I would have never thought five years ago that I would be using advanced monoclonal antibodies to treat acute viremia in a potentially fatal illness to help a patient avoid hospitalization or death. Yet, early research done by Dr. Ralph Baric who conceived SARS-CoV-2 in his 2015 papers also anticipated the development of a countermeasures such monoclonal antibodies directed against SARS-CoV-2.
Operation Warp Speed is an impressive public-private partnership to rapidly develop and test countermeasures against COVID-19. It’s main products were vaccines, oral antivirals, and monoclonal antibodies. COVID-19 vaccines, continue to be a debacle with record injuries, disabilities, and death with no proven reductions in hospitalization or death from proper trials. Sadly, Paxlovid and Mulnupiravir were very slow to develop and were not gamechangers in the pandemic.
The clear winner from OWS was its very first acute ambulatory product, monoclonal antibodies. Kip et al used electronic medical records and comparative data for those treated and denied monoclonal antibodies for acute COVID-19. The risk for hospitalization or death at 28 days was 4.6% in 2571 treated patients and 7.6% in 5135 nontreated control patients (risk ratio [RR], 0.61 [95% CI, 0.50 to 0.74]). In subgroup analyses, those receiving monoclonal antibodies when the Alpha and Delta variants were presumed to be predominant had estimated RRs of 0.55 and 0.53, respectively, compared with 0.71 for the Omicron variant period. Relative risk estimates for individual products all suggested lower risk for hospitalization or death. Among immunocompromised patients, the RR was 0.45 (CI, 0.28 to 0.71).
Despite these impressive results, the US CMS has repeatedly pulled monoclonal antibodies off the market for predicted not actual losses in efficacy. Here is a list of CMS statements on the products:…