AstraZeneca wants Serum Institute of India listed as manufacturing site

AstraZeneca asked the European Medicines Agency (EMA) to add Serum Institute of India (SII) as a manufacturing site for the Covid vaccine developed by the British-Swedish company at the end of May. It hasn’t applied for full marketing authorisation for SII’s Covishield, which may cast some uncertainty over the European regulator's approval for the India-made vaccine, according to people with knowledge of the process.
“We have requested the addition of Serum Institute of India as an alternative manufacturing site on the Vaxzevria licence,” an AstraZeneca spokesperson told ET. The EMA has approved AstraZeneca’s Vaxzevria but Covishield, which is made by SII using the same technology, hasn’t got the nod.

Adar Poonawalla, CEO of SII, had said on July 13 that the company had applied for EMA approval at the end of May for Covishield through AstraZeneca and hoped to get this in less than a month.

The AstraZenaca statement comes days after EMA said that it hadn't got any application to authorise Covishield.

Travel from India is currently restricted by most countries. But once these restrictions are removed, the absence of Covishield from the list of approved jabs could prevent travel to those countries that are

Travel Plans may be Affected

The AstraZenaca statement comes days after EMA said that it hadn't got any application to authorise Covishield.

Travel from India is currently restricted by most countries. But once these restrictions are removed, the absence of Covishield from the list of approved jabs could prevent travel to those countries that are yet to grant an approval. To be sure, more than 15 European countries have given their assent to Covishield without waiting for the EMA’s green light.

The EMA website lists four vaccines under rolling review--Sputnik V, Covovax, Curevac and Sinovac.

As reported by ET last month, the EMA has not mandated that Covishield be accepted by countries that issue the Green Pass, intended to ease travel within the European Union.