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Gilead puts emergency access to experimental coronavirus drug on hold amid surging demand

Remdesivir has been touted by many - including President Donald Trump - as one of the more promising potential treatments for the virus.

March 23, 2020 / 11:39 AM IST

Gilead Sciences Inc said on Sunday that it was temporarily putting new emergency access to its experimental coronavirus (COVID-19) drug Remdesivir on hold due to overwhelming demand and that it wanted most people receiving the drug to participate in a clinical trial to prove if it is safe and effective.

The drugmaker said in a statement that there had been an exponential increase in so-called compassionate-use requests for the drug. The spread of the virus in Europe and the United States has "flooded an emergency treatment access system that was set up for very limited access to investigational medicines and never intended for use in response to a pandemic," it said.

Gilead said it would keep processing previously approved requests.

Remdesivir has been touted by many - including President Donald Trump - as one of the more promising potential treatments for the virus.

The company said that it was shifting from a system of individual compassionate-use requests to expanded access programs, which it expects will start in a similar time frame that new requests for compassionate use would have been processed.

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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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Gilead said it would make exceptions for pregnant women and children under 18 with severe COVID-19, the highly contagious respiratory disease caused by the coronavirus.

"Enrollment in clinical trials is the primary way to access Remdesivir to generate critical data that inform the appropriate use of this investigational medicine," Gilead said.

There are currently no approved treatments or preventive vaccines for COVID-19. Researchers are studying existing treatments and working on experimental ones, but most current patients receive only supportive care such as breathing assistance.

Other potential treatments - like malaria drugs chloroquine and hydroxychloroquine - are in short supply as demand has surged with the rapid spread of the outbreak. Some states have already taken steps to limit prescriptions of the drugs to those who need them most.
Reuters
first published: Mar 23, 2020 11:30 am

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