Adverse Events of Special Interest (AESIs) for Covid-19 Vaccines Surveillance
Public Health Ontario Adverse Events of Special Interest (AESIs) for COVID-19 Vaccines Surveillance Following the authorization of novel Coronavirus Disease 2019 (COVID-19) vaccines in Canada, post- marketing surveillance is being conducted to monitor the safety of these new vaccines throughout the implementation of the immunization program. Provincial reporting of adverse events following immunization (AEFIs) to […]
Covid-19 Vaccines and Children: A Scientist’s Guide for Parents
Byram W. Bridle Pfizer BioNTech’s COVID-19 mRNA vaccine has been Authorized under an Interim Order by Health Canada for use in Canadians as young as 12 years old, with mandatory commitments for the monitoring of long-term safety and efficacy. Authorization under an Interim Order means additional information is needed on the safety, efficacy, and quality […]
Why are Standards So Lax on Covid Drugs Approval?
Vinay Prasad Many scientists made a career fighting for better regulatory standards. Strangely, when it comes to the regulatory policy around COVID-19, they are dead quiet. First, consider that EUA ( emergency use authorization ) is like accelerated approval. Both require lower levels of evidence, and are predicated on the fact that we’re dealing with […]
Pfizer documents: Pharmacokinetics Written Summary
Released March 1, 2022 The ADME profile of BNT162b2 (BioNTech code number BNT162, Pfizer code number PF-07302048) included evaluation of the PK and metabolism of two novel lipid excipients (ALC-0315 and ALC-0159) in the LNP and potential biodistribution using luciferase expression as a surrogate reporter or a radiolabeled lipid marker … Over 48 hours, the […]
Pfizer documents: Cumulative Analysis of Post-authorization Adverse Event Reports
Released April 1, 2022 Although the report contains a list of adverse events spanning 9 pages (Appendix 1), Pfizer still concludes that these findings of their “signal detection analyses are consistent with the known safety profile” of their product BNT162b2 and the “cumulative post-marketing experience confirms a favourable benefit-risk balance”.
A Personal Declaration Of Opposition To The Abuse of Our Charter of Rights and Freedoms By The State
I am writing this because I feel an obligation given that I am the last living First Minister who help craft the Constitution Act 1982 and The Charter of Rights and Freedoms that forms part of it. Secondly, I am doing it because I must speak on behalf of those deceased First Ministers, the majority […]
