Not received any application from SII for authorisation of Covishield vaccine in EU: European Medicines Agency

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KEY STORY

  • The European Medicines Agency (EMA) on Thursday claimed that it is yet to receive an application from the Serum Institute of India (SII) for the marketing authorisation of its Covid-19 vaccine ‘Covishield’ in the European Union.
  • “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 EU medical agency has officially recognised Pfizer-BioNTech’s Comirnaty, Moderna’s Spikevax, AstraZeneca’s Vaxzevria and Johnson & Johnson’s Janssen as Covid-19 vaccines for people travelling to member countries.

“Serum Institute is confident of getting approval from the EMA for its Covid-19 vaccine Covishield in a month,” CEO Adar Poonawalla had said earlier.
He said that the issue of the European Union not recognising Covid-19 vaccines from India is “not a controversy” as it is imperative that vaccine manufacturers must take approval.

CONCLUSION

“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,” Poonawala said at the India Global Forum 2021, according to news agency ANI.
Belgium, The Netherlands, Latvia, Finland, Austria, Germany, Slovenia, Greece, Iceland, Ireland, Estonia, Spain and Switzerland are the only countries in the European Union that have recognised Indian vaccines so far.

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