BREAKING: Oxford and AstraZeneca's COVID-19 vaccine trials were halted after a UK participant had a “serious” suspected reaction to the lead candidate
- Late studies for the vaccine developed by AstraZeneca and Oxford University have been suspended
- In the UK, a "serious adverse event" and a possible response to the shot were reported
- It is not clear what happened to the individual, but an adverse event is considered "serious" if it is hospitalization, life threatening, or fatal
- Stat News reported that the person is expected to recover, but little is known about their identity
- It's not clear whether regulators, AstraZeneca or Oxford, called for the negotiation
- The shot was named by the WHO as the best hope for a vaccine and is one of nine attempts in phase three – the final tests before approval can be requested
According to Stat News, phase 3 trials for the coronavirus vaccine developed by Oxford University and AstraZeneca were suspended after a "serious adverse event" was reported in a participant in the UK.
Serious adverse events are suspected reactions to vaccines or drugs that must be hospitalized, are life threatening, or are fatal.
It is unclear what exactly the reaction was, but a person familiar with the matter told Stat News that the person is expected to recover.
Trial periods are not uncommon, but it's a blow to global hopes that a shot will be ready in the coming months, as the AstraZeneca shot has been viewed as the world's leading candidate by many – including the World Health Organization.
For example, Australia has spent $ 1.7 billion ($ 1.24 billion) to secure access to 84 million COVID-19 vaccines if the clinical trial is successful.
Phase 3 trials for the coronavirus vaccine, developed by Oxford University and AstraZeneca, were suspended after a "serious adverse event" was reported in a participant in the UK
The hold was called after a "standard screening process triggered a vaccination pause to allow verification of safety data," an AstraZeneca spokesman told Stat.
AstraZeneca's vaccine candidate is in Phase 3 trials – the final phase before safety and efficacy data can be submitted to regulatory agencies for approval – in dozens of locations in the US and around the world.
Together with Pfizer and Moderna, AstraZeneca and its partner Oxford University had hoped to know if the shot worked and was safe by the end of the year.
While safety data review studies aren't necessarily harmful, the hiatus in AstraZeneca's study may very well delay the highly anticipated results and the completion of one of the fastest vaccine development pipelines in human history.
Market confidence in the pharmaceutical giants was severely damaged as soon as reports of the test ban emerged.
AstraZeneca's shares fell eight percent in after-hours trading.
The company is currently in damage control mode to try to stay as close as possible to the study completion date.
AstraZeneca is working to "expedite the review of each event to minimize any potential impact on the test schedule," the spokesman told Stat News.
The UK-based company did not immediately respond to requests for comment from DailyMail.com.
While any signs that could point to potential flaws in a leading vaccine for the disease that killed nearly 190,000 Americans are troubling, trying to abandon a trial over safety concerns can be comforting to some.
Hours before the trial was temporarily halted, AstraZeneca and eight other companies working on COVID-19 vaccines signed a pledge to give the safety of their shots a priority over rapid development.
They pledged to "maintain the integrity of the scientific process as they work towards potential global filings and approvals of the first COVID-19 vaccine".
The pledge was made in response to growing concerns that governments would urge corporations and research institutes to speed up a vaccine through trial and approval processes in order to bolster political capital and restore normalcy amid the pandemic.
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