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Govt may nudge Serum to apply for EMA clearance for Covishield, taking up matter at diplomatic level with European Union

The EMA has so far approved only four vaccines, including the Vaczevria version of the AstraZeneca vaccine, for use in the EU

June 28, 2021 / 07:54 AM IST
The Centre, on May 13, increased the gap between two doses of the AstraZeneca vaccine to 12-16 weeks from the earlier 6-8 weeks and said that this was based on a recommendation from the COVID-19 Working Group. (Representative Image: AP)

The Centre, on May 13, increased the gap between two doses of the AstraZeneca vaccine to 12-16 weeks from the earlier 6-8 weeks and said that this was based on a recommendation from the COVID-19 Working Group. (Representative Image: AP)

Government may nudge the Serum Institute of India (SII) to apply for clearance from the European Medicines Agency (EMA) for inclusion in the ‘Green Pass’ vaccine passport programme for the entry of Covishield-vaccinated Indians to Europe, and is also taking up the matter at the diplomatic level both with the European Union and individual European countries .

The EMA has so far approved only four vaccines, including the Vaczevria version of the AstraZeneca vaccine, for use in the EU and hence, for the ‘Green Pass’ programme which is to kick in from July 1, allowing people vaccinated with those four vaccines entry into Europe.

SII is yet to apply to EMA for similar authorisation to Covishield as the company did not make any supplies to the EU so far. A senior government official told News18 that the SII may now be nudged to do so and “follow the due process” for EMA authorisation, the same way as the World Health Organisation (WHO) has approved the Indian Covishield vaccine.

Simultaneously, the Indian government through the diplomatic channels is also speaking to the European Union and various European countries on the issue as EMA has given European countries some liberty to allow entry to people jabbed with other vaccines too.

The Ministry of Foreign Affairs may make a case here that since Covishield is already approved by WHO and its virtual twin, Vaczevria, is approved by EMA as well, Indians jabbed with Covishield be considered “vaccinated” and allowed “green entry” to the European countries.

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COVID-19 Vaccine

Frequently Asked Questions

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How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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“The thumb rule should be that vaccines approved by WHO should also be considered by the EMA for the ‘Green Pass’ programme, or the various European countries under EU should adopt the same,” a senior government official said.

As per the website of the EMA, only four vaccines have so far got approval for EU - Comirnaty (Pfizer), Spikemax (Moderna), Vaxzevria (AstraZeneca) and Janssen. Four more vaccines are “currently under rolling review” including Sputnik V, but that does not include SII’s Covishield implying that SII is still to apply for clearance. EMA also says “no marketing authorisation applications are currently under evaluation” with it.

The road for EMA clearance may, however, be tougher for India’s other vaccine, Bharat Biotech’s COVAXIN, which is still to get clearance from the WHO too.

A query sent by e-mail to EMA was unanswered by the time this report was published. It will be updated when the EMA responds.
Aman Sharma is a writer at News18
first published: Jun 28, 2021 07:54 am
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