RSV: Infant mortality rate increased after vaccination was introduced in hospitals
Source: Report24.news, Vanessa Renner, 10 April 2024
Since the coronavirus years, RSV has been hyped as a danger to newborns and children. This has paved the way for new drugs – including the monoclonal antibody nirsevimab, known as Beyfortus. Explosive: independent French scientists found that after the introduction of this “vaccination” in hospitals in France, the mortality rate among infants increased. The educational program Impfgeflüster took a closer look at the data on the active ingredient.
Why do babies need to be vaccinated against RSV? Is RSV really that dangerous?
Is it really a vaccination and what do Chinese hamsters have to do with it?
Infections with the respiratory syncytial virus (RSV) have been mentioned very frequently in the media for around three years. A new opportunity for the pharmaceutical industry to create panic and earn money with vaccination products. According to the package insert, the vaccine nirsevimab (trade name: Beyfortus) is a human monoclonal immunoglobulin G1-kappa antibody produced using recombinant DNA technology in Chinese hamster ovary cells. This technology uses genetic engineering to recombine DNA molecules.
Absolute risk reduction in hospitalization only 1 to 2 percent
In the authorization study, which was published in the New England Journal of Medicine, only the relative risk reduction is stated. The clinical data on the efficacy of Beyfortus indicate “up to 75% relative risk reduction in the prevention of lower respiratory tract infections requiring medical attention in infants and 78% relative risk reduction in the prevention of hospitalization”.
According to the French health authority HAS, studies showed the absolute risk of RSV infection was reduced by only 3.8% in the five months following an injection, and the absolute risk of hospitalization was reduced by only 1% to 2% in the same period.
Severe side effects and even death
In France, the use of the new drug “Beyfortus” led to an increase in neonatal deaths. The drug is offered as a one-off vaccination for babies born shortly before or during the RSV season and for babies who are less than eight months old before the start of the season. Also for some high-risk infants 8 to 19 months of age.
Beyfortus was jointly developed by AstraZeneca and Sanofi. However, data suggests a high prevalence of side effects – including bronchiolitis – even though the treatment is designed to protect newborns from respiratory disease.
The HAS findings state that there is “no potential impact of Beyfortus in terms of shorter hospital stays, transfers to intensive care units and mortality”.
If this product does not significantly reduce hospital admissions, what is the point?
Bronchiolitis: Vaccination triggers the disease it is supposed to protect against
The report from Eudra Vigilance, the EU’s adverse event database, confirmed 64 adverse events related to Beyfortus in newborns aged one month or younger and 68 in babies and toddlers aged between 2 months and 2 years on 24 December 2023.
One death of a baby under one month of age was recorded, as well as 60 entries containing the word bronchiolitis. According to VigiAccess, the WHO’s adverse event database, 104 adverse events were reported, including 57 infections and respiratory illnesses.
In another study of premature and newborn babies with heart or lung disease, comparing Beyfortus with other monoclonal antibodies previously used in high-risk babies, six deaths were recorded – five of which were due to bronchiolitis. Of the six babies who died, five had been treated with Beyfortus.
Infant mortality rate increased
The INSEE in France is the authority that compiles the official birth and death data. This data indicates an improbably high mortality rate – “an increase in deaths among infants aged 2 to 6 days” – in France in September and October 2023. According to INSEE data, 54 deaths out of 55,489 births were registered in France in September 2023, although the average number of expected deaths was 38.
For October 2023, the data showed 61 deaths out of 57,940 births, although the average number of expected deaths was 40. The so-called single vaccination is administered 2 days after birth.
This increase, the researchers suspect, coincides with the introduction of Beyfortus in French hospitals, which began on 15 September 2023.
In 2021, the CDC published a study of all RSV deaths in the US over the past 12 years. In a review of all death certificates, they found that there were only 26 deaths per year with RSV. Only 17 deaths were caused by RSV in infants under one year of age.
Experts: Little risk from RSV, but high risk from vaccination
According to Dr Peter McCullough, “the annual risk of RSV hospitalization in the 22.4 million children in the US under the age of 5 is well below one percent”. The data indicate a low risk for RSV.
Dr Meryl Nass, internist, epidemiologist, member of the Children’s Health Defense (CHD) Scientific Advisory Committee, told The Defender:
“Administering drugs or biologics to newborns should be done with extreme caution, let alone a novel injected monoclonal antibody. It is impossible to say whether the infant will be harmed by the injection if we do not yet know how healthy the newborn is and how it normally behaves. This should be a major warning signal for both the manufacturers and the parents.” End of quote.
Non-specific symptoms: RSV detection by PCR
How is a potential RSV disease actually diagnosed? An RSV infection can show a spectrum of symptoms ranging from a simple respiratory infection to a severe respiratory disease of the lower respiratory tract that requires ventilation, or it can be completely asymptomatic. Although RSV usually causes mild symptoms similar to the common cold, the viral disease can become more severe in some infants and lead to complications such as bronchiolitis or pneumonia.
Laboratory diagnostics
The RKI explains: Genome detection using polymerase chain reaction (PCR) is very specific, rapid and highly sensitive, even with a low viral load in the sample. RSV-specific PCR detection systems and multiplex PCR for parallel detection of RSV and other pathogens of respiratory tract infections are available. In general, there are major differences in the sensitivity and specificity of the tests from different providers. The positive predictive value depends heavily on the age of the patient and the epidemiological situation.
Doesn’t this form of laboratory diagnostics remind us of the last 4 years? Once again there is obviously no standardization of PCR tests and once again the RKI points out the major differences between the various test providers.
