NIH ‘Very Concerned’ About Serious Side Effect in Coronavirus Vaccine Trial

NIH ‘Very Concerned’ About Serious Side Effect in Coronavirus Vaccine Trial

The Food and Drug Administration is weighing whether to follow British regulators in resuming a coronavirus vaccine trial that was halted when a participant suffered spinal cord damage, even as the National Institutes of Health has launched an investigation of the case.
“The highest levels of NIH are very concerned,” said Dr. Avindra Nath, intramural clinical director and a leader of viral research at the National Institute for Neurological Disorders and Stroke, an NIH division. “Everyone’s hopes are on a vaccine, and if you have a major complication the whole thing could get derailed.”
A great deal of uncertainty remains about what happened to the unnamed patient, to the frustration of those avidly following the progress of vaccine testing. AstraZeneca, which is running the global trial of the vaccine it produced with Oxford University, said the trial volunteer recovered from a severe inflammation of the spinal cord and is no longer hospitalized.
AstraZeneca has not confirmed that the patient was afflicted with transverse myelitis, but Nath and another neurologist said they understood this to be the case. Transverse myelitis produces a set of symptoms involving inflammation along the spinal cord that can cause pain, muscle weakness and paralysis. Britain’s regulatory body, the Medicines and Healthcare Products Regulatory Agency, reviewed the case and has allowed the trial to resume in the United Kingdom.
AstraZeneca “need[s] to be more forthcoming with a potential complication of a vaccine which will eventually be given to millions of people,” said Nath. “We would like to see how we can help, but the lack of information makes it difficult to do so.”
Any decision about whether to continue the trial is complex because it’s difficult to assess the cause of a rare injury that occurs during a vaccine trial — and because scientists and authorities have to weigh the risk of uncommon side effects against a vaccine that might curb the pandemic.
“So many factors go into these decisions,” Nath said. “I’m sure everything is on the table. The last thing you want to do is hurt healthy people.”
The NIH has yet to get tissue or blood samples from the British patient, and its investigation is “in the planning stages,” Nath said. U.S. scientists could look at samples from other vaccinated patients to see whether any of the antibodies they generated in response to the coronavirus also attack brain or spinal cord tissue.
Such studies might take a month or two, he said. The FDA declined to comment on how long it would take before it decides whether to move forward.
Dr. Jesse Goodman, a Georgetown University professor and physician who was chief scientist and lead vaccine regulator at the FDA during the Obama administration, said the agency will review the data and possibly consult with British regulators before allowing resumption of the U.S. study, which had just begun when the injury was reported. Two other coronavirus vaccines are also in late-stage trials in the U.S.
If it determines the injury in the British trial was caused by the vaccine, the FDA could pause the trial. If it allows it to resume, regulators and scientists surely will be on the watch for similar symptoms in other trial participants.
A volunteer in an earlier phase of the AstraZeneca trial experienced a similar side effect, but investigators discovered she had multiple sclerosis that was unrelated to the vaccination, according to Dr. Elliot Frohman, director of the Multiple Sclerosis & Neuroimmunology Center at the University of Texas.
Neurologists who study illnesses like transverse myelitis say they are rare — occurring at a rate of perhaps 1 in 250,000 people — and strike most often as a result of the body’s immune response to a virus. Less frequently, such episodes have also been linked to vaccines.
The precise cause of the disease is key to the decision by authorities whether to resume the trial. Sometimes an underlying medical condition is “unmasked” by a person’s immune response to the vaccine, leading to illness, as happened with the MS patient. In that case, the trial might be continued without fear, because the illness was not specific to the vaccine.
More worrisome is a phenomenon called “molecular mimicry.” In such cases, some small piece of the vaccine may be similar to tissue in the brain or spinal cord, resulting in an immune attack on that tissue in response to a vaccine component. Should that be the case, another occurrence of transverse myelitis would be likely if the trial resumed, said Dr. William Schaffner, an infectious disease specialist at the Vanderbilt University School of Medicine. A second case would shut down the trial, he said.
