New Delhi: The European Medicines Company (EMA) has not obtained any software from the COVID-19 vaccine Covishield maker Serum Institute of India (SII) for authorisation. “For the COVID-19 vaccine Covishield to be evaluated to be used within the EU, the developer must submit a proper advertising and marketing authorisation software to EMA, which up to now has not been obtained,” the EMA stated at a press briefing.
The European Medicines Company additionally added that “EMA’s remit is the analysis of vaccines & medicines in view of their use within the EU. EMA has no duty relating to COVID19 vaccinations accepted within the EU for journey functions.”
For the #COVID19vaccine Covishield to be evaluated to be used within the EU, the developer must submit a proper advertising and marketing authorisation software to EMA, which up to now has not been obtained. #EMAPresser
— EU Medicines Company (@EMA_News) July 15, 2021
Thus far, the EMA has permitted solely 4 vaccines particularly, Comirnaty of Pfizer/BioNTech, Moderna’s Spikevax, Vaxzervria by AstraZeneca-Oxford and Johnson & Johnson’s Janssen.
The SII’s CEO Adar Poonawalla had earlier stated that the corporate is assured of receiving approval from the European Medicines Company (EMA) for its COVID-19 vaccine Covishield in a month.
Talking at India World Discussion board 2021, Poonawalla stated, “It isn’t an argument, it’s simply that blown out of proportion and the problem of vaccine passports ought to be on the premise of reciprocity between the international locations.”
“The EMA is completely appropriate in asking us to use, which we have now by AstraZeneca, our companions, a month in the past, and that course of has to take its time. Even the UK MHRA, WHO took its time and we have now utilized to the EMA,” added Poonawala.
(With ANI inputs)
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