In the USA, the CDC’s Advisory Committee on Immunization Practices recommended that Beyfortus be included in the vaccination schedule for children and that manufacturers be granted an exemption from liability. For insurance purposes, however, Beyfortus should be coded as a drug and therefore removed from the National Vaccine Injury Compensation Program (NVICP).
The US and European authorities have classified Beyfortus differently. In some cases it has been classified as a vaccine, in others not. French researchers and other medical experts warn that no long-term studies have been conducted with Beyfortus and newborns and that the administration of monoclonal antibodies to newborns is unprecedented.
Despite these facts, the French government recommends that Beyfortus be injected into newborns before they leave the maternity ward from 15 September 2023. The new vaccines, which are also expected to boost Moderna’s sales in 2025, include a vaccination against RSV. This vaccine is due to come onto the market as early as 2024.
Links season 5, episode 3 (retrieved February 2024)
https://www.ema.europa.eu/en/medicines/human/EPAR/beyfortus
Beyfortus, Nirsevimab, Date of authorisation: 31 October 2022, Last updated: 15 January 2024
Authorisation of Beyfortus by the EMA
https://www.nejm.org/doi/full/10.1056/NEJMoa2309189
Nirsevimab for Prevention of Hospitalisations Due to RSV in Infants, Simon B. Drysdale, Katrina Cathie et al, N Engl J Med, Dec 28, 2023
In the pivotal study published in the New England Journal of Medicine, again only the relative risk reduction is reported. The clinical data on the efficacy of Beyfortus indicates that it was “up to 75% relative risk reduction in the prevention of lower respiratory tract infections requiring medical attention in infants and 78% relative risk reduction in the prevention of hospitalisations”.
In France, the use of the new drug “Beyfortus” led to an increase in neonatal deaths. However, the data indicate a high prevalence of side effects – including bronchiolitis – even though the treatment is intended to protect recipients from respiratory disease.
If this product does not significantly reduce hospital admissions, what is the point?
Monoclonal antibodies: copies of an antibody that seek out foreign material to destroy, but the treatments carry “the risk of the body triggering a strong reaction to the antibodies”.
Complications can be severe and include “acute anaphylaxis or life-threatening massive allergic reactions that can lead to organ damage”. This phenomenon is one of the negative effects of Beyfortus.
https://childrenshealthdefense.org/defender/cdc-beyfortus-nirsevimab-rsv-shots-newborns/
Despite 12 Deaths During Clinical Trials, CDC Signs Off on RSV Shots for Newborns, Michael Nevradakis, Ph.D., The Defender, 08/04/23
12 dead babies
https://www.cdc.gov/vaccines/programs/vfc/index.html
Vaccines for Children (VFC) Programme, CDC, Last Reviewed: December 19, 2023
ACIP (Advisory Committee on Immunisation Practices) has voted to include nirsevimab in the Vaccines for Children program, which provides recommended vaccines and immunizations free of charge to about half of the nation’s children.
“CDC is currently working to make nirsevimab available through the Vaccines for Children programme.”
https://tkp.at/2024/01/05/hohe-sterblichkeitsrate-bei-neugeborenen-nach-neuer-rsv-impfung/
High mortality rate in newborns after new RSV vaccination, Dr Peter F. Mayer, tkp.at, 5 Jan. 2024
https://www.insee.fr/fr/statistiques/4487988?sommaire=4487854
Nombre de décès quotidiens France, régions et départements, Insee, last update 26 Jan. 2024.
INSEE is the authority that compiles the official birth and death data in France.
https://www.rki.de/DE/Content/Infekt/EpidBull/Merkblaetter/Ratgeber_RSV.html#doc2394298bodyText7
RSV infections, RKI guide, Robert Koch Institute, as of 02/02/2024
Clinical symptoms and laboratory diagnostics PCR
Genome detection using polymerase chain reaction (PCR) is very specific, fast and highly sensitive, even with a low viral load in the sample. RSV-specific PCR detection systems and multiplex PCR for the parallel detection of RSV and other pathogens of respiratory tract infections are available.
In general, there are major differences in the sensitivity and specificity of the tests from different providers.
https://www.boerse-online.de/nachrichten/aktien/impfstoffe-lassen-moderna-aktie-zweistellig-steigen-doch-fuer-analysten-ist-noch-deutich-mehr-drin-jetzt-einsteigen-20346767.html
Vaccines cause Moderna shares to rise by double digits – but analysts believe there is much more to come. Get in now? BÖRSE ONLINE editorial team, 03.01.2024
The new vaccines that are expected to boost Moderna’s sales in 2025 include a vaccination against RSV. This vaccine is due to be launched on the market as early as 2024.
https://mein.sanofi.de/produkte/beyfortus/downloads?id=/resources/SPC/ChronID-002555/data&pdfName=ChronID-002555
Sanofi Beyfortus® Information for healthcare professionals, December 2023
Package insert Beyfortus Sanofi
https://childrenshealthdefense.org/defender/newborns-rsv-shot-beyfortus-death-rate-france/
French Researchers Identify ‘Improbably High Rate of Deaths’ in Newborns Who Received New RSV Shot, Michael Nevradakis, Ph.D., The Defender, 01/02/24
https://apnews.com/article/rsv-babies-drug-cdc-astrazeneca-sanofi-shot-c03b72aaa51e59176cfa3feb3ceac06c
Babies should get recently approved drug for RSV, CDC says, CARLA K. JOHNSON, AP News, Aug. 4, 2023
http://caillou5310.free.fr/index_alertez_bb.php#mort_inf_2_7
Travaux sur l’épidémie de Covid, Christine Mackoi
Website of the French statistician Christine Mackoi
