All About FDA’s Antibody Treatment Authorization

Food and Drug Administration Authority officials recently authorized the monoclonal form of antibody treatment for COVID. The treatment is called REGEN-COV, and it got the nod under the emergency use authorization.

The treatment is valid for adults and children of 12 years and above exposed to SARS-COV-2 and those who might be at higher risk of contracting COVID-19.

The FDA officials believe that REGEN-COV treatment can be effective post-exposure prophylaxis to COVID-19, especially for patients at higher risk of contracting the virus. These patients may be at risk of hospitalization or even death. The officials express these views in a letter to the company that makes these products.

Officials further added that even though the product has known and potential risks, these risks are outweighed when used in severe conditions mentioned earlier.

So, how does REGEN-COV work? In a recent post, Healthline shared some interesting insights about REGEN-COV and how it works to cure COVID-19 patients showing severe symptoms.

Expert Opinion Suggest Monoclonal Antibodies are Critical for COVID-19 Treatment

According to Dr. William Schaffner, an expert on infectious diseases at Vanderbilt University, Tennessee, monoclonal antibodies have a critical role in fighting COVID-19 agents inside the body.

He believes that there is way too much focus on vaccines, and it’s a pleasant change as scientists try their hands-on therapeutic forms of treatment. Moreover, it’s quite essential, given that a lot of people have become seriously ill. Therefore, it’s only logical to take whatever help is available right now.

COVID-19 virus.

Given that Vanderbilt University is a hub for monoclonal antibody COVID-19 treatment, there is an obvious emphasis on this form of treatment from an infectious disease expert.

Taking the Right Measures Ensure Proper Treatment

Dr. Schaffner also added that they have set up a special clinic for the treatment. It’s encouraging to see that the clinic admins and stakeholders are convinced that the treatment methods can work. In addition, they believe that the treatment can prevent COVID-19 symptoms from becoming more severe, thus saving lives.

Schaffner said that when a person is assessed for certain conditions and symptoms, monoclonal antibody treatment becomes available for them.

He also added that it might not be necessary to have severe symptoms. At times, even the minor symptoms can fall into the eligibility criteria. The whole point of the exercise is to prevent the disease from getting stronger.

Suppose you talk about those who are at higher risks. In that case, nursing home workers, unvaccinated or partially vaccinated, and immunocompromised individuals are mainly the ones most likely to be affected.  

Treatment Focuses on Attacking the Virus Early

Generally, monoclonal antibodies are designed to attach to the critical parts of the virus. So, these antibodies attach to the SARS-COV-2 virus and help the immune system get stronger while responding to the attacks from the virus.

The three monoclonals used for the treatment are authorized for emergency use to help to prevent the disease from getting any stronger inside the body. The idea is to reduce the severity level of the illness to that specific level.

The Disease Progresses in Two Phases

According to Dr. Schaffner, the disease develops through two stages. Firstly, it leaves the throat and the bronchial tracts and spreads in the lungs. From there, it travels throughout the body through the bloodstream.

From that point, the virus starts to infect the organs, which eventually causes organ dysfunction. Upon the dysfunctions, the body’s immune system gets into the action, recognizes the intruder, and starts to fight it.

However, the immune system can often overreact to the intruder, causing pneumonia and other lung damage. Schaffner believes it’s likely bombing a city to kill the enemy troops. However, bombing will also cause damage to the civilians, which is not affordable when it comes to the internal organs.

Therefore, the monoclonal antibodies come in handy by acting proactively. They attack the virus in the initial phase before it gets out of control. In addition, since the antibodies attach themselves to the virus, they prevent these viruses from entering new cells and multiplying further.

Effectively, they don’t let the virus reach stage two, so there are no chances of an overreactive response from the immune system. So, they are like snipers pointed at the enemy and not the bombs that destroy entire colonies.

Monoclonal Treatment is Effective but Not a Substitute for Vaccines

Someone holding a COVID vaccine and needle.

The FDA also clarified that even though the treatment is an effective method to prevent the disease, people should not think of it as a vaccine substitute.

Therefore, everyone must continue to get their vaccines and only consider the treatment in case of emergency or when they are exposed to the virus.

Schaffner added that he often advises his patients that prevention is better than the cure. It’s easier to fight from the front than to deal with it at the backend. Moreover, the vaccination process is so simple, so why not try it.


Even though some experts suggest that treatment may not be a great substitute for vaccination, there are many reasons to believe that monoclonal antibody treatment can help people at higher risk of contracting the COVID-19 virus.

As more results come up, the experts are hopeful that the treatment might gain substantial working proof to be established across the country and worldwide. Therefore, the quiet approval from FDA seems to be a valuable decision in the fight against COVID-19.

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