In 1976, a massive swine flu vaccination program was halted when doctors began diagnosing a similar disorder, Guillain-Barré syndrome, in people who received the vaccine. At the time no one knew how common GBS was, so it was difficult to tell whether the episodes were related to the vaccine.
Eventually, scientists found that the vaccine increased the risk of the disorder by an additional one case among every 100,000 vaccinated patients. Typical seasonal flu vaccination raises the risk of GBS in about one additional case in every 1 million people.
“It’s very, very hard” to determine if one rare event was caused by a vaccine, Schaffner said. “How do you attribute an increased risk for something that occurs in one in a million people?”
Before allowing U.S. trials to restart, the FDA will want to see why the company and an independent data and safety monitoring board (DSMB) in the U.K. felt it was safe to continue, Goodman said. The AstraZeneca trial in the United States has a separate safety board.
FDA officials will need to review full details of the case and may request more information about the affected study volunteer before deciding whether to allow the U.S. trial to continue, Goodman said. They may also require AstraZeneca to update the safety information it provides to study participants.
It’s possible that the volunteer’s health problem was a coincidence unrelated to the vaccine, said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security. Studies aren’t usually stopped over a single health problem, even if it’s serious.
Yet many health leaders have expressed frustration that AstraZeneca hasn’t released more information about the health problem that led it to halt its U.K. trial.
“There is just so little information about this that it’s impossible to understand what the diagnosis was or why the DSMB and sponsor were reassured” that it was safe to continue, Goodman said.
AstraZeneca has said it’s unable to provide more information about the health problem, saying this would violate patient privacy, although it didn’t say how.
But there’s an exceptional need for transparency in a political climate rife with vaccine hesitancy and mistrust of the Trump administration’s handling of the COVID-19 response, leading scientists say.
“While I respect the critical need for patient confidentiality, I think it would be really helpful to know what their assessment of these issues was,” Goodman said. “What was the diagnosis? If there wasn’t a clear diagnosis, what is it that led them to feel the trial could be restarted? There is so much interest and potential concern about a COVID-19 vaccine that the more information that can be provided, the more reassuring that would be.”
The FDA will need to balance any possible risks from an experimental vaccine with the danger posed by COVID-19, which has killed nearly 200,000 Americans.
“There are also potential consequences if you stop a study,” Goodman said.
If the AstraZeneca vaccine fails, the U.S. government is supporting six other COVID vaccines in the hope at least one will succeed. The potential problems with the AstraZeneca vaccine show this to be a wise investment, Adalja said.
“This is part of the idea of not having just one vaccine candidate going forward,” he said. “It gives you a little more insurance.”
Schaffner said researchers need to remember that vaccine research is unpredictable.
“The investigators have inadvisedly been hyping their own vaccine,” Schaffner said. “The Oxford investigators were out there this summer saying, ‘We’re going to get there first.’ But this is exactly the sort of reason … Dr. [Anthony] Fauci and the rest of us have been saying, ‘You never know what will happen once you get into large-scale human trials.’”



This KHN story first published on California Healthline, a service of the California Health Care Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.USE OUR CONTENTThis story can be republished for free (details).

For a term that’s at least 100 years old, “herd immunity” has gained new life in 2020.
When Joshua Martz tested positive for COVID-19 this summer in a Montana jail, guards moved him and nine other inmates with the disease into a pod so cramped that some slept on mattresses on the floor. Martz, 44, said he suffered through symptoms that included achy joints, a sore throat, fever and an unbearable headache. Jail officials largely avoided interacting with the COVID patients other than by handing out over-the-counter painkillers and cough syrup, he said. Inmates sanitized their hands with a spray bottle containing a blue liquid that Martz suspected was also used to mop the floors....
