No application received for EU authorisation of Covishield: Drug regulator

The European Medicines Agency (EMA) hasn't got any application to authorise Covishield, the vaccine made by the Serum Institute of India

 

New Delhi [India], July 16 (ANI): The European Medicines Agency (EMA) said it has not received any application from the COVID-19 vaccine Covishield maker Serum Institute of India (SII) for authorisation.

"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.

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

SII was confident of receiving approval from the European Medicines Agency (EMA) for its COVID-19 vaccine Covishield in a month, the company's CEO Adar Poonawalla had earlier said.

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.