The Medicines Health Regulatory Authority (MHRA) in the UK has said that the clinical trials of the Oxford/AstraZeneca Covid-19 vaccine candidate are safe to resume.
Reshape regional strategies to navigate global uncertainties
- Macroeconomic
- Political
- Social
- Technological
- Environmental
- Legal
AstraZeneca voluntarily paused the late-stage trials of the vaccine last week after a participant in the UK study experienced an unexplained illness.
The company noted that the pause was a routine action to enable review of safety data by an independent committee.
Related
In a statement, AstraZeneca said: “On 6 September, the standard review process triggered a voluntary pause to vaccination across all global trials to allow review of safety data by independent committees, and international regulators.”
The independent committee in the UK has completed its review and recommended to the MHRA that trials in the country are safe to restart.
AstraZeneca and the University of Oxford said that further medical information cannot be disclosed.
The company added: “All trial investigators and participants will be updated with the relevant information and this will be disclosed on global clinical registries, according to the clinical trial and regulatory standards.
“AstraZeneca is committed to the safety of trial participants and the highest standards of conduct in clinical trials.”
The company will work with global health authorities to resume trials in other countries. The Oxford/AstraZeneca vaccine is in late-stage trials in the UK, UK, Brazil, India and South Africa, with additional trials planned in Japan and Russia.
According to Reuters, the Serum Institute of India expects to restart its trials of the vaccine after obtaining approval from the Drugs Controller General of India.
On 12 September, Brazil’s health regulator ANVISA said that it had authorised the resumption of trials after analysis of data sent by the MHRA.
So far, AstraZeneca has signed agreements to supply nearly three billion doses of the Covid-19 vaccine to governments worldwide.
Related Companies
Reshape regional strategies to navigate global uncertainties
- Macroeconomic
- Political
- Social
- Technological
- Environmental
- Legal