The domestic pharmaceutical giant Serum Institute of India (SII) has applied for an emergency use authorization for the Covishield COVID-19 vaccine from the European Medicines Agency (EMA). This application was made when Covishield beneficiaries were deemed ineligible for a trip to the European Union.
SII CEO Adar Poonawalla tweeted on this issue on Monday, “recognizing that many Indians taking Covishield are facing problems when traveling to the EU. This issue is regulated. It quickly becomes a problem, both at the authorities and at the diplomatic level with the country. “
SII has applied for an emergency use authorization with the EMA, and the company expects the vaccine to be cleared soon, Live Mint quoted sources familiar with the development.
Poonawalla’s tweet was released after reports that the EU’s digital COVID-19 certificate required to travel the area did not recognize SII’s Covishield COVID-19 vaccine.
According to the report, EU guidelines state that only those who have been vaccinated with EMA-approved vaccines are considered vaccinated. Member States add that coverage can be extended to travelers who have received other vaccines “approved at the national level or by the World Health Organization (WHO)”. Covishield is one of the vaccines that received an emergency use list from WHO.
The COVID-19 vaccine, developed by AstraZeneca, Pfizer, Moderna and Johnson & Johnson, is licensed for emergency use by EMA. Those who receive these vaccines are subject to EU digital certificates. According to EU guidelines, the final dose of vaccine must be given at least 14 days before the digital certificate is issued.
The EU also allows unvaccinated individuals. Digital certificates are intended for travelers who have been negative for COVID-19 by either a rapid antigen test or an RT-PCR test prior to entering the EU. Infected individuals must recover from COVID-19 at least 180 times before traveling. The test results of the PCR test will only be accepted if the test is done within 72 hours of travel. For rapid antigens, this time limit is 48 hours.
For other vaccines administered in India, the developers of Covaxin (Bharat Biotech) and Sputnik V (Gamaleya Research Institute of Epidemiology and Microbiology) are currently seeking an emergency use authorization from WHO.
Serum is applied to the EMA emergency nod in the Covid vaccine certificate column
https://www.businesstoday.in/industry/pharma/story/serum-applies-for-emas-emergency-nod-amid-covid-vaccine-certificate-row-299934-2021-06-28?utm_source=rssfeed Serum is applied to the EMA emergency nod in the Covid vaccine certificate column