Haven’t received application for Covishield’s authorisation, says European Medicines Agency

Adar Poonawalla of Serum Institute of India had said on June 28 that he had taken up the issue of Covishield with the concerned authorities.

The exterior of the European Medicines Agency, EMA, is seen in Amsterdam, Netherlands, Tuesday March 16, 2021.

The European Medicines Agency (EMA) has not received any application from the Serum Institute of India for authorisation of the COVID-19 vaccine, Covishield. The comment from the agency came a fortnight after the EU introduced the EU Digital Covid Certificate (EUDCC), also known as the “green pass” that makes intra-EU travel possible.

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

India’s Covishield vaccine, which is based on AstraZeneca’s formula, is not among the authorised vaccines under the EMA. The EMA has maintained that it authorises vaccines based on the application seeking authorisation. As of now, lack of authorisation for Covishield is causing difficulties for Indian travellers who have taken the vaccine but are dependent on exemptions from EU member States as the EU-wide authorisation has not yet been given to Covishield.

Adar Poonawalla of Serum Institute of India had said on June 28 that he had taken up the issue of Covishield with the concerned authorities. “I assure everyone, I have taken this up at the highest levels and hope to resolve this matter soon, both with regulators and at a diplomatic level with countries,” said Mr. Poonawalla.

The EMA maintains that, as of now, there are only four vaccines that are authorised for marketing in the EU, and the list does not extend beyond that.