Clinical trials of vaccine developed by the pharmaceutical company AstraZeneca and Oxford University are suspended, it was learned 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 testing of the vaccine, which is considered one of the most promising in the world, is stalled, which for the Prime Minister, António Costa, is “bad news” and a factor of “uncertainty” “. But this is not the first time that testing has stopped.
The information was revealed during a videoconference between Pascal Soriot, executive director of the multinational AstraZeneca, and investors. The site specializing in health news Stat News had access to the videoconference content through three investors who attended the meeting. Soriot said that in July the tests stopped because a volunteer started showing neurological symptoms, having been diagnosed with multiple sclerosis, but it was found to be unrelated to the potential vaccine against covid-19.
In the video conference, Stat News also writes, the pharmaceutical executive director says that this new stop in clinical trials is related to a woman, a volunteer in the UK, who presented neurological symptoms consistent with an inflammatory disease of the spinal cord, transverse myelitis, but made it known that the disease has not yet been diagnosed.
It should be noted that transverse myelitis can be manifested 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 women’s health status is improving and it should be discharged this Wednesday. He added that the volunteer was given the potential vaccine against covid-19 and not a placebo.
The large-scale clinical trials of phase 3, the most advanced and the one that precedes approval by regulatory authorities, are suspended “to allow a review of the safety data” of the vaccine, said the pharmacist.
AstraZeneca said that it is “a routine action”, which occurs “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 tests, diseases happen by chance, but they must be independently reviewed in order to be carefully checked. We are working to accelerate the review of a single event to minimize any potential impact on the test schedule. We are committed to the safety of our participants and 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 carried out on a large scale in several locations in the United States and the United Kingdom, where the adverse reaction to the drug was reported, will last. However, in a statement released this 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 USA. Phase 2/3 tests were previously initiated in the UK, Brazil and South Africa.
European Commission officialized the purchase of 300 million doses of the vaccine
“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, to be distributed on a proportional basis to the population,” the institution said at the time.
According to the results of the first clinical trials, released last July, this possible vaccine “looks safe and generates antibodies”, thus showing promising results with regard to 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 1077 volunteers (aged 18 to 55) who participated in the first phase of the “Oxford vaccine” clinical trial, as it is known, developed antibodies against the SARS-CoV-2 virus.
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