Excerpt: More recently, the US Centers for Disease Control and Prevention (CDC) have proposed estimates of impact ranging between 3,000 and 49,000 yearly deaths. When actual death certificates are tallied, influenza deaths on average are little more than 1,000 yearly. So, the actual threat is unknown (but likely to be small) and so is the estimation of the impact of vaccination.
In healthy adult trials a high serological response is matched by a very small clinical effect (71 healthy adults need to be vaccinated to prevent one of them experiencing influenza). This weak effect cannot be explained simply by the mismatch of vaccine antigens with wild virus ones. A larger effect is observed in children over the age of two (five children need to be vaccinated to prevent one case of influenza, although there is huge uncertainty around these estimates). There is little evidence on prevention of complications, transmission, or time off work. Other reviews have drawn similar conclusions.5
EXCERPT ON COMPLAINTS ON HOW THE AGENCY IS HANDLING VACCINE APPROVALS/RECOMMENDATIONS:
- experts who had declared current direct interests in a pharmaceutical company or for a particular medicinal product were allowed to participate in the Scientific Advisory Group meeting.”
- We don’t have confidence that the agency [EMA] has interpreted these documents in a way that ensures openness, gives the administration legitimacy, makes it accountable to the citizens, and respects fundamental rights of access to information that is important for the citizens when they make decisions about healthcare…”
- internal report and all other documents related to this case should therefore be made publicly available, without redactions.”
- The EMA’s procedures for evaluating the safety of medical interventions need to be fundamentally reworked and made transparent to the public.
- “I have come into possession of documentation which leads me to believe multiple individuals and organizations deliberately set out to mislead Japanese authorities regarding the safety of the human papillomavirus (HPV) vaccines, Gardasil® and Cervarix®”
Flu Vaccine for All: A Critical Look at the Evidence
Does the evidence support the call for universal influenza vaccination?
|Response from Eric A. Biondi, MD, MS
Assistant Professor of Pediatrics, Pediatric Hospitalist, University of Rochester Medical Center, Rochester, New York
|Response from C. Andrew Aligne, MD, MPH
Assistant Professor of Pediatrics, Director of The Hoekelman Center, University of Rochester School of Medicine & Dentistry, Rochester, New Yor