Confident of receiving EMA approval for Covishield in a month, says Adar Poonawalla

Serum Institute of India (SII) chief executive Adar Poonawalla has said the Pune-based vaccine maker is confident of receiving approval from the European Medicines Agency (EMA) for its Covid-19 vaccine, Covishield, in about a month. He also said the issue of vaccine passports depends on "reciprocity" between the two 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 at India Global Forum 2021, PTI reported.

He said Covishield is based on AstraZeneca data and is more or less like it. "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 said.

He also said the issue of vaccine passport was a different one. "What I am trying to say is that let us take a manufacturer outside of India. Let's say they have been approved by WHO and everyone in that country gets vaccinated taking that product and now when those citizens need to travel, what good is their vaccine certificate if it is not acknowledged and reciprocity is not there between the countries," Poonawalla said.

Poonawalla on Monday said he took up the issues being faced by Indians vaccinated with Covishield in travelling to European Union (EU). Reports say Covishield may not be a part of the vaccines approved by EU for its 'vaccine passport' for travel to the member states.

While Vaxzevria, COVID-19 vaccine developed by AstraZeneca-Oxford, produced in Europe and UK is likely to be part of the vaccine passport, Covishield has been left out. Covishield is AstraZeneca-Oxford's vaccine manufactured in India by SII.

"I realise that a lot of Indians who have taken COVISHIELD are facing issues with travel to the EU, 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," Poonawalla tweeted on Monday.

Covishield and Bharat Biotech's Covaxin were approved by Indian drug regulator in January this year for the country's vaccination programme against COVID-19. In April, Russia's Sputnik V vaccine was also granted approval by the regulator, while many other vaccines are in the pipeline and are undergoing clinical trials. SII has told the Drugs Controller General of India (DCGI) that it has produced over 10 crore doses of Covishield in June so far.

Also read: Covishield left out of EU travel list: Poonawalla to take up issue, hopes for quick resolution