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EU regulator urges caution on Sputnik COVID-19 vaccine

Sputnik V has already been approved or is being assessed for approval in three EU member states - Hungary, Slovakia and the Czech Republic - and EU officials have said Brussels could start negotiations with a vaccine maker if at least four member countries request it.

March 08, 2021 / 11:26 AM IST
Source: Reuters

Source: Reuters

A senior European Medicines Agency (EMA) official urged European Union members on Sunday to refrain from granting national approvals for Russian COVID-19 vaccine Sputnik V while the agency reviews its safety and effectiveness.

"We need documents that we can review. We also don't at the moment have data...about vaccinated people. It is unknown. That's why I would urgently advise against giving a national emergency authorisation," EMA managing board head Christa Wirthumer-Hoche told a talk show on Austrian broadcaster ORF.

"We can have Sputnik V on the market here in future when the appropriate data have been reviewed. The rolling review has begun now at EMA," she added after the agency said last week it had launched such a review.

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"Data packages are coming from Russian manufacturers and of course they will be reviewed according to European standards for quality, safety and efficacy. When everything is proven then it will also be authorised in the European Union," she added.

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COVID-19 Vaccine

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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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Sputnik V has already been approved or is being assessed for approval in three EU member states - Hungary, Slovakia and the Czech Republic - and EU officials have said Brussels could start negotiations with a vaccine maker if at least four member countries request it.

Wirthumer-Hoche said EMA's Committee for Medicinal Products for Human Use (CHMP) would hold an extraordinary meeting on March 11 to review Johnson & Johnson's COVID-19 vaccine for use in the EU.

"We expect a positive assessment and that the (European) Commission will quickly grant authorisation," she added.

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Reuters
first published: Mar 8, 2021 04:44 am

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