Monoclonal Antibodies (mAb) Bebtelovimab. Effective on Omicron Variants?
February 14, 2022. The US Food and Drug Administration approved Eli Lilly And Co’s COVID-19 antibody drug for persons aged 12 and older who are at risk of severe illness on Friday, adding a tool that has been shown to work against the highly contagious Omicron variant.
Bebtelovimab has been approved by the FDA for emergency use in patients with mild-to-moderate COVID-19, who are at high risk of progressing to severe disease, including hospitalization or death.
According to FDA, “Today’s action makes available another monoclonal antibody that shows activity against omicron, at a time when we are seeking to further increase supply,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research.
“This authorization is an important step in meeting the need for more tools to treat patients as new variants of the virus continue to emerge.”
What is a monoclonal antibody?
Monoclonal antibodies are laboratory-created molecules that act as replacement antibodies, restoring, enhancing, or mimicking the immune system’s attack on cells.
To fight infection, your body naturally produces antibodies. Your body, on the other hand, may lack antibodies developed to recognize a novel or new variant of virus, such as SARS-CoV-2, the virus that causes COVID-19.
Monoclonal antibodies, or mAbs, are created in a laboratory to combat a specific illness (in this case, SARS-CoV-2) and are sent directly to you by infusion. If you are at high risk of significant symptoms or hospital admission, the mAb treatment may be beneficial.
The discovery of monoclonal antibodies to combat COVID-19 is critical for several reasons, including
- Until a COVID-19 vaccine is available, monoclonal antibodies may be a viable approach for prevention.
- For those who have been exposed but have not yet been vaccinated, monoclonal antibodies may be able to give prompt protection or therapy.
- People who cannot establish or maintain an appropriate immune response following vaccination, such as elderly adults, (Eligibility Given Below) may require monoclonal antibodies.
Monoclonal Antibody (mAb) and vaccines are the same?
A COVID-19 mAb therapy is not the same as a COVID-19 vaccination. The vaccine stimulates your body’s natural immune response, but it can take weeks for adequate antibodies to build against a virus.
A vaccine stimulates and prepares your immune system to respond if you are exposed to the virus.
Monoclonal antibodies stimulate the immune system after you’ve already been sick, accelerating your immunological response and preventing COVID-19 from worsening.
So, if you have the virus, the mAb treatment provides your body with the antibodies it requires to defend itself. The mAb treatment does not replace the need for vaccination protection, but it can assist you if you are at risk of having significant COVID-19.
People receive a vaccine in traditional research, and scientists wait to observe if their bodies respond to the vaccine by producing antibodies against the virus.
We bypass this phase in antibody experiments and just give people the antibodies. Intravenous infusions, also known as “getting an IV,” are performed via shots into the skin or infusions beneath the skin.
Another distinction is that whereas antibodies created naturally by your body in response to a vaccine can last a long time, laboratory-made monoclonal antibodies only last a few months, necessitating additional infusions or injections regularly.
How do Monoclonal Antibodies(mAb) work?
Scientists produce monoclonal antibodies by exposing a certain type of immune cell to a specific viral protein, SARS-CoV-2, the virus that causes COVID-19. They can then tailor the mAb to attack a specific virus or stage of the infection process.
Scientists created various mAbs that attach to the spike protein on the virus’s surface for COVID-19. The virus is unable to infect human cells as a result of this.
People with COVID-19 are given monoclonal antibodies by IV or a single-dose injection. COVID-19 antibodies are used in this therapy to assist the body fight infection. In comparison to infusion therapy, the injection has a smaller dosage.
According to research, these antibodies reduce the amount of virus in a person’s body, or “viral load.” Symptoms are milder in people with lower virus loads. Hospitalization and death may be avoided if the viral load is reduced.
What is the new approval of the FDA for Monoclonal Antibodies?
In January 2022, the FDA stated that two previously approved mAb therapies (bamlanivimab plus etesevimab and casirivimab plus imdevimab) are unlikely to work against Omicron and should be avoided in most situations.
Other drugs, like antivirals, may be more successful against the Omicron variety, according to the FDA.
