By Peter A. McCullough
Americans can see the light at the end of the dark COVID-19 tunnel. Both the Pfizer-BioNTech and Moderna vaccine trials were stopped early for overwhelming benefit after about 2 months of observation after the booster injection. While the topline results of > 90% effective were impressive, the details of the trials set appropriate community vaccination boundaries and raised sobering issues.
In the trials, Pfizer-BioNTech, Moderna, and the US FDA agreed that children under age 16-18, pregnant women, females without contraception, and persons with prior confirmed or suspected COVID-19 should not get vaccinated. In these groups the risks outweigh potential benefits and according to scientific and regulatory principles, these individuals should not be vaccinated during the community rollout. In an unprecedented manner, CDC/FDA guidance has only excluded children and with the hubris of mass vaccination, 514 pregnant women and countless COVID-19-recovered individuals received the vaccine in the first week (ending Dec 18) of availability. With the first injection 3150/112,807 suffered “health impact events” including unable to do normal activities, work, or had to see a doctor. There were six cases of anaphylactoid reactions which are serious and require immediate treatment. The rate of these events is expected to skyrocket with the booster injection in a few weeks. Thus moving forward, a doctors approval is advised based on risks and benefits so we can get the populations at greatest risk vaccinated first, and authorize proper deferments.
Pfizer-BioNTech and Moderna clinical trials suggested that the immunity created from these new mRNA vaccines is not complete meaning not all infections were stopped and there was no reduction in the handful of serious cases requiring hospitalization. This trend can only worsen over time as more vaccinated individuals are exposed to the SARS-CoV-2 virus in the community. Incomplete immunity is expected since these vaccines raise antibody and cellular responses only to the spike protein portion of the virus. The mRNA vaccine directs human cells to produce the spike protein temporarily, and then the immune system responds to it within and outside of cells. While the CDC calls the spike protein “harmless,” research has shown it is not only responsible for viral entry, but it may be responsible for many of the symptoms of COVID-19. Thus, the illness caused by the vaccine especially on the booster injection is explained. Because the Pfizer-BioNTech and Moderna clinical trials were analyzed prematurely after 2 of the planned 24 months of observation, we simply cannot know at this time if the vaccination will provide durable protection. Already there is discussion of once vaccinated, to make a commitment to annual or semiannual booster shots.
The durability and completeness of natural immunity enjoyed by COVID-19 survivors appears far superior to vaccination. With over 80 million confirmed cases worldwide, there have been just a handful of recurrent infections none of which are well supported given the uncertainties of SARS-CoV-2 testing technologies. If natural immunity was not complete or durable, we would have seen hundreds of thousands of second and third cases by now. In the US, for the 19 million COVID-19 recovered and 190 million COVID-19-like illness but not tested, natural immunity can be relied upon and vaccination is neither clinically indicated nor medically necessary. Put simply, the COVID-19 vaccine should be only given to COVID-19 naive Americans, saving valuable product, and sparing many from any potential harm.
We have already heard news of vaccination potentially being required for school, employment, travel, and many other aspects of life returning back to normal after COVID-19. This is not feasible given the large numbers of COVID-19 recovered and others for whom the vaccine should not be administered. Unfortunately, antibody testing whether after the natural infection or vaccination is not reliable and titers tend to wane over time. There are no commercial tests for cellular immunity. As a result, the only practical method of verification will be attestation of natural infection, vaccination, or deferment based upon a fair waiver method or physician’s direction (children, childbearing woman, allergic reactions, etc). It is expected that an immunity attestation program will be among top priorities for the new White House Coronavirus Task Force in 2021.
A commercially available and partially effective vaccine within a year of the onset of the SARS-CoV-2 outbreak is a duly celebrated achievement. For the appropriate COVID-19 naïve, high-risk individuals the vaccine should be administered and despite the expected side effects, the booster injection should be given to ensure protection. A national immunity attestation process would bring us out of COVID-19 chaos and allow a reasonable return to normal life.
Peter A. McCullough, MD, MPH, is an internist, cardiologist and epidemiologist in Texas. He has authored more than 600 cited works in the National Library of Medicine, including 26 on clinical aspects of the infection, and lectured across the world on contemporary medical issues. In response to the COVID-19 disaster, Dr. McCullough and colleagues published the first guidance for the medical treatment of ambulatory patients in the American Journal of Medicine and has testified in the US Senate Committee on Homeland Security and Government Affairs. The opinions expressed here are his own and not those of his institutions.