The United States’ Department of Health and Human Services’ agency, Food and Drug Administration (FDA), will conduct its trial that postpones the country’s leg in AstraZeneca’s COVID-19 vaccine trial red flag side effect on a person’s spinal cord. The US FDA will begin to investigate on its own, postponing the trials to midweek.
British biopharmaceutical company, AstraZeneca, recently began its Phase Three Clinical Trials in the United States. Still, after more than just a week, it was halted by the company due to a significant side effect affecting a patient’s spinal cord. Over the weekend, the company ruled out the postponement and announced that it would resume vaccine trials, primarily in the United Kingdom.
However, the US FDA will hold its separate investigation to identify the vaccine’s major red flags that prevailed to a patient. According to Reuters, the patient who had side effects is only an individual and resides in the United Kingdom under the UK’s testing procedures.
AstraZeneca and Oxford’s joint vaccine procurement faces major red flags but resumes its Phase Three clinical trials after its safety panel deemed so. The Food and Drug Administration would ensure the safety on their own, to launch a separate investigation that postpones the US testing until the middle of the week.
FDA’s probe did not say how long it would take, along with its US vaccine sign-up, which was put on pause on September 6. The sign-up for the clinical trials in the US would only resume with FDA’s go-signal and approval.
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AstraZeneca’s COVID-19 vaccine produced a concerning side effect to one British patient, which halted the trials across all of the company’s testing facilities scattered worldwide. According to Daily Mail, the solo patient who showed side effects presents a concerning spinal cord inflammation that is now brushed off as trials resume.
The trial patient was only thought to be showing signs of a rare spinal cord inflammation called ‘transverse myelitis.’ The spinal cord disorder is a rare sighting and an alarming case due to its harmful nature, damages the insulating material covering the nerve cell fibers. Transverse Myelitis interrupts the spinal cord’s function to send signals throughout the body.
Despite the COVID-19 Vaccine side effect from the trial is an isolated case and a misconception, the US FDA will continue its probe and perform an exclusive and extensive study about AstraZeneca’s vaccine.
Several countries have AstraZeneca’s approval and go-signal that urges the safe return of the immunization trials. The United Kingdom is the first country to go forth and continue from the postponement, along with Brazil, who currently confirms its return. Tests in South Africa and India are still unconfirmed and are waiting for official announcements from its respective governments.
The US’ clinical trial sign-up listing received a whopping 30,000 interested participants, but the country did not reveal how much it will include on the actual participants. The country’s postponement of the vaccine means falling behind the rest of the world in receiving AstraZeneca’s immunity shots.
AstraZeneca is the World Health Organization’s top candidate for the vaccine race in the world. This postponement now raises concern against the company and its work on the vaccine.
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This article is owned by Tech Times
Written by Isaiah Alonzo