Monoclonal Antibodies

Is the vaccine too experimental and mysterious for you? 

Go ahead and get COVID. There are monoclonal antibody therapies as a backstop.

But heads up. The treatment drugs are experimental, lack full FDA approval, work only some of the time, and are made from humanized tissue of rodents.

Some of the people I talk to in farm country tell me they are not vaccinated. Possibly the real reason is tribal and political. They are members of the team that doesn't trust Democrats. They have a rationale. They tell me the vaccinations seem to them new, unproven, and experimental. "I don't want to be a guinea pig for stuff I don't understand," they tell me.

Their comments were in mind when I received this joke email in my inbox:

KFC has secret spices, Coke has a secret formula, the labels on packaged food include things few people understand or can pronounce, but we eat them. Yet the vaccine is a mystery and people say they don't trust mysteries. It seems odd to me.

It seems less odd in the context of therapies available for the people who contract COVID. There may be a safety net if one gets sick, so why risk a mysterious vaccine. Ivermectin and hydroxychloroquine have mixed word of mouth reputations, getting criticism from health authorities. But one therapy gets support from both Trump and health experts, monoclonal antibodies. Trump was administered them last year and he said he felt better almost immediately. There is a short period after someone knows they are infected, but before hospitalization, when this therapy appears to help. Florida governor Ron DeSantis has emphasized post-infection treatment with monoclonal antibodies. He has set up state-run infusion centers.

CNN described it this way:

As the Delta variant drives a surge of Covid-19 cases in Florida, a rapid-response unit will be deployed to administer monoclonal antibody treatments to residents infected with the virus, Gov. Ron DeSantis said Thursday. This is the most effective treatment that we've yet encountered for people who are infected with Covid-19," DeSantis said. "This, applied early and properly, has the ability to reduce your likelihood of being hospitalized." 

The irony for those worried about unproven and mysterious vaccines is that monoclonal antibody infusions come labeled with prominent warnings that they are new and experimental, with emergency use authorization by the FDA. "Emergency use," rather than full FDA approval, was the widespread excuse used by many for rejecting vaccines. The vaccines now have full FDA approval.

The best known drug is Regeneron's antibody cocktail. It got early criticism for using stem cells from an aborted fetus. In fact it does not contain fetal cells, according to a spokesperson for the drug, New Jersey internist Soma Mandal, MD. Kidney cells from an aborted fetus were used to develop the drug and test the drug, but are not in the drug, she said.

According to the manufacturer, the Regen-Cov antibody cocktail of casirivmab and imdevimab was created using a proprietary genetically engineered "mouse platform" optimized to become fully human antibodies. The drugs come from original study of a genetically humanized mouse but now other mammals. The new cells mimic human cells, but aren't human. They write: 

The manufacture of our monoclonal antibodies starts with a mammalian cell line called the Chinese Hamster Ovary (CHO) cells. These CHO cells are modified with a synthetic DNA sequence to direct them to make antibodies that are indistinguishable from human antibodies.

They supply a graphical description of their process:

They describe their process in text form with a series of superlatives, a self-attestation of cutting edge bioscience:

Our operations follow strict adherence to current Good Manufacturing Practices (cGMP) and use cutting-edge analytical equipment, automated laboratory information management systems and electronic document management systems, all of which are supported by an extensive calibration, validation and preventive maintenance program. Our independent clean-room suites with ultra-modern clean utilities support both single-use and stainless steel cell culture bioreactors and large-scale chromatography systems designed to produce and purify our product candidates.

Folk wisdom has addressed this situation. From the frying pan and into the fire.

If a person doesn't want the vaccine because the vaccine seems new, experimental, and mysterious, there is an alternative now promoted within vaccine-skeptical media. The alternative uses immortalized human fetal tissue, which led to a process to "humanize" mouse tissue, which evolved to using cells from Chinese hamster ovaries, then is filtered and stabilized and ready for infusion. It is newer, more experimental, and more mysterious than the vaccine it replaces.