Answer to Written Question: Speeding up the authorisation of the Sputnik vaccine
(Source: European Parliament)
Answer given by Ms Kyriakides
on behalf of the European Commission
- The priority of the Commission has always been the safety and efficacy of any COVID-19 vaccine authorised for use in the EU. This is why all vaccines, before being administered, go through rigorous and independent safety scrutiny by the European Medicines Agency (EMA). Sputnik V has been under rolling review by EMA since 4 March 2021. This means that EMA reviews data as they become available and can come to an opinion on the medicine’s authorisation sooner. According to the EMA’s human medicines committee, inspections to provide assurances of compliance with ‘Good Manufacturing Practice’ and ‘Good Clinical Practice’ have to take place as part of the assessment and it is currently organising them. The good clinical practice inspection already took place “on-site” from 10 to 27 April 2021. Results from these inspections are necessary before EMA can reach an opinion on the vaccine. EMA applies the same regulatory approach and scientific rigour to Sputnik V as to all other vaccine applications and the speed of the review depends on the availability of adequate data by the developer.
- The EU pharmaceutical legislation provides for a specific regulatory tool to fast track authorisation of medicines for use in emergency situations – the conditional marketing authorisation (CMA). A CMA ensures full evaluation of available data and sets out clear obligations with legal controls on marketing authorisation holders. It also requires a robust pharmacovigilance system to safeguard that any possible medicine related problems, regardless how rare, do not go undetected.