Oxford-AstraZeneca COVID-19 Vaccine Enters Final Lap in Europe, EMA to Announce 'Rolling Review This Week': Report
The report comes around a month after the Oxford-AstraZeneca trials had hit a roadblock, with two volunteers in the UK developing an adverse side-effect that reportedly led to inflammations on their spinal cord. A week after pausing the trials, the UK decided to resume the human tests.
Brussels, October 1: The COVID-19 vaccine being developed by University of Oxford and drugmaker AstraZeneca Plc has entered the final lap before roll out in Europe. Reports claimed that the European Medicines Agency (EMA) is set to begin the "rolling review" of the vaccine candidate shortly. COVID-19 Vaccine Development May Kill Over 5 Lakh Sharks! Here's Why.
Once the medical body grants approval, it would be a matter of days before the vaccine is released for public use, claim experts. While the EMA is yet to issue an official statement, a top source while speaking to Bloomberg claimed that the rolling review, which involves authorities studying clinical trials data before completion of final phase, would be announced this week.
The report comes a couple of weeks after the Oxford-AstraZeneca trials had hit a roadblock, with two volunteers in the UK developing an adverse side-effect that reportedly led to inflammations on their spinal cord. A week after pausing the trials, the UK decided to resume the human tests.
The clinical study of the vaccine also subsequently resumed in South Africa, Brazil and India. However, the United States has refrained from restarting the trials, with the National Health Institutes expressing the need to conduct a detailed probe into the side-effects faced by two volunteers of the UK trials.
What is 'Rolling Review'?
Before authorising a drug or vaccine for public use, the regulatory body conducts a review of the trials conducted by the developer. Such review, which involved a detailed study of the clinical tests data, takes months to complete. In case of emergencies, a "rolling review" is launched to save time. The authorities begin studying the tests outcome even as the final phase of trials are underway.
EMA’s head of vaccines, Marco Cavaleri, had told media outlets back in July that a rolling review of the vaccine could begin after summer. He had expressed the possibility of issuing the first approval for vaccine by end of the year.
(The above story first appeared on LatestLY on Oct 01, 2020 08:45 AM IST. For more news and updates on politics, world, sports, entertainment and lifestyle, log on to our website latestly.com).