New Bebtelovimab from Lilly’s, is an antibody that can be used to treat mild-to-moderate COVID-19 in adults and children aged 12 and above who are at high risk of developing severe COVID-19.
It has been demonstrated that the treatment is effective against the omicron variety. The FDA has declared Lilly’s antibody mixture of bamlanivimab and etesevimab ineffective against omicron. REGEN-COV, a Regeneron antibody, was also grounded for the same reason on that day.
Bebtelovimab is administered as a 175 mg intravenous infusion over at least 30 seconds. The dosage is significantly lower and administration is much faster compared with previous COVID-19 antibody therapies.
The approval is based on data from the phase 2 BLAZE-4 trial, which included non-hospitalized patients who were given bebtelovimab alone or in combination with bamlanivimab and etesevimab.
Bebtelovimab retained 100% neutralizing effectiveness against omicron in both pseudovirus and actual viral testing. In addition, the medication neutralized all other known variants of interest, including omicron’s newly discovered subvariant BA.2.
New Monoclonal antibody (mAb) Bebtelovimab have effects on Omicron Variant BA.2?
The Department of Health and Human Services said in a statement announcing the deal, “Should the BA.2 subvariant grow in proportion in the United States, this potential treatment will help ensure that we can continue to offer a monoclonal antibody treatment that works against that strain of the virus.”
According to Lilly, bebtelovimab is still active against Omicron and its BA. 2 subvariant.
Similar to other monoclonal antibodies that have been approved for the treatment of high-risk individuals with mild to moderate COVID-19 and shown a benefit in reducing the risk of hospitalization or death, bebtelovimab acts by binding to the spike protein of the virus that causes COVID-19.
The FDA is keeping a close eye on viral strains in circulation and their susceptibility to approved monoclonal antibodies, such as bebtelovimab. Bebtelovimab retains action against both the omicron version and the BA, according to laboratory testing. Subvariant of 2 omicron.
The United States has agreed to pay $720 million for the drug bebtelovimab.
Lilly will provide 600,000 treatment courses, with 300,000 being delivered this month and 300,000 by the end of next month. The United States will have the opportunity to purchase 500,000 more antibody courses by July 31.
Who are eligible for monoclonal antibody therapy?
Individuals who are eligible for monoclonal antibody therapy includes,
- Are at a high risk of contracting COVID-19 and
- Have a COVID-19 test result but have not yet been admitted to the hospital and
- Aged 12 years and more (and at least 88 pounds)
Those who have been exposed (and meet the CDC’s close contact criteria) are:
- High risk for developing covid-19
- Not fully vaccinated OR partially vaccinated but immunocompromised and
- At least 12 years old (and at least 88 pounds).
Direct exposure is not always a condition. You are eligible for post-exposure preventative monoclonal antibodies if you match the requirements above and are at a high risk of being exposed to an infected individual due to the presence of infection in other individuals in the same institutional setting.
It’s critical to remember that post-exposure preventative monoclonal antibodies aren’t a substitute for immunization. We strongly advise everyone to get vaccinated against COVID-19.
Any of the following includes a high risk
- 65 years old or older
- Overweight (body mass index over 25)
- Chronic kidney disease
- Diabetes (Type 1 and Type 2)
- The immune system is weakened, and you’re on immunosuppressive medication.
- Hypertension/cardiovascular disease
- Chronic obstructive pulmonary disease (COPD)
- Sickle cell disease
- Disorders of the nervous system
- Medical-related Technological Dependence
When should a patient receive bebtelovimab?
The bebtelovimab is to be administered as a single intravenous infusion (IV) by a qualified health professional as early as possible after a positive viral test for COVID-19 and within seven days of the appearance of symptoms.
Where can I get monoclonal antibody treatment?
The following sites have the details of the monoclonal antibody infusion treatment locations.
What are the side effects of Monoclonal antibodies?
Like most drugs, monoclonal antibodies include dangers and side effects that you and your doctor must consider against any potential benefits.
They can, among other things, produce allergic reactions or infections at the injection site. When the drug is known not to operate against your sickness, the risks become less worthwhile.
You should check with your health care provider for your mAb treatment. They will decide and recommend whether you are eligible for this treatment or not.
Be Safe, Be healthy…