FDA Authorizes First Antibody Treatment To Be Used As Preventive Tool After COVID19 Exposure In The US

People who are at a higher risk of being diagnosed with severe COVID19 infection along with those who are dealing with compromised immune systems now will have an option of receiving preventive monoclonal antibody care if they are exposed to the SARS-CoV-2 virus. The US Food and Drug Administration (FDA) has recently authorized an injectable COVID19 antibody treatment to be used as a preventive means after exposure. Health experts from the FDA have said that around 3 percent of people living in the US who are dealing with compromised immune systems, autoimmune ailments, HIV, organ transplants, and cancer will be benefitted from the new antibody treatment that has been given a green signal by the officials of the FDA. Health experts have said that these people might be at a higher risk of being diagnosed with COVID19 even after vaccination. The new antibody treatment is known as REGEN-COV, said the experts. The lead researcher of the study, Dr. Myron Cohen has said that monoclonal antibodies offer protection against serious COVID19 infection. He has said that monoclonal antibodies can eliminate COVID19 infection while it is present in the nose and throat only and does not let the infection grow in the body. The new antibody treatment has been developed by experts from the University of North Carolina at Chapel Hill. The lead author of the study has said that it is a kind of race between scientists to make a preventive treatment to protect the lungs and the rest of the body from the virus. Experts from the US Food and Drug Administration (FDA) have said that new antibody treatment should not be considered a substitute for vaccination. They have said that people who are eligible for COVID19 vaccination should definitely take vaccines.

Dr. Ghady Haidar has said that issuing emergency use authorization (EUA) to the new antibody treatment is a good move. He has said that people who do not respond to COVID19 vaccines well or are unable to develop enough antibodies can be protected from being infected with the SARS-CoV-2 virus if exposed. Such people can be given the new antibody treatment after virus exposure. Dr. Ghady Haidar is a transplant infectious diseases expert at the University of Pittsburgh Medical Center. Dr. Haidar has been a part of the study that has found that people who have gone through organ transplants and who are dealing with cancer and compromised immune systems are not able to enough antibodies after taking COVID19 shots. However, this study has not been peer-reviewed. There is a growing body of evidence that proves that patients who have weaker immune systems might not be protected after vaccination. Health experts have said that monoclonal antibody treatment can offer protection against fatal COVID19 disease, hospital admissions, and deaths. However, the usage of this treatment is quite limited, as it needs to be given via an IV infusion within 10 days of COVID19 symptoms showing up. As the FDA has given expanded authorization to the treatment, the Regeneron antibody blend can be administered as an injection. Health experts have said that the first dose of this antibody treatment should be given within 96 hours of virus exposure. The FDA has given the sanction to the Regeneron antibody treatment after seeing the findings of the large-scale clinical trial of the antibody blend. Regeneron’s monoclonal antibody cocktail consists of casirivimab and imdevimab antibodies.

The clinical trial has enrolled participants from the United States, Romania, and Moldova. These people have been household contacts of people who have been diagnosed with COVID19 within the past four days. These people have been kept in two different groups. One group has been given a single intramuscular injection of the treatment. People in the control group have been given a placebo. Around 1500 people have been included in the trial. Around 7.8 percent of the people who have been given antibody injections have started showing symptoms of COVID19 within four weeks as compared to 1.5 percent of people in the placebo group. Health experts have said that the antibody treatment has been able to reduce the risk of severe infection by 81 percent. For people who have started showing symptoms of the virus, the treatment has helped them clear the infection much faster. The treatment has reduced the duration of their symptoms as well. All participants have tested negative for COVID19 before they have been given the treatment, said the experts. Experts have said that antibody care has lessened the risk of being diagnosed with severe signs of COVID19 by 32 percent in those who have tested positive for asymptomatic COVID19 infection at the time of study over the next four weeks. None of them who have been given the antibody care have been hospitalized. On the other hand, around 10 people from the placebo group have been admitted to the hospitals. Although the trial has included very few people who have been dealing with the compromised immune system, the FDA has recognized people of this demographic as entrants for preventive care. The study has included people who have been at a greater risk of exposure to infected people at work, in hospitals, or prisons. Health experts have said that people who are at ongoing risk of exposure to the virus from close contact can be given repeated doses of the treatment per month. The makers of the antibody treatment have said that the cost of the care will be covered by the US government. The officials from the FDA have said that only those who are not vaccinated or are dealing with autoimmune disease and are at a higher risk of severe disease are eligible to receive antibody care. People who are living in proximity with people who are have diagnosed with the disease as well are eligible to take the new treatment. Dr. Katharine Bar has said that the new treatment is a kind of reassurance for people who are at a greater risk of exposure to the virus. Dr. Katharine Bar is an infectious disease expert at the University of Pennsylvania.