New Delhi: The European Medicines Agency (EMA) has not received any application from the COVID-19 vaccine Covishield maker Serum Institute of India (SII) for authorisation. “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,” the EMA said at a press briefing.
The European Medicines Agency also added that “EMA’s remit is the evaluation of vaccines & medicines in view of their use in the EU. EMA has no responsibility regarding COVID19 vaccinations accepted in the EU for travel purposes.”
For the #COVID19vaccine 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. #EMAPresser
— EU Medicines Agency (@EMA_News) July 15, 2021
So far, the EMA has approved only four vaccines namely, Comirnaty of Pfizer/BioNTech, Moderna’s Spikevax, Vaxzervria by AstraZeneca-Oxford and Johnson & Johnson’s Janssen.
The SII’s CEO Adar Poonawalla had earlier said that the company is confident of receiving approval from the European Medicines Agency (EMA) for its COVID-19 vaccine Covishield in a month.
Speaking at India Global Forum 2021, 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.”
“The EMA is absolutely correct in asking us to apply, which we have through AstraZeneca, our partners, a month ago, and that process has to take its time. Even the UK MHRA, WHO took its time and we have applied to the EMA,” added Poonawala.
(With ANI inputs)