From NEJM article. Welcome to the party, Stan. Intelligent people have been saying this stuff for decades.
“The widespread vaccine hesitancy observed during the Covid-19 pandemic suggests that the public is no longer satisfied with the traditional safety goal of simply detecting and quantifying the associated risks after a vaccine has been authorized for use.”
“Postauthorization studies are needed to fully characterize the safety profile of a new vaccine, since prelicensure clinical trials have limited sample sizes, follow up durations, and population heterogeneity.”
“It is critical to examine adverse events following immunization (AEFIs) that have not been detected in clinical trials, to ascertain whether they are causally or coincidentally related to vaccination.”
“When they are caused by vaccines (vaccine adverse reactions), the risk attributable to vaccination and the biologic mechanism must be ascertained. That science becomes the basis for developing safer vaccines, if possible, and for determining contraindications to vaccination and the compensation that should be offered for AEFIs.”
“Currently in the United States, when the Advisory Committee on Immunization Practices (ACIP) recommends a new routine vaccine, the only automatic statutory resource allocations that follow are for vaccine procurement by Vaccines for Children (VFC) and for the Vaccine Injury Compensation Program (VICP). Although the ACIP acknowledges the need, there are currently no resources earmarked for postauthorization safety studies beyond annual appropriations, which must be approved by Congress each year.”
“Progress in vaccine-safety science has understandably been slow — often depending on epidemiologic evidence that is delayed or is inadequate to support causal conclusions and on an understanding of biologic mechanisms that is incomplete — which has adversely affected vaccine acceptance.”
“In 234 reviews of various vaccines and health outcomes conducted from 1991 to 2012, the IOM found inadequate evidence to prove or disprove causation in 179 (76%) of the relationships it explored, illustrating the need for more rigorous science.”
“Identifying the biologic mechanisms of adverse reactions — how and in whom they occur — is critical for developing safer vaccines, preventing adverse reactions by expanding contraindications, and equitably compensating vaccinees for true adverse reactions.”
“The public [now] also wants public health authorities to mitigate and prevent rare but serious adverse events – which no longer seem rare when vaccines are given to millions or billions of people.”