National Vaccine Advisory Committee (nvac)

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2004–2005 National Influenza Season Response Operations Plan – Dr. Eddie Wilder

Dr. Wilder noted that he would be giving a brief overview of what the CDC is expecting in the upcoming influenza vaccination season, an update on influenza vaccine production and distribution, including the timing of the distribution, and an overview of the influenza vaccine stockpile.

He began with an overview of the 2004 influenza vaccination season. There are three manufacturers of influenza vaccine. Aventis Pasteur and Chiron produce the inactivated vaccine, and MedImmune produces the live attenuated influenza vaccine. The manufacturers expect to produce approximately 13 million more doses of influenza vaccine this year than in 2003. The distribution of the influenza vaccine began in August for this season.

Mr. Wilder presented data on influenza vaccine production and distribution over the past four years and the projected production for 2004. Projected doses for this season are estimated to be approximately 100 million. Last year, a record number of doses were distributed.

Mr. Wilder then discussed the timing of distribution for the 2004-2005 influenza season. There was a notice to readers in the September 24, 2004 MMWR entitled, “Supplemental Recommendations for Timing of Influenza Vaccine for the 2004/05 Season.” The notice indicated that production was proceeding satisfactorily. However, it also indicated that Chiron, in conducting its final internal review release procedures for its inactivated influenza vaccine (Fluviron), identified a small number of lots that did not meet its sterility specifications and that those lots would not be distributed. Chiron indicated that the problem was localized and that all remaining lots meeting the sterility specifications would be available for distribution once the company completes its quality assurance testing. Chiron’s plans for distribution are pending until regulatory officials in the United States and the United Kingdom complete their reviews of the data from the company’s investigation. Mr. Wilder noted that some concerning information was just received that morning from Chiron regarding their distribution of the influenza vaccine and that the information is still pending. Chiron is expected to issue a press release in the near future.

As noted earlier, Aventis Pasteur began distribution in August and MedImmune will begin distribution in early October or as soon as release protocols are received by them. He noted that the bulk of this year’s influenza vaccine should be available in October and November, which according to ACIP, is the optimal time for vaccination against influenza.

Mr. Wilder discussed the 2004 influenza vaccine stockpile. The CDC has legislative authority to establish an influenza vaccine stockpile through the VFC Program. He noted that 4.5 million doses of influenza vaccine have been purchased for this influenza season to be held as national stockpile. Of these, half will be available for distribution in December 2004 and the remaining half will be available for distribution in January 2005.

Supply, Distribution, and Vaccine Timing Issues for the 2004–2005 Season - Mr. Alan Janssen

Mr. Janssen highlighted the logo for this year, which emphasizes protecting oneself and one’s loved ones by getting the influenza vaccine. He noted that throughout his presentation there would be emphasis on protecting the community by getting the flu vaccine.

Mr. Janssen noted that the primary objectives were to motivate people to receive timely influenza immunizations (particularly high risk individuals), to motivate parents to vaccinate children 6 to 23 months of age, to increase awareness of influenza immunization recommendations and benefits among African Americans and Hispanic Americans, and to provide the resources for healthcare providers to assume a leadership role in encouraging patients to get vaccinated. He noted that the inclusion of pregnant women in all trimesters and parents of children ages 6 to 23 months is new this year.

Mr. Janssen discussed the series of activities undertaken to develop this campaign. There has been ongoing formative and concept research with the influenza target audiences. The research has shown that people are becoming more aware of what influenza is – that it is a virus that can be spread from person to person and may be airborne. However, there are still many individuals who believe that the flu vaccine can cause the flu. Materials are being developed to specifically address these issues.

A series of surveys are conducted annually. A survey with the Gallup Organization asked physicians, pediatricians and family practitioners what they most often heard from parents with respect to the flu vaccine. They indicated that parents questioned whether the flu vaccine was necessary. Materials were developed to help pediatricians and family practitioners encourage parents to get the vaccine. Past focus groups indicated that people were not worried about the flu, but were worried about pneumonia because people die of pneumonia. However, the reported pediatric deaths in Colorado last year raised awareness that influenza can be deadly.

Mr. Janssen highlighted the key messages: influenza is a serious disease causing an estimated 36,000 deaths and 200,000 hospitalizations, annually; vaccination is the best protection against the flu; emphasizing the recommendations for children 6 to 23 months of age; the vaccine is safe and effective; October and November are the best months to get vaccinated, although December is not too late; and that getting vaccinated would protect others. He noted that particularly among African Americans and Hispanic Americans, individuals would not get vaccinated themselves, but would consider getting vaccinated to protect their family.

