National Vaccine Advisory Committee (nvac)

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Dr. Hinman then moved to accept the report as amended, and all voted in favor.

Dr. Hinman asked if they should try to publish the report in a peer-reviewed journal. Health Affairs will be having an issue on vaccines in the spring and has asked Dr. Hinman to submit an article on NVAC’s position. Dr. Gellin noted that there should to be a written response. Dr. Hinman responded that he would work on turning the report into publication format and write a short piece for Health Affairs.

Dr. Whitley-Williams asked Dr. Hinman to consider providing some historical perspective in the article concerning prior NVAC activities, starting with the strategies white paper, so that it does not appear that this is in respond to the flu. Dr. Hinman agreed.

Unmet Needs Program Update - Dr. Benjamin Schwartz

The Unmet Needs Funding Program provides support for high priority vaccine and immunization projects, and accounts for the majority of the NVPO budget. The program priorities are based on the National Vaccine Plan (1994), as well as current DHHS, NVPO, and NVAC priorities. It provides “seed money” and “catalytic funding” to address new and emerging issues, and it also addresses needs that arise outside the normal funding cycle.

Applicants include scientists and project officers from DHHS agencies, DoD, and USAID. Projects are funded for a maximum of two years, and about $5 million are distributed annually for new and continuation projects. Funding decisions are made competitively, based on a defined review process, and this year’s application deadline is November 19, 2004.

For FY 2005, Unmet Needs priority categories are:

  • Adolescent vaccination

  • Future vaccines for emerging infections or with near term U.S. licensure

  • Annual or pandemic influenza

  • Vaccine supply, financing, and economic analysis

  • Vaccine safety

To ensure the strongest possible review process (i.e., scientifically sound, fair, and transparent), the program proposed a scoring system based on the following specified criteria:

  • Meets NVPO priority criterion (absolute requirement)

  • Importance

  • Scientific quality and feasibility

  • Interagency collaboration

The proposal review process is conducted via a review committee composed of agency representatives and NVAC members (to be identified). Dr. Schwartz asked NVAC members to participate in the review process and attend a two-day meeting in January to select and accept the proposals.

The next steps for the Unmet Needs Program include:

  • Program review—identify accomplishments of projects funded between 1995 and 2001

  • Process review—assess potential improvements in establishing priorities, soliciting proposals, and selecting projects for funding, in which there might be potential for a greater role for NVAC

Dr. Schwartz discussed the international focus of the Unmet Needs Program. He added that this funding is dedicated towards the priorities identified in the National Vaccine Plan, well as current DHHS, NVPO, and NVAC priorities. There is great concordance between the areas of discussion and the priorities. $5 million is very limited and is best used when targeted. There is substantial funding for global immunization, most notably from the Gates Foundation. While these international studies are important, there are other mechanisms to get those funded. Additionally, many of the priorities do include an international component. For example, vaccine safety, pandemic influenza, and future vaccines are not just issues for the United States.

READII Update - Ms. Tamara J. Kicera

READII (Racial and Ethnic Adult Disparities in Immunization Initiative) is an attempt to better understand the ongoing disparities in influenza and pneumococcal vaccination coverage among the African-American and Hispanic elderly in the United States.

Through the initiative, it has been indicated that disparities persist despite controlling for things such as socio-economic status, access to care, and insurance coverage. Data show that influenza coverage among African-American and Hispanic individuals 65 years of age and older lags significantly behind coverage among the white population, and that coverage even among the white population is well below the Healthy People 2010 goal of a 90-percent immunization rate. Findings are similar for pneumococcal vaccination.

This initiative began in mid-to-late 2002 and is scheduled to end December 31, 2004. Evaluation of intervention strategies implemented in the five demonstration sites will begin in January 2005. The demonstration sites were San Antonio, Chicago, Milwaukee, Rochester, New York, and 19 counties in the delta region of Mississippi. CDC leads the project in collaboration with CMS, HRSA, AoA, and AHRQ. Because the target population is the elderly, grantees in the five demonstration sites have been encouraged to work closely with their QIOs, CMS regional representatives, and others engaged in the aging services network.

The underlying principles of the initiative were to encourage local buy-in, have communities to engage critical partners and stakeholders, and encourage evidence-based interventions with providers and community groups. It was originally envisioned as a 2-year project, but was extended to three seasons. Almost each year, there has been a significant event or crisis that has challenged the demonstration sites and their immunization partners.

READII activities included developing community plans, engaging in communications research, local community roll-outs, implementation of a variety of interventions, and evaluation (which will begin after the project concludes at the end of the calendar year).

