By ERIN ROLL
Hospitals that are testing potential COVID-19 vaccines are looking for adults who are willing to roll up their sleeves.
Rutgers New Jersey Medical Center, Hackensack University Medical Center and University Hospital in Newark are recruiting healthy adults age 18 and up to take part in phase three clinical trials for Moderna’s mRNA-1273.
Volunteers must not have contracted COVID-19 nor taken part in an investigational COVID-19 vaccine study. Especially needed are adults age 65 and over, essential workers who may come into contact with people with COVID-19 over the course of their work, and people from racial and ethnic minority groups that have been disproportionately affected by COVID-19.
A person who enrolls in any of the clinical studies will be randomly assigned to receive either a trial COVID-19 vaccine or a placebo.
“Our health network has been involved in virtually every facet of COVID-19 research,” said Dr. Ihor Sawczuk, president of Hackensack Meridian Health’s Northern Market and the chief research officer of the network. “We’re eager to do our part with vaccines, which have such enormous potential for millions of people.”
The three hospitals are among 89 testing sites nationwide for mRNA-1273, known as the COVE (Coronavirus Efficacy) Study.
In June, the federal Department of Health and Human Services announced Operation Warp Speed, with a goal to get 300 million doses of COVID-19 vaccine ready to administer by January. The project has received $10 billion in federal funding.
Moderna and Pfizer are among the companies participating in Operation Warp Speed.
“Yes, it is proceeding at warp speed. But what I think a lot of people fail to realize is that the phase three studies are critical,” said Sandra Adams, a professor of biology and virology at Montclair State University.
Phase one tested 20 to 100 volunteers, and phase two moved up to several hundred volunteers, while phase three is recruiting a much larger pool of volunteers from the general public, as many as 3,000.
This broader cross-section is crucial to determine how different people respond to the vaccine, Adams said.
She said that among her colleagues’ concerns is rushing vaccine studies that fail to test a wide demographic and in which crucial data are lacking, and thereby releasing a vaccine that does not work properly.
Phase three clinical vaccine trials typically take at least one year, according to the FDA.
The polio vaccine was developed by Jonas Salk in 1953 and authorized for use in the United States in 1955. A second polio vaccine, developed by Albert Sabin in 1955 and still in use today, started being tested in the Soviet Union in 1957 and was authorized for use in the United States in 1961.
For an influenza virus with pandemic potential, the World Health Organization estimates that it takes about six months for a vaccine to become available once the flu strain is identified and isolated.
The CDC advised states last week to be prepared to administer a COVID-19 vaccine by November. The week before, Dr. Ed Lifshitz, director of communicable disease services for the state Health Department, said that a vaccine would not be ready until 2021, and likely not ready for distribution until the end of that year, citing Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases.
The COVE Study at Rutgers will run for 25 months, or just over two years, and will require participants to visit their testing clinic six times. In addition to receiving two injections, volunteers will have to be tested for COVID-19 and keep a diary of any symptoms or side effects they experience during the testing period.
“We encourage individuals across the state to consider participating in this trial, which could bring the world one step closer to ending this global health crisis,” said Dr. Shobha Swaminathan, principal investigator for Rutgers NJMS and medical director, infectious diseases practice, at the hospital.
Rutgers hopes for at least 500 volunteers, while Hackensack University Medical Center is looking for at least 300.
The next steps depend on the study outcomes, the efficacy and safety of the vaccine, the number of available doses, and how effective the vaccine is at preventing COVID.
The FDA says that a vaccine with at least 50-percent efficacy, or probability of preventing infection, is needed.
Swaminathan said that the most frequent questions from volunteers are when the vaccine will be approved, what the common side effects are, and whether they can get the actual vaccine if it is approved and they were taking the placebo.
Adams said volunteers would be monitored at every step during the study, but warned of the risk that participants could contract COVID-19 and thereby spread it. “This is not like the flu. This is not like the common cold,” she said.
Hospital officials said that anyone who does become infected with a COVID-19-like illness would be assessed further with lab tests and would be assisted in getting care with their primary care provider, who will be given the results.
At least three varieties of a COVID-19 vaccine — produced by the pharmaceutical companies Pfizer, AstraZeneca and Moderna — are either being currently tested or will be tested this fall, and study teams are looking for adult volunteers, including in New Jersey, to receive either one of the vaccines or a placebo.
Nine vaccine makers, including Moderna, Pfizer, Johnson & Johnson and AstraZeneca, signed a joint pledge indicating that they would err on the side of caution when testing COVID-19 vaccines.
It might end up taking several different kinds of COVID-19 vaccine, rather than one single vaccine, to help bring the disease under control, Adams said.