SARS-CoV-2 mass vaccination: Urgent questions on vaccine safety that demand answers from international health agencies, regulatory authorities, governments and vaccine developers
Authors: Bruno Roxana , Mccullough Peter A , Vila Teresa Forcades I , Henrion-Caude Alexandra , García-Gasca Teresa , Zaitzeva Galina P , Priester Sally , Albarracín María J Martínez , Sousa-Escandon Alejandro , Mirones Fernando López , Cifre Bartomeu Payeras , Velilla Almudena Zaragoza , Borini Leopoldo M , Mas Mario , Salazar Ramiro , Schinder Edgardo , Yahbes Eduardo A , Witt Marcela , Salmeron Mariana , Fernández Patricia , Marchesini Miriam M , Kajihara Alberto J , Riva Marisol V De La , Chimeno Patricia J , Grellet Paola A , Lisdero Matelda , Mas Pamela , Baudo Abelardo J Gatica , Retamoza Elisabeth , Botta Oscar , Brandolino Chinda C , Sciuto Javier , Avivar Mario Cabrera , Castillo Mauricio , Villarroel Patricio , Rojas Emilia P Poblete , Aguayo Bárbara , Flores Dan I Macías , Rossell Jose V , Sarmiento Julio C , Andrade-Sotomayor Victor , Baltazar Wilfredo R Stokes , Escobar Virna Cedeño , Arrúa Ulises , Río Atilio Farina del , Esquivel Tatiana Campos , Callisperis Patricia , Barrientos María Eugenia , Fiala Christian , Acevedo-Whitehouse Karina 
Published: May 2021

Since the start of the COVID-19 outbreak, the race for testing new
platforms designed to confer immunity against SARS-CoV-2, has been
rampant and unprecedented, leading to conditional emergency
authorization of various vaccines. Despite progress on early multidrug
therapy for COVID-19 patients, the current mandate is to immunize the
world population as quickly as possible. The lack of thorough testing in
animals prior to clinical trials, and authorization based on safety data
generated during trials that lasted less than 3.5 months, raise
questions regarding vaccine safety. The recently identified role of
SARS-CoV-2 Spike glycoprotein for inducing endothelial damage
characteristic of COVID-19, even in absence of infection, is extremely
relevant given that most of the authorized vaccines induce endogenous
production of Spike. Given the high rate of occurrence of adverse
effects that have been reported to date, as well as the potential for
vaccine-driven disease enhancement, Th2-immunopathology, autoimmunity,
and immune evasion, there is a need for a better understanding of the
benefits and risks of mass vaccination, particularly in groups excluded
from clinical trials. Despite calls for caution, the risks of SARS-CoV-2
vaccination have been minimized or ignored by health organizations and
government authorities. As for any investigational biomedical program,
data safety monitoring boards (DSMB) and event adjudication committees
(EAC), should be enacting risk mitigation. If DSMBs and EACs do not do
so, we will call for a pause in mass vaccination. If DSMBs and EACs do
not exist, then vaccination should be halted immediately, in particular
for demographic groups at highest risk of vaccine-associated death or
serious adverse effects, during such time as it takes to assemble these
boards and commence critical and independent assessments. We urge for
pluralistic dialogue in the context of health policies, emphasizing
critical questions that require urgent answers, particularly if we wish
to avoid a global erosion of public confidence in science and public
health.