No Application Received from SII: EMA on Covishield EU Approval

In a press briefing on 16 July, EMA stated that it has not received any formal marketing authorisation application.

The European Medicines Agency (EMA) on Friday, 16 July stated that it has not received any application for authorisation from Serum Institute of India (SII) for its COVID-19 vaccine Covishield.

In a press briefing, the EMA stated that 'the developer needs to submit a formal marketing authorisation application to EMA, which to date has not been received'.

For the #COVID19vaccine 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. #EMAPresser

— EU Medicines Agency (@EMA_News) July 15, 2021

The European Medicines Agency (EMA) has so far cleared four vaccines – Comirnaty (Pfizer/BioNTech), Moderna, Vaxzervria (AstraZeneca manufactured in the UK and EU countries), and Janssen (Johnson & Johnson).

Quoting SII CEO Adar Poonawalla, The Times of India reported that the vaccine manufacturer is confident in receiving approval in a month from EMA.

"It is not a controversy, it is just blown out of proportion and the issue of vaccine passports should be on the basis of reciprocity between the countries,” said Poonawalla at Indian Global Forum, reported TOI.

Covishield has been excluded from Europes’s Green Pass scheme, reported The Wire Science on 28 June. The scheme, which came into effect on 1 July, serves as proof that the individual has been vaccinated against COVID-19, or has recently tested negative against it, or has natural immunity build up from an earlier version.