September 14, 2020 -- The clinical trials for AstraZeneca’s coronavirus vaccine candidate have resumed in the UK after regulators decided it was safe, the company announced Saturday.
Trials in the U.S. and other countries are still paused as national health authorities review safety data.
“The Company will continue to work with health authorities across the world and be guided as to when other clinical trials can resume to provide the vaccine broadly, equitably and at no profit during this pandemic,” according to the statement.
Earlier this week, the company paused its trials globally for coronavirus vaccine AZD1222 after a participant in the UK had an unexplained illness. The woman had inflammation of the spinal cord, according to CNN.
Specifically, news outlets reported that she had symptoms of transverse myelitis, a rare neurological disorder that affect the protective covering of the spine, according to The Associated Press.
An independent committee reviewed the case to decide whether testing could begin again safely. The committee recommended to resume trials, and the UK Medicines and Healthcare Products Regulatory Agency confirmed, according to the AstraZeneca statement.
“In large trials such as this, it is expected that some participants will become unwell and every case must be carefully evaluated to ensure careful assessment of safety,” according to a statement released Saturday from the University of Oxford, which is developing the vaccine with AstraZeneca
Both the company and the university said they couldn’t provide additional information about the woman’s illness. The trial researchers and participants will be updated with relevant information, according to the statement.
AstraZeneca also paused a trial in July for a safety review after a volunteer had an undiagnosed case of multiple sclerosis. An independent panel concluded that it was unrelated to the vaccine, CNN reported.
More than 18,000 have received the AstraZeneca vaccine globally. The U.S. trial is recruiting 30,000 participants.
Also on Saturday, Pfizer and BioNTech asked regulators in the U.S. to allow them to expand the enrollment for their COVID-19 vaccine from 30,000 to 44,000, according to The Wall Street Journal. They expect to reach their 30,000 target by next week, and the expansion would allow them to increase diversity, include younger participants, and test people who have other viral diseases such as HIV and hepatitis.