New Delhi: The European Medicines Agency (EMA) has not obtained any approval request from the Serum Institute of India (SII), the producer of the COVID19 vaccine Covishield. EMA said at a press conference: “In order to evaluate the use of COVID19 Covishield antibody in the EU, developers must submit a formal marketing authorization application to EMA, but this has not yet been accomplished.”
The European Medicines Agency also added, “EMA’s The role is to evaluate the use of vaccines and drugs in the European Union. EMA does not assume any responsibility for the COVID19 vaccine accepted by the European Union for travel.”
So far, EMA has only approved four vaccines, namely Pfizer’s Comirnaty/BioNTech, Moderna’s Spike Vax, AstraZeneca Oxford’s Vaxzervria and Johnson & Johnson’s Janssen.
SII Executive Director Adar Poonawalla has previously stated that the company is confident of obtaining approval from the European Medicines Agency (EMA) for its COVID19 vaccine Covishield within one month.
Punawala said in a speech at the India Global Forum in 2021: “This is not a controversy, but a disproportionate one. The issue of vaccine passports should be based on mutual benefits between countries.”
“EMA requires that our application is absolutely correct. We did this through our partner AstraZeneca a month ago. This process takes time. Even the UK MHRA and WHO take time. We have already submitted it to the EU. Application. EMA,” added Poonawala.