posted on 2009-12-07 by tobbysims
There has been lots of discussion about the pandemic H1N1 vaccine amongst the protagonists and the antagonists alike.  The protagonists believe the vaccine is safe and we must have it in order to stop the spread of the disease and the antagonist believe it is unsafe and will cause wide spread death and suffering and is part of the Big Pharma response.  Wow – not much middle ground there!

MMWR Report

CDC has just issued the MMWR that details the first reports on vaccine safety in the U.S.  The FDA licensed the first 2009 pandemic vaccine (H1N1 monovalent vaccine or “H1N1 vaccines” on September 15, 2009.

    * None of these vaccines contains an adjuvant.
    * The licensure and manufacturing processes for the vaccine were the same as those used for seasonal flu.

The H1N1 vaccines are available as a:

    * Live, attenuated monovalent vaccine (LAMV) for intranasal administration
    * Monovalent, inactivated, split-virus or subunit vaccines for injection (MIV)

Vaccine Adverse Event Reporting System (VAERS)

To assess the safety profile of H1N1 vaccines in the United States, CDC reviewed vaccine safety results for the H1N1 vaccines from

    * 3,783 reports received through the U.S. Vaccine Adverse Event Reporting System (VAERS)
    * Electronic data from 438,376 persons vaccinated in managed-care organizations in the Vaccine Safety Datalink (VSD), a large, population-based database with administrative and diagnostic data, in the first 2 months of reporting (as of November 24).

VAERS data indicated 82 adverse event reports per 1 million H1N1 vaccine doses distributed, compared with 47 reports per 1 million seasonal influenza vaccine doses distributed.

    * No substantial differences between H1N1 and seasonal influenza vaccines were noted in the proportion or types of serious adverse events reported.
    * No increase in any adverse events under surveillance has been seen in VSD data.

Many agencies are using multiple systems to monitor H1N1 vaccine safety. Health-care providers and the public are encouraged to report adverse health events that occur after vaccination.

Reports to VAERS

VAERS enables early detection of potential new, rare, or unusual patterns of adverse events, which then can be investigated using other methods and systems to determine whether an actual association with vaccination exists. What are the reporting requirements?

    * Health-care providers and manufacturers are required to report to VAERS certain adverse events in vaccinees brought to their attention after vaccination with licensed U.S. vaccines.
    * Health-care providers and members of the public may also report other adverse events voluntarily.

There were several changes made to VAERS to enhance reporting with the initiation of the H1N1 vaccination program.  This included providing VAERS contact information on influenza vaccination record cards, advertising in medical journals, utilizing state vaccine safety coordinators, and increasing the number of staff members who code reports and obtain and review medical records,

CDC and FDA staff members review all VAERS data. Reporting rates were calculated per 1 million doses distributed as of November 20.  Through November 24, VAERS received:

    * 3,783 reports of adverse events after receipt of H1N1 vaccine 204 were categorized as serious
    * 4,672 reports after receipt of seasonal influenza vaccines, of which 283 were serious

Continue to source: http://emssolutionsinc.wordpress.com/2009/12/07/h1n1-swine-flu-vaccine-safety-%E2%80%93-report-of-adverse-reactions-in-the-u-s-october-1-november-24-2009/