FDA Authorizes Two Monoclonal Antibodies For Treatment

Monoclonal antibodies are lab-made proteins that are used to enhance the power of the immunity system to fight against infection. Monoclonal antibodies can enable one to protect the body and battle harmful pathogens. These antibodies are specifically made to build strong immunity and block Sars-CoV-2. The Monoclonal antibodies can prevent the human cells from the infection and restrict the entry of the virus into the body. 

FDA Authorizes Two Monoclonal Antibodies For Treatment

The two monoclonal antibodies Bamlanivimab and Etesevimab were earlier permitted by the FDA to treat low to moderate Covid patients. 

However, As per the official announcement made by the FDA on December 3, 2021, FDA revised these norms and authorized these monoclonal antibodies for all younger patients including newborns. The authorization gave approval on the administration of these antibodies. The approval stated that now Bamlanivimab and Etesevimab can be given together for post-exposure and prevention of Covid 19 infection. 

https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/patrizia-cavazzoniPatrizia Cavazzoni, M.D., director of the FDA’s Center for Drug commented on this expansion and authorization. He said that “Due to the rise in the number of Covid infection cases across the US, all children including newborns are at a high risk of infection. 

The move of the FDA is to make treatment and post-exposure prevention accessible to all. Children under the age of one who are already exposed to the virus are at high risk. This authorization is an attempt to fulfill their medical needs and prevent Covid 19 in children.”. He also emphasized the fact that; therapeutic treatment is just a means to prevent the infection. It is not a substitute for vaccines. 

As per the major health officials in the United States, The vaccine is one of the best ways to protect and shield oneself against the Corvid 19 infection. He emphasized the significance of the vaccine and urged citizens to come forward and take their shot of vaccination. No matter what type of variant arises in the future, vaccination is the only alternative to safeguard the lives of people. 

Dr. Anthony Fauci has advocated that eligible adults must not wait for the booster shots and get it done as soon as possible. 

FDA to support the authorization conducted a trial on 125 pediatric patients. The motive was to evaluate the safety of the antibodies on the children. The results of the trial mentioned the safety and efficiency of the antibodies on the Paediatric patients. 

The wake of the new Covid variant ‘Omicron’ is gaining global attention. FDA is still speculating the effectiveness of these monoclonal antibodies on the new covid variant. Several trials and tests are being conducted across the country to study the characteristics, contagiousness, and impact of the new variant. Meanwhile, the government is working continuously by expanding vaccination centers, promoting booster shots, and introducing rules for international travelers.

The World Health Organization is acting as a watchdog and keeping an eye on all the latest developments on the Omicron variant of Covid 19. Medical Authorities in the United States are working efficiently with the vaccine manufacturing companies to increase the effectiveness of the vaccine.

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