CLOSE

Many people are needed to develop a vaccine against COVID-1

9. Volunteers can be one of the most important.

Wochit

The recent breaks to two large-scale attempts to vaccinate against COVID-19 and a treatment study should reassure people, not scare them, vaccine experts say, though this is reminiscent of the confusion of science.

“This is an indication that the system works because it was designed to work to protect people in clinical trials,” Lawrence Gostin, a public health and law expert at Georgetown and John Hopkins universities, said Tuesday. “This shows that ethical guardrails work in vaccine testing.”

It is not uncommon for tests of drugs and vaccines to be stopped at a late stage for a short time to investigate safety concerns, he and others said.

The discovery of an adverse event and a break in the clinical trial is actually reassuring, said Dr. Bali Pulendran, a professor of immunology and vaccine design at Stanford University.

“Let’s assume that they have reached the end of the clinical trial and there has not been a single report of any adverse event in the tens of thousands of people involved in the trial. That, he said, will worry me. That would be unusually unusual. “

Ellie Lily announced on Tuesday that she was stopping a pause for an experimental drug similar to what President Donald Trump recently said he had cured of COVID-19. On Monday, Johnson & Johnson halted a large-scale study of a candidate COVID-19 vaccine. In September, British regulators halted another trial of a vaccine candidate by AstraZeneca. They lifted the detention a week later, but this continued in the US part of the study.

These events should serve as a reminder that research can be unpredictable, frustrating and time-consuming, experts said.

“After four decades in vaccines, I expect the unexpected,” said Dr. Gregory Poland, director of the Mayo Vaccine Research Group and editor-in-chief of Vaccine magazine. “The nature of vaccine development is always surprises and surprises. Everyone is looking for them, but it must take time before you actually find out. “

According to a new study by Informa Pharma Intelligence, a business intelligence provider and research firm YouGov, 35% of Americans do not believe how fast clinical trials against the COVID-19 vaccine are moving, and 23% do not think pharmaceutical companies have consumers “the best interests in mind.

Society may have unrealistic expectations for the vaccine, which is “100% effective and 150% safe,” said Alan Barrett, director of the Sealy Vaccine Institute at the University of Texas at Galveston Medical Branch.

USA TODAY Editorial Board: Do not inject policy into vaccine policy

But he believes the companies have shown impressive attention to safety, including trial breaks. “We can’t afford to make a mistake,” Barrett said. “The public must have confidence that any vaccine given to them will be safe and effective.”

Only about 31% of all vaccine applicants reach phase 1 clinical trials before being placed on the market, according to a study published last year.

There are 49 vaccine candidates for COVID-19 in clinical trials worldwide, with nine in large, late-stage studies, Barrett said. It is known that only three out of about 300,000 volunteers in all these studies suffered serious side effects. “It’s not a big number,” he said.

The main challenge with vaccines compared to treatment: Vaccines are given to healthy people. While a patient dying of cancer may want to take medications with many side effects, a healthy person should not be vaccinated at risk, said Gostin, a law professor in Georgetown. “That’s why we need to be extremely careful to make our vaccines safe and effective before we implement them.”

Vaccine trials on pause

Late Monday, Johnson & Johnson announced that it was suspending its COVID-19 vaccine candidate, JNJ-78436735, while investigating an “unexplained disease” in a study participant. The company, as well as an independent Data Security Monitoring Board, will consider the participant’s case before deciding whether to resume the process.

About half of the 30,000 participants in the study received a placebo and half an active vaccine. Only members of the Data Safety Monitoring Council know which shot the volunteer received. If it was a placebo, the trial version would probably be restarted quickly; if the problem could have been caused by the vaccine, the investigation will take longer.

A similar study by the pharmaceutical company AstraZeneca was stopped in September after a second study participant developed an unusual neurological condition.

I volunteered for a COVID-19 vaccine trial in New Jersey: Here’s what happened from the shot.

In the United Kingdom, where the volunteer lived, regulators examined her case and decided that the process could be resumed there. But the US Food and Drug Administration has kept the US process pending while investigating its case.

Little has been revealed about her problem, although it is thought to be something called transverse myelitis, a spinal inflammation that can cause temporary paralysis. Both she and the other man, who suffered a serious side effect, a woman who had an exacerbation of undiagnosed multiple sclerosis, have apparently recovered.

If it turns out that the adverse event in the Johnson and Johnson study was also a nerve problem, there is a theoretical but by no means proven reason why it may be related to the way the vaccine delivers its immunological payload.

“There are theoretical reasons that could be,” said Dr. Otto Young, a professor of medicine and associate director of infectious diseases at UCLA’s David Geffen School of Medicine.

Both Johnson & Johnson and AstraZeneca vaccine candidates use a platform based on a harmless human virus called adenovirus. Those they use are unusual in nature, so most people have not built immunity against them.

Very few people who are naturally ill with adenovirus develop transverse myelitis, which is a neurological disorder of the spine that can cause paralysis.

Experts: The policy will hardly prevent a safe, effective vaccine against COVID-19

“No one knows why it’s happening, but it seems to be some kind of immune response, maybe the immune system is reacting to the virus and that’s leading to a cross-reaction,” Ian said.

He warned that the possibility of a connection was extremely theoretical and there was currently no evidence to support it, but said it certainly required a pause while companies investigated.

“Transverse myelitis very rarely occurs on its own. So if it’s an event 1 in 100,000 and you see it in one person, then fine. If you see it in two people, it starts to be suspicious. “

Barrett of the University of Texas said he did not think virus transmission systems could explain the latest problems. “There is no information to suggest that they have problems,” he said.

The trial for treatment has been accepted

Eli Lilly issued a brief statement Tuesday explaining the break in their attempt at a monoclonal antibody that mimics the virus’s natural immune response.

“Safety is paramount for Lily,” said a statement from company spokeswoman Molly McCully. “Lily supports the independent DSMB’s decision to cautiously ensure the safety of patients in this study.”

Last week, Trump highlighted the benefits of the experimental monoclonal antibody, which was given to him a day after he was diagnosed with COVID-19. This medicine is manufactured by Regeneron, a company in Tarrytown, New York.

The Lilly antibody study, conducted by the National Institutes of Health, was to include about 300 volunteers with mild to moderate COVID-19 who were ill for less than 13 days. Half of the participants would receive the antibody by infusion and half by saline. Plans are to expand the study to another 700 participants, including more seriously ill patients, if the antibodies perform well.

The antibody, called LY-CoV555, was isolated from the blood of a recovered patient with COVID-19.

Gostin, who also runs the O’Neill Institute for National and Global Health Law in Georgetown, said he was concerned about the second detention.

“The two medical interventions that are likely to get us out of COVID are vaccines and monoclonal antibodies,” he said. “This shows us that science is miraculous, but it is not reliable and Mother Nature does not always win.”

In the end, Gostin said, we just have to “be patient. Let science take its toll.”

Contact Elizabeth Wise at eweise@usatoday.com and Karen Weintraub at kweintraub@usatoday.com

Patient health and safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Health Ethics, Innovation and Competition. The Masimo Foundation does not provide editorial data

Automatic execution

Show thumbnails

Show captions

Last slide Next slide

Read or share this story: https://www.usatoday.com/story/news/health/2020/10/13/covid-19-vaccine-trials-on-hold-eli-lilly-johnson-johnson/3643936001/