General programmatic strategies included focusing on improving provider vaccination practices (e.g., standing orders, reminder recall, and systems-based changes), increasing access for high risk populations, and increasing demand on the part of those populations. The targeted multiple provider groups included not only physicians, but also other healthcare personnel, pharmacists, and others. Specific interventions were based on local needs and capacities, so each of the five sites had unique aspects to their interventions. The key factors for implementing the interventions were feasibility, the expected impact on the target population, and sustainability.

Ms. Kicera then discussed some of the challenges of the initiative. Identifying and engaging adult providers in some communities was much more challenging than they had anticipated. Many sites found it very difficult to identify providers that serve minority, elderly populations. Another challenge was finding effective communications strategies for providers, who are very busy, and consumers, who have many myths and misconceptions about the vaccines. Evaluation of the project will look at not only the outcomes, but also the process. In the short term, they are looking at lessons learned and in the long term, at successful models that can be replicated and sustained to reduce or eliminate disparities.

Some of the early findings and feedback show significant differences between pediatric and adult providers in terms of buy-in and engagement. While most providers acknowledge the importance of the vaccine, they do not always consider themselves the people who are in a position to provide the immunization services. Adult providers usually see individuals with an acute or chronic illness and focus on these conditions rather than on promoting preventive messages. Given the limited time in these situations, standing orders or systems-based changes may be very effective. Many of these providers assume that their high risk patients receive these services from their specialists. However, specialists are even less likely to be providing these preventive services.

Another surprising finding was the impact of the attitude of office nursing and support staff. Healthcare providers are themselves notoriously poorly immunized. In several sites, even in practices where the READII project was successful in getting cooperation, the attitudes of many of the nurses, administrative staff, office managers, and others were often very negative with respect to providing these immunizations. Ms. Kicera described a situation in Rochester where charts of elderly patients with high risk conditions were flagged and the staff were actually removing the flags from the charts and not promoting immunization, despite the fact that standing orders were in place. They need to make a better effort working with nursing and ancillary staff.

She noted the tremendous level of disorganization in many sites. Some sites could not even identify patients 65 years and older or those with high risk conditions (e.g. diabetes and heart disease). While at the start of the project, many were under the impression that providers had electronic medical records or some type of electronic filing system, this was not the case. Many offices had very small budgets and were overwhelmed by the paperwork, billing processes, and just maintaining medical records for their patients. Similarly, there was much confusion and misinformation regarding the ACIP recommendations for the vaccines, particularly pneumococcal vaccine. The NIP is looking into ways to make the ACIP recommendations more understandable.

Another finding was that there were cases where high risk populations were identified and the communities had no place to hold immunization clinics. Elderly people would have to travel outside of their communities to get immunized. Many supermarkets, pharmacies, senior centers, and other sites had closed because of economics, crime rates, and other reasons, creating a mismatch between where target populations lived and where vaccines were being offered.

Rather than implementing new initiatives or efforts, many of the groups that worked with the demonstration sites were happy to partner with the health departments, QIOs, and others to promote these messages among their constituents. They encouraged integrating immunization and preventive health measures into activities that they were already engaged in (e.g., Meals on Wheels).

The level of success of the childhood program may never be replicated with adults. In terms of building capacity, they may need to consider other models such as collaboration between providers and mass immunizers. If there were a situation where a massive number of adults needed to be immunized, this would not occur in private provider offices.

Much more research is needed with respect to, for example, universal flu recommendations and the attitudes of support staff. In Chicago, they are looking into providing the vaccines upfront. CMS has reimbursed for influenza and pneumococcal vaccines, as well as their administration, for many years. Because providers operate on modest budgets, they often do not have the budget to purchase vaccines upfront and risk not getting reimbursed for unused vaccines because of manufacturer no-return policies. Furthermore, there has not been a great demand for these vaccines in previous years. For these reasons, many providers have opted not to promote or purchase the vaccines. Recently, CMS increased reimbursement rates for administering these vaccines, and the impact remains to be seen.

Providers have also expressed concerns about HIPPA regulations when, for example, citing reasons for not sending out reminder postcards. This remains a concern even though providers have been educated that things such as remind/recall can be done in such a way that there are no HIPPA violations.

Project Bioshield - Dr. Monique K. Mansoura

Biodefense is recognized as a top priority. There is a dedicated commitment among the senior leadership of this administration and generous bipartisan support from Congress. They have a solid scientific foundation to build upon, in large part due to the research that has been developed over many years at DoD on medical countermeasures against biological, chemical, and radiological and nuclear threats and a strong private sector. With this, they have the opportunity to make a difference in reducing the nation’s vulnerability against weapons of mass destruction (WMD).

