Covid-19 vaccine studies may suffer as volunteers consider giving up

© Eva Marie Uzcategui / Bloomberg News

Susan Baker volunteered for the Johnson & Johnson vaccine trial to seek protection against Covid-19. For the same reason, she may abandon the study.

A nurse practitioner at a North Carolina hospital treated patients with Covid-19. She cares for people at high risk, including dialysis patients and her husband and father, both with health problems. If she catches the virus and passes it on to anyone who is vulnerable, “I don’t know if I could forgive myself,” she said.

That’s why Ms Baker might drop the J&J vaccine trial. She had an antibody test showing that she had received a placebo instead of the actual vaccine in the study. With initial positive vaccine results from Pfizer Inc. and Moderna Inc. indicating use in the United States perhaps in a few weeks, she wants to be the first to get one, even though she has previously agreed to opt out. stick to the study so that she can fully control J & J’s. injection.

“Anything that could potentially protect you, you so desperately want it right now,” the 42-year-old said.

The authorization of the most advanced candidate vaccines would mark a turning point in the fight against Covid-19. Yet it could also delay the effort, jeopardizing ongoing vaccine trials, including those from Pfizer and Moderna, by prompting volunteers to quit smoking.

Researchers have scheduled two-year trials for the main vaccines. They did not plan to tell the volunteers if they had received an injection or a placebo until the end of a study. The subjects accepted the conditions when they registered.

Yet Ms Baker and others say it’s unfair to deny them vaccines once they’re available.

She and more than 100 other vaccine study subjects recently wrote to the U.S. Food and Drug Administration asking them to encourage companies to tell them if they had received a placebo and if they were eligible for a. authorized vaccine.

Subjects are free to exit their trials at any time, say pharmaceutical research experts. Yet early departures could undermine studies by preventing the collection of the data necessary to fully assess the safety of inoculations and the duration of their protection against the virus.

“Frankly, people shouldn’t have embarked on this study without feeling like they could wait,” said Arnold Monto, a University of Michigan health researcher who is leading the panel of experts who will advise the FDA on approval of Covid-19 vaccines.

Dr Monto expressed hope that the question would become moot because many volunteers who have been given a placebo are unlikely to be eligible for stocks of scarce vaccine for some time.

The dilemma touches on a larger and more enduring problem with medical testing: Many trial participants volunteer for a chance to get a Covid-19 vaccine quickly, not to further the science. Still, researchers are conducting the studies to see if they can recommend an experimental treatment to the whole community.

“The small group on the placebo wants to access [to a vaccine] at the time of authorization; the world wants more rigorous safety and efficacy data, which means keeping people on placebo, ”said Jennifer Miller, a bioethicist at Yale University.

An exodus of volunteers in the early stages of testing could delay access to injections that could prove to be more effective, easier to administer or less expensive, said Marc Lipsitch, professor of epidemiology at Harvard University.

“If we stop a few months later, we’re kind of wasting the selfless act of those people who volunteered in the first place,” Lipsitch argued. “We’re getting a fraction of the data we could get if we could keep going.”

Frederick Feit, who volunteered for the Pfizer vaccine trial and believes he got a placebo, said he would leave the study as soon as he could to get the vaccine because that was his goal when registering. “It has never been altruistic,” said Dr. Feit, a 72-year-old cardiologist at NYU Langone Health.

About 48 Covid-19 vaccines are currently being tested in people, according to the World Health Organization, studies researchers designed to assess whether vaccines safely protect against disease. To make this assessment, volunteers are randomly given the experimental vaccine or a placebo. Neither the volunteers nor the researchers know who got what.

After a sufficient number of subjects develop Covid-19, the researchers examine the number of volunteers on placebo. The vaccine provides protection if fewer vaccinated people get sick.

Given the urgent need, researchers will assess whether the injections are working safely weeks after inoculation of study subjects. Pfizer and its partner BioNTech SE, as well as Moderna, said their vaccines were around 95% effective and appeared to be safe. AstraZeneca PLC said its injection was 62% to 90% effective, depending on the dosage.

Data on candidate vaccines from Johnson & Johnson and Novavax Inc. are expected in the coming months.

Fast readings compared to the longer testing schedules of most vaccine developments in the past should help speed up vaccine approval and availability. However, it will also be more difficult to answer important questions, especially if there are any long-term side effects and the duration of protection provided by the injections.

Better data would also help doctors and health officials allay the fears of some Americans reluctant to take a Covid-19 vaccine, researchers say.

As companies release data from their late-stage vaccine trials and lead applicants move closer to clearance, some study subjects took antibody tests to see if they had received the vaccine or the drug. placebo. While it looks like they took a placebo, some volunteers have started demanding access to a vaccine.

“These companies were smart enough to recruit high-risk people into their studies. These are the same people who are going to say, “I’m out of here, I’m going to go get something to protect myself” “when a vaccine becomes available, said Amy Warren, 48, a nurse practitioner in Kansas City, Mo. ., who is in a Moderna trial and signed the letter the volunteers sent to the FDA.

Johnson & Johnson last month asked the FDA’s committee of independent experts on vaccines for advice on the matter. J&J expressed concern that authorization of the first vaccine would compromise the ability of other companies to recruit volunteers for their own studies and make it more difficult to keep volunteers enrolled if they are eligible for the first vaccine.

Pfizer, however, wrote in its own comment letter that it has an ethical responsibility to notify trial volunteers if a vaccine has been approved and to provide it to placebo recipients. The company told study subjects this month that it was considering giving the vaccine to those volunteers, but needed approval from regulators.

Marion Gruber, director of the Center for Biologics Evaluation and Research at the FDA, said in a recent appearance before a panel that the agency was discussing with vaccine manufacturers how to meet the goal of data collection while making vaccines available to those who need them most.

Meanwhile, in the UK, regulators sent a newsletter to the subjects of the Covid-19 vaccine study this month, saying they would be contacted if a vaccine was cleared, and informed if they received placebo and were eligible to receive the real vaccine.

Write to Rolfe Winkler at [email protected]