France has joined several other European countries to allow international travellers who have been administered Covishield, a version of AstraZeneca vaccine manufactured by Pune-based Serum Institute of India (SII). Many EU member states have started accepting visitors vaccinated with Covishield after global outcry over the fact that the European Medicines Agency (EMA) has not recognised the India-made vaccine for the ‘Green Pass’.
“Because the vaccines are effective against the virus, and in particular its variant Delta, the constraints weighing on travellers benefiting from a complete vaccination schedule with a vaccine recognised by the European Medicines Agency (Pfizer, Moderna, AstraZeneca or Janssen) will be raised from this Saturday, July 17, regardless of the country of origin,” French Prime Minister Jean Castex said in a statement.
The technical specifications of the ‘Green Pass’ suggests that obligation on the EU member states would be limited to “vaccines that have received EU-wide marketing authorization.” The EMA has approved Comirnaty (Pfizer/BioNTech), Moderna, Vaxzervria (AstraZeneca), Janssen (Johnson & Johnson). But the member states have the option to allow travellers with vaccination certificates other than those approved by the EMA.
After the controversy over the EU digital Covid certificate erupted in late June, SII chief Adar Poonawalla said that the company is expecting to receive approval from the EMA within a month. Taking to Twitter, Poonawalla said that he has taken up the issue at the “highest levels” and “hope to resolve this matter soon, both with regulators and at a diplomatic level with countries.”
Poonawalla had then said that the EMA was “absolutely correct” in asking the SII to apply for approval, adding that the company has already applied for it through AstraZeneca. “We are quite confident that in a month EMA will approve Covishield. There is no reason why not to because it is based on AstraZeneca data and our product is identical to AstraZeneca more or less and it has been approved by WHO, UK MHRA,” Poonawalla added.
The EMA, however, on Thursday said that it has not received a formal marketing authorisation application from the developer to date. It stressed that the manufacturer needs to submit the application for Covidshield to be evaluated for use in the European Union. The EU health regulator also said that it evaluates vaccines and medicines for their use in the EU and it has no responsibility regarding vaccinations accepted for travel purposes.
