Volunteers testing the Covid-19 placebo group, are told not to vaccinate for the next two years, even after the vaccine has been approved.
In October, Judith Munz and her husband Scott Petersen volunteered to participate in the Johnson & Johnson Covid-19 vaccine trial. The two were vaccinated at a clinic near their home.
Petersen is a retired doctor. He suffered from fatigue, redness and swelling in his arm after the injection. Ms. Munz, a social worker, did not feel any anomaly.
“Even if I wanted to, I couldn’t see any expression. Nothing happened,” she said.
Munz knew the probability of getting the Covid-19 vaccine was 50-50. Based on her symptoms, she guessed she received a placebo. Munz thought people like himself would be vaccinated as soon as the trial was completed and the regulator approved the vaccine. This makes her much more reassuring.
By last month, she was asked to sign a pledge form. Accordingly, those who injected placebo have to wait up to two years to be able to use the vaccine. Munz found the application very vague, confusing and, above all, unfair.
“I put myself at risk. They owe me that vaccine,” she said.
As the federal government prepares to distribute Covid-19 vaccine to frontline health workers and the elderly, the tens of thousands of volunteers in the trials became the subject of heated debate among experts. Some scientists concur with Ms. Munz’s view that placebo users should be given a priority when vaccines are available, as a thank you for their contribution to the community.
“I think maybe we are indebted to them. Since I participated in the trial, I think they should be vaccinated first,” said Dr. Francis Collins, director of the National Institutes of Health (NIH), said.
On December 2, 18 leading vaccine experts, including members of the Food and Drug Administration (FDA), argued that early vaccination of the placebo group would have disastrous consequences, photo integrity of the test. Scientists no longer have basis to compare health status between two groups.
“The placebo group in the trial should be the last to be vaccinated,” said Richard Peto, medical statistician at Oxford University. He and his colleagues expressed this view in the New England Journal of Medicine.
When there is no placebo group left, the opportunity to gather data on vaccines will disappear, Peto said. For example, it is difficult for scientists to know the immunity duration of a vaccinated person. Usually, as vaccine protection decreases, the number of people who have received the vaccine but are still sick increases compared with the placebo group. This trend could be clearly seen by experts if the testing persisted after the vaccine was approved by regulators.
For many decades, placebo was a necessary condition when conducting clinical research. Such tests are called “double-blind,” because neither the volunteers nor the health workers know they’ve been given a vaccine or a placebo. This ensures absolute objectivity, avoids the participants’ behavior changes, falsifying research results.
However, the idea of injecting a useless salt water into the bodies of some volunteers in the context of a deadly epidemic is still raging about the medical community. Even Jonas Salk, the father of polio vaccine, opposes this approach.
“I feel that every child who gets a placebo and then polio is his or her own,” he once declared, noting that this was against the Hippocrates oath.
But Dr. Salk failed in that fight. The vaccine he prepared himself is still being studied using a double-blind method. The product is safe and effective enough. Only when the trial is over will the children receiving the placebo be officially vaccinated.
Amid Covid-19, the FDA agreed to consider emergency vaccine approval based on the initial results of the clinical trial. In its new guidelines released in October, the agency said the testing would still run alongside the limited vaccination process.
Pharmaceutical firm Pfizer said it “will have an ethical responsibility to inform all volunteers about emergency approved vaccines”. The company also intends to recommend FDA vaccinations for the placebo group.
Deciding whether to vaccinate people like Ms. Munz, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, becomes more urgent than ever, especially when vaccines are effective to 90-95. %.
Mr. Fauci proposed a possible way to balance the ethical and scientific aspects of the experiment. Next time, the researchers may provide vaccines to people who have received a placebo, and vice versa, to give volunteers a placebo injection to volunteers who had already received the vaccine. As such, testing will continue to take place under the double-blind method. Experts can make a comparison between the two groups to see if vaccine protection weakens over time. If both groups are less susceptible to nCoV infection over time, the vaccine has long lasting effects.
“In my opinion, this is the optimal choice, satisfying ethical standards, while still getting new data,” he said.
The issue could be discussed on December 10, during the meeting of the FDA advisory committee on the approval of the Pfizer vaccine. Dr. Fauci said it is likely that he, Dr. Collins and top NIH officials will discuss this further with Moderna at the December 17 meeting.
Thuc Linh (According to the NY Times)