European Medicines Agency (EMA) would assess the manufacturing sites of the Serum Institute of India (SII) and its production processes as per the European Union (EU) law before approving the Covishield vaccine, and has made it clear that approval for Vaxzevria does not mean an approval for Covishield, too.
The EMA, in a detailed response on Monday evening to queries from News18¸ said it had so far not received a marketing authorisation application for Covishield. Adar Poonawalla of SII on Monday said he was taken up the matter with the EMA for authorisation.
“The only COVID-19 vaccine from AstraZeneca for which a marketing authorisation application was submitted to and evaluated by EMA, leading to its authorisation in the EU, is Vaxzevria. Even though it (Covishield) may use an analogous production technology to Vaxzevria, Covishield as such is not currently approved under EU rules,” Violeta Pashova, Press officer of EMA, said in an e-mail response to News18.
EMA said this was because vaccines are biological products. “Even tiny differences in the manufacturing conditions can result in differences in the final product, and EU law therefore requires the manufacturing sites and production process to be assessed and approved as part of the authorisation process,” the EMA responded. EMA pointed to a list of six current approved manufacturing sites for Vaxzevria in Belgium, US, UK, Netherlands, South Korea and China – that does not include India.
EMA also said, “should it receive a marketing authorisation application for Covishield or should any change to the approved manufacturing sites for Vaxzevria be approved”, it would communicate about it.
EMA stand has no role to play in Travelling to European Union
The EMA in its response also made it clear that it has no role to play in the decision regarding travelling into the European Union (EU) and this was something that is up to the European Commission and individual member states.
“EMA is in charge of the scientific evaluation of medicines or vaccines in view of their marketing authorisation in the EU. However, EMA is not responsible for any decision regarding travelling into the EU and travelling conditions associated with Covid-19 vaccination, such as the EU Digital COVID Certificate. This is a matter for the European Commission and for individual Member States,” the EMA said in an e-mail response to News18.
The European Commission rules regarding ‘EU Digital Covid Certificate’ or ‘Green Pass’ says when it comes to waiving free movement restrictions, Member States will have to accept vaccination certificates for vaccines which received EU marketing authorisation. It, however, says member states may decide to extend this also to EU travelers that received another vaccine.
Since the ‘Green Pass’ is hence linked to EU marketing authorisation for vaccines (which is for only four vaccines so far), SII said it has applied for the same to EMA.As reported first by News18 on June 28 morning, SII has been nudged by the government to do so and simultaneously, the Indian government is also taking up the matter diplomatically with the European commission and individual European countries to recognise Covishield for the Green Pass programme since the Indian vaccine is approved by the World Health Organisation.