Forwarded from DISASTER X (Maximilian Forte)
ARE WE STARTING TO SEE A.D.E.? Supporting source #2:
Informed consent disclosure to vaccine trial subjects of risk of COVID‐19 vaccines worsening clinical disease
Timothy Cardozo and Ronald Veazey
Results of the study
COVID‐19 vaccines designed to elicit neutralising antibodies may sensitise vaccine recipients to more severe disease than if they were not vaccinated. 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: that vaccines designed empirically using the traditional approach (consisting of the unmodified or minimally modified coronavirus viral spike to elicit neutralising antibodies), be they composed of protein, viral vector, DNA or RNA and irrespective of delivery method, may worsen COVID‐19 disease via antibody‐dependent enhancement (ADE). This risk is sufficiently obscured in clinical trial protocols and consent forms for ongoing COVID‐19 vaccine trials that adequate patient comprehension of this risk is unlikely to occur, obviating truly informed consent by subjects in these trials.
Conclusions drawn from the study and clinical implications
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, in order to meet the medical ethics standard of patient comprehension for informed consent.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7645850/
#covid19 #ADE #vaccine_failure #HighWire
Informed consent disclosure to vaccine trial subjects of risk of COVID‐19 vaccines worsening clinical disease
Timothy Cardozo and Ronald Veazey
Results of the study
COVID‐19 vaccines designed to elicit neutralising antibodies may sensitise vaccine recipients to more severe disease than if they were not vaccinated. 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: that vaccines designed empirically using the traditional approach (consisting of the unmodified or minimally modified coronavirus viral spike to elicit neutralising antibodies), be they composed of protein, viral vector, DNA or RNA and irrespective of delivery method, may worsen COVID‐19 disease via antibody‐dependent enhancement (ADE). This risk is sufficiently obscured in clinical trial protocols and consent forms for ongoing COVID‐19 vaccine trials that adequate patient comprehension of this risk is unlikely to occur, obviating truly informed consent by subjects in these trials.
Conclusions drawn from the study and clinical implications
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, in order to meet the medical ethics standard of patient comprehension for informed consent.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7645850/
#covid19 #ADE #vaccine_failure #HighWire
PubMed Central (PMC)
Informed consent disclosure to vaccine trial subjects of risk of COVID‐19 vaccines worsening clinical disease
Patient comprehension is a critical part of meeting medical ethics standards of informed consent in study designs. The aim of the study was to determine if sufficient literature exists to require clinicians to disclose the specific risk that COVID‐19 ...
Forwarded from DISASTER X (Maximilian Forte)
ARE WE STARTING TO SEE A.D.E.? Supporting source #3:
Pfizer says immunity can drop to 83% within four months in people who got its COVID-19 shot, further bolstering the company case for a booster
Last Updated: Aug. 5, 2021
The effectiveness of Pfizer’s COVID-19 shot can drop to 83.7% within four to six months after getting the second dose of its vaccine. This is the latest indication that vaccine-induced immunity to the virus can wane and some kind of boost may be necessary in the future.
New research published Wednesday as a preprint indicates that the Pfizer Inc. PFE, +0.34% shot provides 96.2% protection for the first two months, 90.1% effectiveness between the second and fourth months, and 83.7% of protection for the fourth, fifth, and six months.
“We will need a booster eight to 12 months from the second dose,” Pfizer CEO Albert Bourla said Wednesday, according to a FactSet transcript of the company’s second-quarter earnings call.
The drug maker has been making the case for booster shots, citing limited data from its own clinical research and real-world data out of Israel, where Pfizer’s vaccine is the predominant shot in circulation....
www.marketwatch.com/story/pfizer-says-immunity-drops-to-83-within-six-months-in-people-who-got-its-covid-19-shot-further-bolstering-the-company-case-for-a-booster-11627579817
#covid19 #ADE #vaccine_failure #HighWire
Pfizer says immunity can drop to 83% within four months in people who got its COVID-19 shot, further bolstering the company case for a booster
Last Updated: Aug. 5, 2021
The effectiveness of Pfizer’s COVID-19 shot can drop to 83.7% within four to six months after getting the second dose of its vaccine. This is the latest indication that vaccine-induced immunity to the virus can wane and some kind of boost may be necessary in the future.
New research published Wednesday as a preprint indicates that the Pfizer Inc. PFE, +0.34% shot provides 96.2% protection for the first two months, 90.1% effectiveness between the second and fourth months, and 83.7% of protection for the fourth, fifth, and six months.
“We will need a booster eight to 12 months from the second dose,” Pfizer CEO Albert Bourla said Wednesday, according to a FactSet transcript of the company’s second-quarter earnings call.
The drug maker has been making the case for booster shots, citing limited data from its own clinical research and real-world data out of Israel, where Pfizer’s vaccine is the predominant shot in circulation....
www.marketwatch.com/story/pfizer-says-immunity-drops-to-83-within-six-months-in-people-who-got-its-covid-19-shot-further-bolstering-the-company-case-for-a-booster-11627579817
#covid19 #ADE #vaccine_failure #HighWire
MarketWatch
Pfizer says immunity can drop to 83% within four months in people who got its COVID-19 shot, further bolstering the company case…
The effectiveness of Pfizer’s COVID-19 shot can drop to 83.7% within four to six months after getting the second dose of its vaccine. This is the latest...