Video of my comments to the FDA's VRBPAC meeting on more boosters, in 2 parts:
Pt 1: You need to ask yourselves: why did only half of all eligible Israelis go back for the 2nd booster? Could it be due to adverse events experienced by them or people they know from previous doses?
What you didn’t hear about today from the Ministry of Health is a survey they conducted last fall of about 2,000 Israelis 3 to 4 weeks after they received the first booster. The survey asked about adverse events they had experienced.
The adverse event rate per million doses calculated from the survey shows that people experienced unacceptably high rates of severe adverse events like bell’s palsy, hospitalization, and seizures.
In September, representatives from the ministry of health told this committee that there were only 19 serious adverse events reported to their safety monitoring system following the booster dose. And today they reported 12.
But a comparison between the survey results and their monitoring system clearly shows it [the monitoring system] is totally unreliable, as it undercounts adverse events by several orders of magnitude. @IsraelMOH
The MOH survey shows that sizeable percentages of people with pre-existing conditions reported that their conditions got worse after the 1st booster.
A large majority said their adverse event was either new or worse than the previous doses.
A significant minority said their condition was still ongoing 3 to 4 weeks later at the time of the survey and that they had sought medical care.
The fact that the vast majority of events started within 1 week of the vaccination and were not spread evenly over the time period strongly suggests they were caused by the booster.
The research from Sheba hospital on the 4th dose corrects for many biases that plague all of the large N observational studies on vaccine effectiveness, including the study you heard about today.
nejm.org/doi/full/10.10…
It showed a very high rate of severe systemic reactions and all signals of benefit were below 50%, which should make it ineligible for EUA.
Notably, there was no statistically significant reduction in infections or viral load, despite a strong antibody response. Could this be due to T-cell exhaustion? The European Medicines Agency has raised this concern.
bloomberg.com/news/articles/…
We now know that the first doses of these mRNA injections have varied and unexpected effects on the immune system in ways we are only beginning to understand. The effect of repeated doses is uncharted territory.
medrxiv.org/content/10.110…
But one troubling indicator is that the per dose reporting rate of ‘immunodeficiency syndromes’ after the 3rd dose is 16 to 21 times higher than for previous doses. These are NOT like flu vaccines.
Approving additional boosters without having solid answers to the questions on this slide would be negligent and only serve to further erode the public’s rapidly waning trust in the FDA and other public health agencies.
Why did the 4th injection offer almost no protection despite increase in antibodies?
What are long term impacts of repeated injections of mRNA and LNPs (esp. on the immune system)?
Protection wanes quickly, so how can annual boosters help?
Why do so many not return for boosters?
@IsraelMOH @NitzanHorowitz @PECC_eng @PECC_Israel @P_McCulloughMD @akheriaty @AaronSiriSG @HighWireTalk @ChildrensHD @RobertKennedyJr @galileoisback @RMConservative
For more on the MOH survey, see here: jackanapes.substack.com/p/the-israeli-…
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