FINALLY DOING ITS JOB: FDA PLACES HOLD ON ALL CLINICAL STUDIES OF RSV VACCINES IN INFANTS
Dec. 19, 2024
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 documentnotes 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. 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 trial, which consisted of approximately 150-200 infants at the time, was paused.
The study of RSV vaccines in infants follows the recent approval of three RSV vaccines for adults. Referencing Vaccine-Associated Enhanced Respiratory Disease (VAERD),the study reports that due to observed events of VAERD following RSV vaccination in infants, the approach to pediatric development of RSV vaccines has “proceeded with a high degree of caution, and was largely limited to live, attenuated vaccine candidates,” which they state are considered less likely to be associated with VAERD.
VAERD is a condition where vaccination against a respiratory pathogen paradoxically worsens the severity of disease following natural infection with the pathogen.
“I think we are confronted by a very complicated situation. We know that passive acquisition of antibody is protective — highly protective — and does not produce severe disease in any way. We now have a platform which should be only inducing antibody formation, which I think it’s the right antibody, [but] I think it’s very clear that there is a safety signal, and the trials cannot continue, at least in the youngest age group.”
Of the six severe cases (including one in the placebo group) that led to the trial being paused, five infants were hospitalized, with one in the ICU and one infant requiring mechanical ventilation. Michael Nelson, M.D., Ph.D., the chief of the asthma, allergy, and immunology division at the University of Virginia’s School of Medicine, said during the meeting:
“The system worked. The safety signal was reached. A proper pause was put in place. I’m not totally convinced that the finding of the safety signal means that the safety signal is real. In particular, I don’t think we’ve learned enough from those who experience the severe adverse events. More attention to investigating what happens to them in real-time, I think, could be incorporated into future clinical trials.”
For his part, Monto stated that he believes the safety signal is legitimate and deserves more study, sharing that the answers will not emerge if companies and regulators “shut down programs.” Ignoring other more holistic treatments, like traditional Chinese medicine, for example, that has been shown to enhance immunity to prevent RSV infection, Monto wants to move forward with more clinical trials. On the flip side—offering insight that aligns more with the views of those aiming to restore health in our country—Nicholas Hulscher, MPH, shared his thoughts on mRNA RSV injections, writing in in Dr. Peter McCullough’s Courageous Discourse Substack:
“This is yet another instance of mRNA injections failing to meet essential safety requirements. Rather than protecting infants from RSV, these novel injections seem to have worsened the severity of infections. Instead of persisting with the development and rollout of this flawed mRNA platform, our public health agencies should prioritize interventions that do not commonly result in serious adverse events.”
https://thehighwire.com/editorial/finally-doing-its-job-fda-places-hold-on-all-clinical-studies-of-rsv-vaccines-in-infants/