“The review procedure has led to a voluntary pause in vaccination in all global trials to enable review of protection knowledge through independent committees and foreign regulators,” AstraZeneca said.
“The UK committee concluded its investigations and recommended that the MHRA resume trials in the UK,” the vaccine manufacturer said.
Oxford University said in a statement that the UK regulator had advised the resumption of testing after an independent review of protection data.
Oxford University previously said that about 18,000 people had won “study vaccines” as a component of the trials. “We disclose medical data on the disease for reasons of confidentiality of the participants,” he said.
The Serum Institute of India suspended clinical trials of a COVID-19 vaccine in the country this week. This resolution came a day after the Pune-based vaccine manufacturer obtained a justification from the General of the Indian Drug Controller (DGCI) VGMr. Somani.
“We are reviewing the scenario and postponing rehearsals in India until AstraZeneca restarts them. We are following DCGI’s orders and will not be able to comment further on the same,” the Serum Institute said Thursday.
The Serum Institute of India partnered with AstraZeneca to manufacture the COVID-19 candidate vaccine developed through Oxford University for India and low- and middle-income countries. Phase II clinical trial of the COVID-19 vaccine involving at least 1,600 applicants between the age of 18 and 55.
The central drug regulator has asked the Serum Institute of India to suspend recruitment in its clinical trials of AstraZeneca Plc’s COVID-19 vaccine in the country until new orders are placed, news firm ANI reported.
“Increase monitoring of the protection of subjects already vaccinated with the vaccine in testing and submit the plan and report. Submit authorization from DSMB, UK and DSMB, India to download permission for this before resuming long-term recruitment in the trial,” read DCGI Statement, according to ANI.
V. G. Somani, General Drug Controller of India, also called for greater protection for the follow-up of others already vaccinated with the experimental vaccine, according to the ANI report.
Click here to read that Mint ePapermint is now on Telegram. Join the mint channel in your telegram and updated
Log in to our to save your favorites. It’ll only take a moment.
Your query has expired, reconnect.
You are now subscribed to our newsletters. If you can’t find any of our emails, check your spam folder.