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Gilead's COVID-19 antiviral remdesivir gets conditional EU clearance

The decision comes just days after the company allocated nearly all of its supply of the antiviral to the United States over the next three months, stirring concerns about availability elsewhere.

July 03, 2020 / 07:34 PM IST

The European Commission said on Friday it had given conditional approval for the use of antiviral remdesivir in severe COVID-19 patients following an accelerated review process, making it the region's first therapy to be authorised to treat the virus.

The move comes just a week after the European Medicines Agency (EMA) gave its go-ahead for the drug produced by Gilead Sciences to be use in adults and adolescents from 12 years of age who are also suffering from pneumonia and require oxygen support.

It also comes just days after the company allocated nearly all of its supply of the antiviral to the United States over the next three months, stirring concerns about availability elsewhere.

"We will leave no stone unturned in our efforts to secure efficient treatments or vaccine against the coronavirus," said Stella Kyriakides, EU Commissioner for Health and Food Safety, in a statement.

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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 Commission said on Wednesday it was in negotiations with Gilead to obtain doses of remdesivir for the 27 European Union countries.

A conditional marketing authorisation is one of the EU regulatory mechanisms created to facilitate early access to medicines that fulfil an unmet medical need, including those for emergency situations in response to public health threats such as the current pandemic, the Commission said.

The agency reviews data as they become available on a rolling basis, while development is still ongoing. The EMA's rolling review begun at the end of April.

Remdesivir is in high demand after the intravenously-administered medicine helped to shorten hospital recovery times in a clinical trial. It is believed to be most effective in treating COVID-19 patients earlier in the course of disease than other therapies like the steroid dexamethasone.

Still, because remdesivir is given intravenously over at least a five-day period it is generally being used on patients sick enough to require hospitalisation.

 
Reuters

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