- The use of the medicine was authorized to be used in the early stages of the viral disease, even before showing symptoms.
- President Trump was among the first to take publicly this remedy.
- Vaccines seem to still take precedence of the FDA
The United States Food Administration (FDA) has issued an emergency use authorization for Regeneron’s antibody cocktail to treat people who are in high-risk categories, those over 65, and younger people with medical conditions. This product was used on President Trump when he entered Wallter Reed Medical Center.
The use of the medicine was authorized to be used in the early stages of the viral disease, even before showing symptoms, but after having been tested positive. This is the first emergency authorization of the FDA for treatment of people in the early stages of Coronavirus.
After the outbreak of Coronavirus in March, a doctor in the Upstate New York town of Monroe, Dr. Vladimir Zelenko, experimented with early stage treatment of Coronavirus in his clinic using a combination of Hydrochloroquine Sulphate, Zinc Sulphate, and Azithromycin. He claimed exceptional success with his patients and notified President Trump about the possibility of using this combination to save lives of Americans.
President Trump received his recommendation from Dr. Zelenko, which requested emergency authorization for treatment from the FDA. The FDA, at this time, gave authorization for the use of Hydrochloroquine in hospitals for patients who had already developed symptoms needing hospitalization.
The idea of Dr. Zelenko was to use this treatment in the early stages of the infection and not in moderate or serious cases. Later, after experimenting with Hydrochloroquine in hospital use, the authorization was removed by the FDA as not effective or possibly being dangerous.
Until now, the FDA did not consider authorization of any medical solutions for patients in the early stages of the virus. Now, after President Trump has lost the election, the FDA has approved Rengeron’s antibody cocktail remedy for high risk Coronavirus patients and patients that have mild to moderate symptoms.
The treatment works best when used early on after diagnosis. The cocktail is being shipped nationwide and works by mimicking an immune system’s response to an infection. It has already reduced COVID-19 related hospitalizations and emergency room visits for people across the country.
The FDA now is beginning to act fast to respond to the urgent needs for patients instead of waiting for the disease to penetrate the lungs of the patients. Doctors in outpatient clinics now have a tool to prevent hospitalization and to save lives. The government will establish who will get the initial supply, which is enough for 300,000 people, which will surely be insufficient.
The CEO of Rengeron is encouraging federal and state governments to distribute the drug fairly. Further testing will be made to satisfy all the qualifications of the FDA for a complete approval, not only for emergencies.
Drugs have been recommended by doctors to treat Coronavirus in the early stages, but in the past, the FDA refused to consider these recommendations like hydroxychloroquine, Remdesvir, and other anti-viral drugs. There were front line doctors who were suspended for making decisions to use these drugs without FDA approval.
President Trump attempted to initiate the idea of treating COVID-19 in the early stages with Hydrochlorquine when he himself took the drug for prophylactic treatment to show that it was not dangerous. When he went into Walter Reed Medical Center, he was treated with this cocktail and Remdesvir, even before he developed symptoms.
Many people feel that the FDA did not act fast enough for Americans in high-risk categories, which could have prevented deaths. Dr. Zelenko and his recommendation was not given the proper attention by the FDA. They did not even make experiments to do research on the use of anti-virals on Coronavirus patients in the early stages.
Now that President Trump has lost the election, and vaccines have been developed, which are for sure important, the FDA has removed its sanctions on treatment of Coronavirus patients in the early stages with this cocktail.