AstraZeneca, an Anglo-Swedish pharmaceutical company, is putting their experimental coronavirus vaccine on hold after a patient in the United Kingdom experienced a serious adverse reaction, according to Stat News.
The experimental vaccine, called AZD1222, was considered a frontrunner in the race to find a COVID-19 vaccine, and was being tested in 62 sites around the country, Stat News reports. That all changed Tuesday when AstraZeneca announced its study was being placed on hold after the company’s “standard review process triggered a pause to vaccination to allow review of safety data,” according to an AstraZeneca spokesperson. (RELATED: Trump Says US Could Have Coronavirus Vaccine By October)
— Rebecca Robbins (@RebeccaDRobbins) September 8, 2020
In a follow-up statement, AstraZeneca clarified the pause was voluntary “to allow review of safety data by an independent committee.” The company called the process “routine,” saying, “in large trials illnesses will happen by chance but must be independently reviewed to check this carefully.”
— Rebecca Robbins (@RebeccaDRobbins) September 9, 2020
“We are working to expedite the review of the single event to minimize any potential impact on the trial timeline. We are committed to the safety of our participants and the highest standards of conduct in our trials,” the statement concluded.
Symptoms that require hospitalization or are life-threatening are classified as serious, Fox News reported. The serious adverse reaction that happened in the U.K. is presumed to have occurred during phase 2 or 3 trials. Phase 3 trials began in the U.S. late August, per Stat News.
AstraZeneca was already conducting Phase 2/3 trials in the U.K., Brazil, and South Africa, according to Stat News.
A Phase 1/2 study showed 60% of participants who took the vaccine experienced side effects in July.
While these holds are not uncommon, the world is eagerly awaiting the arrival of a vaccine to combat the global pandemic. Furthermore, the vaccine developed by the University of Oxford and Vaccitech is the first of 9 vaccine candidate contenders in Phase 3 to pause its studies. A long delay could be costly.
AstraZeneca announced last week its COVID-19 vaccine candidate entered the final testing stage in the U.S., a study that would involve up to 30,000 adults.
AZD1222 utilizes monoclonal antibodies that mimic natural antibodies and are delivered from the convalescent plasma of COVID-19 patients in hopes of stopping the disease in its tracks, Fox News reported.