Their call to action for the public is that high risk people and their contacts should get vaccinated in October or November. Parents of children 6 to 23 months of age should call now to make an appointment to discuss vaccinating their children. There will be emphasis this year on household contacts and caregivers to protect themselves and people around them.

Mr. Janssen noted that the campaign consists of two parts – media and print materials. The print materials are in English and in Spanish and are written for low literacy audiences. The media campaign includes video news releases (VNRs) and audio news releases (ANRs) featuring Dr. Gerberding. He noted that one of these would go out this week emphasizing vaccinating children ages 6 to 23 months. The final VNR is scheduled to go out in December. There are Spanish language VNRs and ANRs. They have done a series of possible targeted radio advertisements which was put in with another component, the radio satellite news tour. He noted that each year there seems to be a new challenge and that they hope to have something in place to address such issues as they come up. They also did outreach at the UNITY conference for minority journalists which was held in Washington, D.C. They have news conferences linked with the MMWR articles. They do a series of “Matte Articles” which are articles containing a great deal of factual information about influenza and the influenza vaccine, and which can be tailored to local audiences. They participate in the NFID press conference and other media opportunities. There have also been a series of press interviews with Dr. Gerberding.

Mr. Janssen noted that with respect to print materials for the public and for patients, pediatricians and family practitioners are seen as a trusted source of information and CDC materials are being developed for them. The focus groups showed that people do not expect to see pretty, glossy brochures from the CDC, but they do look at the source of the information and the CDC continues to carry a great deal of weight with this particular audience. The CDC developed flyers, posters, brochures, buttons, and stickers. He noted that the buttons and stickers were for the leadership role they hope the physicians will take with the influenza vaccine.

One important finding from research on other vaccines, concerning healthcare workers especially, is that if the healthcare workers see the physicians taking the vaccine and promoting the vaccine, they are more likely to make the personal choice to get vaccinated themselves.

Mr. Janssen showed samples of the flyers where CDC is trying to dispel some of the myths about the vaccine, discuss the new target audiences, identify who is high risk, etc. He also showed examples of posters that have been developed with special emphasis on community aspects, children, and the value of the vaccine during pregnancy. The materials will be distributed through health departments, healthcare providers, and the CDC website. He noted that CDC has a website where people can download and print the posters.

With the call to action for healthcare providers, they are trying to emphasize the importance of the leadership role for physicians to set an example and get vaccinated, encourage staff and colleagues to get vaccinated, and recommend vaccination to all patients, particularly those at high risk. With respect to provider print materials, there are about 85,000 “Immunize Now” provider kits that include materials for doctors, nurses, administrators, and patients. In addition, there are articles in professional society journals and newsletters, as well as ads in medical journals they are co-branding with CMS.

Mr. Janssen showed examples of the campaign materials emphasizing that influenza is here, what to do to get the vaccinations, and the importance to others. Materials in English and Spanish are available for children, parents, and caregivers. Distribution of print materials will be through professional societies, the CDC website, health departments, and direct mail. In addition, NIP will exhibit at the major provider conferences in the fall and winter.

Mr. Janssen noted that there are several hundred thousand hits on their website for influenza and influenza immunization. Educational materials for the public and providers will be available for download from the CDC flu website:

Pandemic Influenza Preparedness and Response Plan - Dr. Benjamin Schwartz

Dr. Schwartz commented that after several months of giving presentations on the pandemic plan and saying that it would be released, he was pleased to be able to say that the Pandemic Influenza Preparedness and Response Plan has been released and that he appreciated the opportunity to discuss pandemic influenza preparedness and response with NVAC. The pandemic clock is ticking; we just don’t know what time it is.

He noted that the objectives of his presentation were to comment on the H5N1 threat in Asia and then summarize recent and ongoing pandemic preparedness activities, looking first at the HHS Pandemic Influenza Preparedness and Response Plan, and other activities implemented by the department.

Dr. Schwartz noted that H5N1 influenza in Asia, first identified in Hong Kong in 1997, is the greatest current pandemic threat. Recently, in Thailand, there was a cluster of a 12-year old girl who had contact with infected poultry. The child went home to her mother, who did not have contact with infected poultry, and the mother became infected and died, as did the child. This would be the first evidence of human-to-human transmission of the H5N1 strain in the recent cluster and is particularly concerning in terms of the possibility of a pandemic.

