AstraZeneca Plc’s AZN.L COVID-19 vaccine trial in the United States is expected to resume as early as this week after the U.S. Food and Drug Administration completed its review of a serious illness in a study participant, four sources told Reuters. AstraZeneca’s large, late-stage U.S. trial has been on hold since Sept. 6, after a participant in the company’s UK trial fell ill with what was suspected to be a rare spinal inflammatory disorder called transverse myelitis.
The sources, who were briefed on the matter but asked to remain anonymous, said they have been told the trial could resume later this week. It was unclear how the FDA would characterize the illness, they said. An FDA spokeswoman declined to comment. The agency is requiring researchers conducting the trial to add information about the incident to consent forms signed by study participants, according to one of the sources.
Sinopharm Able to Make Over 1 Billion Coronavirus Vaccine Doses in 2021
China National Pharmaceutical Group (Sinopharm), one of several Chinese firms developing coronavirus vaccines, said it may have the capacity to produce more than 1 billion doses in 2021, Chairman Liu Jingzhen said on Tuesday.
About 60,000 people have received Chinese coronavirus vaccine candidates during Phase III clinical trials, with no serious side effects reported so far, Tian Baoguo, an official at China’s Ministry of Science and Technology, said at the same government media briefing.In addition, hundreds of thousands of people in China have been given experimental trial-stage vaccines as part of an emergency inoculation programme launched in July.