What to know before entering a vaccine trial
The good news came in July: Moderna and Pfizer, two U.S.based drug development companies, were ready to move into large-scale testing of their novel coronavirus vaccine candidates.
But to know whether the vaccines are effective, the companies are seeking people to participate in trials — half the participants will receive the investigatory shots, while the other half receives a placebo.
If you’re interested in getting a COVID-19 vaccine in its earliest form for consumers, here’s what you need to know about qualifying for the trials.
Q: What do we know about a possible COVID-19 vaccine?
A:
The Moderna and Pfizer vaccines are in Phase 3 of a clinical trial, meaning the scientists are expanding the test population to study its effects on preventing COVID-19 and minimizing the impacts if the test subject catches the virus.
The Moderna vaccine is a two-part injection a month apart, where the vaccinated would have to monitor their temperatures and possible symptoms or side effects for up to two years after the injection, to evaluate the short- and long-term consequences of the shots. Pfizer’s vaccine is administered similarly.
If approved by the fall for emergency use in the U.S., up to 100 million doses of the Pfizer vaccine could be available by the end of the year.
Dr. Richard Rupp, assistant director of the University of Texas Medical Branch at Galveston’s Sealy Center for Vaccine Development, said the trials are designed to get researchers an inkling of how effective a vaccine is by the six- to nine-month mark.
“That way, we can tell whether the vaccine’s working in less time,” Rupp said.
Government projections estimate that a consumer-ready vaccine will be available by the end of the year. Officials have tapped Texas A&M as a vaccine manufacturing site, offering $265 million in federal funds to jumpstart production for Novavax, another company producing a COVID-19 vaccine candidate.
Q: Where are vaccine trials
starting?
A: In the Houston area, vaccine trial sites are planned for Houston, Tomball, Bellaire, League City and Galveston. Trials are also coming to Fort Worth, Austin and other parts of Texas, and by the end of the year, some 200 clinical test sites could be open across the country.
The Moderna vaccine is expected to start trials at UTMB’s League City location soon, Rupp said.
Moderna has a trial going at DM Clinical in Tomball. Pfizer and Moderna are testing at the Texas Center for Drug Development in Bellaire.
Clinical trials for vaccines produced by other pharmaceutical companies are expected to begin in late summer and early fall, said Dr. Larry Corey, who oversees the COVID-19 Prevention Network. The list of trials is regularly updated at clinicaltrials.gov.
Q: Is this safe?
A: The Moderna and Pfizer vaccines are in Phase 3 trials, meaning that the companies have already confirmed that their vaccine is safe to test on humans. The first two phases of a clinical trial are to confirm the safety and effectiveness of the drug in people.
Researchers are choosing specific candidates to ensure that people aren’t putting themselves at higher risk of catching the virus; rather than ask someone who is working from home to knowingly expose themselves to the coronavirus, they’re looking for people who might already be in higher risk situations.
“Entering a trial is not being a guinea pig,” Corey said.
Before starting the vaccine process, participants are usually subject to a host of training and safety procedures explaining any known side effects. During the infusions, if a participant gets COVID-19, study staff will help the patient find care, according to the COVID-19 Prevention Network. The federal Public Readiness and Emergency Preparedness Act or the research institution may pay for the costs.
A spokesperson for the Texas Center for Drug Development said patients go through a “very lengthy” consent process, but liability forms can vary depending on the vaccine company.
Under the PREP Act, though, manufacturers and vaccine distributors have liability immunity — a plaintiff can sue successfully only if there’s “willful misconduct” during the trial by the drug developer.
Q: Am I a good candidate for vaccine trials?
A:
Researchers want people 18 and older who may have more exposure than usual to COVID-19. If you’re an essential worker, such as someone who comes face to face (even with a mask on) to people constantly at, say, a grocery store or a big-box retailer, then you’re a prime candidate.
Sarah Hasan, who leads trial recruitment for DM Clinical Research in Tomball, said the pool of candidates might also include people who live in a household where someone is an essential worker or someone who goes out frequently for groceries and dining in at restaurants.
Aside from that, though, scientists are seeking a diverse audience to test the vaccine.
“We need to make these trials look like our society, because our society is economically, racially and age-wise diverse,” Corey said.
People who have autoimmune disorders and cancer may not react well to the vaccine and likely will not be selected for the test.
There is a potential to get paid for the vaccine; the amount the trials pay varies. But it’s not a get-rich-quick scheme — Hasan said the Moderna trial pays up to $2,000 for the time and effort tracking symptoms and what it takes to travel to the clinic. But you’re also going to be participating in something that requires extensive safety procedures and long-term monitoring. Funds are distributed throughout the course of trial, usually after each visit.
“It really is different than going into the doctor’s office and just getting a shot,” Hasan said.
Currently, the COVID-19 Prevention Network, an operation by the National Institute of Allergy and Infectious Diseases, is collecting volunteer information across the nation. Its operations are based at the Fred Hutchinson Cancer Research Center in Seattle and at FHI 360 in Durham, N.C.
After completing a 10-minute questionnaire that will ask for information including your occupation, demographic data and how frequently you interact with people at work, your information will be entered into a volunteer registry. If a clinical trial begins near you and researchers are testing on people in your demographic, scientists may reach out to get you into the study. Sign-ups are at coronaviruspreventionnetwork.org.
To volunteer specifically for the Houston version, locals can register at houstonfightscovid.com. A researcher from the Texas Center for Drug Development will call back within a business day and walk prospective testers through the process.
Q: How do I sign up? A: