Source : 'The Pink Sheet'
An EU decision on approving the Oxford University/AstraZeneca PLC COVID-19 may come by the end of this month.
The European Medicines Agency expects AstraZeneca to apply for the conditional approval of the vaccine next week. Depending on the data submitted and how the evaluation progresses, the EMA expects a “possible conclusion” of its assessment process by the end of January, EMA executive director Emer Cooke said at the agency’s second public stakeholder meeting on COVID-19 vaccines, held virtually on 8 January.
The EMA has been looking at the Oxford/AZ vaccine as part of a rolling review. On 21 December, the agency had announced that although it had already received some safety and efficacy data on the vaccine, it was yet to receive more information “deemed necessary to support the rigor required for a conditional marketing authorisation.” ()
At the public hearing, Cooke announced that the EMA had “just received some additional data and now expects the AstraZeneca [marketing authorization] file to be submitted next week… Once we actually receive the application, we will make a public announcement on this,” she said.
The UK was the first country to grant emergency approval to the vaccine despite significant uncertainties about its efficacy. ()
Several other countries have since granted emergency/conditional approval to the vaccine, mostly relying on the assessment work done by the UK regulators. Approvals have been issued by Argentina, El Salvador and India among others. () ()
The Oxford/AZ vaccine’s greatest advantage over mRNA-type vaccines (such as those developed by Pfizer/BioNTech and Moderna - both of which are approved in the EU) is that it is cheaper and easier to transport as it can be stored at normal fridge temperatures like the flu vaccine (2-8°C). () ()
In the US, however, a decision on approving the Oxford/AZ vaccine may not come through soon. The Food and Drug Administration is likely to await the results from US Phase III trials, which are expected to yield a clearer picture about its efficacy thanks to its single trial protocol and larger size.
By Vibha Sharma