[Comment] COVID‑19 vaccine safety

Abstract

In response to the SARS-coV-2 outbreak, and the resulting cOVId-19 pandemic, a global competition to develop an anti-cOVId-19 vaccine has ensued. The targeted time frame for initial vaccine deployment is late 2020. The present article examines whether short-term, mid-term, and long-term vaccine safety can be achieved under such an accelerated schedule, given the myriad vaccine-induced mechanisms that have demonstrated adverse effects based on previous clinical trials and laboratory research. It presents scientific evidence of potential pitfalls associated with eliminating critical phase II and III clinical trials, and concludes that there is no substitute currently available for long-term human clinical trials to ensure long-term human safety. Vaccine safety testing There are three ways of testing for vaccine safety, in order of increasing credibility: computer simulations, animal experiments and human trials. Computer simulations. While the growth of statistical software packages and chemical descriptors allows the development of new models, safeguards that account for deficiencies of

Vaccine- and natural infection-induced mechanisms that could modulate vaccine safety

“…This disinterest is most pronounced in the present efforts to have a COVID-19 vaccine on the market, perhaps made mandatory, within a year after starting development. There cannot be any credible safety testing under such a schedule [ 161 ]. There are many potential adverse health effects that can result from vaccine-induced mechanisms, as our present study has shown, and these effects could emerge in the near-term or the long-term.…”

“…Vaccines are being promoted by the healthcare industry, politicians, decision-makers, and the mainstream media as the best hope for containing the COVID-19 pandemic, and this is reflected in the funding their accelerated development is receiving (Moderna, a leading COVID-19 vaccine contender, has “scored $2.48 billion in R&D and supply funding from the U.S. government for its program” [ 161 ]). The goal appears to be initial vaccine distribution by around end of 2020, although it is questionable whether such an accelerated vaccine development program would include adequate mid-term and long-term safety testing [ 161 ].…”

Tracking and Mining the COVID-19 Research Literature

“…To a striking degree, certain demographic groups (the elderly and those with weakened immune systems) are highly vulnerable, whereas others (healthy younger cohorts) are nearly invulnerable. That calls into question which societal policies and approaches would best counter the pandemic (Kostoff et al, 2020a , b ).…”

Challenges and Opportunities from Targeting Inflammatory Responses to SARS-CoV-2 Infection: A Narrative Review

“…Another chapter in proof in the chronicles of therapy regards vaccines against the SARS-CoV-2. [ 32 , 36 , 37 , 38 ]. Even if we consider the flurry of recent vaccine announcements from pharmaceutical giants as reason to think positively about a return to normality [ 39 , 40 , 41 ], once a vaccine gets emergency approval, large-scale vaccination campaigns around the world should then follow (which are not simple tasks) and, inevitably, it will take some other time to study and verify the impact of vaccines on COVID-19 pandemic [ 42 , 43 , 44 ].…”