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We conclude that outbreaks of measles can occur in secondary schools, even when more than 99 percent of the students have been vaccinated and more than 95 percent are immune.
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AUTHORS' CONCLUSIONS:
In people not previously exposed to hepatitis B, vaccination has unclear effect on the risk of developing infection, as compared to no vaccination. The risk of lacking protective antibody levels as well as serious and non-serious adverse events appear comparable among recipients and non-recipients of hepatitis B vaccine.
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Are the vaccines safe?
According to the firms they are safe. Initially, the vaccine was compared with a placebo group being vaccinated with physiological serum, whereby the number of adverse reactions was much higher and much more serious than in the control group. After comparing 320 patients in the saline placebo group a quick move was made to an aluminium-containing placebo, in order to be able to only evaluate the effects of the active substance. However, this distorted the comparison, because no one voluntarily wants to be vaccinated with toxic aluminium, as this is not really necessary, when inoculation with a harmless saline solution can be done. The differences between Gardasil and the saline placebo group were, however, already noticeable15. Here we can refer to the Vioxx scandal, where the adverse reactions in fact were known, but concealed by the firm. Here also the difference between the vaccine and the saline placebo is concealed in all publications, as the table below clearly shows. For serious adverse reactions one suddenly takes the saline and aluminium group together, perhaps to cover up the major differences between these two groups.”
These two experts question seriously the prevailing assumption, apparently also at the EMA, that the vaccine is so important for public health that it is justified not to communicate to the public 1) that there are uncertainties related to vaccine safety, 2) that drug companies cannot be trusted; and 3) that it is wrong to lump together results obtained with a genuine placebo with those obtained with a potentially neurotoxic placebo. We agree with the two experts when they suggest that this lumping may represent a cover up and we also find that the EMA should have informed the public about this unacceptable lumping of a true placebo with an active placebo instead of keeping it secret. This is totally unacceptable and contrary to good scientific practice to such a degree that we consider it outright scientific misconduct committed by the EMA.
The EMA’s procedures for evaluating the safety of medical interventions - where the companies are by and large their own judges - need to be fundamentally reworked and all procedures and information should be made transparent to the public. Our societies should no longer accept that assessments of drug safety are left to companies with huge financial interests and to a drug agency that receives 80% of its funding from the drug industry.
The secrecy imposed by the EMA is not in the public interest. Drug regulators tend to have a narrow vision, either because of their remit or because they have become too close to the drug industry by their daily work, which often involves contacts with the industry, and by employment of people with long careers in the industry. As an example, the EMA’s director, Guido Rasi, has brought in a number of people from the drug company Sigma Tau that include Stefano Marino, his head of legal affairs. Rasi has worked with this company for many years and apparently owns several patents together with the company (15).
Public health is about the promotion of health and prevention of disease and disability through the organised efforts of society. This entails protection from harms and involves progression of knowledge in open collaboration. As far as we can see, the actions of the EMA in this case indicates that the agency is more concerned about protecting its own previous decisions and the vaccine than about protecting the citizens and giving them the option of choosing for themselves whether or not they would like to get vaccinated against HPV. Some people will prefer to avoid the vaccine, even if the risk of serious harm is very small, and some will prefer screening instead. It is not within the powers of regulatory authorities to deny citizens’ right to make informed choices about their own health by withholding important information. The citizens need honest information about the vaccine and the uncertainties related to it; not a paternalistic statement that all is fine based on a flawed EMA report (2).
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While improved vaccine and vaccination techniques have played a significant role in the progress to date, the principal changes have occurred because of a better understanding of the epidemiology of smallpox and the application of surveillance procedures to interrupt transmission.
With modification of the strategy in vaccination programmes to deal with high risk groups and with intensified surveillance and the institution of specific measures to interrupt the chains of transmission, dramatic changes in smallpox incidence have occurred within the past two years.
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Stay away from people who are sick. This includes people with colds, flu, measles, or chicken pox. You also need to stay away from children who just had a “live virus” vaccine for chicken pox or polio. Call your doctor, nurse, or local health department if you have any questions.
To avoid contact with a person who has a rash after recently receiving the chickenpox (varicella) vaccine.
To avoid contact with a person who has received a intranasal flu vaccine within one week. This applies only if your child is severely immune suppressed such as in the hospital after a recent bone marrow transplant There is no similar risk with the inactivated, injectable flu vaccine.
If a household contact (infant) has recently received rotavirus vaccination, all family members should wash hands thoroughly and frequently after contact with the vaccinated infant, especially when changing diapers.
Household contacts not receive the Oral Polio Vaccine. Note that the oral polio vaccine is not used in the United States
ricordare che tutti i bambini sono potenziali portatori di malattie virali (es. morbillo, varicella), pertanto evitate assolutamente i contatti con bambini vaccinati di recente.
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( www.giornaledicardiologia.it/articoli.ph...vol_id=2852&id=28779 )Il nostro studio ha evidenziato che il fenomeno della mancata segnalazione di ADR da parte dei medici è rilevante e riguarda anche farmaci sottoposti a monitoraggio addizionale e reazioni avverse gravi.
Purtroppo, in talune occasioni si osserva un uso distorto delle segnalazioni di sospette reazioni avverse, finalizzato spesso a giustificare la scelta di un particolare farmaco.
