FDA Uses “Omicron” as Excuse to End Emergency Use Authorization for Monoclonal Antibody Treatments

FDA Uses “Omicron” as Excuse to End Emergency Use Authorization for Monoclonal Antibody Treatments

Legal Insurrection readers who have watched Senator Ron Johnson’s (R-WI) “Second Opinion” panel are now well versed in the many examples of the US Food and Drug Administration (FDA) promoting the use of expensive, novel covid treatments over less pricey or repurposed drugs. The agency’s policies on covid are also almost entirely focused on vaccination rather than early treatments.

The FDA’s actions have created a great deal of mistrust, especially because the pandemic policy has completely failed to stop the spread and the virus is now endemic. It has just added to the level of skepticism and misgiving, as it has just ended the emergency use authorization for monoclonal antibody treatment.

Covid-19 antibody drugs from Regeneron and Eli Lilly should no longer be used because they don’t work against the omicron variant that now accounts for nearly all U.S. infections, U.S. health regulators said Monday.

The Food and Drug Administration said it was revoking emergency authorization for both drugs, which were purchased by the federal government and have been administered to millions of Americans with Covid-19. If the drugs prove effective against future variants, the FDA said it could reauthorize their use.

The regulatory move was expected because both drugmakers had said the infusion drugs are less able to target omicron because of its mutations. Still, the federal action could trigger pushback from some Republican governors who have continued promoting the drugs against the advice of health experts.

There are several problems with this act. The Delta variant is still out there, and Regeneron has been effective against that strain. It can be difficult to distinguish between the two variants, so perhaps it would be wiser to have doctors decide.

And while it may be true that Regeneron isn’t as effective against Omicron, the move has the appearance of being politically motivated due to the fact several red states have had success with monoclonal antibody treatment clinics. Florida Gov. Ron DeSantis railed against the decision.

DeSantis referenced anecdotal cases in which people were helped by the monoclonal antibody treatments and said it was “reckless” to block the drugs.

“People have a right to access these treatments, and to revoke it on this basis is just fundamentally wrong and we’re going to fight back,” DeSantis said at a news conference.

Of course, the American press took this as an opportunity to mock and deride the Florida governor.

Many are frustrated that there are few effective early treatment options. Now one of the few that has success has been pulled.

A new study has pointed to why the antibody treatments have proven ineffective and why there are so many vaccine breakthrough cases with Omicron. The variant has so many mutations it bypasses the antibody defenses.

A team from the University of Minnesota discovered that specific mutations create interference in the surface of the variant, preventing antibodies from binding to it, while others result in a complete loss of interaction between the antibodies and the virus. Therefore, the antibodies won’t work against Omicron.

This suggested that preexisting immunization (whether from vaccination or previous infection) may no longer be able to provide optimal protection against the Omicron variant, allowing it to bypass antibodies and enter the immune system, the study said.

“The purpose of antibodies is to recognize the virus and stop the binding, which prevents infection,” Singh said. “However, we found many of the mutations in the Omicron variant are located right where the antibodies are supposed to bind, so we are showing how the virus continues to evolve in a way that it can potentially escape or evade the existing antibodies and therefore continue to infect so many people.”

It appears that T-cells, which are attainable via natural immunization after recovering from infections, work against Omicron, as a study by South African researchers shows.

“Despite Omicron’s extensive mutations and reduced susceptibility to neutralizing antibodies, the majority of T cell response, induced by vaccination or natural infection, cross-recognizes the variant,” the researchers reported on Tuesday on medRxiv ahead of peer review.

“Well-preserved T cell immunity to Omicron is likely to contribute to protection from severe COVID-19,” which supports what South African doctors had initially suspected when most patients with Omicron infections did not become seriously ill, they said.

The good news: After the Omicron surge, a substantial portion of the American population now has T-cell immunity. And while the SARS-Cov-2 virus that causes covid is now endemic, we are on a trajectory to getting back to pre-covid life.

That is if we can loosen the grip of pandemic-power drunk politicians and bureaucrats who are bitterly clinging to the glory days of a fawning press and the possibility of conducting a response experiment on the global level.

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