Introduction: In 2020, prior to COVID-19 vaccine rollout, the Coalition for Epidemic Preparedness Innovations and Brighton Collaboration created a priority list, endorsed by the World Health Organization, of potential adverse events relevant to COVID-19 vaccines. We leveraged the Brighton Collaboration list to evaluate serious adverse events of special interest observed in phase III randomized trials of mRNA COVID-19 vaccines.
• mRNA vaccines promote sustained synthesis of the SARS-CoV-2 spike protein.
• The spike protein is neurotoxic, and it impairs DNA repair mechanisms.
• Suppression of type I interferon responses results in impaired innate immunity.
• The mRNA vaccines potentially cause increased risk to infectious diseases and cancer.
• Codon optimization results in G-rich mRNA that has unpredictable complex effects.
• Vaccination confers broader IgG binding of variant RBDs than SARS-CoV-2 infection
• Imprinting from initial antigen exposures alters IgG responses to viral variants
• Histology of mRNA vaccinee lymph nodes shows abundant germinal centers
• Vaccine spike antigen and mRNA persist for weeks in lymph node germinal centers
Question: Does prior mRNA-1273 vaccination influence anti-nucleocapsid antibody seroconversion and/or seroreversion after SARS-CoV-2 infection?
DSA ADS Course - 2022
COVID19, Public Policy, Health Policy, mRNA Vaccines, Vaccines, Clinical Trial Design, Evidence Hierarchy
This is a FOIA document of the first 2.5 months after the vaccine roll-out. Discuss clinical trial design and hierarchy of evidence in context of mRNA vaccines.
5.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021