Influenza pandemic (H1N1) 2009 (49): FDA vaccine update

Date: Tue 15 Sep 2009
Source: FDA (U.S. Food and Drug Administration), Vaccines, Blood and
Biologics [edited]
<http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm181950.htm>


[The following update comprises a listing of the FDA approved
monovalent influenza pandemic (H1N1) 2009 vaccines which will undergo
the usual testing and lot release procedures that are in place for
seasonal influenza vaccines.

Readers are recommended to consult the Key Resources and Key Links
below as sources of information for all aspects of influenza pandemic
(H1N1) 2009 vaccine development and related matters. - Mod.CP]

Influenza A (H1N1) 2009 Monovalent Vaccines
-------------------------------------------
FDA approved these vaccines as a strain change to each manufacturer's
seasonal influenza vaccine. There is considerable experience with
seasonal influenza vaccine development, and production and influenza
vaccines produced by this technology have a long and successful track
record of safety and effectiveness in the USA. The Influenza A (H1N1)
2009 Monovalent vaccines will undergo the usual testing and lot
release procedures that are in place for seasonal influenza vaccines.

Injectable Vaccines
-------------------
- Influenza A (H1N1) 2009 Monovalent Vaccine (CSL Limited)
- Influenza A (H1N1) 2009 Monovalent Vaccine (Novartis Vaccines and
Diagnostics Limited)
- Influenza A (H1N1) 2009 Monovalent Vaccine (Sanofi Pasteur, Inc.)

Intranasal Vaccine
-----------------------
- Influenza A (H1N1) 2009 Monovalent Vaccine (MedImmune LLC)

Key Resources
-------------------
- Influenza A (H1N1) 2009 Monovalent Vaccines Questions and Answers
<http://www.fda.gov/BiologicsBloodVaccines/Vaccines/QuestionsaboutVaccines/ucm182335.htm>

- Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot
Release Composition, Lot Release, and Other Information
<http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Post-MarketActivities/LotReleases/ucm181956.htm>

- Influenza A (H1N1) 2009 Monovalent Vaccine Safety Monitoring
<http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm182290.htm>

- FDA Approves Vaccines for 2009 H1N1 Influenza Virus
<http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm182399.htm>

- Influenza Virus Vaccine Actions - 2009 H1N1 (Swine) Flu Virus
(Biologics). H1N1 specific information for vaccines, blood and other
areas of concern
<http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm161448.htm>

- FDA 2009 H1N1 (Swine) Flu Page. FDA is working to address human
infection with the 2009 H1N1 flu virus as part of a team led by the
Department of Health and Human Services.
<http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm150305.htm>

Key Links
------------
- Flu.gov <http://flu.gov/>
- CDC H1N1 Flu Page <http://www.cdc.gov/h1n1flu/>