When Joe Prude called Rochester, New York, police to report his brother missing, he was struggling to understand why Daniel Prude had been released from the hospital hours earlier. Joe Prude described his brother’s suicidal behavior. “He jumped 21 stairs down to my basement, headfirst,” Joe said in a video recorded by the responding officer’s body camera in the early hours of March 23. Joe’s wife, Valerie, described Daniel nearly jumping in front of a train on the tracks that run behind their house the previous day. “The train missed him by this much,” Joe said, holding his thumb and pointer...
Can’t see the audio player? Click here to listen.
Protecting people with preexisting medical conditions is an issue that has followed President Donald Trump his entire first term. Now, Trump has signed an executive order that he says locks in coverage regardless of anyone’s health history. “Any health care reform legislation that comes to my desk from Congress must protect the preexisting conditions or I won’t sign it,” Trump said at a Sept. 24 signing event. With the executive order, Trump said, “This is affirmed, signed and done, so we can put that to rest.” Health law and health policy experts say Trump has put nothing to rest. Here’s why.
When it comes to health care, President Donald Trump has promised far more than he has delivered. But that doesn’t mean his administration has had no impact on health issues — including the operation of the Affordable Care Act, prescription drug prices and women’s access to reproductive health services.
STERLING, Colo. — Tonja Jimenez is far from the only person driving an RV down Colorado’s rural highways. But unlike the other rigs, her 34-foot-long motor home is equipped as an addiction treatment clinic on wheels, bringing lifesaving treatment to the northeastern corner of the state, where patients with substance use disorders are often left to fend for themselves.
President Donald Trump, outlining his “America First Health Plan” on Thursday, announced that his administration will allow the importation of prescription drugs from Canada. The final plan clears the way for Florida and other states to implement a program bringing medications across the border, despite the strong objections of drugmakers and the Canadian government. But it does not allow states to import biologic drugs, including insulin. Florida, the biggest swing state in the presidential election, is one of six states to pass laws seeking federal approval to import drugs. Trump’s...
Matthew Fentress was just 25 when he passed out while stuffing cannolis as a cook for a senior living community six years ago. Doctors diagnosed him with viral cardiomyopathy, heart disease that developed after a bout of the flu. Three years later, the Kentucky man’s condition had worsened, and doctors placed him in a medically induced coma and inserted a pacemaker and defibrillator. Despite having insurance, he couldn’t pay what he owed the hospital. So Baptist Health Louisville sued him and he wound up declaring bankruptcy in his 20s.
Working as a fast-food cashier in Los Angeles, Juan Quezada spends a lot of his time these days telling customers how to wear a mask. “They cover their mouth but not their nose,” he said. “And we’re like, ‘You gotta put your mask on right.'” Quezada didn’t expect to be enforcing mask-wearing. Six months ago, he was a restaurant manager, making $30 an hour, working full time and saving for retirement. But when Los Angeles County health officials shut down most restaurants in March because of the spreading pandemic, Quezada lost his job. The only work he could find pays a lot less and is part...
KHN chief Washington correspondent Julie Rovner discussed the impact of the death of Justice Ruth Bader Ginsburg on the Affordable Care Act with Noel King, host of NPR’s “Morning Edition” on Monday and “Newsy Tonight” on Tuesday.
Al trabajar como cajero de comida rápida en Los Angeles, Juan Quezada pasa mucho de su tiempo estos días diciéndole a los clientes cómo usar una máscara. “Se cubren la boca pero no la nariz”, dijo. “Y nosotros les decimos: ‘Tienes que ponerte la máscara bien'”. Quezada nunca imaginó que acabaría haciendo cumplir el uso de la máscara. Hace seis meses, era gerente de un restaurante, ganaba $30 la hora, trabajaba a tiempo completo y ahorraba para su jubilación. Pero cuando los funcionarios de salud del condado de Los Angeles cerraron la mayoría de los restaurantes, en marzo, por la pandemia,...
