After demonizing almost all drugs with the potential to reduce the severity of COVID-19 symptoms, the National Institutes of Health (NIH) finally recommended monoclonal antibodies earlier this summer. Prior to the official recommendation, some suppliers used them under an emergency use authorization (US) granted by the FDA in November 2020. The FDA has just granted a US to allow its use for SARS-CoV-2 post-exposure and continuous prophylaxis. This approval will increase demand.
Recently, the treatment has had great media coverage. Although the Department of Health and Human Services (HHS) has been promoting treatment on the Combat Covid website since early summer, one man secured a nationwide media campaign. Once Florida Gov. Ron DeSantis decided to promote outpatient antibody treatment and establish infusion centers, the media reacted because it’s a very dangerous Republican.
Related: Only Ron DeSantis would be criticized for doing exactly what Biden HHS wants
During the week leading up to Labor Day festivities, DeSantis was back on the road, announcing the success of the Florida program in disconnecting COVID-19 infection from hospitalization in the state. Patients gave a personal testimony about their experience with the treatment. Hospitalizations in the state decreased by 20% during the first weeks that infusion centers were in operation. Then something interesting happened.
On Friday, someone claiming to be an urgent care specialist tweeted that HHS had informed him that the government would now decide which facilities would receive doses of monoclonal antibodies. Jim Jackson wrote: “So now the government is getting involved [read: restricting] distribution of monoclonal antibodies. Before, I could only order everything we needed and the next day they sent it by air. It is now a government. committee will decide when, if and how much I can get for my points [patients]. “If you have any questions about this update in ordering and distribution procedures, please email the federal COVID-19 response team.” Wonderful. “
He added the HHS alert confirming his claim. Now, only facilities participating in the HHS Protect program can request treatment and the agency will review all orders. Suppose the current distribution map provided by HHS includes HHS Protect facilities. In this case, the new order review process seems like a big administrative burden for the program. It may delay or limit treatment for patients at risk.
Monoclonal antibodies for outpatient use are approved and recommended. HHS instructs patients who meet the requirements to access it within ten days of the onset of symptoms. Regeneron also has FDA approval for use after exposure and for prevention. All approved uses are time-dependent and do not lead to a heavy order review process. It is curious the time of change in how health care providers access it.
If supply is really so limited that the federal government has to get involved in distribution decisions, the question should be why. The use of monoclonal antibodies is restricted and is only provided for specific risk groups. By managing and approving distribution, HHS isolates manufacturers from real market demand. Now, some at-risk and unvaccinated vaccinated patients require effective treatment, and it is restricted. If new variants appear and become dominant, this trend may continue.
Recommended: Get ready: Biden approval rating for COVID-19 will decline faster than vaccine immunity
To date, therapy and drugs reused to reduce the severity of the disease have been underlined and even demonized. Monoclonal antibodies did so through all the noise and endorsement of President Trump. It is time for the federal response to encourage greater production of monoclonal antibodies, challenge manufacturers to develop formulations against worrying variants, and place them in the hands of professionals.