FDA Approves Coronavirus Vaccine
Chief scientist for the Food and Drug Administration (FDA), Denise Hinton, issued a letter of approval to Gilead Sciences, Inc. giving the company full approval to issue the drug Remdesivir–also known as Veklury–to hospitals for the treatment of all patients with COVID-19 on Oct 22.
This approval comes after the results of phase three trials conducted by Gilead were declared to have “met all applicable scientific and legal standards and demonstrated that Veklury is safe and effective for the approved use” by the FDA.
Remdesivir is an antiviral drug that works by preventing a virus from duplicating, which stops it from spreading. It was created in 2009 by Gilead Sciences Inc. as a hopeful treatment of Hepatitis C. It ultimately failed at its intended use, but after being restudied and tested, it was found to have antiviral properties which made it successful in the treatments of Ebola Viruses and SARS.
In May, Gilead was granted Emergency Use Approval (EUA) in hospitals to administer Veklury in emergency situations for patients with severe cases of COVID-19.
On Aug. 28, the EUA was revised to allow Gilead to expand its treatment to patients with COVID-19, even if the case wasn’t considered severe.
In a scientific study conducted by the World Health Organization in September, 533 patients that had been diagnosed with COVID-19 received Remdesivir treatment and concluded that the patients “did not have a statistically significant difference in clinical status compared with standard care”
Gilead responded to the WHO’s criticism and said the findings “appeared inconsistent with evidence from other studies validating the clinical benefit of Remdesivir, which was used to treat U.S. President Donald Trump’s coronavirus infection.”