Serum Institute hasn't applied for full marketing approval of Covishield in Europe: Sources

A vial of the Oxford University-AstraZeneca COVID-19 vaccine, which is produced in India and marketed as Covishield (Representative image: Reuters)

Serum Institute of India (SII) hasn't applied for full marketing authorisation of Covishield in Europe, as it doesn't consider it as a core territory for vaccine distribution, sources told Moneycontrol.

However, the company through its partner AstraZeneca has reached out to the European Medicines Agency (EMA) in May seeking to consider SII as an alternate manufacturing site for the production of Covishield which is identical to AstraZenaca's Vaxzevria.

An email sent to AstraZeneca seeking clarification on the filing is yet to elicit a response.

EMA on July 16 said it hasn't received any application for authorisation of Covishield from the developer.

"For the COVID-19 vaccine Covishield to be evaluated for use in the EU, the developer needs to submit a formal marketing authorisation application to EMA, which to date has not been received," EMA said in a tweet.

EMA earlier said that even though (SII's Covishield) may use an analogous production technology to Vaxzevria, Covishield as such is not currently approved under EU rules.

"This is because vaccines are biological products. Even tiny differences in the manufacturing conditions can result in differences in the final product, and EU law, therefore, requires the manufacturing sites and production process to be assessed and approved as part of the authorisation process," the EMA spokesperson said earlier.

Many Indians who are vaccinated with Covishield are concerned about their travel plans to Europe, as European Union declined Green Pass or vaccine passports to travellers vaccinated with the jab produced in India. The pass is required for easy travel to and within the EU and will be launched from July 1.

The Indian government took up this diplomatically, and many countries since then have individually begun accepting Covishield. Covishield had received the WHO and UK MHRA approval as well.