Gilead's drug remdesivir gets US FDA's emergency use authorisation for COVID-19

The EUA will facilitate broader use of remdesivir to treat hospitalized patients with severe COVID-19 disease, enabling access to remdesivir at additional hospitals across the country

Moneycontrol News

May 02, 2020 / 14:33 IST

Gilead Sciences office (REUTERS/Stephen Lam/File Photo)

Gilead Sciences on May 2 announced that the United States Food and Drug Administration (USFDA) has granted emergency use authorisation (EUA) for the investigational antiviral remdesivir to treat COVID-19.

Remdesivir is now authorised for emergency use for the treatment of hospitalised patients with severe COVID-19 disease. The optimal duration of treatment is still being studied in ongoing clinical trials. Under the EUA, both 5-day and 10-day treatment durations are suggested, based on the severity of disease.

US President Donald Trump, on May 1, said that the FDA has granted Emergence Use Authorisation (EUA) for the investigational antiviral remdesivir.

Also Read | Exclusive: Gilead says open to collaborate with govts, drug firms to make Remdesivir globally available

The authorization is temporary and does not take the place of the formal new drug application submission, review and approval process, the company said.

COVID-19 Vaccine

Frequently Asked Questions

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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