Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release
The four manufacturers will make the Influenza A (H1N1) 2009 Monovalent vaccines using the established manufacturing processes for their seasonal influenza 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 United States. The Influenza A (H1N1) 2009 Monovalent vaccines will undergo the usual testing and lot release procedures that are in place for seasonal influenza vaccines.
Lot release information will be updated weekly. Last update: 4/1/2010.
| Manufacturer | Total Number of Lots Released by FDA |
|---|---|
| CSL Limited | 47 |
| ID Biomedical | 11 |
| MedImmune LLC | 96 |
| Novartis Vaccines and Diagnostics Limited | 88 |
| Sanofi Pasteur, Inc. | 227 |
Approved Vaccines
- Influenza A (H1N1) 2009 Monovalent Vaccine (CSL Limited)
- Influenza A (H1N1) 2009 Monovalent Vaccine (ID Biomedical Corporation of Quebec)
- Influenza A (H1N1) 2009 Monovalent Vaccine (MedImmune LLC)
- Influenza A (H1N1) 2009 Monovalent Vaccine (Novartis Vaccines and Diagnostics Limited)
- Influenza A (H1N1) 2009 Monovalent Vaccine (Sanofi Pasteur, Inc.)
Key Resources
- Influenza A (H1N1) 2009 Monovalent
- Influenza A (H1N1) 2009 Monovalent Vaccines Questions and Answers
- Influenza A (H1N1) 2009 Monovalent Vaccine Safety Monitoring
- 2009 H1N1 (Swine) Flu Virus (Biologics)
- Use of Influenza A (H1N1) 2009 Monovalent Influenza Vaccine in Pregnant Women