Infatti, in alcuni casi, quando il medicinale aggiudicato è un equivalente, la segnalazione di sospetta ADR è utilizzata quale strumento per permettere l’accesso al farmaco brand
uno sproporzionato aumento del numero di segnalazioni di sospette reazioni avverse per alcuni principi attivi per i quali è scaduto il brevetto e quindi esistono i medicinali equivalenti e biosimilari
La maggior parte di queste segnalazioni proviene da medici che non avevano mai segnalato una reazione avversa prima del 2014 e da Regioni in cui sono stati stipulati accordi attraverso i quali sostanzialmente il farmacista è autorizzato a non sostituire il prodotto originator con l’equivalente o biosimilare a patto che il paziente sia intollerante a quest’ultimo e che ciò sia dimostrato dall’inserimento nella RNF dell’apposita scheda di segnalazione di sospetta reazione avversa.
In altri casi, la segnalazione è utilizzata per giustificare la prescrizione di un medicinale la cui prescrivibilità a carico del SSN è subordinata alla comparsa di una ADR ad un altro principio attivo.
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The ethical dilemma – the trolley problem
This commentary does not attempt to examine if these
excess deaths after vaccination (presumed to be caused by
the vaccine) can be offset by the lives saved through disease
prevention owing to the vaccine. In her classical thought
experiment, called the “Trolley dilemma”, Philippa Foot asks
if it is ethical to redirect a runaway trolley from a track on
which it would kill five persons to another track where only
one would die (11). In a variation of the trolley dilemma, the
single person on the alternative track is the child of the person
who can switch the tracks. Judith Thomson assumes that five
lives can be saved with organ transplants from one healthy
donor, and asks if it would be ethical to surreptitiously kill
one person to save the other five (12). Ethicists argue that the
end cannot justify the means. If one glosses over the deaths
after vaccination, one can prevent/delay the evaluation of the
vaccine’s safety profile and this has the potential to result in
more, unnecessary deaths, which is difficult to justify ethically.
Summary and conclusion
von Kries (1) reported a statistically significant increase in the
SMR in children in their second year of life, within two days of
vaccination with Hexavac® (one of the two licensed hexavalent
vaccines, now withdrawn).
In its periodic safety update reports, GSK, the company
manufacturing Infanrix hexa, evaluates whether the number
of sudden deaths reported after vaccination with their product
exceeded the number that could be expected by chance. The
clustering of deaths soon after immunisation suggests that the
deaths could have been caused by the vaccine.
Furthermore, our analysis shows that the deaths
acknowledged in the PSUR 16 have been deleted from the
PSUR 19. The observed deaths are spontaneously reported to
GSK and are likely to be underestimated. Adding in the deaths
deleted from the PSUR 16, there is a statistically significant
increased risk of death in the first four days after vaccination,
compared to the expected deaths. The manufacturers will need
to explain why these deaths were not included in the PSUR
19. The increased risk of death was not communicated to the
regulatory authorities or to the health personnel administering
this vaccine.
Given the above, it is difficult to understand how the EMA
accepted the PSUR 19 at face value. It may be argued that due
diligence was not exercised, as a result of which numerous
children were unnecessarily exposed to the risk of death.
The safety and efficacy of Infanrix hexa in children over 36 months of age have not been established.
No data are available.
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m4x ha scritto: Ho visto di tutto, ma questo, questo ha estinto ogni mia speranza nel genere umano:
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L’indagine era stata aperta nel 2016 e ora il gruppo farmaceutico Sanofi è stato iscritto nel registro degli indagati per “omicidio involontario” nell’inchiesta sulla commercializzazione del farmaco Dépakine impiegato per il trattamento dell’epilessia. L’indagine mira a determinare se il colosso francese può essere ritenuto responsabile della morte, nel 1990, 1996, 2011 e 2014, di quattro neonati di età tra alcune settimane e alcuni mesi le cui madri, durante la gravidanza, avevano assunto il medicinale, che sul feto provoca malformazioni e disturbi dello sviluppo neurologico. Già il 2 luglio il Tar di Montreuil, alle porte di Parigi, aveva condannato l’azienda farmaceutica a risarcire tre famiglie i cui figli sono rimasti pesantemente handicappati dopo essere stati, ancora in utero, esposti agli effetti del farmaco. Per i giudici le responsabilità sono condivise anche dal laboratorio farmaceutico Sanofi e dai medici che hanno prescritto il Depakine. Per la sua commercializzazione il gruppo è già finito sotto inchiesta per “truffa aggravata” e “lesioni involontarie”.
All’apertura dell’inchiesta nel 2016, era stata lanciata anche dall’Apesac, l’associazione delle vittime di cui facevano parte circa duemila famiglie, la prima class action francese in ambito sanitario. Il sodio valproato, il principio attivo presente nel medicinale prodotto da Sanofi dal 1967, aumenta infatti i rischi di malformazioni nei feti. L’Apesac chiedeva che venisse riconosciuta la “responsabilità del laboratorio nel ritardi rispetto alle informazioni sul sodio valproato quando invece ne conosceva i rischi”. Quel principio attivo è considerato fondamentale per curare gli epilettici ma assunto dalle donne in stato di gravidanza può aumentare del 10% la possibilità per i feti di nascere con malformazioni congenite e del 40% i problemi autistici o ritardi psicomotori.
Sanofi è lo stesso gruppo farmaceutico col quale la Commissione europea ha stretto l’accordo per la fornitura di un massimo di 300 milioni di dosi del loro candidato vaccino contro Covid-19, sviluppato dal colosso francese in collaborazione con la britannica GlaxoSmithKline (GSK). Il prodotto si basa sulla tecnologia ricombinante utilizzata da Sanofi per produrre un vaccino antinfluenzale, e sulla tecnologia adiuvante di Gsk.
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