The cancellation of a study on an mRNA vaccination for infants in the USA indicates a return to stricter testing procedures by the responsible authority (FDA). The employees may already be acting in anticipation of the upcoming Trump administration with Robert F. Kennedy Jr.
Source: Thomas Maul, 07 January 2025, Achgut
It began as a success story for the pharmaceutical industry: in June 2024, an mRNA vaccine against respiratory syncytial virus (RSV) for adults was approved in the USA (and a little later in Europe) (after just 3 [!] years of testing without an emergency being declared). However, a corresponding study in infants and young children was stopped by the US Food and Drug Administration (FDA) at the end of the year due to “safety signals”. (See also the interview with Gunter Frank and Kay Klapproth on Achgut).
After the Covid-19 vaccines, the new RSV preparation was the second authorised vaccine based on the immature mRNA technology. This is despite the increasing awareness that it has not really proven itself against coronavirus. The absolute risk reduction with regard to the event “cold symptom plus positive coronavirus test” was just 0.8 per cent. An effect that only lasted a few weeks. To date, there is no evidence-based proof of a positive effect on the prevention of “severe courses”.
Any “external protection” was not even claimed by the regulatory authorities at the time and is no longer propagated by mRNA fans today. On the other hand, there are now even reports in the mainstream about serious side effects that are disproportionate to the supposedly prevented disease. And the former conspiracy theory of the “vaccination lottery” has now also found its way into official documents from the Paul Ehrlich Institute (PEI). This did not stop the authorities from waving through another mRNA injection against another cold virus – at least for the purpose of immunising adults.
Vaccination against RSV?
The respiratory syncytial virus (RSV) has always been part of the pathogen mix that leads to colds and flu-like illnesses in autumn and winter. During their seasonal peak, the proportion of RS viruses rises to up to 20 per cent, as can be read in any of the RKI’s weekly influenza reports. As is always the case with viral colds, they are usually mild respiratory illnesses which, in exceptional cases, develop into severe lower respiratory tract illnesses. As always, adults over the age of 75 and older adults with certain underlying conditions are at an increased risk of contracting severe RSV infections. In contrast to corona, for example, but similar to influenza, infants and babies, “especially premature babies and babies with certain underlying diseases”, also belong to the “risk group”(Federal Ministry of Health).
As always, there is the fundamental dilemma that healthy people do not need a vaccination because their immune system can cope with cold viruses, while it is questionable whether those in need of protection who are weakened by age or previous illnesses can even have their damaged immune system activated by an injection.
Despite this, the pharmaceutical industry and its lobbyists naturally have a business interest in vaccinating everyone from birth as often as possible against every conceivable disease, inflating the effects and downplaying the side effects as far as is permissible.
Bad experience of childhood immunisation repeats itself
However, the RSV vaccination of (young) children in particular had stalled since the 1960s:
“In the 1960s, 80 per cent of the children vaccinated in an RSV vaccine trial fell ill and two died. This vaccine contained a completely inactivated RSV antigen. Apparently, the immune system of the young patients was misdirected by the vaccination. T-cell reactions were weakened and large quantities of ineffective antibodies were produced, which formed dangerous immune complexes. This tragedy has blocked the development activities of RSV vaccines for decades.” (Pharmazeutische Zeitung, 19.12.2024)
However, the mRNA euphoria fuelled by the state and the media against all scientific evidence since coronavirus made it possible for the biotechnology company Modernadiesesesto carry out another RSV vaccine experiment on infants and young children – with results that bring back memories of the 1960s:
“In a study conducted by Moderna in Panama to test the safety of the monovalent mRNA vaccine, five out of 40 children aged five to eight months developed severe or very severe RSV-related illnesses. In the placebo group, only one in 20 children fell ill. In addition, three out of 27 infants who received the combination vaccine developed hMPV infections in a Phase I trial. In contrast, no infection was observed in the placebo group.” (Ibid.)
The US regulatory authority has now considered this to be a relevant “warning signal”. Following an expert meeting, the FDA ordered a halt to the inclusion of children under two years of age in all clinical trials testing RSV vaccine candidates that do not contain an attenuated live virus. The halt also applies to children between the ages of two and five who have never been infected with RSV.
“Old” and “new” FDA
For Moderna, the mRNA enthusiasm and the pharmaceutical industry as a whole, this alone is a major setback. And it could get worse. This study stop is still the responsibility of the “old” FDA, although it can be speculated that the “warning signals” already known in the summer (before the Trump election) are only now (i.e. before Trump’s inauguration on 20 January) leading to the stop, because some FDA employees want to continue to be employed.
This is because the “new” FDA under Trump and presumably Robert F. Kennedy Jr. and Marty Makary has a lot planned (see also here on Achgut). One is that almost every available or recommended vaccine would have to prove its supposedly positive risk-benefit balance against gold standards of research. The other concerns an issue that is often confused with fundamental opposition to vaccination, scepticism or “esotericism”.
Even if each individual vaccination on its own had a positive balance, the basic credo with regard to paediatric vaccinations can also be doubted by “conventional medicine”: that children have actually become healthier overall with each vaccination that has been added in recent decades on the basis of recommendations or compulsory vaccinations (especially in the USA) (i.e. in total for all individual vaccinations), or have become less likely to fall ill (seriously) with whatever.
So instead of injecting infants and small children with all kinds of pharmaceuticals against all conceivable (even less dangerous) eventualities as a preventive measure, we could think again about prioritisation, i.e. about limiting ourselves to the essentials or the really urgent (i.e. really effective remedies against really serious illnesses that are likely to occur without vaccination).
According to the announcements by Trump and Kennedy, a lot could happen on this front in the USA in the coming years…
