In These New Times

According to the government’s own web site at http://www.flu.gov/professional/federal/monitor_immunization_safety.html#v_assesing , these are the Current Federal Plans to Monitor 2009 H1N1 Monovalent Vaccine Safety

“The primary method the government will employ to detect vaccine safety signals is VAERS, a national passive surveillance system that accepts reports from physicians, other healthcare providers, and the public. FDA and CDC co-manage VAERS, which was established in 1990. VAERS is an important tool for signal detection of clinically significant AEFIs, such as with intussusception following RotaShield vaccine[iii]. The strengths of VAERS are that it is national, it can include any sub-population that receives the vaccine, it can detect signals of rare events, and it can monitor adverse events on a lot-specific basis. However, there are a number of limitations to what VAERS can accomplish in isolation. VAERS is affected by potential reporting biases, including under-reporting (not all events that occur are reported) and media-stimulated reporting leading to over-reporting. Further, VAERS submissions may be incomplete (reports with missing data or insufficient information to validate diagnoses). VAERS can only collect events without the context of the number of doses given (denominator). Distributed doses may act as a crude surrogate denominator, but there is no true denominator available for vaccine administration. Consequently, the data do not allow true incidence or prevalence data to be generated. In addition, VAERS data do not include a control (unvaccinated) group, thus not providing a comparison of the risk of adverse events among persons vaccinated to those who were not vaccinated. Given its limitations, VAERS can provide an early signal that a possible vaccine safety problem requires further investigation (signal detection), VAERS data alone are not suitable to evaluate associations between vaccines and adverse events or to establish causality.”

So far, no testing has been done on the vaccine. The government is counting on clinicians and others to report adverse effects.

Package inserts for the vaccines provide additional information:

• the insert  for Fluzone states the multi-dose vial contains thimerosal (exposures are associated with mental retardation, loss of coordination in speech, writing, gait, stupor, and bad temper) and state the vaccine’s safety has not been established in pregnant or nursing mothers or in children younger than 6 months at https://www.vaccineshoppe.com/image.cfm?doc_id=10913&image_type=product_pdf
• the insert for Fluarix states safety has not been established in pregnant or nursing women. Novartis has several lines of flu vaccines; safety data includes “proven by years of experience.” http://www.novartisvaccines.com/products-diseases/influenza-products/index.shtml
• For other inserts, visit http://www.health.state.mn.us/divs/idepc/diseases/flu/hcp/vaccine.html

A critical review on influenza vaccination during pregnancy contends the Advisory Committee on Immunization Practices recommendation “of routinely administering influenza vaccine during pregnancy is ill-advised and unsupported by current scientific literature, and it should be withdrawn.”  The full analysis is available at http://www.jpands.org/vol11no2/ayoub.pdf