Want to participate in the coronavirus vaccine trial? Consider these five things first.

The US effort to produce a coronavirus vaccine is on track and pharmaceutical companies are now recruiting hundreds of thousands of volunteers to test their candidates. New York TimesHeather Murphy deals with five things patients should know before volunteering for a clinical trial of a coronavirus vaccine.

Is it ethical to infect volunteers with the new coronavirus? Experts will consider.

1. Vaccine clinical trial system

Murphy said that clinical trials of vaccines have three phases, and participating in a Phase 1 trial means being one of the first to receive the vaccine. According to Murphy, Phase 1 vaccine trials usually focus on safety and look at whether a vaccine candidate will experience negative side effects in humans. When participating in a Phase 1 vaccine trial, researchers[t]Oddly enough… you and each of the dozens of other subjects are carefully monitored after each dose, then checked in regularly for about a year thereafter. “Murphy writes.

Researchers typically use Phase 2 trials to further observe the potential side effects of vaccines and to determine whether a vaccine candidate will generate an immune response. Fred Hutchinson Cancer Research Center Leader with Covid-19 prevention networkSaid Murphy. These trials typically involve hundreds of participants.

However, even if a candidate for vaccine in a Phase 2 trial elicits an immune response in a participant, the vaccine does not necessarily protect the participant from infection from the target pathogen (in this case, the novel coronavirus).

According to Murphy, Phase 3 clinical trials are underway at this stage. In Phase 3 trials, researchers enroll up to hundreds of thousands of participants and try to determine if a vaccine will effectively prevent infection. Researchers will administer vaccine candidates to at least half of the participants to form a test group. The remaining participants receive placebo or alternative treatment and serve as a control group for the trial.

In Phase III trials of coronavirus vaccine candidates, researchers do not intentionally expose participants to the virus. Instead, we plan to enroll many participants from locations with many cases of coronaviruses. Researchers will track participants in both test and control groups to determine how many have been infected with the new coronavirus. The researchers then determined whether the vaccines reduced the frequency of infection or the severity of the disease caused by coronavirus, Covid-19, between the groups compared to the control group. I will try.

Currently, there are no ongoing trials in which participants are intentionally exposed to the new coronavirus, Murphy writes. Clinical trials in which participants are intentionally exposed to pathogens are known as challenge trials, Longstanding debateThere is particular concern about the new coronavirus. Currently, there is no proven cure or cure for Covid-19, which is deadly.

However, some public health experts argue that challenge trials can speed up the vaccine development and approval process, Oxford University In July, they announced they would soon start recruiting participants for the coronavirus vaccine challenge trial. Some pharmaceutical companies in the United States also say they are considering conducting such trials.

2. We cannot guarantee to join the test group

Murphy says the vaccine candidates are , so there is no “real guarantee of coronavirus protection at any stage of the vaccine trial.” In addition, participation in a Phase 3 trial may eventually result in a control group. In other words, you will not receive vaccine candidates.

Nir Eyal, Director Population-level bioethics center so Rutgers School of Public HealthExplained that a control group is needed to evaluate the efficacy of the group. Without a control group, the trial would tell researchers “basically nothing,” Eyal told Murphy.

3. You get paid, but you also face risks

Manna notes that participants in clinical trials of candidate coronavirus vaccines are rewarded and the amount they receive is “varied by study.” According to Murphy, the amount can range from hundreds of dollars to thousands of dollars.

Daniel Hoft, Director University of St. Louis Vaccine Development CenterThe researchers, told Murphy, pay trial participants to compensate for their “time and trouble.”

But bioethicist Arthur Caplan warns that those who think compensation is a “very attractive” incentive to participate in a vaccine trial should also consider the risks associated with receiving an vaccine. did. “I don’t want to be informed that compensation needs to pay attention to risks.”

4. If you have side effects, you may eventually pay for your care

Participants are rewarded for participating in clinical trials of the vaccine, but if the vaccine candidate has an adverse reaction, he or she may incur the cost of care for that reaction.

“If you get hurt in an experiment, insurance companies will rarely pay you,” Kaplan said. Also, if vaccine developers agree to cover the costs associated with side-effect care, they typically only promise to reimburse those costs to the participant’s health insurance company, he explained.

Corey recommends that you ask your study manager for compensation and support if you are harmed by a vaccine candidate.

Corey will also, in some cases, ensure that participants who are victims of the vaccine are under the public reserves and provisions law or, in the case of the coronavirus vaccine, under the federal epidemic relief fund. So, he said he might be eligible for compensation.

5. How to register

Those who are considering enrolling in the coronavirus vaccine trial can visit ClinicalTrials.gov, All currently active coronavirus vaccine studies are listed. in addition National Institute of Allergy and Infectious Diseases Established Covid-19 prevention network website To connect volunteers to the coronavirus vaccine trial.

further, COVID dashMurphy, which is governed by a group of clinical researchers, doctors, and students seeking to encourage people to participate in coronavirus clinical trials.

Murphy is also people 1 Day Sooner website Sign up for future coronavirus vaccine challenge trials (Murphy, New York Times, 8/5).