The Pfizer-BioNTech and Moderna vaccines were tested in thousands of people, some of whom were later likely exposed to the virus. The effect wasn’t seen in the trials.
Dr. Malone explained that if ADE occurs, it generally starts as the protection the vaccine originally provided begins to wane. He said that this appears to be happening with the mRNA vaccines right now, at about the six month mark. The tests likely weren’t run long enough to detect this effect, because of the mad rush to develop something, anything. If I understood the technical reasons correctly, ADE occurs because the weakening vaccine puts just enough pressure on the virus to adapt, while not being effective at killing it, that it causes the virus to mutate and the mutated virus then multiplies and spreads from the “vaccinated” host. So in that scenario, being vaccinated actually makes you both more susceptible to the virus and more capable of spreading it to others. We’re currently seeing multiple signs that this appears to be what is happening.
His conclusion was that if ADE is occurring, the vaccination program must be stopped immediately.
There were no long term, phase 3 studies completed. Those are still technically in process and the EUA can’t be lifted until those are complete and they have FDA review. By law the moment that status is revoked in current state, not one of those vaccines can be given. They are skating the regulations. Formal trial results I believe are expected early to mid 2023 at which point they will go through review. Probably fast tracked.
Pfizer https://clinicaltrials.gov/ct2/show/study/NCT04368728#studydesign
Actual Study Start Date: April 29, 2020
Estimated Primary Completion Date: November 2, 2021
Estimated Study Completion Date: May 2, 2023
Moderna https://clinicaltrials.gov/ct2/show/study/NCT04470427#studydesign
Actual Study Start Date: July 27, 2020
Estimated Primary Completion Date: October 27, 2022
Estimated Study Completion Date: October 27, 2022