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Japan approves Gilead Sciences' remdesivir as COVID-19 drug

Japan reached the decision just three days after the US drugmaker filed for fast-track approval for the treatment.

May 07, 2020 / 10:00 PM IST

Japan on Thursday approved Gilead Sciences Inc's remdesivir as a treatment for COVID-19, making it the country's first officially authorised drug to tackle the coronavirus disease.

Japan reached the decision just three days after the US drugmaker filed for fast-track approval for the treatment.

"There has so far been no coronavirus medicine available here so it is a significant step for us to approve this drug," a Japanese health ministry official said at a press briefing. Remdesivir will be give to patients with severe COVID-19 symptoms, he added.

With no other approved treatments for COVID-19, interest in the drug is growing around the world. Administered by intravenous infusion, it was granted authorisation last week by the US Food and Drug Administration for emergency use for the disease caused by the novel coronavirus.

Gilead says the drug has improved outcomes for people suffering from the respiratory disease and has provided data suggesting it works better when given in the early stages of infection.

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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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Japan, with just over 16,000 infections and under 800 deaths, has recorded fewer cases than other major industrialized nations.

However, a steady rise in cases has put pressure on medical facilities in some parts of the country, and a drug that helps patients recover more quickly could help in freeing up hospital beds.

A trial performed by the US Institutes of Health (NIH) showed the drug cut hospital stays by 31 percent compared with a placebo treatment, although it did not significantly improve survival.

On Monday, Japanese Prime Minister Shinzo Abe extended a month-long state of emergency until the end of May in an attempt to slow the spread of the coronavirus.

Japan as yet does not know when it will get its first doses of remdesivir or how much, the health ministry official said.

Gilead on Tuesday said it was in discussion with several companies, including generic drugmakers in India and Pakistan to produce remdesivir in large quantities.

Remdesivir, which previously failed as a treatment for Ebola, is designed to disable the ability by which some viruses make copies of themselves inside infected cells.

Follow our full coverage of the coronavirus pandemic here.
Reuters

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