The National Institutes of Health (NIH) is concerned about a potential coronavirus vaccine being developed by British manufacturer AstraZeneca after a test subject had an adverse reaction during clinical trials, The L.A. Times reported. Authorities in Britain, however, have allowed the pharmaceutical company to resume its research into the potentially life-saving drug.
As previously reported by The Inquisitr, the Cambridge, England-based pharmaceutical company has been conducting large-scale clinical trials involving thousands of volunteers on a potential coronavirus vaccine it developed in conjunction with a British university. AZD1222, also known as the "Oxford vaccine," showed great promise during animal testing and has moved into clinical trials on human test subjects.
Unfortunately, those tests had to be halted once a patient got sick. A British review board, the Medicines and Healthcare Products Regulatory Agency (MHRA), investigated the circumstances behind the patient getting sick and, after its investigation, cleared the manufacturer to resume its trials -- at least, in the U.K.
However, in the U.S., at least two federal agencies aren't convinced that the matter is settled.
Dr. Avindra Nath, intramural clinical director and a leader of viral research at the National Institute for Neurological Disorders and Stroke -- a division of the NIH -- said that any complications in the development of the vaccine could thwart any efforts to get it released to the public.
"The highest levels of NIH are very concerned. Everyone's hopes are on a vaccine, and if you have a major complication the whole thing could get derailed," Nath said.
Similarly, the Food and Drug Administration (FDA), which is tasked with giving (or not giving) the green light for the trials to resume in the U.S., has yet to authorize the resumption of the studies, and has not given a timeline for when or if that will happen.
Part of the problem is that AstraZeneca has apparently not been sufficiently forthcoming about what happened to the test patient to satisfy U.S. regulators' concerns. Dr. Nath said he's been given to understand that the test subject came down with transverse myelitis, a rare inflammation of the spinal cord that can cause pain and muscle weakness, among other symptoms. However, he said that he needs to know more.
"[AstraZeneca need[s] to be more forthcoming with a potential complication of a vaccine which will eventually be given to millions of people. We would like to see how we can help, but the lack of information makes it difficult to do so," he said.
So far, the NIH is waiting on tissue and/or blood samples from the sickened British patient, possibly with a view toward comparing them to similar samples taken from other patients. That process could take months.
Meanwhile, at least two other potential coronavirus vaccines are also in late-stage clinical trials in the U.S. No timeline is in place for when those may be ready.