No application received from SII for Covishield authorisation: EMA
New Delhi: The European Medicines Agency (EMA) said it 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 EMA has approved Pfizer BioNTech's Comirnaty, Moderna's Spikevax, AstraZeneca's Vaxzevria and Johnson and Johnson's Janssen as vaccines for COVID-19.
SII was confident of receiving approval from the European Medicines Agency (EMA) for its COVID-19 vaccine Covishield in a month, the company's CEO Adar Poonawalla had earlier said.
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.
Read also: Covishield to get EMA approval in a month: Serum Institute CEO Adar Poonawalla
Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.