COVID Trials and the People Who Are in Them
Lindy Washburn, a health care reporter for NorthJersey.com and The Record newspaper, is chronicling her journey as one of nearly 30,000 volunteers in Phase 3 of Moderna Inc.’s clinical trial for a coronavirus disease 2019 (COVID-19) vaccine. The volunteers will receive two injections, half will get a saltwater placebo, and the other half will receive the vaccine.
Washburn said her arm hurt a little after receiving her first injection, but so far, she has not shown any COVID-19 symptoms, such as headaches, fatigue, muscle aches, or nausea. Because this is a double-blind study, Washburn said neither researchers nor participants know which volunteers received a placebo and which ones will get the vaccine.
Scientists worldwide are working on developing a vaccine that prevents or reduces the severity of COVID-19 and is safe for adolescents and adults. According to the ClinicalTrials.gov database, 3,662 COVID-19 studies are currently underway in 121 countries. Included in those figures are 51 studies conducted by researchers at pharmaceutical and biotechnology companies, university medical centers, and hospitals in the United States.
The U.S. Food and Drug Administration (FDA) requires clinical trials before a new product can be sold on the U.S. market. Because the potentially fatal COVID-19 has devastated the country, the FDA created a special emergency program for groups working on vaccines. The FDA’s Coronavirus Treatment Acceleration Program (CTAP) was set up to move new treatments to patients as quickly as possible, while at the same time finding out whether the therapies are helpful or harmful.
Moderna, a Cambridge, Massachusetts-based biotechnology company, and the National Institute of Allergy and Infectious Diseases (NIAID) at the U.S. National Institutes of Health, co-developed the investigational “mRNA-1273” vaccine, a trial in which Washburn is a volunteer.
Moderna developed a new method of generating an immune response in the recipient by using “messenger” RNA (a component of cells that transmits genetic information) to cause the body to produce coronavirus antigens that would stimulate the immune system, according to Washburn.
The vaccine will be considered effective if it reduces the risk of getting COVID-19 by 60 percent, which means the vaccine will be seen as a success if it prevents 6 out of 10 trial participants from developing the coronavirus.
Clinical Trial Volunteers May Have Side Effects
Moderna and Pfizer, a pharmaceutical company that is also conducting COVID-19 clinical trials, reported that some volunteers have had side effects from the investigational vaccines, including a sore arm, low fever and muscle aches, the usual side effects of vaccines.
However, one participant in the Pfizer study said the pain in his arm from the first injection kept him up all night. The pain was followed by “intense flu-like symptoms” and uncontrollable chills that made his teeth chatter so hard that he chipped a tooth. He eventually went to see a doctor. But, even after all that, the participant said he still supports the development of a COVID-19 vaccine and is a “big advocate for science.”
In a report on its Phase 1 clinical trial for the mRNA-1273 vaccine, Moderna said some of its volunteers experienced fatigue, chills, headache, myalgia, and pain at the injection site.
While the experimental vaccines may cause side effects, researchers say the vaccines do not give participants COVID-19. Dr. Richard Novack, the lead investigator of the Moderna clinical trial at the University of Illinois at Chicago (UIC), said it’s a common myth that participants would get COVID-19 from the vaccines. It is also not true, Novak said, that researchers give the coronavirus to volunteers to see if the vaccine works. Novack said the trial accepts people who are at risk for getting COVID-19, and if volunteers develop COVID-19, they will develop it naturally.
More Volunteers Needed For Clinical Trials
Dr. David B. Agus, a professor of medicine and engineering at the University of Southern California Keck School of Medicine, put out a call in late September for more Americans to volunteer for COVID-19 clinical trials.
Although nearly 500,000 Americans had signed up, the COVID-19 Prevention Network (COVPN) needed 1 million more volunteers, particularly from diverse backgrounds, Agus said. COVPN was formed by NIAID and is managing the recruitment of volunteers for COVID-19 vaccine clinical trials conducted by AstraZeneca, Novavax, Moderna, and Janssen, a unit of Johnson & Johnson.
Karen Tibbals, a 65-year-old Washington, N.J. resident, signed up on COVPN’s site to volunteer for one of the four clinical trials. Tibbals has first-hand knowledge about clinical trials because she worked as a pharmaceutical marketing executive at Novartis and Merck before retiring.
Tibbals, who has rheumatoid arthritis, said being a volunteer for a COVID-19 vaccine trial gives her a chance of helping other people. Besides that, she’s interested in the emerging technology in clinical trials that have not been widely used before. And, Tibbals said she is confident that companies will follow procedures for conducting clinical trials.
Priority Populations Sought for Clinical Trials
Researchers want to enroll a wide range of volunteers for vaccine clinical trials, preferably those with a high risk of developing COVID-19, such as adults over 65, people with pre-existing conditions, and people from minority groups.
Chicago resident Bonnie Blue meets the criteria, she is black, 68 years old, and has asthma. Blue said she had not intended to be a volunteer in the Moderna vaccine clinical trial at UIC. But, with the coronavirus deaths mounting nationwide, Blue said she saw an opportunity to help save lives.
Blue, who has already received a second injection, said she does not know if she received a placebo or a vaccine. So, over the next two years, researchers will study Blue’s reactions to the injections and if the experimental vaccine prevents her from developing COVID-19.
Blue said her family and close friends tried to talk her out of participating because of her severe asthma and the history of racism in past clinical trials. Studies have found that long-standing medical distrust, lack of information, hidden costs connected with clinical trials, language barriers, and implicit biases against minorities are among the reasons why members of minority communities are underrepresented in clinical trials.
Blue did not allow their concerns to stop her from participating. “Will you not do something that you really want to do to try to help humanity?” she asked.