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NIH and FDA investigate serious side effects emerging in COVID vaccine trials



Arthur Allen and Liz Szabo, Kaiser Health News

Monday, September 14, 2020 (Kaiser News)-Food and Drug Administration is following UK regulators to consider whether to resume Coronavirus vaccine A trial that was canceled when a participant suffered a spinal cord injury, even though the National Institutes of Health had begun investigating the case.

“The highest levels of NIH are of great concern,” said Dr. Avindra Nath, Intrawall Clinical Director and Leader of Virus Studies at the National Center of Neurology and Neurology, NIH Division. “Everyone’s hope vaccine, And if you have major complications, everything can derail. “

There remains considerable uncertainty in the frustration of patients who are enthusiastic about advancing vaccine testing as to what happened to unnamed patients. AstraZeneca vaccine Produced at Oxford University, test volunteers said they had recovered from a serious condition inflammation Spinal cord and not hospitalized.

AstraZeneca has not confirmed that the patient is suffering from transverse myelitis, but Nath and other neurologists said he understood this to be the case. Transversal osteomyelitis causes a series of symptoms with inflammation along the spinal cord, pain, muscle weakness, paralysis.. The UK Regulatory Authority, the Pharmaceuticals and Medical Products Regulatory Agency, has considered the matter and has allowed the resumption of trials in the United Kingdom.

AstraZeneca “Necessary[s] Nath said: “I want to see how we can help, but it’s difficult to do because of the lack of information.”

Deciding whether to continue the trial because it is difficult to assess the cause of rare injuries that occur during a vaccine trial and scientists and authorities need to weigh the risks of uncommon side effects on the vaccine. Is complicated. Pandemic..

“There are so many factors involved in these decisions,” said Nath. “I’m sure everything is ready. The last thing you want to do is hurt a healthy person.”


NAS said the NIH has not yet obtained tissue or blood samples from patients in the United Kingdom and the study is in the “planning stage.” U.S. scientists look at samples from other vaccinated patients and they Coronavirus It also attacks the brain and spinal cord tissue.

He said such a study could take a month or two. The FDA declined to comment on the time it will take to decide whether to move forward.

Dr. Jesse Goodman, a professor at Georgetown University and a doctor who led the FDA’s vaccine regulator under the Obama administration, said with UK regulators before the FDA reviewed the data and allowed the US to resume research. He said there was a possibility of discussion. It started when the injury was reported. The other two coronavirus vaccines are also in late-stage trials in the United States.

If a UK trial determines that the injury was caused by the vaccine, the FDA may suspend the trial. If it allows resumption, regulators and scientists will certainly monitor similar symptoms for other study participants.

Early volunteers in the AstraZeneca trial also experienced similar side effects, but investigators said she Multiple sclerosis According to Dr. Elliott Froman, director of the Center for Multiple Sclerosis and Neuroimmunology at the University of Texas, it was unrelated to vaccination.

Neurologists studying diseases like transverse myelitis say it is rare-perhaps in 1 in 250,000-most often as a result of the body’s immune response to the virus. Attack. Less often, such episodes are also associated with vaccines.

The exact cause of the disease is the key to the authorities’ decision on whether to resume the trial. At times, the underlying medical condition is “uncovered” by a person’s immune response to the vaccine, leading to illness as it did in MS patients. In that case, the illness was not specific to the vaccine and the trial may continue without fear.


What is even more worrisome is the phenomenon of “molecular mimicry.” In such cases, a small piece of vaccine may resemble tissue in the brain or spinal cord, causing an immune attack on that tissue in response to the vaccine component. Dr. William Schaffner, an infectious disease specialist at Vanderbilt University School of Medicine, said that in such cases, transverse myelitis is likely to recur if the trial is resumed. He said the second case would terminate the trial.

In 1976, a large pig Flu vaccination The program was discontinued as doctors from vaccinated people began diagnosing a similar disease, Guillain-Barré syndrome. At the time, no one knew how common GBS was, so it was difficult to determine if an episode was vaccine-related.

Ultimately, scientists found that the risk of this disorder was increased by increasing the vaccine by one more case for every 100,000 vaccinated patients. Typical season Flu vaccination The risk of GBS increases in the case of 1 in 1 million.

Schaffner said it was “very difficult” to determine if the vaccine caused a rare event. “What do you think about the increased risk that occurs in 1 in 1 million people?”

According to Goodman, the FDA wants to know why the FDA and the UK’s independent data and safety monitoring committee (DSMB) felt safe to continue before allowing the US trial to resume. .. The AstraZeneca trial in the United States has a separate safety committee.

According to Goodman, FDA officials need to carefully consider the details of the case and provide more information about the affected research volunteers before deciding whether to allow the trial to continue in the United States. You may request it. They may also require AstraZeneca to update the safety information provided to study participants.

Dr. Amesh Adalla, a senior researcher at the Johns Hopkins Health and Safety Center, said volunteer health problems could have been a coincidence unrelated to the vaccine. Research usually does not stop with a single health problem, even if it is serious.


Still, many medical leaders have complained that AstraZeneca has not released detailed information on health issues that have stopped clinical trials in the United Kingdom.

“There is so little information about this that it is impossible to understand what the diagnosis was, or why the DSMB and sponsors were relieved,” Goodman said.

AstraZeneca said it could not provide any further information on health issues, which would infringe on patient privacy, but did not mention how to do so.

However, according to key scientists, there is an exceptional need for transparency in the political situation, where hesitation in vaccines and distrust of the Trump administration’s treatment of COVID-19 compliance is widespread.

“I respect the important need for patient confidentiality, but I think it’s really helpful to know what their assessment of these issues was,” Goodman said. “What was the diagnosis? What did you feel you could resume the trial without a clear diagnosis? The information we can provide because of the enormous interest and potential concerns of the COVID-19 vaccine. The more you have, the more peace of mind you have. “

The FDA needs to balance all the risks of experimental vaccines with the risks posed by COVID-19, which killed nearly 200,000 Americans.

“If you stop the study, there are potential consequences,” Goodman said.

If the AstraZeneca vaccine fails, the US government supports six other COVID vaccines in the hope that at least one will succeed. The potential problem with the AstraZeneca vaccine shows that this is a wise investment, Adalha said.

“This is part of the idea that there is more than one vaccine candidate,” he said. “It gives you a little more insurance.”

Schaffner said researchers need to keep in mind that vaccine research is unpredictable.

“Researchers are promoting their vaccine,” Schaffner said. “This summer, Oxford investigators said,’We’re going there first.’ But that’s exactly why … Dr. [Anthony] Fauci and all of us say, “I don’t know what will happen when I enter a large human trial.”

WebMD News from Kaiser Health News

© 2013-2020 Henry J. Kaiser Family Foundation. all rights reserved.


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