting people vaccinated. African Americans and Latinos are about three times as likely as whites to become infected with COVID-19 and twice as likely to die.
Planning for the fair allocation of any vaccine must happen now, Bailey said. “It’s important that all who need the vaccine can get it.”
At the university, Laurens acknowledged recruitment will be tough for several reasons, including distrust in the community and language barriers. He said researchers are working with community organizations to include minority groups in specific ZIP codes where transmission is highest.
For the study, researchers will draw blood and vaccinate participants twice, four weeks apart. Half will get the vaccine, half a placebo. They all will be encouraged to continue distancing, wearing masks and taking precautions to avoid infection.
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Participants will keep a journal of symptoms and side effects and check in weekly. Those with signs of COVID-19 will be tested and referred for treatment if needed. Researchers will follow them for two years to see if their immunity lasts.
Laurens called all of the work on vaccines encouraging.
“We are on track with this and so many other vaccines,” he said. “Many vaccine candidates need to be tested so we can advance the ones that work as quickly as possible. We’ll also need more than one approved. There could be production or safety issues with one or another.”
Across Baltimore at Johns Hopkins, researchers are working to develop a vaccine that is not yet ready for human testing.
Other Hopkins researchers are working on a potential therapy made from blood plasma collected from recovered COVID-19 survivors. The effort began as a collaboration among doctors nationwide who were using plasma on COVID patients without a lot of evidence. Hopkins doctors got started on studies with $4 million from Bloomberg Philanthropies and the state of Maryland and, more recently, they received $35 million from the U.S. Department of Defense.
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Trials will test whether the plasma helps prevent infections in people at high risk, such as those living or working closely with infected people. They also will also test whether such plasma prevents those recently infected from becoming more severely ill.
Early research suggests that plasma benefits those with less severe cases, though it’s currently only being used in patients sick enough to be hospitalized, said Dr. Shmuel Shoham, an associate professor in the Hopkins School of Medicine helping lead the trials.
The trials will include 1,100 people in several states and the Navajo Nation. Shoham said Hopkins will seek to enroll people of varying racial and economic backgrounds, as well as the elderly.
Participants will be monitored over four weeks for symptoms. Researchers should know if the plasma treatments work by late September or early October, setting up a quicker process for approval and use than the vaccines.
“We will have a definitive answer if this works and in which people it works best,” Shoham said. “We didn’t want to do a smallish trial hinting at something. Is this yes or no? As a physician, I’m interested in something I can offer patients.”