What are monoclonal antibodies and do they help prevent COVID-19?
HUNT VALLEY, Md. (SBG) — Governor Ron DeSantis, R-Fla., is both expanding access to and increasing awareness of a specific COVID treatment as the virus sweeps through his state.
The Florida governor says there’s been so much attention paid to the COVID vaccines that many don’t know about treatment options available to them — specifically, monoclonal antibody treatments.
Monoclonal antibodies are used to treat many diseases including cancer, rheumatoid arthritis and Crohn’s disease, among others. The antibodies are human-made proteins that find and attach to the spike protein that sticks out of the coronavirus, causing COVID-19. The antibodies then block the virus’s ability to enter cells and slow the infection.
Last year, the Food and Drug Administration granted emergency use authorization (EUA) for multiple different monoclonal antibodies to treat COVID-19 symptoms, since early clinical data showed they could successfully reduce hospitalization rates, emergency department visits and even the amount of virus found in an infected person’s blood.
The FDA first granted an EUA to Eli Lilly and Co. Nov. 6 for the use of bamlanivimab alone to treat mild to moderate COVID-19 in adults and pediatric patients, along with those at high risk for progressing to severe illness and/or hospitalization. However, the FDA revoked that EUA April 16 when variants increased the risk of treatment failure. But, Eli Lilly and Co. was granted EUA for another monoclonal antibody — bamlanivimab and etesevimab administered together — Feb. 9, and the treatment has still proven to be effective in dominating the spike protein.
The other monoclonal antibody treatment, which was administered to former President Donald Trump when he caught the virus in October, is REGEN-COV, which is casirivimab and imdevimab administered together. The FDA granted the pharmaceutical company, Regeneron, EUA Nov. 21. Furthermore, as it proved to be effective, the FDA July 30 added that based on the clinical trial data, “It is reasonable to believe that REGEN-COV may be effective for use as post-exposure prophylaxis of COVID-19 in individuals who are at high risk for progression to severe COVID-19.” In other words, the treatment can be used as a post-exposure preventative measure against COVID-19 — the first of its kind for the virus.
This authorization is the answer to why COVID-positive Governor Greg Abbott, R-Texas, began receiving the antibody treatment by Regeneron earlier this week despite being fully vaccinated with no symptoms. In short, the 63-year-old governor hopes to prevent severe infection and a hospital visit.
Under the Trump Administration as part of Operation Warp Speed, the U.S. government signed a $450 million contract with Regeneron to make and supply its double-antibody cocktail for COVID-19. Once the cocktail received EUA, the government committed to making doses available to Americans at no cost and distributing them. The government did the same in an $812.5 million agreement with Eli Lilly and Co., and now has on hand nearly 532,000 doses of the two treatments.
Some patients may have to pay for the administering of the drug, as it must be infused by a health care provider, and for the best results, within 10 days of initial symptoms or exposure. Monoclonal antibodies are administered with a one-time intravenous infusion in about an hourlong process. Those who best qualify for the infusion include both vaccinated and unvaccinated COVID-19 patients with mild symptoms, individuals with immunodeficiencies who have tested positive for the virus but have yet to experience symptoms and individuals with immunodeficiencies who have been exposed to COVID but haven’t yet tested positive.
Regeneron drugs, when given in that 10-day time frame, have been shown to cut rates of hospitalization and death by roughly 70%. Once patients are hospitalized with severe symptoms, the monoclonal antibodies won’t do much. But, for those with weakened immune systems who may not be protected after vaccination, the treatment is ideal, since their bodies cannot make antibodies.
They (monoclonal antibodies) are in high tier,” said Dr. Stuart Ray, vice-chair of Medicine for Data Integrity and Analytics and professor of medicine at Johns Hopkins School of Medicine. “And they can be measured for their activity against individual variants. So, we know right now, because we can test it, that the combinations that are currently being used have good activity against the delta variant.
He added that there’s “always the possibility” a variant could evade the monoclonal antibody cocktails being used, but the combinations are likely less susceptible to variant changes than treatments that use a single target, like the original bamlanivimab from Eli Lilly and Co.
In the past month, the nation has seen a 1,200% increase in orders for monoclonal antibody treatments, 75% of which are going to regions with low vaccination rates. On Wednesday, DeSantis announced the opening of a new monoclonal antibody therapy treatment site in Broward County, Fla. and that additional sites could be identified in the future — largely to alleviate demand on hospital resources. He also directed a standing order in the state that allows patients to receive the treatment without a prescription or referral if it is administered by an eligible health care provider.
It’s my belief that had this been known more, I think we would have kept more people out of the hospital,” DeSantis said during a news conference Thursday. “I think we can keep a lot of people out of the hospital going forward.
Overall, monoclonal antibodies have shown to reduce hospitalization and death by roughly 70%, which both saves lives and eases the burden on hospitals. With that in mind, experts are still trying to tout the effectiveness of the vaccines in protecting against severe COVID-19 infection from the delta variant. Both doses of Pfizer are 96% effective at preventing severe disease with the COVID-19 virus caused by the delta variant; one dose of Moderna is 96% effective at preventing severe disease from the delta variant; and the Janssen/Johnson & Johnson vaccine is 85% effective at preventing severe disease from the delta variant.
Dr. Francis Collins, the director of the National Institutes of Health, said his department had “a lot to do with developing and testing those (monoclonal antibodies),” so he’s “glad those are being made available for people who otherwise could be in trouble.”
Collins added:
But people shouldn’t count on having those waiting for them if they happen to get sick downstream. If you’re not at the current time ill and you’re not vaccinated, boy, is it time to get off the fence and roll up your sleeve and take advantage of this amazing scientific development of these vaccines that are safe and are effective.
Both DeSantis and Abbott encourage their state residents to get the vaccine, and both have been vaccinated. However, Florida and Texas are two of five states with intensive care unit beds exceeding 90% capacity and each state's governor has received criticism for not promoting the vaccines enough, while promoting the monoclonal antibody treatments more, yet opposing mask mandates and vaccine passports. DeSantis was also criticized for promoting Regeneron because one of his top donors invested millions of dollars into the company. Chicago-based hedge fund Citadel has nearly $16 million in shares of Regeneron Pharmaceutical, and Citadel’s CEO donated $10.75 million to a political committee supporting DeSantis. His press secretary pointed out the disclosure in one of the articles further down, that it’s not unusual for hedge funds to have a wide range of investments on both sides of the aisle.
Despite both governors getting vaccinated and promoting its effectiveness, roughly 35% of both Florida’s and Texas’ populations remain unvaccinated. For those who choose not to get vaccinated, the governors are promoting the next best thing.
The bottom line for experts is that monoclonal antibody treatments are effective at preventing severe disease after people are infected, but the vaccines are more effective at preventing severe disease and could stop the infection from happening at all.