BioShield is part of “Biodefense for the 21st Century,” which was unveiled on April 28, 2004 following a comprehensive evaluation of biological defense capabilities, and provides a blueprint for our future biodefense program. Dr. Mansoura noted that medical countermeasure development is part of a much larger strategy of potential interventions that the nation has to reduce our vulnerabilities. The pillars of this strategy include: threat awareness; prevention and detection; surveillance and detection; and response and recovery, should an event occur. While medical countermeasure development is part of response and recovery, vaccines also offer a prevention opportunity. HHS will take the lead in medical countermeasure development and will work closely with interagency partners. The goals, with respect to medical countermeasures, are to develop, acquire, and stockpile the medical countermeasures needed to protect the U.S. population against bioterrorism; to coordinate stockpile acquisitions with response plans; and to make balanced investments in countermeasures commensurate with potential threats and response plans, within the limits of the budget.

The purpose of Project BioShield is to accelerate the process of research, development, purchase, and availability of effective countermeasures against agents of bioterrorism. Project Bioshield is a three-pronged program that establishes a secure funding source for purchase of critical biomedical countermeasures; increases NIH/NIAID authorities and flexibility to expedite research and development of critical biomedical countermeasures; and establishes an FDA Emergency Use Authorization (EUA) for critical biomedical countermeasures to minimize the regulatory burden during a declared emergency and address serious and life-threatening conditions caused by biologic, chemical, and radiological/nuclear substances. The EUA applicability for drugs, vaccines, and devices is for the use of approved products for unapproved indications, as well unapproved products.

In terms of funding sources for purchasing critical biomedical countermeasures, the first Department of Homeland Security (DHS) appropriations bill created a discretionary reserve of $5.6 billion to fund the program through FY2013. An amount not to exceed $3.4 billion was made available to be obligated during FY2004-2008. Although the funding sits in DHS, HHS will be the procuring authority, managing and executing contracts with the private sector to secure countermeasures. The amounts appropriated become available only upon the approval by the President.

The path of countermeasure development is complicated and involves many partners – not just the government. Basic research is done in large part at NIAID, and work done by DoD, academia, and the private sector all come together to identify targets and move products through development. BioShield is at the end of the rainbow creating a polar incentives mechanism for these products to be developed.

The Office of Public Health Emergency Preparedness, under Assistant Secretary Simonson, has worked very cooperatively with NIH, FDA, and CDC to provide an environment where they are dedicated to the development of these products. Monthly risk-management meetings are held to talk about basic research, development of targets, expediting regulatory approval to the extent feasible, how the products will be stored and deployed (with CDC), how they are engaging state and local partners, and accountability for executing contracts within their Office of Research and Development Coordination (ORDC).

There is interagency coordination to identify targets appropriate for Project BioShield procurements. The WMD Medical Countermeasures Subcommittee is the focal point where deliberations across government occur to discuss priorities and optimal targets. Government stakeholders include HHS, DHS, DoD, CDC, FDA, NIH, Department of Agriculture, Department of Commerce, Department of Energy, VA, EPA, National Space and Aeronautics Administration, FBI, CIA, Homeland Security Council, National Security Council, Office of the Vice President, Office of Science and Technology Policy, and OMB.

The goals of the WMD Medical Countermeasures Subcommittee are to prioritize Federal initiatives (i.e., address immediate and long-term needs; recommend national requirements for vaccines, drugs, antitoxins, and diagnostics; and represent the needs of civilian and military communities); to coordinate research, development, and acquisition efforts of key Federal agencies (HHS, DHS, and DoD); and to accelerate the development of critical products.

Dr. Mansoura discussed some of the factors considered in developing and prioritizing requirements. The first consideration is the credibility and immediacy of the threat. While $5.6 billion is a large amount of money, there are 300 million people to protect and a long list of threat agents. Many difficult decisions will have to be made about which agents present the greatest threat and should be addressed. Other considerations include: who is targeted (e.g., civilian, military, or high risk groups); in what setting countermeasures should be used; the current and projected availability of alternative countermeasures (current and projected); the dosing schedule for prevention or treatment; feasibility of deployment in a public health emergency; and product shelf-life and ongoing requirements. While there are other factors, these are the most critical.

Dr. Mansoura then discussed evaluating the effectiveness of countermeasures – for example, whether the antibiotic stockpile is sufficient to protect the nation against the anthrax threat, or whether an additional vaccine needs to be considered for use pre- or post-event. These issues are heavily reliant on mathematical models to help estimate the extent of the threat and the relative value of response strategies. Mathematical models also help identify gaps in knowledge and assist in setting research and development priorities.

