US Food and Drug Administration (FDA) Authorized Antibody Serum Emergency Use Is Justified; mRNA for Antibody Production To Come
25 August 2020
EIRNS)—President Donald Trump announced Aug. 23 that the U.S. Food and Drug Administration has approved the use of blood serum taken from people who have had COVID-19, to make use of their antibodies produced in the natural course of the illness. The FDA cited the results of informal observations that the use of the serum prior to three days after diagnosis of COVID-19 is associated with a 35% decrease in deaths, compared to use of the serum more than three days after the diagnosis is made. Thus far, 70,000 Americans have been treated with the serum under the FDA rules of compassionate care, since there is some justification for anticipating that the antibodies would be helpful. A similar approach has been shown to be effective in cases of Ebola, flu, tetanus, hepatitis B, measles, and many other infectious diseases.
Following the President’s announcement, the anti-Trump section of the news media carried attacks on the serum action, claiming that the action was premature, and should have awaited controlled double-blind studies to ensure safety and effectiveness. However, the FDA has guidelines for compassionate use, which include that the disease must be potentially severe, and that there is no other available treatment. The FDA also recommends that there is some evidence of safety for humans, and some evidence of effectiveness. The first two criteria are certainly met for COVID-19; it is potentially lethal, and there is no currently available alternative treatment. The second two criteria are more than satisfied by the experience nationally with this treatment for 70,000 Americans, though the treatments have not been done under controls or blinded. This release was well within FDA guidelines, and the guidelines make medical sense.
Meanwhile there are several controlled double-blind studies on human serum use that are ongoing. Also, Operation Warp Speed is funding Regeneron for producing mouse-derived antibodies. And more interesting, the development of lab-derived single-type antibodies, termed monoclonal antibodies, is reviving up explosively. An article in Science on 8/4/2020, entitled“Designer Antibodies Could Battle COVID-19 Before Vaccines Arrive,” quotes Anthony Fauci saying, “If you were going to put your money down, you would bet that you get the answer with the monoclonal before you get the answer with a vaccine.”
Currently monoclonal antibodies are produced in vats of antibody-producing cells, which is time-consuming and expensive to manufacture. Companies working on this type of production include Lilly, AbCellera, AstraZeneca, GlaxoSmithKline, Genentech, and Amgen. Lilly, working with AbCellera, started the first human Phase 1 trial using a monoclonal antibody on May 29, 2020. But the main push for advanced technology is coming from the Defense Advanced Research Projects Agency (DARPA), which has been heavily funding monoclonal antibody research and production since 2018.
Amy Jenkins, head of the Pandemic Prevention Platform at DARPA, says that the real aim of the program is to have the body itself produce the antibody by injecting the person with DNA or mRNA which codes for the monoclonal antibody, which is a protein. This will speed up the production and decrease the cost, and it will also be easier to retool for new diseases. This would tie in to Moderna’s use of mRNA for producing the spike antigen vaccine, which is now in Phase 3 testing. What we are witnessing is a spectacular Riemann singularity potential in disease treatment. This kind of Riemann singularity potential is what Lyndon LaRouche identified as the basis of his anti-entropic economic model, which is based on non-linear discontinuous jumps in the economy due to major creative breakthroughs in technology, such as the change from wood to fossil fuels, the invention of the steam engine, and the potential of large-scale nuclear energy.