When the next pandemic might occur and its severity is unknown. The 1918 pandemic resulted in 675,000 deaths in the United States, making it the single most fatal even in U.S. history. Projecting those deaths to the current U.S. population would result in 1 million to 2.2 million deaths. He noted that the case fatality rate was 3 percent. Comparing this rate to the case fatality rates for avian influenza in the Asian countries, a catastrophic situation could result should it become a pandemic.

The HHS Pandemic Influenza Preparedness and Response Plan provides a road map for the critical activities that will help decrease the health impact, as well as the economic and social impacts of the next pandemic. The plan was released for a 60-day public comment period on August 26, 2004 and a number of comments have already been submitted. He added that the plan is a “living document” that will be revised periodically as needed and that comments are always welcomed.

There is a core plan with preparedness and response sections that provides an outline of the various activities that need to be undertaken before a pandemic, as well as the activities that would be undertaken as part of a pandemic response. The HHS Conops (Concept of Operations) plan for public health and medical emergencies is also included. Finally, 12 annexes provide guidance to health departments and other health care organizations and detailed information on critical issues (e.g., vaccines, antivirals, surveillance), as well as interesting comparative and historical perspectives.

Dr. Schwartz noted that there are also a number of outstanding issues including: the purchase and distribution of pandemic vaccine and whether it would be public, private or both; the development of a list of priority groups for vaccination; strategies for antiviral drugs approaches (e.g., therapy vs. prophylaxis); and the resolution of approaches to indemnification and liability protection. There is also a need for additional specificity for issues such as determining strategies to decrease international and community transmission and how to implement them and frontline healthcare workers or essential community service providers, who may be target groups for vaccination and antivirals, need to be better defined. Materials need to be developed to monitor vaccination coverage, recall people for a second dose if necessary, monitor for vaccine adverse events, and for communication and educational purposes. CDC has developed working groups to address these issues and will provide important input for pandemic planning and preparedness, but more widespread involvement is still needed.

Dr. Schwartz highlighted the pandemic preparedness activities that are ongoing and were ongoing while the plan was being developed. In terms of vaccine, NIH is receiving H5N1 investigational lots for clinical testing and will explore the immunogenicity and safety of the vaccine. CDC has completed a contract with a vaccine manufacturer for a 2-million-dose stockpile of the H5N1 vaccine, and an RFD is being finalized to assure the security of the egg supply for vaccine and to produce annual investigational lots of pandemic-like vaccines that can be clinically tested. An RFD is entering its final stages that will lead to diversification of U.S. influenza vaccine production and an increase in surge capacity through cell-culture based vaccines produced in the United States. There are also a number of research projects underway to improve the development of reference strains for vaccine production, explore new vaccine production technologies, and increase immunogenicity of influenza vaccine.

With respect to antiviral drugs, oseltamivir has been added to the Strategic National Stockpile. Currently, approximately 1 million courses are included in the stockpile, and discussions are ongoing about acquiring more antiviral drugs. An interagency meeting (HHS, DoD, VA) was recently held to coordinate antiviral strategies and negotiations for stockpile purchases.

There are a range of activities for state health department and healthcare system preparedness. These include the addition of pandemic planning in the BT cooperative agreement as a critical benchmark where all states will be required to develop pandemic plans by the end of FY’05. Regional planning meetings are being set up for health departments. In addition, tabletop exercises are being developed and several field exercises are being undertaken in several states. HRSA is supporting a BT hospital preparedness program that was funded at about $500 million this year.

Dr. Schwartz then discussed international activities that are of increased importance given the H5N1 situation in Asia. CDC recently completed a cooperative agreement enhancing surveillance in 10 Asian countries. HHS provided support for the WHO that will help coordinate human and animal surveillance and will provide support to the Western Pacific Regional Office (WPRO) of the WHO for pandemic planning in Asia. Projects have been implemented through the APEC Health Task Force to assess pandemic planning, promote inter-sectoral involvement, and enhance preparedness in the Pacific Rim countries. Finally, NIH is providing support for activities to model the containment of an initial pandemic outbreak using public health measures and antiviral drugs.

In conclusion, Dr. Schwartz noted that during the past couple of years, there has been substantial progress in preparedness. However, many challenges remain, and many key decisions have to be made. Further planning has to be done at the state, local, and healthcare system levels, as well as in filling the important gaps, improving the specificity, and developing materials to support pandemic response activities. In addition, international surveillance and cooperation remains a priority. The release of the pandemic plan allows broader engagement and facilitates stakeholder involvement in planning and preparedness activities. Dr. Schwartz commented that they look forward to this and to NVAC’s comments on the pandemic preparedness plan.

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