Serum Institute of India (SII) is confident of getting approval for Covishield from European Medicines Agency (EMA) within a month.
SII’s CEO Adar Poonawalla also said that the issue of vaccine passports should be on the basis of reciprocity between 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. An approval process even with UK MHRA, WHO took its time and we have applied to the EMA,” Poonawalla said on Wednesday.
“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. So it’s just a matter of time. It is not really going to hinder anything,” he added.
Covishield, the Oxford-AstraZeneca vaccine against COVID-19 being manufactured in India by Serum Institute, is not on EMA’s list for inclusion in Green Pass, which will be issued from July 1 to people travelling to European Union countries.
Union External Affairs minister S Jaishankar also raised the issue with Josep Borell Fontelles, senior EU representative on foreign policy.
“Discussed vaccine production and access. Took up ‘Covishield’ authorisation for travel to Europe. Will be following up,” Jaishankar tweeted after meeting Borell on the sidelines of G-20 foreign ministers’ meeting in Italy.
