Antibody treatment of coronavirus may aid in overcoming the spread of the disease. The outbreak of coronavirus causes drastic effects on individuals and countries. Pharmaceutical companies and scientists are working day and night to find a cure or permanent solution for coronavirus. One of the possible treatments is the use of monoclonal antibodies. However, the antibody treatment for COVID-19 is under investigation.
The antibody is also known as immunoglobulin. It is a large Y-shaped protein whose production initiates due to the presence of a foreign body. The human immune system is responsible for the production of antibodies. One of the five types of lymphocytes is B-lymphocytes. These B-lymphocytes produce antibodies when they detect any foreign body, including bacteria or viruses.
Each antibody is specific to the specific antigen present on the outer surface of the pathogen. An antigen is an infectious agent that attaches to the host’s cells and causes damage to the host’s cells. Antibodies attach to antigens and form an antigen-antibody complex.
Furthermore, the purpose of this complex is to make pathogens unable to bind and attack the host’s cells.
The antibody-antigen complex is also known as immune-complex. The immune system conducts various processes like phagocytosis, complement deposition, or action of proteases, to break down or kill the immune complex. Thus, the activity of the immune system renders the pathogen inactive. Furthermore, white blood cells may also kill the pathogen.
Regeneron is a pharmaceutical company. Furthermore, it’s working to develop REGN-COV2, a novel anti-viral antibody cocktail. REGN-COV2 has the potential to treat people with COVID-19 and also to prevent SARS-COV-2 infection.
Moreover, via genetic engineering production of virus-neutralizing antibodies occurs. Moreover, isolation of the antibodies that are present in the blood of coronavirus patients that have recovered is a must. Thus, REGN-COV2 contains two types of antibodies with a different mechanism of action. However, both antibodies work to treat and prevent COVID-19 infection.
REGN-COV2 has reached Phase 3 of clinical trials. Phase 3 studies are in process with the help of the National Institute of Allergy and Infectious Diseases (NIAID). The company has doses available for approximately 50,000 patients. By the next few months, the company aims to have doses for 300000 patients.
The company is working to achieve maximum production capacity. Furthermore, safety profiles have positive outcomes. However, research is ongoing. Regeneron is collaborating with Roche to increase the supply of REGN-COV2 across the globe. Moreover, after approval from the FDA, Regeneron will distribute REGN-COV2 in the U.S. Furthermore, Roche will be responsible for distribution outside the U.S.
Approval For REGN-COV2 (Antibody cocktail) From FDA
According to Regeneron, the company has applied to the U.S. Food and Drug Administration. Furthermore, to get approval to use monoclonal antibody therapy in case of emergency. The company states that they have an agreement with the U.S government for initial doses of REGN-COV2.
Furthermore, in case of approval for emergency use authorization, the government will distribute the initial-doses in the American population without any charges.
President Donald Trump, after the approval of the FDA, was given REGN-COV2. Hence, Regeneron wants the U.S. Food and Drug Authority to approve REGN-COV2 for emergency use. According to Regeneron CEO Dr. Leonard Schleifer, no side-effects have become visible to Trump. Moreover, after the administration of an 8-gram dose of treatment. Furthermore, this class of drug is extremely safe and boosts the immune system.
The response to Regeneron REGN-COV2 varies from person to person. Dr. Richard Besser is a former acting director of the U.S. Centers for Disease Control and Prevention. According to him, antibody therapy does seem to be logical. But without considering the safety data profile, it is not easy to recommend it.
Furthermore, he thinks that the company is more concerned about the potential business it can make rather than science. However, Dr. Thomas Frieden suggests that REGN-COV2 has the potential to provide promising treatment.