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Uncertainty persists over EMA approval for SII’s Covishield

An industry executive aware with the matter, however, contended that the certification is following a different route since Serum Institute of India – the maker of Covishield – will not seek to sell the vaccine.
By HT Correspondent, Hindustan Times, New Delhi
UPDATED ON JUL 17, 2021 04:15 AM IST
A vial of the Covishield Covid-19 vaccine, developed by Oxford-Astrazeneca Plc. and manufactured by Serum Institute of India Ltd., at a vaccination center set up at a school in Dharamshala, Himachal Pradesh. (Bloomberg)

The European Medicines Agency (EMA) on Thursday said it was yet to receive a market authorisation application for Covishield, which is yet to be recognised by the European Union (EU) for vaccination certifications that may soon become mandatory for international travel.

An industry executive aware with the matter, however, contended that the certification is following a different route since Serum Institute of India – the maker of Covishield – will not seek to sell the vaccine. Instead, along with its UK-based partner AstraZeneca, it is seeking to be recognised as an alternative production site for the Oxford-AstraZeneca dose.

“EMA is technically not wrong because the application that has been sent via AstraZeneca is not really for grant of market authorisation in EU. It is actually for grant of approval to recognise SII as an alternate manufacturing site of the AstraZeneca vaccine. EMA would obviously say no if you ask them if Serum has applied for marketing authorisation because it is not an application for full marketing authorisation,” said this person who asked not to be named. “It is basically an extension of the already granted approval to AstraZeneca’s vaccine, Vaxzevria. They have not applied for full marketing authorisation (for Covishield), and rightly so as Europe is not Serum’s territory to market Covishield. This arrangement was clear from the start that Europe is AstraZeneca’s territory,” this person added.


When contacted, an AstraZeneca spokesperson confirmed: “We have requested the addition of Serum Institute of India as an alternative manufacturing site on the Vaxzevria licence.”

To be sure, the request is a variation to the marketing authorisation process, and not a full marketing authorisation.

In a tweet on Thursday, EMA said: “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 has approved Pfizer BioNTech’s Comirnaty, Moderna’s Spikevax, AstraZeneca’s Vaxzevria and Johnson & Johnson’s vaccine for Covid-19.

Covishield is one of the four vaccines that have been granted emergency use authorisation by the Indian drugs regulator Drugs Controller General of India, and it accounts for nine of every 10 doses given to people in India.

The person quoted above said the SII application to EMA was sent along with all necessary documents in May. “Ideally travel should have been allowed based on the WHO emergency use listing,” said the person familiar with the matter.

To be sure, India is still on blacklists of most countries for incoming travel due to the prevalence of the Delta variant, which is linked to faster transmission and somewhat more severe disease.

SII chief executive officer Adar Poonawalla said at an event recently that the company was confident of receiving approval from the EMA in about a month’s time. Speaking at India Global Forum 2021 on June 30, Poonawalla said: “It is not a controversy, it is just that blown out of proportion and the issue of vaccine passports should be on the basis of reciprocity between the countries.”

“EMA is absolutely correct in asking us to apply, which we have through AstraZeneca, a month ago, and that process has to take its time,” added Poonawalla

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