India questions EU refusal to approve Covishield vaccine

Indian officials are scrambling to figure out why the country’s Covishield vaccine has not been included in the list of jabs that the European Union (EU) has approved for its digital Covid certificate.

Starting July 1, the EU has put in place a system of ‘green pass’ that will allow vaccinated people to travel between 27 member states and four other countries - Iceland, Norway, Switzerland and Liechtenstein. 

The vaccines approved by the European Medicines Agency (EMA) include Pfizer/BioNTech’s Comirnaty, Moderna, Johnson & Johnson’s Janssen and Vaxzervia by AstraZeneca. 

It also means people who have been inoculated by Covishield or Covaxin, another Indian vaccine, will have to complete a mandatory quarantine period if they travel to the EU. 

The Covishield developed by Serum Institute of India (SII) under a license is the same as the AstraZeneca vaccine. 

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Hundreds of millions of people in India and other developing countries including many in Africa have received Covishield shots. 

Meanwhile, eight European countries — Germany, Slovenia, Austria, Greece, Iceland, Ireland, Spain and Switzerland — have reportedly included Covishield on their list of approved jabs.

“I see no need to regard the SII vaccines as being any different to the AZ vaccines,” Professor Stephen Evans, of the London School of Hygiene and Tropical Medicine, told TRT World. 

“SII have generally in the past had a very good record for producing vaccines. I cannot predict what the EMA and the EC (European Council) will do, but would hope that they would be sensible and base decisions on data regarding the manufacturing standards.” 

The privately owned SII is the world’s largest vaccine producer, churning out more than a billion doses a year for illnesses ranging from tetanus, measles to hepatitis. It’s Covid-19 vaccine is among those developing countries are relying upon to vaccinate their populations. 

Professor Evans said the decision of EMA to not include Covishiled in the ‘green pass’, which is like a vaccination passport, might be part of the regulatory process. “If SSI has not applied for an authorisation in the EU then the EMA cannot issue an authorisation without such an application.” 

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The UK MHRA has made clear that  the regulatory standard set for the SII vaccines is to be exactly at the same levels as the AZ vaccine, he said. 

Adar Poonwalla, SII’s CEO, told Indian news agency PTI that he was hopeful that the EU will approve his company’s vaccine in about a month’s time. 

“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.” 

But the Indian government has taken issue with the EU decision with The Hindu reporting that New Delhi is considering a retaliation by making quarantine mandatory for citizens of European countries that have refused to accept the efficacy of Indian vaccines. 

"Indeed this does not seem fair. In particularly because the SII vaccine is listed by the WHO since February of this year," Ellen t' Hoen, director at the Medicine Law and Policy, an NGO which advocates affordable drugs, told TRT World. 

International travel is already suspended or made difficult by quarantine requirements in many countries. But Indian officials fear that the EU decision can become an excuse for other governments to deny Indian citizens entry. 

India has slowly recovered from a second wave of pandemic, which overwhelmed hospitals and resulted in thousands of deaths. 

“I see no need to regard the SII vaccines as being any different to the AZ vaccines,” said Professor Evans.