India is seeking approval from the European Medicines Agency (EMA) for Covishield, one of its COVID-19 vaccines. Covisheld approval is being sought on an emergency authorisation basis from the bloc’s apex medical regulatory body.
The Serum Institute of India (SII) manufactures Covishield, which is the Indian variant so to speak of the COVID-19 vaccine produced by drugmaker AstraZeneca. That jab – Vaxzevria – is approved for authorisation in the European Union. However, Covishield approval has yet to be granted with the vaccine presently ineligible for a so-called ‘green pass’ which would allow those vaccinated with the SII-manufactured jab to travel to European Union member states. Covishield inoculations presently account for the majority of vaccinations in India, accounting for 284 million of the approximately 323 vaccinations administered.
Covishield is one of three vaccines authorised for use in India, alongside Russian-manufactured Sputnik-V and indigenously-manufactured Covaxin by Bharat Biotech. Research recently suggested a single dose of Covishield may be sufficient to protect against COVID-19 for those previously infected with the novel coronavirus.
The European Union has stated that “concerning a possible EMA authorisation for Covishield, as of yesterday, the…EMA stated that it had not received a request for approval. It will examine any such request when received, as per its procedures.”
“The only COVID-19 vaccine from AstraZeneca for which a marketing authorisation application was submitted to and evaluated by EMA, leading to its authorisation in the EU, is Vaxzevria,” EMA spokesperson Alessandro Faia said. “In the EU, the vaccine called Covishield does not currently have a marketing authorisation. Even though it may use an analogous production technology to Vaxzevria (the COVID-19 AstraZeneca vaccine authorised in the EU), Covishield as such is not currently approved under EU rules.”
SII chairman Adar Poonawalla is reported by the Press Trust of India as having said to Minister of External Affairs Dr Subrahmanyam Jaishankar that “India has a large population. However, not including Covishield into the EU COVID-19 Vaccination Passport will not allow Covishield vaccinated people to travel to European countries and this will affect students, business travellers back and forth, and cause severe disruptions to our economy and to the global economy.” On Twitter, Poonawalla said “I realise that a lot of Indians who have taken COVISHIELD are facing issues with travel to the E.U., I assure everyone, I have taken this up at the highest levels and hope to resolve this matter soon, both with regulators and at a diplomatic level with countries.”
Presently, the EMA has approved four vaccines for emergency use within the bloc. These include Vaxzevria, the vaccine manufactured by BioNTech and Pfizer (Comirnaty), the vaccine manufactured by Johnson & Johnson (Janssen), and the Moderna vaccine.