AstraZenecas building in Luton, UK.
Tim Ireland | Xinhua News Agency | Getty Images
Phase 3 studies for AstraZeneca's coronavirus vaccine have resumed in the UK after being discontinued earlier this week due to safety concerns, the company said on Saturday.
AstraZeneca said it has received confirmation from the UK drug health regulator that it is safe to resume clinical trials. The company declined to disclose medical information about the study interruption, but said earlier this week that it was investigating a potentially unexplained disease.
The company said "the standard review process has triggered a voluntary hiatus" on all global trials on September 6 to allow independent committees and internal regulators to review the safety data. While studies can now be resumed in the UK, the status of studies elsewhere remains unclear.
"The company will continue to work with health authorities around the world to seek advice on when to resume other clinical trials to deliver the vaccine generally, equitably and for no profit during this pandemic," AstraZeneca said in a statement.
Oxford University, which developed the vaccine in partnership with AstraZeneca, announced on Saturday that around 18,000 people have received the vaccine in studies to date.
"In large studies like this one, it is expected that some participants will feel uncomfortable and each case must be carefully assessed to ensure a thorough safety assessment," Oxford said in a statement.
STAT News reported earlier this week that Pascal Soriot, CEO of AstraZeneca, said during a private conference call that the "possibly unexplained disease" occurred in a woman in the UK who had neurological symptoms related to an inflammatory spinal disease called transverse myelitis. The call was made by the investment bank J.P. Morgan, STAT, established.
On the same phone call, Soriot also confirmed that AstraZeneca's clinical trials had already been canceled once in July after a participant developed neurological symptoms. However, it was found that the disease was unrelated to the experimental vaccine.
AstraZeneca's potential coronavirus vaccine, AZD1222, is at the forefront of creating a safe and effective vaccine that could contain the global pandemic. The company started its late-stage trials in late August. It is one of at least three vaccine candidates, along with Pfizer and Moderna, in late-stage trials.
World Health Organization officials have already named AstraZeneca's vaccine candidate as one of the most promising currently in development. On Thursday, WHO chief scientist Dr. Soumya Swaminathan stated that there was no need to be "unduly discouraged" by the news of the pause in the process, adding that "these things are happening".
"I think that's good … maybe a wake up call or a lesson for everyone to realize the fact that there are ups and downs in research, there are ups and downs in clinical development, and we need to be prepared for that be, "she said.
The United States invested more than $ 10 billion in six efforts to bring a coronavirus vaccine to market. On May 21, the US announced it would invest $ 1.2 billion in AstraZeneca's efforts to obtain at least 300 million doses if the candidate proves safe and effective enough.