AstraZeneca suspends study of vaccine for Covid-19 due to suspicion of serious adverse reaction in participant in the United Kingdom and action plummets

A strong blow suffered the search for a vaccine for Covid-19. Today the US site specialized in health, Stat News, reported that the phase 3 study for a vaccine being developed by the pharmaceutical company AstraZeneca and the University of Oxford was suspended due to suspicions of a serious adverse reaction in a participant in the United Kingdom.

As soon as the news broke, the company’s shares plummeted in after-market trading and fell 5.87%. During the day, their papers had risen 2.11%.

An AtraZeneca spokesperson said in a statement that the company’s “standard review process caused a pause in vaccination to allow for review of safety data.”

Stat News reported that it was not immediately clear who put the suspension of the study, although it is possible that AstraZeneca did so voluntarily and was not ordered by any regulatory agency. The nature of the adverse reaction and when it happened were also not immediately known, although the participant is expected to recover, according to a person familiar with the matter.

The spokesperson described the pause as “a routine action that should happen whenever there is a potentially unexplained illness in one of the tests, while it is investigated, ensuring that we maintain the integrity of the studies.” The spokesperson also said the company is “working to expedite the review of the one-time event to minimize any potential impact on the testing schedule.”

A person familiar with the development told Stat News that investigators had been told the test was discontinued out of “extreme caution.” A second person familiar with the matter, who also spoke on condition of anonymity, noted that the finding is having an impact on other ongoing AstraZeneca vaccine trials, as well as clinical trials being conducted by other vaccine manufacturers.

There are currently nine candidate vaccines in phase 3 trials. AstraZeneca is the first phase 3 Covid-19 vaccine trial known to have been discontinued.

AstraZeneca just began its phase 3 trial in the US in late August and is currently underway at 62 sites across the country, according to Clinicaltrials.gov, a government registry, although some have yet to begin enrolling. participants. Phase 2/3 trials were previously started in the UK, Brazil and South Africa.

As detailed by Stat News, “while it is not yet clear how severe and rare the adverse event may be, the finding could affect how quickly efficacy data from the UK trial will be available. These data are considered an integral part of any attempts to obtain an emergency use authorization for the vaccine from the US Food and Drug Administration and potentially jeopardize President Trump’s efforts to accelerate a vaccine before the November election.