The European Medicines Agency (EMA) would assess the manufacturing sites of Pune-based Serum Institute of India (SII) and its production processes as per the European Union (EU) law before approving the Covishield vaccine.
The EMA has also made it clear that an approval for Vaxzevria vaccine does not mean an approval for Covishield too. AstraZeneca’s shot Vaxzevria has been produced in the UK and Europe.
The EMA, in a detailed response on Monday evening to queries from News18, said it has so far not received a marketing authorisation application for Covishield.
Adar Poonawalla, CEO of SII, said on Monday that he has taken up the matter of Covishield approval with the EMA.
“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,” said Violeta Pashova, Press officer of EMA, in an email response to News18.
The 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.
It also pointed to a list of six currently approved manufacturing sites for Vaxzevria — Belgium, the US, the UK, Netherlands, Korea and China — that does not include India.
The 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 has no role to play in travel to EU
The EMA in its response also made it clear that it has no role to play in the decision regarding travelling to the European Union (EU) and that it 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 added.
The European Commission rules regarding ‘EU Digital Covid Certificate’ or ‘Green Pass’ say 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 linked to EU marketing authorisation for vaccines, which is for only four vaccines so far, the SII said it has applied for the same to EMA.
As reported first by News18 on June 28, the 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 has been approved by the World Health Organisation.