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The clinical trials of the vaccine developed by the pharmaceutical AstraZeneca and the University of Oxford are suspended, it was known this Tuesday, but the situation is not new. The tests had already been interrupted in July when a possible adverse reaction was detected, which ended up not happening.
This Tuesday, the world learned that the tests of the vaccine, considered one of the most promising in the world, are stagnant, which for Prime Minister António Costa is “bad news” and a factor of “uncertainty.” “But this is not the first time testing has been stopped.
The information was revealed during a video conference between Pascal Soriot, CEO of the multinational AstraZeneca, and investors. The content of the videoconference was accessed by the health news website Stat News through three investors who attended the meeting. Soriot said testing was stopped in July because a volunteer began showing neurological symptoms, after being diagnosed with multiple sclerosis, but it was found to be unrelated to the possible COVID-19 vaccine.
In the video conference, Stat News also writes, the CEO of the pharmaceutical company says that This new stop in clinical trials is related to a woman, a volunteer in the United Kingdom, who presented neurological symptoms compatible with an inflammatory disease of the spinal cord, transverse myelitis, but disclosed that the disease has not yet been diagnosed.
It should be noted that transverse myelitis can manifest itself by muscle weakness, pain, and even paralysis. Stat News indicates that, in rare cases, vaccines can trigger cases of transverse myelitis, although it can also be caused by viral infections.
Pascol Soriot said that the the health status of women is improving and must be discharged this Wednesday. He added that the volunteer was given the possible vaccine against covid-19 and not a placebo.
Large-scale phase 3 clinical trials, the most advanced and the one preceding approval by regulatory authorities, are suspended “to allow a review of the safety data” of the vaccine, the pharmacist said.
AstraZeneca said it is “a routine action”, occurring “whenever there is a potential unexplained disease during a trial, so that it can be investigated, ensuring the integrity of the trials.”
“In large-scale trials, diseases happen by chance, but they need to be independently reviewed so they can be carefully monitored. We are working to speed up the review of a single event to minimize any potential impact on the testing program. We are committed to the safety of our participants and to the highest standards of conduct in our tests.“says the AstraZeneca statement sent to CNN.
It is not yet known how long the suspension of clinical trials that were being conducted on a large scale in various locations in the United States and the United Kingdom, where the adverse drug reaction was reported, will last. However, in a statement released Wednesday by the pharmacist it is said that a committee of independent experts will help determine when the suspension of clinical trials can be lifted.
Phase 3 trials of the AstraZeneca vaccine began in late August in the US Phase 2/3 trials previously began in the UK, Brazil and South Africa.
The European Commission made official the purchase of 300 million doses of the vaccine
On August 27, the European Commission, on behalf of the European Union, made an official order for 300 million doses of a possible Covid-19 vaccine from AstraZeneca.
“Through the contract, all member states will be able to purchase 300 million doses of the AstraZeneca vaccine, with an option for another 100 million doses, which will be distributed proportionally to the population,” the institution said at the time.
According to the results of the first clinical trials, published last July, this possible vaccine “appears safe and generates antibodies”, thus showing promising results in terms of safety and immunity.
The World Health Organization considered the AstraZeneca vaccine to be one of the most promising in the world. Ninety percent of the 1,077 volunteers (ages 18 to 55) who participated in the first phase of the clinical trial of the “Oxford vaccine,” as it is known, developed antibodies against the SARS-CoV-2 virus.
