European drug regulator says 'no application received yet' for Covishield approval
PremiumThe Serum Institute had earlier this month said that it is confident of receiving approval from the EMA for Covishield
The European Medicines Agency (EMA) has said that it has not yet received any authorisation application from the developers of the Covishield vaccine, reported news agency ANI.
"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.
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The Serum Institute of India (SII) -- producer of Covishield in India -- had said in the last week of June that it has applied for emergency use authorization (EUA) for its Covid-19 vaccine with the EMA.
“I realize that a lot of Indians who have taken Covishield are facing issues with travel to the EU. I assure everyone I have taken this up at the highest levels and hope to resolve this matter soon, both with the regulators and at a diplomatic level with countries," said Adar Poonawalla, chief executive officer (CEO) of SII.
A day after this as well, the European medical body had said that it has not received a request for approval of Covishield.
Why is it significant?
Recognition from the EU is necessary for people to people avail the EU Digital Covid Certificate or "Green Pass" that aims to facilitate free movement during the Covid-19 pandemic.
Under this framework, persons who have taken vaccines authorised by the EMA will be exempted from travel restrictions within the EU region. The document will be mandatory to travel to European countries.
The individual member states have the flexibility to also accept vaccines that have been authorised at the national level or those recognised by the WHO.
The EMA has approved Pfizer BioNTech's Comirnaty, Moderna's Spikevax, AstraZeneca's Vaxzevria and Johnson and Johnson's Janssen as vaccines.
Presently, a total of 15 countries in the EU have confirmed that they will allow travellers from India who have taken the Covishield shots to enter their territory.
Why Covishield not approved?
India's version of AstraZeneca's coronavirus vaccine (Covishield) is not authorised in the EU due to the possibility of "differences" with the original, the EMA was earlier quoted as saying by news agency AFP.
"Even though it may use an analogous production technology to Vaxzevria (AstraZeneca's vaccine), Covishield as such is not currently approved under EU rules," the drug regulator had said.
"This is because vaccines are biological products. Even tiny differences in the manufacturing conditions can result in differences in the final product, and EU law therefore requires the manufacturing sites and production process to be assessed and approved as part of the authorisation process," it added.
The World Health Organization has however approved Covishield and lamented the fact that some countries were rejecting Covishield's use on vaccination passes.
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