No application received from SII for EU authorisation of Covishield vaccine: EMA

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.

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

Poonawalla said last month that he was 'taking this up at the highest levels... with regulators and diplomats' and that he 'hoped to resolve this matter soon'.

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.

This includes Pfizer BioNTech's Comirnaty, Moderna's Spikevax, AstraZeneca's Vaxzevria, and Johnson and Johnson's Janssen.

India's Covishield vaccine, developed on AstraZeneca's formula, is not among the authorised vaccines under the EMA. The lack of authorisation for Covishield is creating hurdles for Indian travellers to the EU.

Covishield has also been excluded despite holding a EUL, or emergency use listing, from the World Health Organisation. The EUL was granted in February this year.

This means people who have taken Covishield vaccines are unlikely to be eligible to travel to the EU member states under the 'Green Pass' scheme as the vaccine is yet to be cleared by the EMA. 

They will be subject to quarantine protocols as enforced by individual EU member countries, and may even be blocked from entering some others.

The EU Digital COVID certificate or 'Green Pass' will be mandatory to travel to European countries and the document is likely to serve as proof that a person is vaccinated against COVID-19.