FDA issues emergency use authorization to Gilead Services Inc for the use of the drug remdesivir to treat severely ill COVID-19 patients
On May 1, 2020, the U.S. Food and Drug Administration (FDA) has issued the emergency use authorization (EUA) to the biopharmaceutical company, Gilead Services Inc., for the use of the drug remdesivir to treat severely ill COVID-19 patients who are hospitalized and in need of breathing support.
The FDA says that remdesivir will be given intravenously to severely ill COVID-19 patients who have “low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a medical ventilator.”
Secretary of Health and Human Services Alex Azar is quoted as saying about the FDA’s decision, “FDA’s emergency authorization of remdesivir, two days after the National Institutes of Health’s clinical trial showed promising results, is a significant step forward in battling COVID-19 and another example of the Trump Administration moving as quickly as possible to use science to save lives.”
Two days before the FDA issued the EUA to Gilead Services Inc., one of the researchers and lead investigator, Dr. Andre Kalil, working on the COVID-19 treatment trials spoke with CNN’s Chris Cuomo about his team’s findings.
Dr. Kalil told Cuomo that on February 21, 2020, his team began testing remdesivir on a critically ill patient who was aboard the Diamond Cruise Ship.
According to Dr. Kalil, the patient recovered four days faster than those who did not receive the drug. Other severely ill COVID-19 patients who were given the drug recovered within the same time.
Dr. Kalil also noted that when treated with remdesivir the chances of a severely ill COVID-19 patient dying decreased from 11.6% to 8.0%.
The testing of the remdesivir drug on severely ill COVID-19 patients has been done at approximately 70 sites, in 7 countries, with the United States having the most sites, 50, and the remaining 20 sites being spread out over 6 countries ((South Korea, Singapore, Japan, Denmark, Germany, and Spain).
Dr. Kalil and the FDA have stressed that remdesivir is a drug that should only be used on COVID-19 patients who are severely ill.
And therefore, remdesivir should not be given to the public because it is not, as Dr. Kalil told Cuomo, “a cure” but “a treatment” for severely ill COVID-19 patients who have pneumonia, have been hospitalized, and are in need of a ventilator and or who have other respiratory illnesses.
Like all drugs, there are side effects associated with taking the remdesivir drug. Those side effects are an inflamed liver, low drop in blood pressure, feeling nauseated, vomiting, water dripping everywhere because of sweat, and shivering like you’re cold.
I know there are those of you who are saying to yourself, “I can just light up a Mary J, feel better, and not have to worry about any side effects.”
The only problem with all of that is Mary J doesn’t cure you of the COVID-19 and you’ll probably end up in the dirt where they plant all the Mary J.
Plus, I’ve heard that COVID-19 makes you so sick that not even Mary J can take the pain away.
Therefore, just stick to what the docs say and y’all should be all right.
The FDA says that remdesivir will be given intravenously to severely ill COVID-19 patients who have “low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a medical ventilator.”
Secretary of Health and Human Services Alex Azar is quoted as saying about the FDA’s decision, “FDA’s emergency authorization of remdesivir, two days after the National Institutes of Health’s clinical trial showed promising results, is a significant step forward in battling COVID-19 and another example of the Trump Administration moving as quickly as possible to use science to save lives.”
Two days before the FDA issued the EUA to Gilead Services Inc., one of the researchers and lead investigator, Dr. Andre Kalil, working on the COVID-19 treatment trials spoke with CNN’s Chris Cuomo about his team’s findings.
Dr. Kalil told Cuomo that on February 21, 2020, his team began testing remdesivir on a critically ill patient who was aboard the Diamond Cruise Ship.
According to Dr. Kalil, the patient recovered four days faster than those who did not receive the drug. Other severely ill COVID-19 patients who were given the drug recovered within the same time.
Dr. Kalil also noted that when treated with remdesivir the chances of a severely ill COVID-19 patient dying decreased from 11.6% to 8.0%.
The testing of the remdesivir drug on severely ill COVID-19 patients has been done at approximately 70 sites, in 7 countries, with the United States having the most sites, 50, and the remaining 20 sites being spread out over 6 countries ((South Korea, Singapore, Japan, Denmark, Germany, and Spain).
Dr. Kalil and the FDA have stressed that remdesivir is a drug that should only be used on COVID-19 patients who are severely ill.
And therefore, remdesivir should not be given to the public because it is not, as Dr. Kalil told Cuomo, “a cure” but “a treatment” for severely ill COVID-19 patients who have pneumonia, have been hospitalized, and are in need of a ventilator and or who have other respiratory illnesses.
Like all drugs, there are side effects associated with taking the remdesivir drug. Those side effects are an inflamed liver, low drop in blood pressure, feeling nauseated, vomiting, water dripping everywhere because of sweat, and shivering like you’re cold.
I know there are those of you who are saying to yourself, “I can just light up a Mary J, feel better, and not have to worry about any side effects.”
The only problem with all of that is Mary J doesn’t cure you of the COVID-19 and you’ll probably end up in the dirt where they plant all the Mary J.
Plus, I’ve heard that COVID-19 makes you so sick that not even Mary J can take the pain away.
Therefore, just stick to what the docs say and y’all should be all right.
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