2009-H1N1 Influenza Vaccine Development Next Steps: Questions and Answers

U.S. Department of Health and Human Services

1.	What do the new orders on these contracts support? The objective of the new orders on these contracts is to allow the U.S. government to manufacture and test pre-pandemic vaccines against the newly emerging 2009-H1N1 virus for the U.S. pre-pandemic influenza vaccine stockpile. This is an important step in order to build a stockpile of at least 40 million doses of 2009-H1N1 vaccine and add it to the stockpile of pre-pandemic vaccines. Because of the virus’ recent emergence, there were no doses of 2009-H1N1 in the U.S. stockpile.
2.	How is the 2009-H1N1 different from seasonal influenza? Each influenza season H1N1 is one of the viruses circulating in people and causing disease. The 2009-H1N1 has acquired H1 and N1 genes from swine to create a new version of the H1N1 virus (called 2009-H1N1) that is significantly different from the seasonal H1N1 that has been circulating in people.
3.	Will the seasonal vaccine protect me against the 2009-H1N1 influenza? Preliminary analysis of serum from people immunized with the seasonal influenza vaccine done at the CDC suggests that the seasonal vaccine is unlikely to provide protection against 2009-H1N1.
4.	Will this vaccine be made differently than the seasonal influenza vaccine? No. This vaccine will be made using the same processes and facilities that are used to make the currently licensed seasonal influenza vaccines.
5.	Will all this vaccine be injectable? No. Some of the vaccine will be a live attenuated vaccine that is sprayed into the nose to immunize a person.
6.	What about other vaccine manufacturing technologies, like recombinant or cell-based vaccines? For this phase the U.S. government response has been focused on the currently licensed vaccine manufacturers. We are continuing to investigate how the U.S. government may use other technologies as part of the response to the 2009-H1N1.
7.	When will the work on the 2009-H1N1 vaccine start? The work has already started to develop a vaccine, and these new orders on existing contracts are for the first large-scale manufacturing of ingredients that could be used in a potential H1N1 vaccine. Laboratories are already working on the generation of the seed viruses needed for vaccine production. These should be available for the distribution to the vaccine manufacturers around June 1. Once the manufacturers have completed their seasonal influenza vaccine production, they will start production of the 2009-H1N1 vaccine.
8.	What testing will be done on these vaccines? In addition to the usual testing done for seasonal influenza vaccines, there will be clinical testing in people to determine the most effective and safest dose to generate a strong immune response to the 2009-H1N1 virus.
9.	How many doses will be needed to be immunized? This will be determined during the clinical studies. It could be one dose, like the seasonal vaccine, but it could be two doses since the population has little or no immunity to the 2009-H1N1 virus, which has not infected humans previously.
10.	What is an adjuvant? An adjuvant is an additive to a vaccine that helps to generate a stronger immune response to the vaccine. When using an adjuvant it is often possible to reduce the size of the vaccine dose and the number of doses needed. So the use of an adjuvant can reduce the amount of vaccine needed to immunize a population.
11.	Does the current seasonal influenza vaccine use an adjuvant? No, there are currently no U.S. licensed influenza vaccines with adjuvant.
12.	How will it be decided if an adjuvant will be used in this vaccine? Experts will review the safety and immunogenicity data from the clinical testing of this vaccine and make a determination based on what is the safest and most effective dosage for the generation of a strong immune response.
13.	What is an influenza pandemic? An influenza pandemic is a global outbreak of disease that occurs when a new influenza virus appears in the human population, causes serious illness, and then spreads easily from person to person. Unlike seasonal influenza, people will have little immunity to the virus that causes a pandemic.