Biosecurity Briefing

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May 2, 2008

• IOM Report Provides Recommendations for Antiviral Distribution and Dispensing Planning; Toronto Stockpiles Antivirals for Workers
• HHS Spends $192.5 Million on H5N1 Vaccine

IOM Report Provides Recommendations for Antiviral Distribution and Dispensing Planning; Toronto Stockpiles Antivirals for Workers

On April 25, 2008, the Institute of Medicine’s (IOM) Committee on Implementation of Antiviral Medication Strategies for an Influenza Pandemic released a report, Antivirals for Pandemic Influenza: Guidance on Developing a Distribution and Dispensing Program, which was requested by the U.S. Department of Health and Human Services (HHS) to assess best practices and policies for antiviral prophylaxis and treatment during a pandemic event.¹

According to the report, the use of the antiviral medications oseltamavir (Tamiflu™) and zanamivir (Relenza™) will be one of several strategies employed to mitigate a pandemic, particularly because of the lead time required to develop an effective vaccine. Recognizing that the pandemic influenza planning process is evolving and characterized by uncertainty, changing parameters, and scarcity of resources, the committee concluded that “several overarching goals need to be kept in the forefront: developing in advance an ethical framework, communication and education of the public with clear and consistent messages, the need to reconcile actual supply and antiviral program goals, and flexibility to on the one hand react to the changes in the course of the pandemic and on the other hand, address the diverse needs of localities.”¹

In addition, the committee issued the following 8 recommendations:

1. The federal government should clarify the national goals for antiviral use in an influenza pandemic. If the goals include treatment of all cases and prophylaxis, then appropriations will be needed to expand the national stockpile.
   
2. The federal government’s Shelf-Life Extension Program (SLEP) should be expanded to include other public and private sector antiviral stockpiles, and HHS should develop a process to use FDA’s SLEP knowledge to facilitate the use of properly stored but recently expired medications in non-SLEP supplies.
   
3. Public health agencies should develop agreements with private sector entities to promote trust and collaboration and facilitate information sharing during a pandemic.
   
4. A federal advisory body should be formed to advise the federal government and its partners on planning and implementing public health and medical responses to a pandemic, including measures such as antiviral use.
   
5. During the pre-pandemic period, HHS should undertake an effort similar to that for influenza vaccine priorities to develop a prioritization scheme for antiviral treatment and prophylaxis with public input.
   
6. Outbreak prophylaxis for healthcare and emergency personnel who are in short supply and will have repeated exposure should be a first priority for prophylactic antiviral use, followed by post-exposure prophylaxis for other healthcare and emergency personnel. In that regard, efforts such as proper use of personal protective equipment and staggering shifts should be made to minimize the need for outbreak prophylaxis.
   
7. HHS should support and fund public health agencies to develop or expand systems for tracking dispensed antivirals and consider options to capture adverse events associated with antiviral use.
   
8. Federal pandemic influenza grant guidance should state that jurisdictions may fulfill certain exercise requirements through responding to actual biologic emergencies.¹

However, a Center for Infectious Disease Research and Policy (CIDRAP) article on the report stated that “because of the limited size of the national antiviral stockpile and the unclear [national] goals for its use, the committee was unable to provide specific guidance regarding the best methods and sites for dispensing.”² The U.S. has approximately 72 million treatment courses of antivirals (with an ultimate goal of obtaining 81 million courses) in federal and state stockpiles, but it is estimated that more than twice the goal of 81 million courses would be needed to treat 25 percent of the U.S. population and provide prophylaxis to groups that would have occupational exposure.^1,2 In addition, “[b]ased on federal government documents, it is not yet clear whether the goal of antiviral use is treatment, or a combination of treatment and prophylaxis,” according to the IOM report.¹

In a National Academies News Release on April 25, the antiviral committee chair, June Osborn, stated, “We need to engage the public in a discussion about the use and distribution of antiviral drugs in advance of a pandemic when there will be limited time for deliberations because large numbers of people will be getting sick.  Through a similar public dialogue, state and federal officials already have effectively built broad understanding of how a pandemic vaccine would be allocated.”³

In related news, an April 29, 2008, CIDRAP article reported that the city council for Toronto recently approved a $1.5 million plan to purchase the antiviral medication oseltamivir (Tamiflu™) to treat 13,000 city employees, or nearly one-half of the municipal employee workforce, in the event of an influenza pandemic. This plan for purchasing antivirals was executed based on the recommendation of the city’s medical officer of health, David McKeown.⁴ Toronto, which also appropriated over $600,000 for warehouse storage of these medicines, is the first major city in Canada to stockpile antivirals.⁴ The article noted that although most of the city council members support the plan, some have questioned how officials would dispense the antivirals, which employees would receive the medicine, and whether the city rushed into the decision to purchase the stockpile.⁴

