14 September 2020
The Medicines Health Regulatory Authority (MHRA) in the UK has said that the clinical trials of the University of Oxford/AstraZeneca Covid-19 vaccine candidate are safe to resume. AstraZeneca voluntarily paused the late-stage trials of the vaccine last week after a participant in the UK study experienced an unexplained illness. The independent committee in the UK completed its review and then recommended to the MHRA that trials were safe to restart. AstraZeneca and the University of Oxford said that further medical information cannot be disclosed.
Pfizer and BioNTech have submitted a proposal to the US Food and Drug Administration (FDA) to expand their Phase III pivotal Covid-19 vaccine trial to include up to 44,000 volunteers. The initial target enrolment was 30,000 participants, which the companies expect to achieve by next week. The propose expansion would enable the enrolment of a diverse population of individuals as young as 16 and people with chronic, stable HIV, hepatitis C and hepatitis B.
US-based Merck has started participant enrolment for its Phase I/II Covid-19 vaccine clinical trial, according to the government database clinicaltrials.gov. Based in Belgium, the study is designed to assess the investigational vaccine V591 in 260 healthy volunteers. Merck gained the vaccine candidate as part of a deal signed in May with Austrian vaccine company Themis Bioscience.
Johnson & Johnson (J&J) subsidiary Janssen will commence Phase II clinical trials of its Covid-19 vaccine candidate in Spain today, said the programme's lead investigator. La Paz University Hospital clinical trials unit chief Alberto Borobia said that 190 participants will be enrolled at three hospitals in the country. The Phase II trial will also be conducted in Germany and the Netherlands, noted Reuters.