made worse
??
Which disease? The purpose of a vaccine is to shut down the growth of an infectious microorganism.
>made worse
??
Which disease? The purpose of a vaccine is to shut down the growth of an infectious microorganism.
If only this had happened with the deadly mRNA COVID-19 jabs, which triggered thousands upon thousands of severe adverse events. What, you ask? The pause of a trial due to severe adverse events, of course. Enrollment in a Phase 1 trial by Moderna that was evaluating the safety and efficacy of two mRNA-based RSV vaccine candidates in infants aged 5 to 8 months was halted—as it should be—following the observation of five severe to very severe cases of lower respiratory tract infection (LRTI) caused by RSV among participants in the vaccine groups of the trial. Yes, just five. A briefing document released on December 12, 2024, by the U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) highlights the facts that led to the committee placing a hold on all clinical studies of vaccines for RSV in infants.
Titled ‘Considerations for Respiratory Syncytial Virus (RSV) Vaccine Safety in Pediatric Populations,’ the 39-page VRBPAC document notes that the trial had a predefined criterion—a study pause criterion—in place to pause if two or more participants developed severe RSV LRTI that was confirmed by a polymerase chain reaction (PCR) test. This threshold was met when two severe cases of RSV LRTI were reported. Following that, upon further monitoring, five clinically significant and very severe cases were identified in the vaccine groups of Part B (Cohorts 3 and 4). Cohort 3 (15 µg mRNA-1345) reported two severe cases, and Cohort 4 (15 µg mRNA-1365) reported three very severe cases. In comparison, only one severe RSV LRTI case was reported in the placebo group.
On top of that, the rate of progression to severe disease between the vaccine group and the placebo was profound. In the vaccine group, 22% to 30% of the cases progressed to severe or very severe LRTI. In the placebo group, only 8.3% progressed to severe LTRI. Imagine if the COVID jabs had been tested in this way. Indeed, in response to the predefined safety signal of “any severe LRTI with positive PCR for RSV in ≥2 participants,” the trial, which consisted of approximately 150-200 infants at the time, was paused. . .
Source (thehighwire.com)
>If only this had happened with the deadly mRNA COVID-19 jabs, which triggered thousands upon thousands of severe adverse events. What, you ask? The pause of a trial due to severe adverse events, of course. Enrollment in a Phase 1 trial by Moderna that was evaluating the safety and efficacy of two mRNA-based RSV vaccine candidates in infants aged 5 to 8 months was halted—as it should be—following the observation of five severe to very severe cases of lower respiratory tract infection (LRTI) caused by RSV among participants in the vaccine groups of the trial. Yes, just five. A briefing document released on December 12, 2024, by the U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) highlights the facts that led to the committee placing a hold on all clinical studies of vaccines for RSV in infants.
>Titled ‘Considerations for Respiratory Syncytial Virus (RSV) Vaccine Safety in Pediatric Populations,’ the 39-page VRBPAC document notes that the trial had a predefined criterion—a study pause criterion—in place to pause if two or more participants developed severe RSV LRTI that was confirmed by a polymerase chain reaction (PCR) test. This threshold was met when two severe cases of RSV LRTI were reported. Following that, upon further monitoring, five clinically significant and very severe cases were identified in the vaccine groups of Part B (Cohorts 3 and 4). Cohort 3 (15 µg mRNA-1345) reported two severe cases, and Cohort 4 (15 µg mRNA-1365) reported three very severe cases. In comparison, only one severe RSV LRTI case was reported in the placebo group.
>On top of that, the rate of progression to severe disease between the vaccine group and the placebo was profound. In the vaccine group, 22% to 30% of the cases progressed to severe or very severe LRTI. In the placebo group, only 8.3% progressed to severe LTRI. Imagine if the COVID jabs had been tested in this way. Indeed, in response to the predefined safety signal of “any severe LRTI with positive PCR for RSV in ≥2 participants,” the trial, which consisted of approximately 150-200 infants at the time, was paused.
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[Source](https://thehighwire.com/editorial/finally-doing-its-job-fda-places-hold-on-all-clinical-studies-of-rsv-vaccines-in-infants/)
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