(Jim Hoft) The Food and Drug Administration on Monday granted its full approval of the COVID-19 antiviral treatment Veklury (remdesivir) for infants and young children. The treatment was previously under emergency use authorization for children.
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by Jim Hoft, April 25th, 2022
According to the news release, FDA would expand the treatment of Remdesivir to include pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7 pounds) with positive results of direct Covid-19 viral testing, and are either hospitalized or at high-risk of severe illness.
More from FDA, read here and below:
This action makes Veklury the first approved COVID-19 treatment for children less than 12 years of age. As a result of today’s approval action, the agency also revoked the emergency use authorization for Veklury that previously covered this pediatric population.
Before now, Veklury was only approved to treat certain adults and pediatric patients (12 years of age and older who weigh at least 40 kilograms, which is about 88 pounds) with COVID-19.
“As COVID-19 can cause severe illness in children, some of whom do not currently have a vaccination option, there continues to be a need for safe and effective COVID-19 treatment options for this population,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Today’s approval of the first COVID-19 therapeutic for this population demonstrates the agency’s commitment to that need.”
Veklury is not a substitute for vaccination in individuals for whom COVID-19 vaccination and booster doses are recommended. The FDA has approved two vaccines, and three vaccines are available for emergency use, to prevent COVID-19 and the serious clinical outcomes associated with COVID-19, including hospitalization and death. The FDA urges the public to get vaccinated and receive a booster when eligible. Learn more about FDA-approved and authorized COVID-19 vaccines.
Given the similar course of COVID-19 disease in adults and pediatric patients, today’s approval of Veklury in certain pediatric patients is supported by efficacy results from phase 3 clinical trials in adults. Information on the trials in adults can be found in the FDA-approved drug labeling for Veklury. This approval is also supported by a phase 2/3, single-arm, open-label clinical study of 53 pediatric patients at least 28 days of age and weighing at least 3 kilograms (about 7 pounds) with confirmed SARS-CoV-2 infection and mild, moderate or severe COVID-19. Patients in this pediatric phase 2/3 trial received Veklury for up to 10 days. The safety and pharmacokinetic results from the phase 2/3 study in pediatric subjects were similar to those in adults.
The only approved dosage form is Veklury for injection.
Possible side effects of using Veklury include increased levels of liver enzymes, which may be a sign of liver injury; and allergic reactions, which may include changes in blood pressure and heart rate, low blood oxygen level, fever, shortness of breath, wheezing, swelling (e.g., lips, around eyes, under the skin), rash, nausea, sweating or shivering.
The FDA granted approval to Gilead Sciences Inc.
About The Author
Jim Hoft is the founder and editor of The Gateway Pundit, one of the top conservative news outlets in America. Jim was awarded the Reed Irvine Accuracy in Media Award in 2013 and is the proud recipient of the Breitbart Award for Excellence in Online Journalism from the Americans for Prosperity Foundation in May 2016.
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the WHO banned the use of remdesivir at the end of 2020
Geneva: The World Health Organization (WHO) on Friday warned that the antiviral drug remdesivir should not be used to treat Covid-19 patients no matter how ill they are as there is no evidence it works.
“The panel found a lack of evidence that remdesivir improved outcomes that matter to patients such as reduced mortality, need for mechanical ventilation, time to clinical improvement, and others,” Xinhua news agency quoted the WHO’s Guideline Development Group (GDG) panel assaying in a statement.
“Any beneficial effects of remdesivir, if they do exist, are likely to be small and the possibility of important harm remains,” the panel added.