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SII won’t seek special marketing nod from EU body for vax – Times of India


MUMBAI: Serum Institute of India will not be seeking a separate marketing approval from Europe’s regulator for its Covid-19 vaccine, Covishield, as its partner Astra Zeneca has asked that SII be considered as an alternative manufacturing site. The marketing approval is a requirement linked to the jab being accepted as part of ‘Green Pass’ for travel to the EU.
UK drug company, AstraZeneca, which developed the vaccine with Oxford University, has asked the regulator European Medicine Agency (EMA) to add SII as ‘an alternative manufacturing site’, on the approval given for its vaccine, Vaxzevria.
So far, of the 27 EU countries, 17 have accepted Covishield for quarantine-free travel. SII-manufactured Covishield is identical to the one made by its licensee, AstraZeneca and used in Europe, hence a separate approval is not required, sources told TOI. The company does not need to apply for a marketing licence as it will not be marketing Covishield in Europe, they added.
The request made by the UK firm to the EMA made in May is pending, and is being processed. “We have requested the addition of SII as an alternative manufacturing site on the Vaxzevria licence,” an AstraZeneca spokesperson told TOI. Besides AstraZeneca, vaccines from Pfizer, Moderna and Johnson and Johnson have received EMA’s authorisation and are eligible for the ‘vaccine passport’. This comes in the midst of issues and travel restrictions being faced by several students flying to the EU to study, and people wanting to travel for work.
The EU’s Digital Covid certificate or ‘Green Pass’ came into effect from July 1. Under this, people who have taken vaccines authorised by EMA will be exempted from travel restrictions within the EU. Individual member-states can also accept vaccines that have been authorised at the national level or approved by the WHO.
EU member-states are encouraged to accept WHO-authorised vaccines, experts say. It may be noted that SII’s Covishield was authorised by WHO earlier this year.
(With inputs from Indrani Bagchi)





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