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After demonizing nearly every drug that could reduce the severity of COVID-19 symptoms, the National Institutes of Health (NIH) finally recommended monoclonal antibodies earlier this summer. Before the official recommendation, some suppliers used them under an Emergency Use Authorization (EUA) granted by the FDA in November 2020. The FDA has just granted an EUA to allow their use for post-exposure SARS-CoV-2 and ongoing prophylaxis. This approval will increase demand.
Recently, the treatment has received wide media coverage. While the Department of Health and Human Services (HHS) has been promoting the treatment on the Combat Covid website since the start of the summer, a man has ensured a nationwide media campaign. After Florida Governor Ron DeSantis decided to promote outpatient treatment using antibodies and establish infusion centers, the media reacted because he is a very dangerous Republican.
Related: Only Ron DeSantis reportedly criticized for doing exactly what Biden’s HHS wants
In the week leading up to Labor Day, DeSantis was on the road again, touting the success of Florida’s program to disconnect COVID-19 infection from hospitalization in the state. Patients have personally testified about their experience with the treatment. Hospitalizations in the state fell 20% in the first few weeks the infusion centers were operational. Then something interesting happened.
On Friday, someone claiming to be an emergency care specialist tweeted that HHS had informed them that the government would now decide which facilities would receive doses of monoclonal antibodies. Jim Jackson wrote: “So now the government is involved in [read: restricting] distribution of monoclonal antibodies. Before, I could just order as many as we needed, and they would airmail it the next day. Now a government. the commission will decide when, if and how much I can get for my points [patients]. “If you have any questions regarding this update to ordering and distribution procedures, please email the Federal COVID-19 Response Team.” Marvellous.”
He added the HHS alert which confirmed his claim. Now, only establishments participating in the HHS Protect program can order processing, and the agency will review all orders. Assume that the current distribution map provided by HHS includes HHS Protect installations. In this case, the process for reviewing new orders appears to be a heavy administrative burden on the program. It can delay or limit the treatment of patients at risk.
Monoclonal antibodies are approved and recommended for outpatient use. The HHS asks qualifying patients to access it within ten days of symptom onset. Regeneron also has FDA approval for use after exposure and for prevention. All approved uses are time dependent and not conducive to a tedious order review process. The timing of the change in the way health care providers access it is curious.
If the supply is really so limited that the federal government has to get involved in decisions about distribution, the question should be why. The use of monoclonal antibodies is restricted and only intended for specific risk groups. By managing and approving distribution, HHS isolates manufacturers from actual market demand. From now on, certain patients at risk vaccinated as well as unvaccinated require an effective treatment, and this one is constrained. If new variants emerge and become dominant, this trend may continue.
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To date, therapies and drugs reused to reduce the severity of the disease have been underestimated and even demonized. The monoclonal antibodies have gone through all the noise and approval of President Trump. It’s time for the federal response to encourage increased production of monoclonal antibodies, get manufacturers to develop formulations against variants of concern, and get them into the hands of practitioners.
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