AstraZeneca, which was in the third phase of COVID-19 vaccine testing, has refuted rumors and said that the woman participating in the test as a volunteer was officially not diagnosed with Transverse Myelitis. Recently, multiple news organizations had claimed that one of the participants of the AstraZeneca trial had become sick and the pharmaceutical company was forced to halt the trials.
The spokesperson of the company spoke to CNBC and confirmed that the trial has been halted. But the spokesperson said that the woman participant has not been officially diagnosed with the rare neurological disorder. The company is of the opinion that reports were the result of misinterpreting comments of AstraZeneca CEO Pascal Soriot.
The company said that the diagnosis is not official and that the tests will be delivered to an independent safety committee that will review the situation and establish a final diagnosis on the woman participant's health. Transverse myelitis is a serious condition connected to inflammation of the spinal cord. This disease can cause muscle weakness, paralysis, pain and bladder problems.
Trial Halted Previously in July
During a private conference call with investors, Soriot had revealed that the company had halted the clinical trial previously in July after one of the participants showed neurological symptoms. But after thorough tests it was found that the participant was diagnosed with multiple sclerosis. This disease was said to be not related to the COVID-19 vaccine treatment. The trial was continued following the diagnosis results.
AstraZeneca's statement says that the company will take the help of a committee of independent experts in determining when to lift the hold on the current trial. The company will continue with the trials at the earliest opportunity to provide this vaccine broadly, equitably and at no profit during this pandemic, said the statement.
AstraZeneca's Plans to Proceed With Phase 3 Trial
AstraZeneca began its Phase 3 trial in the U.S. in the end of August. Currently trials are being conducted in 62 locations across the country. But some centers are yet to start the trial on participants. The company plans to enroll about 30,000 participants in 80 locations in the U.S. during the third phase of trials. Meanwhile, the company is continuing its second and third phase of trails in various locations in the U.K., Brazil, and South Africa.
The vaccine being developed by AstraZeneca has been named AZD1222. The vaccine uses an adenovirus that carries a gene for one of the proteins in SARS-CoV-2. It is designed to induce the immune system to generate a protective response against SARS-2. Though the use of it is not approved yet, it has been tested in experimental vaccines against other viruses, including the Ebola virus.
According to health website Stat News, the decision to halt the trials was routine temporary process to ensure that safety is the priority of the company. "This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials," AstraZeneca had said in a statement.