A company spokesman said the patient’s life was not in danger and described the suspension of the investigation as “a routine action to be taken whenever there is a potentially unexplained illness in one of the research trials”.
AstraZeneca and the University of Oxford announced the temporary suspension of the Phase 3 trials for the new coronavirus vaccine, following suspicion of a serious adverse reaction in a patient who volunteered for the program in Britain. According to the company, this development may delay or even derail efforts to accelerate the immunization of the population against the pandemic.
A spokesman for AstraZeneca said that “the formal review process of the company caused a pause in vaccination to allow for a review of safety data”.
No further details were released, although it was clarified that the life of the patient who developed the reaction to the vaccine was not endangered.
A spokesman for AstraZeneca described the cessation of research as “a routine of action whenever there is a potentially unexplained illness in the research tests, ensuring that we maintain the integrity of the tests”. The spokesman also said that the company “is working to expedite the review of the individual incident to minimize any potential impact on the test schedule”.
At the heart of our core values is to “follow the science” and we are committed to adhere to the highest scientific and clinical standards as we research a potential #COVID19 vaccine. @Sanofi will you join us as #WeStandWithScience? https://t.co/uEaOpNBba8 pic.twitter.com/WgJestzs3D
— AstraZeneca (@AstraZeneca) September 8, 2020
Researchers are now looking for similar cases of side effects by combing databases checked by the so-called Data Monitoring and Security Council.
AstraZeneca began testing Phase 3 in the US only at the end of August. The US trial is currently being conducted on 62 sites across the country, according to clinicaltrials.gov, although some have not yet started registering participants. Phase 2/3 trials have previously started in the United Kingdom, Brazil and South Africa.
It was also not clear in which clinical trial the side effect occurred.
According to sources, the head of the US expert group, Anthony Fauci, said on Tuesday that it is “unlikely” that a vaccine will be available to the public before November 3.
As for the image of the share of AstraZeneca in New York, it fell up to 8.3% overnight, while on the contrary, the shares of Moderna and BioNTech rose.