British-Swedish firm Astrazeneca said it had resumed testing of the coronavirus vaccine from the University of Oxford in the UK following confirmation from the Medicines Health Regulatory Authority (MHRA). The advanced COVID-19 vaccine trial developed by the University of Oxford and Astrazeneca was suspended this week after illness in a study subject in Britain.
“The standard review process resulted in a voluntary pause in vaccination in all global trials to allow for review of safety data by independent committees and international regulators,” said AstraZeneca.
“The UK committee has concluded its investigations and recommended to the MHRA that it is safe to resume trials in the UK,” said the manufacturer of the vaccine.
The University of Oxford said in a statement that the UK regulator had recommended that the trials be resumed after an independent review of safety data.
Oxford University previously said that about 18,000 people have received “study vaccines” as part of the trials. “We cannot disclose medical information about the disease for reasons of confidentiality of the participants,” he said.
The Serum Institute of India had halted clinical trials of a COVID-19 vaccine in the country this week. The move came a day after the Pune-based vaccine maker received a notice of demonstration cause from India’s Drug Inspector General (DGCI) VG Somani.
“We are reviewing the situation and stopping the trials in India until AstraZeneca restarts them. We are following DCGI’s instructions and will not be able to comment further on them, “the Serum Institute said in a statement Thursday.
Serum Institute of India partnered with AstraZeneca to manufacture the COVID-19 candidate vaccine developed by the University of Oxford, for India and low- and middle-income countries. The Pune-based vaccine manufacturer previously shortlisted 17 sites in India for the phase II clinical trial of the COVID-19 vaccine. At least 1,600 candidates between the ages of 18 and 55 will participate in the trial.
The central drug regulator has asked the Serum Institute of India to suspend recruitment in its clinical trials of the potential COVID-19 vaccine from AstraZeneca Plc in the country until new orders are placed, the news agency reported. AND ME.
“Increase the safety control of subjects already vaccinated with the test vaccine and submit the plan and report. Submit authorization from DSMB, UK and DSMB, India to obtain clearance from this office prior to resumption of future recruitment in the essay “, read the DCGI statement, according to AND ME.
VG Somani, India’s general drug controller, has also called for tighter safety checks on those already vaccinated with the experimental vaccine, according to AND ME report.
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