COVID-19 Vaccine Safety Considerations

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Kostoff, Ronald N.
Kanduc, Darja
Porter, Alan L.
Shoenfeld, Yehuda
Briggs, Michael B.
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The SARS-CoV-2 pandemic has produced global health and economic adverse impacts. The main measures being taken to control the spread of SARS-CoV-2 and of the virus-associated diseases (COVID-19) are conceptually those that were taken to control the spread of SARS-CoV in the previous coronavirus-driven pandemic of 2002-2003: good hygiene, facemasks, and quarantine (lockdown). The difference is the larger scale of these measures for SARS-CoV-2. A degraded/dysfunctional immune system appears to be the main determinant of serious/fatal reaction to viral infection (for COVID-19, SARS, and influenza alike). There are four major approaches being employed or considered presently to augment or strengthen the immune system, in order to reduce adverse effects of viral exposure. The three approaches that are focused mainly on augmenting the immune system are based on the concept that pandemics can be controlled/prevented while maintaining the immune-degrading lifestyles followed by much of the global population. The fourth approach is based on identifying and introducing measures aimed at strengthening the immune system intrinsically in order to minimize future pandemics. Specifically, the four measures are: 1) restricting exposure to virus; 2) providing reactive/tactical treatments to reduce viral load; 3) developing vaccines to prevent, or at least attenuate, the infection; 4) strengthening the immune system intrinsically, by a) identifying those factors that contribute to degrading the immune system, then eliminating/reducing them as comprehensively, thoroughly, and rapidly as possible, and b) replacing the eliminated factors with immune-strengthening factors. A previous monograph [1] focused mainly on strengthening the immune system intrinsically, and secondarily on vaccine-related issues. It identified many hundreds of factors that contribute to weakening the immune system, as well as measures that can strengthen it. The present monograph focuses on vaccine safety. A future COVID-19 vaccine appears to be the treatment of choice at the national/international level globally. Vaccine development has been accelerated to achieve this goal in the relatively near-term, and questions have arisen whether vaccine safety has been/is being/will be compromised in pursuit of a shortened vaccine development time. In addition to identifying short-term adverse vaccine effects, the present monograph identifies potential mid-and long-term adverse vaccine effects that cannot be identified in short-term tests characteristic of vaccine efficacy testing. To ensure vaccine safety, long-term testing under real-life conditions (exposures to multiple toxic stimuli) is required. There is an incompatibility between the accelerated vaccine development times being pursued by government and industry and the long times required for validation of vaccine safety. In summary, it is difficult to see how safe COVID-19 vaccines can be developed and fully tested for safety on development time scales of one or two years, as proposed presently. The only real protection against a future COVID-19 pandemic or any other viral pandemic is the one that was demonstrated to work in the SARS, MERS, and COVID-19 pandemic, and in the annual influenza pandemics: a healthy immune system capable of neutralizing incoming viruses as nature intended.
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Attribution 3.0 United States