New Delhi [India], July 16 (ANI): The European Medicines Agency (EMA) stated it has not obtained any utility 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 stated at a press briefing.
The EMA has permitted Pfizer BioNTech’s Comirnaty, Moderna’s Spikevax, AstraZeneca’s Vaxzevria and Johnson and Johnson’s Janssen as vaccines for COVID-19.
SII was assured of receiving approval from the European Medicines Agency (EMA) for its COVID-19 vaccine Covishield in a month, the corporate’s CEO Adar Poonawalla had earlier stated.
Speaking at India Global Forum 2021, Poonawalla stated, “It is just not an issue, it’s simply that blown out of proportion and the difficulty of vaccine passports ought to be on the idea of reciprocity between the nations.”
“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.
