BackSerum Institute applies for European regulator's EUA amid vaccine passport issues
Move follows reports that people vaccinated with Covishield weren’t being allowed to enter EUReports said EU’s vaccine passport recognizes Astra-Zeneca’s Vaxzevria but not Covishield
PremiumNEW DELHI : Serum Institute of India (SII) has applied for an emergency use authorization (EUA) for its covid-19 vaccine with the European Medicines Agency (EMA), following reports that those who were administered Covishield were not being allowed to enter the European Union (EU).
“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 on Twitter.
The company has recently applied for an EUA with the EMA, said a person aware of the development. “The clearance is expected soon," he said, seeking anonymity.
Poonawalla‘s statement follows news reports that the EU’s digital covid vaccine certificate for travelling in the region, or ‘vaccine passport’, recognizes AstraZeneca’s covid-19 vaccine Vaxzevria but not Covishield, SII’s version of the vaccine.
According to EU guidelines, only beneficiaries who have received vaccines authorized by the EMA will be considered vaccinated, while member states can extend this to travellers who have received another vaccine “that have been authorized at the national level or by the World Health Organization (WHO)". Covishield had received an emergency use listing from WHO in February. Besides AstraZeneca, vaccines candidates from Pfizer, Moderna, and Johnson and Johnson have received the EMA’s authorization and are eligible for the vaccine passport.
According to the guidelines, the second dose of the vaccine must be administered at least 14 days before the certificate is issued. Generally, it takes about two weeks after the final dose for immunity to reach optimum levels.
The digital certificate will also cover people who have a negative covid-19 test result using either the RT-PCR test or the rapid antigen test, or patients recovered from covid-19 at least 180 days earlier. Negative RT-PCR test results will be accepted if they are done 72 hours before the certificate is issued. For the antigen test, the timeline is 48 hours.
Recipients of Bharat Biotech International’s Covaxin and Russia’s Sputnik V are also not eligible as the vaccines are not authorized either by WHO or the EMA. Both Bharat Biotech and the innovator of Sputnik V, Gamaleya Research Institute of Epidemiology and Microbiology, have sought WHO’s emergency use licence.
Last week, Bharat Biotech executives met WHO officials before submitting data for its EUA application. It expects the authorization in July-September.
Vaccine passports are gaining significance as several countries such as the US, UK and the EU start opening borders for travellers from other countries with stringent conditions.
The US and the EU are giving preference to their own regulators over WHO.
In an interview with Mint last week, R. S. Sharma, chief executive officer, National Health Authority, and chairman, CoWin panel, had said that while WHO had initially formed a committee to look at multilateral agreements on vaccine passports, the group is “apparently not functioning" now, and countries, including India, now have to look at bilateral pacts.
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