H1N1 Vaccine Safety: FDA Letter to Health Care Professionals

Commissioner’s Letter to Health Care Professionals
Letter from the Commissioner to Nation’s Health Care Professionals on H1N1 Vaccine Safety
U.S Food and Drug Administration (FDA) Jan 14, 2010

KEY points and excerpts:

  • FDA and CDC are assessing H1N1 vaccine safety on a continuing basis and have published a detailed report describing the safety profile of H1N1 vaccines in the United States.
  • To date, our experience with the H1N1 influenza vaccination program has met high safety expectations, based on the track record of the licensed seasonal vaccines, including live attenuated and inactivated vaccines.
  • At the heart of our monitoring efforts are two surveillance systems used to help identify safety issues: the Vaccine Adverse Event Reporting System (VAERS) and the CDC’s Vaccine Safety Datalink (VSD).
  • 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 of the pre-selected adverse events under surveillance, such as Guillain-Barré syndrome, has been seen in VSD data.
  • The National Vaccine Advisory Committee (NVAC) created the H1N1 Vaccine Safety Risk Assessment Working Group to review 2009 H1N1 vaccine safety data. This working group of outside experts conducts regular, rapid reviews of available data from the federal safety monitoring systems.. for policy followup.

VIDEO:  More from Norman Baylor, Director of the Office of Vaccines Research Review in the Center for Biologics Evaluation and Research.


Eat Cookies Lose Weight

CDC: Safety of Influenza A (H1N1) 2009 Monovalent Vaccines — United States, October 1 — November 24, 2009 (MMWR)
FDA: 2009 H1N1 (Swine) Flu Page
HHS: National Vaccine Advisory Committee – Report on 2009 H1N1 Vaccine Safety Risk Assessment

HHS: Vaccine Adverse Events Reporting System – H1N1 Updates

Be Sociable, Share!

2 Trackbacks

  1. […] This post was mentioned on Twitter by Influenza Monitor, Influenza Monitor. Influenza Monitor said: H1N1 Vaccine Safety: FDA Letter to Health Care Professionals: Commissioner’s Letter to Health Care Professionals … http://bit.ly/8mUtoF […]

  2. By vaccine safety - StartTags.com on January 25, 2010 at 12:33 pm

    […] were being born with huge dis-formities and then the truth came out concerning thalidomide. …H1N1 Vaccine Safety: FDA Letter to Health Care Professionals …FDA and CDC are assessing H1N1 vaccine safety on a continuing basis and have published a detailed […]