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Serum applies for EMA's emergency nod amid Covid vaccine certificate row

Serum applies for EMA's emergency nod amid Covid vaccine certificate row

Serum Institute of India (SII) has applied for emergency use authorisation with the European Medicine Agency (EMA) at a time when beneficiaries of Covishield were termed ineligible for travelling to the EU

Covishield is one of the vaccines that has received emergency use listing from WHO Covishield is one of the vaccines that has received emergency use listing from WHO

Domestic pharma giant Serum Institute of India (SII) has applied for emergency use authorisation with the European Medicine Agency (EMA) for its Covishield COVID-19 vaccine. The application has come at a time when beneficiaries of Covishield were termed ineligible for travelling to the European Union.

On the issue, SII CEO Adar Poonawalla tweeted on Monday, "I realise 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 regulators and at a diplomatic level with countries".

SII had applied for an emergency use authorisation with the EMA, the firm expects the vaccine to be cleared soon, LiveMint quoted sources familiar with the development.

Poonawalla's tweet came out after reports emerged that the EU's digital COVID-19 certificate, which is needed to travel in the region, is not recognising SII's Covishield COVID-19 vaccine.

According to the reports, EU's guidelines state that only those who have been administered EMA approved vaccine will be considered vaccinated. It adds that member states can extend coverage to travellers who have been administered other vaccines "that have been authorised at national level or by the World Health Organization (WHO)". Covishield is one of the vaccines that has received emergency use listing from WHO.

COVID-19 vaccines developed by AstraZeneca, Pfizer, Moderna and Johnson and Johnson have received EMA's emergency use authorisation. Those administered these vaccines are eligible for the EU's digital certificate. As per the EU guidelines, the last dose of the vaccine must have been administered at least 14 days before the digital certificate was issued.

EU is also allowing in non-vaccinated individuals. The digital certificate will cover travellers who tested negative for COVID-19 either through a rapid antigen test or an RT-PCR test before setting foot in the EU. Infected individuals must have recovered from COVID-19 at least 180 before travelling. The test results of the PCR test will only be accepted if the test was taken less than 72 hours prior to travel. In the case of rapid antigen, this time limit is 48 hours.

As for other vaccines being administered in India, developers of Covaxin - Bharat Biotech - and Sputnik V - Gamaleya Research Institute of Epidemiology and Microbiology - are both currently seeking emergency use approval from the WHO.

Also Read: COVID-19: Over 1.15 cr vaccine doses available with states, UTs: Centre

Also Read: COVID-19: Current vaccines may be less effective against Beta variant, says UK study

 

Published on: Jun 28, 2021, 10:34 PM IST
Posted by: Mohammad Haaris Beg, Jun 28, 2021, 10:25 PM IST