'Serum Institute yet to apply for marketing Covishield COVID vaccine in EU,' maintains EMA

As India awaits Covishield's inclusion into the 'EU Green Pass', the European Union's Medicines agency (EMA) has clarified on Thursday that Serum Institute of India (SII) is yet apply for formal marketing authorisation in the EU. EMA stated that only after SII applies can Covishield be evaluated for use in the EU. Nine European countries have approved Covishield allowing vaccinated travellers unrestricted movement.

EMA: SII yet to apply for distribution in EU

Covishield accepted in nine countries

On 2 July, EU member nations namely Austria, Germany, Slovenia, Greece, Iceland, Ireland and Spain accepted Covishield for the 'EU Green Pass', which came into force in July 1. Moreover other European states like Switzerland and Estonia too have allowed Covishield for entering their respective nations. The EU Green Pass allows unrestricted movement in all EU member states for business and tourism purposes.

SII CEO Adar Poonawalla said that he was in touch with EU regulators and at a diplomatic level with different countries to resolve Covishield's exclusion, while its British version -Vaxzevria was approved. In response, the EU pointed out that the European Medical Agency (EMA) has not received a request for Covishield to be approved. EU added that EMA does not investigate any drugs unless they are asked to do so by the companies and said that the member states of the EU have the option to accept vaccinations authorised by the WHO.

Covishield excluded from EU Green Pass

As European states started unlocking amid reduced COVID cases, the EU created the European COVID-19 travel certificate to restore the freedom of travel, removing entry bans, quarantine obligation, and testing, according to EU's official visa portal (schengenvisainfo.com). Though the member states are not legally obliged to implement the certificate, all EU member states have agreed to a 'Green Pass' to travel across the continent from July 1. Furthermore, three types of EU’s COVID-19 passport has been launched - Vaccination passport, Test certificate and Recovery certificate, based on the traveller’s status.

However, only four vaccines have been approved by the European Medicine Agency - namely Comirnaty (BioNTech, Pfizer), Moderna, Vaxzevria (previously COVID-19 Vaccine AstraZeneca, Oxford) and Janssen (Johnson & Johnson). Covishield - which is produced by SII in partnership with AstraZeneca, has not been specifically mentioned, leading to confusion as to whether Indians vaccinated on Covishield can travel to EU or not. As Bharat Biotech's Covaxin and SII's Covishield has been excluded, India said that it will recognise the EU digital Covid certificate in reciprocation for acceptance of both vaccines.