Mumbai: Serum Institute of India will not look for marketing approval separately from the European Regulator for the Covid-19 vaccine, Covishield, because its partner Astra Zeneca has requested that SII be considered an alternative manufacturing site.
Marketing approval is a requirement associated with Jab received as part of ‘Green Pass’ to travel to the EU.
UK drug company, AstraZeneca, who developed a vaccine with Oxford University, has asked the European (EMA) regulator treatment agency to add SII as a ‘alternative manufacturing site’, at the approval given by the vaccine, Vaxzevria.
So far, from 27 UE countries, 17 has received a covishield for quarantine-free trips.
The Covishield produced by SII is identical to those made by licensees, astrazeneca and used in Europe, therefore separate agreements are not needed, said the source to TOI.
The company does not need to apply for a marketing license because it will not market Covishield in Europe, they add.
Requests made by British companies to EMA made in May are waiting, and being processed.
“We have requested the addition of SII as an alternative manufacturing site on the Vaxzevria license,” A spokesman Astrazeneca told Toi.
Besides Astrazeneca, vaccines from Pfizer, Moderno and Johnson and Johnson have received EMA authorization and qualified for ‘vaccine passports.’.
It comes in the midst of troubleshooting and restrictions facing by some students flying to the EU to study, and people who want to travel to work.
COVID Digital EU or ‘Green Pass’ certificates come into force since 1.
July.
This, people People who have taken vaccines authorized by EMA will be released from restrictions on travel in the EU.
Individual countries can also receive vaccines that have been authorized at the national level or approved by WHO.
EU countries are encouraged to receive the authorized vaccine, experts said.
It can be noted that Sii’s Covishield is authorized by WHO earlier this year.
(With input from Indrani Bagchi)
SII will not look for special marketing nod from the EU body for Vax
