Why Two COVID-19 Treatments Got Yanked

There are no cures for COVID-19. That’s why federal health officials recommend that we get fully vaccinated and receive a booster shot. 

As for treatments, some of the best have been several monoclonal antibodies that target SARS-CoV-2, the virus that causes COVID-19. 

But this week the Food and Drug Administration pulled its emergency use authorization for two such drugs: Regeneron’s REGEN-COV, which is a combination of the antibodies casirivimab and imdevimab, and Eli Lilly’s combo of bamlanivimab and etesevimab. 

The FDA said both treatments are “highly unlikely” to work against the now-predominant omicron variant.

As Science Editor Jessica McDonald wrote: “Because of its mutations, the shape of the omicron variant’s spike protein is different — and these particular antibodies can’t neutralize the omicron variant very well if at all, as numerous lab studies have shown.”

The manufacturers of both drugs — Eli Lilly and Regeneron — issued statements saying they agreed with the FDA’s decision.

Nevertheless, Florida Gov. Ron DeSantis misleadingly claimed the FDA's decision had been made “without a shred of clinical data” to support it. There may not be data from patients, but Dr. Michael S. Diamond, an infectious disease specialist and microbiologist and immunologist at the Washington University School of Medicine in St. Louis, told Jessica that waiting on clinical data isn’t practical in this situation. 

Diamond should know. He is the senior author of a recent study that found the Regeneron and Eli Lilly antibody cocktails “lost all neutralizing activity” when tested in cultured cells against live omicron virus. 

“I think there is no way to test in humans fast enough,” Diamond told Jessica. “I would prefer to give drugs (antibodies, small molecules) that do not show such loss in efficacy based on cell culture and animal data.”

For more information, read Jessica’s story “DeSantis Misleads on Omicron-Resistant COVID-19 Antibody Treatments,” and our updated SciCheck Digest item “What treatments are available for COVID-19?”

Reader: Are [COVID-19] vaccines being made that use a weakened form of the virus, much like conventional flu shots?  If not, why not?  

FactCheck.org Science Editor Jessica McDonald: Conventional flu shots are typically the inactivated kind, meaning using killed virus. The nasal flu vaccines, however, are weakened/live attenuated (not fully killed). 
 
Some COVID-19 vaccines that were developed elsewhere (not in the U.S.) are inactivated, for example, the Chinese shots. The U.S. did not back any inactivated or live attenuated designs, however.
 
While I cannot answer the exact reasons why, there are several potential reasons. First, with weakened vaccines, these still contain virus that can replicate, and would not be safe to give to immunocompromised people, for example. For the killed vaccines, this requires a lot of manufacturing of virus that could be hard to scale up quickly.
 
The U.S. decided to bet on the mRNA vaccines as well as another conventional protein subunit design, along with the viral vector designs that other countries have also used. While it is hard to directly compare, the Chinese vaccine looks less effective than the mRNA ones. 

Wrapping Up

Here's what else we've got for you this week:

• "Viral Post Makes False Claim About Medicare Coverage of Dental Work": Democrats tried but failed to expand Medicare coverage to include dental benefits in the Build Back Better bill. Yet a Facebook post tells seniors they have until Jan. 31 to apply for “free dental work” under a recently announced Medicare “stimulus.” There is no such program, and traditional Medicare doesn’t cover dental work except in rare circumstances.
• "Trump on ‘Race-Based Medicine’ for COVID-19": At a rally in Arizona on Jan. 15, former President Donald Trump waded into the debate over state policies allowing health systems to consider race as a risk factor when prioritizing the allocation of limited supplies of some COVID-19 therapeutics. According to Trump, it translates to white people being denied life-saving medicines and vaccines. We look at the facts.
• "Ted Nugent Posts Fake Headline, Claim About Sotomayor’s Health": Justice Sonia Sotomayor, who as a diabetic is at higher risk for severe illness from COVID-19, has participated remotely in recent Supreme Court arguments. But Ted Nugent posted a bogus headline on Facebook — using a CNBC logo and byline — with the unfounded claim that Sotomayor tested positive for the disease. A CNBC spokesperson said the outlet didn’t publish it.

• "Conservadores promueven video editado de comentarios de la directora de los CDC sobre la efectividad de las vacunas contra COVID-19": Rochelle Walensky, directora de los Centros para el Control y la Prevención de Enfermedades, analizó un estudio reciente que encontró que en las raras ocasiones en las que personas completamente vacunadas murieron por COVID-19, la mayoría de ellas tenía múltiples factores de riesgo de enfermedad grave. Pero una versión editada de la entrevista eliminó la referencia a personas vacunadas, lo que algunos conservadores aprovecharon para afirmar de manera tendenciosa que Walensky hablaba del total de muertes por COVID-19.