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NBSB Pandemic Influenza Working Group Detailed Report Vaccine may take the form of a nasal spray, prefilled syringes, or 10-dose vials of antigen and 10-dose vials of adjuvant that could be combined manually. The total vaccine output by manufacturer is projected as follows: Novartis: 45.7% Sanofi Pasteur (vial plus syringe): 26.4% CSL: 18.7% MedImmune (nasal spray): 5.8% GlaxoSmithKline (GSK): 3.4% Dr. Robinson outlined the distribution options, which are subject to change along with production schedules. CDC has identified McKesson as its prime wholesale distributor, and up to four more distributors could be involved. Dr. Robinson said the system allows for quick distribution, but if seasonal influenza vaccine is also being distributed, the carrier system will be worn down, even if the distribution system is seamless and no logistical problems arise. Delivery through point-of-delivery systems (PODS), State and local health departments, and private providers are all under consideration as the system gears up to delivery 40,000–90,000 parcels per day. The President wants the vaccination effort done safely and quickly. Dr. Robinson said the current pandemic influenza strategy prioritized critical workers, children, and pregnant women as the first tier of vaccine recipients. He reminded the group that the World Health Organization declared a pandemic of H1N1 influenza on June 11, 2009. Discussion (paraphrased) 1 Tim Gallagher: Do you anticipate an increased demand for seasonal influenza vaccine? Dr. Robinson: We’ve taken that into account, and the amount of seasonal vaccine may reflect an increased demand. Kathy Neuzil, M.D., M.P.H.: I would like to see this strategy applied to seasonal influenza. I think the theme of today is that we can’t look at H1N1 in isolation but rather should look at how it intersects with seasonal influenza in terms of immunogenicity, distribution, antigenicity, etc. Dr. Robinson: We are working with manufacturers, talking with CDC and others, engaging in meetings like this and others, but the clock is ticking, and we need to decide soon. Some manufacturers have not finished production of their seasonal influenza vaccine yet, but it’s not interfering now. It would take another level of coordination, but it’s worth discussing further. Dr. Neuzil: The Advisory Committee on Immunization Practices (ACIP) has worked hard to evaluate risk groups and has included more people in its seasonal influenza vaccine recommendations. This will be the first year of full implementation of our recommendations for pediatric patients. It’s important to be careful about messaging, especially if there are different target groups. There is potential for confusion—there’s 1 This and subsequent discussions paraphrase the questions and comments of the participants. This document does not represent a verbatim transcript. 6
NBSB Pandemic Influenza Working Group Detailed Report always confusion about vaccines. Our compromise with the American Academy of Pediatrics was to recommend that children get two doses of seasonal influenza vaccine in the first year that they are vaccinated. Does H1N1 vaccine count toward that? Should they get two doses of seasonal vaccine also? You can see how the decision on H1N1 will affect our implementation. Dr. Pavia: Given the data needed to make recommendations, and what’s been done in clinical trials so far, the concept of priming patients for seasonal influenza and novel H1N1 adds another level of complexity. [Unidentified]: Can we reach the goal of 600 million doses? Dr. Robinson: We have been able to cobble together with the manufacturers the capacity to get that. [Unidentified]: When does the six-month clock start? October? Dr. Robinson: May. That’s our assumption. On May 22, the Secretary put the pandemic influenza money toward vaccine development. [Unidentified]: Is it possible to get more product before October? Dr. Robinson: Maybe we could have some in July, but what amount of antigen should it contain? How much adjuvant? We could make blind decisions, but we want science informing us where possible. Update: Domestic and International Surveillance Update and Plans—CAPT Anthony Fiore, M.D., M.P.H., CDC CAPT Fiore said he could provide some information from early U.S. surveillance data. We have illness and we are seeing outbreaks, he said, although there has not been much media attention in recent weeks. In the United States, 17,855 cases of H1N1 influenza have been confirmed and 45 deaths have resulted. The figures are rising. Around the world, there have been approximately 36,000 cases in 76 countries. Clearly, the H1N1 virus is persisting and will continue to circulate. Surveillance information comes from various sources, including: swabs taken at doctors’ offices, hospital-based surveillance, State and territorial epidemiologists (who report weekly), pediatric mortality statistics, and sentinel providers’ systems (which look for influenza-like illness (ILI)). Virologic surveillance involves about 165 public health and hospital laboratories. They get reagents from CDC and report daily on virus changes and antiviral susceptibility. The 2008–2009 influenza season followed typical patterns until the outbreak of H1N1 in April. CDC saw a late surge in acute respiratory disease, mostly due to novel H1N1. Because more people were tested later in the influenza season, CDC found that the typical influenza season appeared to last into May, which is longer than previously thought. Morbidity surveillance relies on several systems, including the ILI Surveillance Network (ILINet, also called the sentinel providers’ system), which now provides daily reports on people who present with acute respiratory infection. It includes 2,400 health care providers and about 16 million visits per year. Reports identify the percentage of patients 7
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