Experimental vaccine created by Oxford University and Astrazeneca enters regulatory assessment process
Earlier this week, the body that assesses new medicines for use within the EU – the European Medicines Agency (EMA) – began a rolling review of an experimental COVID-19 vaccine developed by Oxford University and Astrazeneca. The vaccine, which is currently in final-stage clinical trials, becomes the first to enter a regulatory process that could see it approved for public use in the EU.
Under normal circumstances, clinical trials run to conclusion and all resulting data is submitted for evaluation at that time. However during a health crisis, a rolling review – in which segments of data are submitted and assessed as they become available – can be used to speed up the approval process. The rolling review process has been used once already during the Coronavirus pandemic, to expedite the approval of the therapeutic drug, remdesivir. While the agency are unable to say how quickly the vaccine will be approved should it be found to be safe and effective, the rolling review process shortened remdesivir’s approval time from around seven months to one month.
The EMA said of the decision to being the rolling review process: “The Committee for Medicinal Products’ decision to start the rolling review of the vaccine is based on preliminary results from non-clinical and early clinical studies suggesting that the vaccine triggers the production of antibodies and T cells (cells of the immune system, the body’s natural defences) that target the virus.”
While the start of the EMA rolling review process is no guarantee that the Oxford Astrazeneca vaccine is safe and effective – phase three clinical trials will continue until enough data is collected to make that determination – should clinical trial results, which are expected in next couple of months, return satisfactory conclusions, it is possible that the vaccine could be approved for use in the EU before the end of the year. EU pharmaceutical law applies to the UK until December 31st, when the Brexit transition period ends. BarLifeUK were unable to find a definitive description of drug approval process for the UK when the transition period has ended.
You can read the European Medicines Agency rolling review statement in full here.