Can’t see the audio player? Click here to listen on SoundCloud. The death of Supreme Court Justice Ruth Bader Ginsburg — and the insistence of President Donald Trump and the GOP-led Senate to fill that vacancy this year — could have major implications for health care. The high court will hear yet another case challenging the constitutionality of the Affordable Care Act the week after the November election, and a long list of cases involving women’s reproductive rights, including both abortion and birth control, are working their way through lower federal courts.
SANTA CRUZ, Calif. — California will allow public health officials to participate in a program to keep their home addresses confidential, a protection previously reserved for victims of violence, abuse and stalking and reproductive health care workers. The executive order signed by Democratic Gov. Gavin Newsom late Wednesday is a response to threats made to health officers across California during the coronavirus pandemic. More than a dozen public health leaders have left their jobs amid such harassment over their role in mask rules and stay-at-home orders.
Most Americans have never heard of Dr. Richard Whitley, an expert in pediatric infectious diseases at the University of Alabama-Birmingham. Yet as the coronavirus pandemic drags on and the public eagerly awaits a vaccine, he may well be among the most powerful people in the country. Whitley leads a small, secret panel of experts tasked with reviewing crucial data on the safety and effectiveness of coronavirus vaccines that U.S. taxpayers have helped fund, including products from Moderna, AstraZeneca, Johnson & Johnson and others. The data and safety monitoring board — known as a DSMB — is...
For the past month, record-breaking wildfires have torched millions of acres from the Mexican border well into Canada, their smoke producing air so toxic that millions of people remained indoors for days on end while many visited hospitals because of respiratory distress. Last week, Hurricane Sally left a trail of watery devastation in Mississippi, Alabama and the Florida Panhandle, even as more storms brewed offshore. All of that on top of the COVID-19 pandemic, which has killed nearly 1 million people worldwide.
Laura Stutzman had no doubts that this year’s Twin Falls County Fair should go on despite the pandemic still raging across the U.S. — and several outbreaks tied to such community fairs. Though she saw few people wearing masks from her volunteer station in the fair’s hospitality tent in southern Idaho earlier this month, she said she wasn’t concerned. Stutzman, 63, had been attending the fair off and on for 30 years, and she didn’t consider this year that different. People in rural communities know how to respect one another’s space, she said, and don’t have time to “fret and worry” about the...
DENVER — For Laura Stoutingburg and her family, Halloween has always been a monthlong celebration of corn mazes, pumpkin patches and, of course, trick-or-treating in their suburban Denver neighborhood. However, the COVID-19 pandemic has forced the mother of two to change their plans. “Traditional trick-or-treating house to house does not feel like a smart choice to me this year,” Stoutingburg said. Families across the nation are haunted by the same dilemma: How can they safely keep the pandemic from overshadowing Halloween? Can families trick-or-treat and go to haunted houses, or should they...
La reapertura de universidades en los Estados Unidos provocó un aumento de 3,000 nuevos casos de COVID-19 por día, según un nuevo estudio. El estudio, realizado por investigadores de la Universidad de Carolina del Norte-Greensboro, la Universidad de Indiana, la Universidad de Washington y el Davidson College, rastreó los datos de teléfonos celulares y los comparó con las fechas de reapertura de 1,400 facultades, junto con las tasas de infección del condado.
Reopening colleges drove a coronavirus surge of about 3,000 new cases a day in the United States, according to a draft study released Tuesday. The study, done jointly by researchers at the University of North Carolina-Greensboro, Indiana University, the University of Washington and Davidson College, tracked cellphone data and matched it to reopening schedules at 1,400 schools, along with county infection rates. “Our study was looking to see whether we could observe increases both in movement and in case count — so case reports in counties and all over the U.S.,” said Ana Bento, an infectious...

 

DISCLAIMER: The information found on this Web Site is dynamic and subject to change. Please use the "CONTACT US" section of the Web Site to submit any questions or comments.