Many checks and balances are worked into the BioShield system. In addition to the interagency process, the approval of the President is required prior to any acquisition. Intermediate to the President’s approval are a number of determinations that have to be made by the Secretary of DHS and the Secretary of HHS. There must be a determination of a threat to the U.S. population made by the DHS Secretary. The Secretary of HHS must determine if countermeasures are necessary and the appropriateness of the countermeasure. Once all of criteria are met, it goes to OMB and then the President.

There are contract terms built in by statute that make acquisitions under Project Bioshield unique. First, no payment may be made until a portion of the total number of units contracted for has been delivered, creating a fair amount of risk on the part of both the government and the contractor. Discounted payment is allowed for products not licensed, cleared, or approved at the time of delivery, and delivery to the stockpile is contingent on the availability of sufficient data to support emergency use. Sufficient data will be determined on a case-by-case basis. There is a statutory requirement that the vendors seek approval, clearance, or licensure of the product, and additional payment will be made upon licensure, clearance, or approval. Contract duration will be 5 to 8 years.

Before the Secretary of HHS makes a determination that a particular countermeasure is appropriate, certain conditions must be met. A case must be made that the product will be approved or licensed within 8 years, and this is by no means a sure thing. There must be sufficient data to assure that there are no major obstacles to licensure. On a case-by-case basis, there will need to be toxicology studies, Phase 1 trials to show safety in humans, pharmacokinetics or immunogenicity, animal studies of efficacy, and a demonstration of manufacturing capability. Products in early development are ineligible, and products in early and mid-stage development must be funded by other government programs (DoD, NIAID) or industry to get them to the point of eligibility for consideration in Project BioShield.

Dr. Mansoura used the example of the rPA Anthrax vaccine to demonstrate how this is not business as usual. The anthrax attacks took place in October 2001. A draft NIAID RFP was put out 4 months later (February 2002) for the accelerated development of a next generation vaccine. Comments were received from stakeholders, the RFP was published in April 2002, and contracts were awarded in September 2002. In March 2003, 2,000 doses were filled and finished. There was an RFP for advanced development contracts released in May 2003. Contracts were awarded 6 months later, and soon after they were looking into acquisition. They are moving forward aggressively in a high-risk environment, but the vulnerability to the nation dictates that they do so. The first major BioShield RFP was released in March 2004, and ORDC is moving forward to evaluate proposals and make an award.

Dr. Mansoura then went over details of the RFP released in March 2004 for which proposals were received in April 2004. She encouraged those interested in BioShield to read through the Statement of Work and the RFP (Solicitation Number: RFP-DHHS-ORDC-04-01, which provide a lot of insight into the thinking behind how the program will be implemented. Deliverables include up to 75 million doses of rPA Anthrax vaccine, 25 million of which must be delivered within 2 years of the contract award. There must be licensure for the product in a pre-exposure prophylactic indication, as well as a post-exposure prophylactic indication. Stability is a critical issue – products should have some acceptable shelf-life. Final study reports are deliverable for evidence of special population trials, including pediatric and geriatric populations. Ensuring that there be a warm base that would maintain the capacity to manufacture the products if needed is critical.

The RFP for the acquisition of therapeutic products for treatment of inhalational Anthrax disease was issued on August 18, 2004, and proposals were due October 26, 2004 (Solicitation Number 2004-N-01385 Different therapeutic products to treat inhalational anthrax include immune globulin and polyclonal antibodies; monoclonal antibodies; and non-antibody toxin inhibitors (e.g., small molecular entities). There are multiple product classes and a larger pool of potential applicants. A process has been set up where the initial deliverables is a pilot lot for the government to do comparative testing to get a sense of the relative value of products that may be eligible for the acquisition and then to move forward with a subsequent acquisition of 10,000 to 200,000 therapeutic courses of treatment from one or more producers.

Dr. Hinman asked if these are the only proposals currently active.

Dr. Mansoura noted that there is a third – botulinum antitoxins. The first use of BioShield funds was in 2003 to help support the botulinum antitoxin program.

Dr. Gellin noted that NVAC needs some expansion of its liaison members and that they had talked about having someone from DHS. He asked how NVAC might be helpful to the BioShield process. Now that BioShield is real, he asked if there is a role NVAC should have since much, though not all, of what is being done is vaccine-related.

Dr. Mansoura responded that they welcome input from all stakeholders and NVAC’s work is highly relevant. To the extent that there is information sharing, they welcome such opportunities, and she would think of more ways they can work together.

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