US regulators are “very concerned” about the potential side effects of AstraZeneca’s and Oxford University’s coronavirus vaccine and are debating whether or not the trials should be resumed.
Last week, the trial was suspended when a British participant was rushed to hospital after a severe reaction that triggered spinal cord inflammation.
On Saturday, the drugmaker announced that trials for the vaccine in the UK would continue, but the US arm has not restarted.
The waiting area remains while the U.S. Food and Drug Administration (FDA) conducts an independent investigation, as does the National Institutes of Health (NIH).
US regulators say they are “very concerned” about the AstraZeneca and Oxford University coronavirus vaccine after the trial was interrupted because of a British participant suffering from spinal cord inflammation. Pictured: A participant is dosed in the AstraZeneca vaccine trial
The trial has resumed in the UK, but US scientists want to determine whether the inoculation caused the vaccine or if it was due to some other factor, such as an underlying condition, before resuming the US arm. Pictured: AstraZeneca’s headquarters in 2013
“The highest levels of NIH are very concerned,” said Dr. Avindra Nath, clinical director of the National Institute of Neurological Disorders and Stroke at the NIH. Kaiser Health News.
“Everyone is hoping for a vaccine, and if you have a major complication, the whole thing can go off the rails.”
The exact nature of the reaction is unclear, but Nath and other neurologists believe the patient has been diagnosed with transverse myelitis, an inflammation of part of the spinal cord.
It damages the myelin sheath, an insulating barrier of fatty proteins that protects the nerves, and interrupts messages sent by the nerves of the spinal cord.
This results in pain, weakness, abnormal feelings, and bladder and bowel problems – and can even lead to permanent paralysis.
Transverse myelitis can be caused by a variety of conditions, including infections such as influenza and immune system disorders.
According to the National Organization for Rare Disorders, about 1,400 cases are diagnosed in the US every year.
AstraZeneca says the volunteer has recovered and is no longer hospitalized, but has declined to confirm whether he or she had transverse myelitis.
Nath told Kaiser Health News officials should be “ more prepared with a potential complication from a vaccine that will eventually be given to millions of people.
‘We would like to see how we can help, but this is difficult due to a lack of information.’
The Medicines and Healthcare Products Regulatory Agency – responsible in the UK for making sure medicines and medical devices are safe – has allowed trials to resume in Great Britain.
But the FDA and NIH first try to determine what caused the reaction, such as whether it was the vaccine, an underlying medical condition, or some other unknown factor.
Regulators want to test tissue or blood samples from the British patient and compare them with samples from other volunteers, Kaiser Health News reported.
This will be to see if they have generated antibodies from the immunization that are also attacking the brain or spinal cord tissue.
If scientists determine that the vaccine has caused the volunteer to contract transverse myelitis, the arm can be permanently paused.
However, authorities must also determine whether the risk of the rare side effect outweighs the benefits the vaccine could provide in reducing the pandemic that killed nearly 200,000 people in the US.
If the trial is allowed to continue, the FDA may require AstraZeneca to provide more safety information to the participants before receiving a dose of the vaccination.
“There are so many factors involved in these decisions,” Nath told Kaiser Health News.
‘I’m sure everything is on the table. The last thing you want is to hurt healthy people. ‘
Two other vaccines are in the final stages of testing in the US, one from Moderna Inc and the other from Pfizer Inc and its German partner BioNTech.
Recently, Pfizer said it should find out by the end of October if its experimental vaccine works.