The Fed ‘Very Concerned’ About AstraZeneca Cov-19 Vaccine Side Effect

THe is weighing the Food and Drug Administration on whether to follow British regulators in resuming a coronavirus vaccine trial when a participant suffered spinal cord damage, even as the National Institutes of Health launched an investigation into the case Should be

“The highest levels of NIH are very concerned,” Dr. Said Avindra Nath, a clinical clinical director and a leader of viral research at the National Institute for Neurological Disorders and Stroke, an NIH division. “Everyone’s expectations are on a vaccine, and if you have a big complication the whole thing can derail.”

To the frustration of those following the progress of the vaccine trial, there remains a great deal of uncertainty about what happened to the unnamed patient. AstraZeneca, which is conducting a global trial of vaccines produced with the University of Oxford, said the trial volunteer has recovered from severe spinal cord inflammation and is no longer hospitalized.

AstraZeneca has not confirmed that the patient was suffering from transverse myelitis, but Nath and another neurologist said they understood the case. Transverse myelitis produces a group of symptoms involving inflammation along the spinal cord that can cause pain, muscle weakness, and paralysis. The Medicines and Healthcare Products Regulatory Agency, a UK regulatory body, reviewed the case and allowed the trial to resume in the United Kingdom.

The last thing you want to do is hurt healthy people.

– Dr. Avindra Nath, NIH

AstraZeneca “needed[s] With the potential complexity of a vaccine to be more forthcoming that 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 test is complicated because it is difficult to assess the cause of a rare injury during a vaccine test — and because scientists and authorities risk unusual side effects against a vaccine that would cause an epidemic. Can curb. .

“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 not yet received tissue or blood samples from a British patient, and its investigation is “in the planning stages”, Nath said. US scientists can look at samples from other vaccinated patients to see if any antibodies generated in response to coronovirus attack the brain or spinal cord tissue.

He said that such studies may take one or two months. The FDA declined to comment on how long it would take before proceeding.