Home India No Application Received For Covishield Authorisation, says EU Medical Body

No Application Received For Covishield Authorisation, says EU Medical Body

No Application Received For Covishield Authorisation, Says EU Medical Body

Covishield has also been excluded despite holding emergency use listing by WHO

New Delhi:

The European Medicines Agency (EMA) has not received any application from the Serum Institute of India for authorisation of Covishield, a  COVID-19 vaccine, almost a fortnight after the EU introduced the EU Digital Covid Certificate that makes intra-EU travel possible.

“For the COVID19-vaccine Covishield to be evaluated for use in the EU, the developer needs to submit a formal marketing authorisation application to EMA, which to date has not been received,” the EMA said at a press meeting.

The EMA had earlier said minor differences in manufacturing processes could result in differences in the final product, and the EU law required assessments as part of the authorisation process.

So far, the EMA has approved only those vaccinated by either of the four vaccines – Comirnaty of Pfizer/BioNTech, Moderna’s Spikevax, Vaxzervria by AstraZeneca-Oxford and Johnson & Johnson’s Janssen – for restriction-free travel within the EU during the pandemic.

India’s Covishield vaccine, developed on AstraZeneca’s formula, is not among the authorised vaccines under the EMA. The lack of authorisation for Covishield is creating hurdles for Indian travellers to the EU.

Covishield has also been excluded despite holding an EUL, or emergency use listing, from the World Health Organization; the EUL was granted in February and it is one of only seven vaccines on that list.

This means people vaccinated with Covishield will be subject to quarantine protocols as enforced by individual member countries, and may even be blocked from entering some others.

Serum Institute CEO Adar Poonawalla had said last month that he was “taking this up at the highest levels… with regulators and diplomats” and that he “hoped to resolve this matter soon”.

Source link


India Logged 39,361 Cases In 24 Hours Monday, Marginally Lower Than Sunday

<!-- -->The country also reported 416 deaths over a 24-hour period Monday (File)New Delhi: India Monday added 39,361 cases of coronavirus in 24...

Religious Code Violated During Uttarakhand Chief Minister Pushkar Singh Dhami’s Gurdwara Visit: Top Sikh Body

<!-- -->Uttarakhand Chief Minister Pushkar Singh Dhami recently visited Gurdwara Sri Nanakmatta SahibAmritsar: The Shiromani Gurdwara Parbandhak Committee (SGPC) Monday claimed that the...

Rs 2 Crore Reward, Promotion For Weightlifter Mirabai Chanu After Olympic Silver

<!-- -->Mirabai Chanu lifted a total of 202kg in the 49kg categoryNew Delhi: Minister for Railways Ashwini Vaishnaw felicitated weightlifter Mirabai Chanu on...


Please enter your comment!
Please enter your name here

Most Popular

Britney Spears files petition to remove her father from her conservatorship

Britney Spears and her lawyer officially petitioned a judge on Monday to remove her father, James Spears, from the conservatorship that has controlled...

US Secretary Of State Antony Blinken Arrives In India Today; Extensive Agenda For Talks

<!-- -->The Indo-US defence ties have been on an upswing in the last few years.New Delhi: US Secretary of State Antony Blinken will...

Tokyo Olympics: Indians Misfire In 10m Mixed Air Pistol Qualifiers, Fail To Make Finals

Manu Bhaker, Saurabh Chaudhary failed to make it to the medal round of Air Pistol mixed team.© Getty ImagesThe Indian pair of Saurabh...

Melbourne To Lift Lockdown As Delta Outbreak Contained

<!-- -->Pedestrians walk through the quiet streets of Melbourne.Melbourne, Australia: Melbourne's coronavirus lockdown will be lifted late Tuesday, as authorities signalled a Delta...

Recent Comments