EU Medical body says not received application for Covishield's authorisation

Almost a fortnight after the EU introduced the EU Digital Covid Certificate that makes intra-EU travel possible, the European Medicines Agency (EMA) has asserted that it has not received any application from the Serum Institute of India (SII) for authorisation of the COVID-19 vaccine Covishield.

"For the COVID-19 vaccine Covishield to be evaluated for use in the EU, the developer needs to submit a formal marketing authorisation application to EMA, which to date has not been received," the EMA said at a press briefing.

"We confirm that we have not received a marketing authorisation application for Covishield," said Salvador Ruiz Carrillo de Albornoz, Press Officer of EMA.

The EMA had earlier said minor differences in manufacturing processes could result in differences in the final product, and the EU law required assessments as part of the authorisation process.

For restriction-free travel within the EU during the pandemic, the EMA so far has approved those vaccinated by either of the 4 vaccines.

The EMA has approved Pfizer BioNTech's Comirnaty, Moderna's Spikevax, AstraZeneca's Vaxzevria and Johnson & Johnson's Janssen as vaccines for COVID-19.

SII CEO Adar Poonawala had earlier asserted that his company was confident of receiving approval from the European Medicines Agency (EMA) for its COVID-19 vaccine Covishield in a month. 

Speaking at India Global Forum 2021, Poonawalla said, "It is not a controversy, it is just that blown out of proportion and the issue of vaccine passports should be on the basis of reciprocity between the countries."

"The EMA is absolutely correct in asking us to apply, which we have through AstraZeneca, our partners, a month ago, and that process has to take its time. Even the UK MHRA, WHO took its time and we have applied to the EMA," added Poonawala.