The CIDRAP article noted that “many countries have made stockpiling oseltamivir and other antiviral medications a component of their pandemic planning.”⁴ According to McKeown, “it is a prudent measure to take for an event that is highly likely to occur.”⁵

Brooke Courtney

References

1. Institute of Medicine, Committee on Implementation of Antiviral Medication Strategies for an Influenza Pandemic. Antivirals for Pandemic Influenza: Guidance on Developing a Distribution and Dispensing Program. April 25, 2008. http://books.nap.edu/catalog.php?record_id=12170. Accessed May 1, 2008.
   
2. Roos R. US likely to need bigger antiviral stockpile. CIDRAP News. April 25, 2008. http://www.cidrap.umn.edu/cidrap/content/influenza/biz-plan/news/apr2508iom.html. Accessed May 1, 2008.
   
3. National discussion needed on antiviral drug distribution during a flu pandemic [news release]. Washington, DC: The National Academies; April 25, 2008. http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12170. Accessed May 1, 2008.
   
4. Schnirring L. Toronto officials approve antivirals for city workers. CIDRAP News. April 29, 2008. http://www.cidrap.umn.edu/cidrap/content/influenza/avianflu/news/apr2908tamiflu-jw.html. Accessed May 1, 2008.
   
5. Hanes A. Cash-strapped city to spend $1.5 million on Tamiflu. National Post. April 29, 2008. http://network.nationalpost.com/np/blogs/toronto/archive/2008/04/29/ cash-strapped-city-to-spend-1-5m-on-tamiflu.aspx. Accessed May 1, 2008.
    

HHS Spends $192.5 Million on H5N1 Vaccine

On April 29, 2008, CIDRAP reported that the U.S. Department of Health and Human Services (HHS) purchased $192.5 million worth of clade 2.2 H5N1 vaccine from sanofi pasteur. The purchase will provide 6.4 to 38.5 million doses of the vaccine to the Strategic National Stockpile (SNS) for clade 2.2 of the virus, which has been seen widely across Europe, Asia, and Africa. This variant of H5N1 has affected animals in 60 countries and humans in 8 countries.¹

According to an April 28, 2008, sanofi pasteur press release, the $192.5 million purchased bulk vaccine antigen. The final formulation of the vaccine will depend on the concentration of the antigen needed to protect against a pandemic strain, and this cannot be determined until the pandemic strain emerges. The purchase is regarded as an “effort to diversify the vaccine stockpile.”² The addition of a vaccine against clade 2.2 reflects growing concern about the viruses’ potential to cause disease.  According to the World Health Organization, clade 2.2 viruses have caused outbreaks in “more than 60 countries in Africa, Asia, and Europe, with human cases in Azerbaijan, China, Djibouti, Egypt, Iraq, Nigeria, Pakistan, and Turkey, the World Health Organization.”¹

Dr. Robin Robinson, newly appointed director of HHS’s Biomedical Advanced Research and Development Agency (BARDA), noted that the SNS already contains vaccines for clade 1, clade 2.1, and clade 2.3 of the H5N1 virus.¹ The CIDRAP story notes that “Robinson said the stockpile currently contains enough H5N1 vaccine to cover about 12 million to 13 million people, assuming two 90-microgram (mcg) doses per person.”¹ Robinson also stated that “HHS is supporting the development of adjuvants by [GlaxoSmithKline], Novartis, and Iomai, Inc.” ¹ The use of adjuvants, which are substances that increase the effectiveness of vaccine, could decrease the dosage necessary for vaccination. Combining a licensed adjuvant with a vaccine could increase the number of doses added to the SNS well beyond the current estimates. Robinson also noted that should an adjuvant be licensed, HHS would consider its addition to the SNS as well.

Kunal Rambhia

References

1. HHS adds H5N1 clade 2.2 vaccine to stockpile. CIDRAP News. April 29, 2008. http://www.cidrap.umn.edu/cidrap/content/influenza/avianflu/news/apr2908sanofi.html. Accessed May 2, 2008.
   
2. U.S. government accepts $192 million of sanofi pasteur H5N1 bulk vaccine antigen for pandemic stockpile [news release]. Swiftwater, PA, and Lyon, France: sanofi Pasteur; April 28, 2008. http://198.73.159.214/sanofi-pasteur/ImageServlet?imageCode=22787&siteCode=SP_HQ. Accessed May 2, 2008.