Covishield did not apply for approval, says EMA on leaving it out of its ‘Green Pass’

Covishield has been an important part of the international COVAX alliance, the vaccines with this initiative meed to have the WHO’s approval and on the other side, the Green Pass initiative was based on the EMA’s approval.

The new vaccine passport programme of Europe recognises a few vaccines whose recipients would be able to travel in and out of Europe with fewer roadblocks than others, it includes the AstraZeneca vaccine but not India’s Covishield.

Covishield was derived from AstraZeneca’s shot called Vaxzevria outside India. Shahid Jameel, a Virologist, said that the Vaxzevria and Covishield were qualitatively same.

Serum Institute of Pune which makes the Covishield in India with a license from AstraZeneca did not apply for the vaccine to be approved by the European Medicines Agency (EMA).

The EMA’s email to Serum Institute had not elicited a response at the time of publication.

Adar Poonawalla, the CEO of Serum Institute said that last year in September, that the company and the Government of India had committed to reserve half the company’s stock for India and to supply the remaining to low income nations through GAVI. Hence the Serum Institute did not need to apply for EMA’s approval.

Covishield has been an important part of the international COVAX alliance, the vaccines with this initiative meed to have the WHO’s approval and on the other side, the Green Pass initiative was based on the EMA’s approval.

The EMA regulated drugs and medical products in the European nations, thr nation’s vaccine passport programme also called the ‘Green Pass’ had approved four vaccines only. The vaccines approved were Vaxzevria, Comitnaty, Spikevax, and Jansseen – Johnson & Johnson.

The doses of the Oxford AstraZeneca COVID-19 vaccines, Vaxzevria, is largely produced by three firms which are the S.K Biosciences in South Korea, Serum Institute of India, and the four manufacturing sites of AstraZeneca.

So far, WHO had given an emergency nod to eight COVID-19 vaccines, whereas the India’s major COVID-19 vaccine, Covaxin, had neither been approved by WHO nor the EMA.

In an assessment on February 2021 of Covishield after the Serum Institute filed an application for emergency use approval experts of the WHO also noted that various parameters of the immune response induced by the two vaccines, Covishield and Vaxzevria, were comparable.

The drug-regulating bodies like EMA or the India’s Drug Controller General, receives applications from manufacturers for approval, even the different manufacturers of the same vaccine need to file separate applications as the approval process involves an inspection of the manufacturing facilities.

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