'Not received Covishield approval request,' says EU body amid concerns
The Serum Institute of India (SII) has not yet applied for the approval of its coronavirus vaccine Covishield in the "Green Pass" issued by the European Union, according to a statement from the EU. The Green Pass allows unrestricted travel within all the EU member countries for business and tourism purposes. Covishield's exclusion had sparked concerns over Indians facing issues in traveling to Europe.
"Concerning a possible EMA authorization for Covishield, as of yesterday, the European Medicine Agency (EMA) stated that it had not received a request for approval. It will examine any such request when received, as per its procedures," the EU statement read, according to reports. On Monday, Serum CEO Adar Poonawalla said he had taken up the matter and hoped it would be resolved soon.
"I realize that a lot of Indians who have taken COVISHIELD are facing issues with travel to the E.U., I assure everyone, I have taken this up at the highest levels...both with regulators and at a diplomatic level with countries," Poonawalla had tweeted yesterday.
The exclusion of Covishield from the EU pass implies that Indians or other nationals who have been vaccinated with this jab would not be eligible for restriction-free travel within European countries. They would hence be subject to strict rules concerning quarantine and testing as enforced by each country they travel to. However, EU member countries are free to include other vaccines in the list.
The EMA has listed four vaccines - Vaxzevria (developed by Oxford-AstraZeneca), Comirnaty (Pfizer-BioNTech), Spikevax (Moderna), and Janssen (Johnson & Johnson). Both Covishield and Vaxzevria are notably the same jab developed by the Oxford University and UK-based AstraZeneca. While Covishield is manufactured in India by the SII, Vaxzevria is manufactured in the United Kingdom and other locations across Europe.
The EMA also said that even tiny differences in the manufacturing conditions can result in differences in the final product. "This is because vaccines are biological products," EMA press officer Zala Grudnik said, according to India Today.
Covishield is India's most prevalent coronavirus vaccine as the country has administered more than 28 crore doses of this jab. India has two other approved COVID-19 vaccines - the indigenously-developed COVAXIN and Russia's Sputnik V vaccine. Though over 19% of the Indian population has received at least one dose, just above 4% of Indians have been fully vaccinated as yet.