By: Greg Staley
According to a medical paper published in the US National Library of Medicine on October 28th, 2020 “COVID‐19 vaccines designed to elicit neutralizing antibodies may sensitize vaccine recipients to more severe disease than if they were not vaccinated.”
The paper reviewed 20 different published papers intending to determine if sufficient literature exists to require clinicians to disclose the specific risk that COVID-19 vaccines could worsen disease upon exposure to challenge or circulating virus.
The paper noted that “vaccines for SARS, MERS and RSV have never been approved and the data generated in the development and testing of these vaccines suggest a serious mechanistic concern.” They added that “this risk is sufficiently obscured in clinical trial protocols and consent forms for ongoing COVID-19 vaccine trials” which means that adequate patient comprehension of this risk is unlikely to occur – making adequately informed patient consent unlikely.
The idea of informed patient consent was explored in the paper “Assessment of Length and Readability of Informed Consent Documents for COVID-19 Vaccine Trials” as well. The findings were that “informed consent documents were too long, difficult to read, and exceeded grade 9 in language complexity.” The paper further noted that “It was possible to create a shorter, more readable informed consent document for these trials.”
Pfizer FDA Application
In the Pfizer application to the FDA for their COVID-19 vaccine to receive approval, they addressed the history surrounding “vaccine-enhanced disease” also called “Antibody-dependent Enhancement“. Pfizer’s FDA application says that “available data do not indicate a risk of vaccine-enhanced disease, and conversely suggest effectiveness against severe disease within the available follow-up period. They do note that the “risk of vaccine-enhanced disease over time, potentially associated with waning immunity, remains unknown and needs to be evaluated further in ongoing clinical trials and observational studies.”
The paper concluded that “the specific and significant COVID-19 risk of ADE should have been and should be prominently and independently disclosed to research subjects currently in vaccine trials, as well as those being recruited for the trials and future patients after vaccine approval.”
All in all, it seems like Pfizer’s FDA application acknowledges the potential issue raised in this paper and noted that “risk of vaccine-enhanced disease over time, potentially associated with waning immunity, remains unknown and needs to be evaluated further in ongoing clinical trials and observational studies.” I take this to read everything is looking good right now but based on the history of similar studies we need to keep an eye.
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