In this commentary, we discussed only two of the areas in need of full disclosure: recombinant vaccine as a superior but delayed alternative to the customary vaccines, and U.S. dependence on foreign sources of vaccine. There are other documents, information, and ideas that should be disclosed to the public:
- Contracts as well as performance evaluations of contractors. All such documents (namely, all those that available under the Freedom of Information Act) should be disclosed voluntarily and posted online.
- Possible government subsidies to increase domestic manufacturing capacity. The pros and cons of subsidies should be discussed online.
- Plans for dealing with patent rights and other intellectual property rights, including material transfer agreements, and the government's past and present position on compulsory licensing – of proprietary adjuvants, for example. These should be posted online.
- The federal budget for vaccine production, including comments that cover the range of views. Not only the views supporting official policy but dissenting views among senior scientists and other officials of DHHS should be posted. In addition, the views of experts outside government should be sought and posted.
- Disclosure of strategies: How were certain decisions made, and what are the plans now? The subjects in need of full public disclosure are:
- The decision by the FDA either to approve the use of adjuvanted vaccine, or not, when nationwide vaccinations begin. Adjuvanted vaccines are widely used in Europe; they are particularly useful in stretching vaccine supplies quickly during a shortage. The FDA's position on adjuvanted vaccines should be disclosed in greater detail.
- Accelerated production of recombinant vaccine
- Accelerated production of additional live attentuated vaccine1
Disclosure of strategies: How were certain decisions made, and what are the plans now? The subjects in need of full public disclosure are:The decision by the FDA either to approve the use of adjuvanted vaccine, or not, when nationwide vaccinations begin. Adjuvanted vaccines are widely used in Europe; they are particularly useful in stretching vaccine supplies quickly during a shortage. The FDA's position on adjuvanted vaccines should be disclosed in greater detail. Accelerated production of recombinant vaccine Accelerated production of additional live attentuated vaccine1
There have been major successes and some failures in the government's program for producing vaccine for a flu pandemic. Just how serious were the failures, and how much harm have they caused? It's not known, in large part because the program has suffered from a lack of transparency. During the past 18 months, POGO has repeatedly called for more documents and more information in all facets of the government's program for producing pandemic flu vaccine.2
The government's flu vaccine program and thus the public would benefit from a policy of full transparency. Disclosure of the relevant documents and information would make the current vaccine shortage easier to understand. This understanding in turn will spur actions likely to mitigate shortages of flu vaccine and other vaccines in the future.
1A different type of H1N1 swine flu vaccine – live attenuated vaccine – sold by MedImmune as FluMist, is a live virus vaccine, unlike the other conventional vaccines, which are inactivated (killed) virus vaccines. FluMist, when administered intranasally, causes an inapparent or mild infection that creates partial or complete immunity to flu. FluMist has been used in the U.S. since 2003 for vaccination against seasonal flu.
Live attenuated vaccine has several well‑known advantages over conventional inactivated vaccines. Among them are faster production of the live attenuated vaccine and far more vaccine produced per egg (20-fold or more). There are, however, unresolved questions about the relative efficacy of live attenuated versus inactivated vaccines for novel H1N1 swine flu. Live attenuated vaccine has been much discussed and often supported as an alternative to inactivated vaccines. However, it currently constitutes only about 6% of the U.S.'s total supply of vaccine for H1N1 swine flu. The failure by DHHS to support the production of live attenuated vaccine on a larger scale should be reconsidered, discussed publicly, and justified.
2 The first POGO report on the pandemic, Pandemic Flu: Lack of Leadership and Disclosure Plague Vaccine Program, by Ned Feder, was released on March 6, 2008, and posted at http://www.pogo.org/pogo-files/reports/public-health/pandemic-flu-vaccine-program/pandemic-flu-vaccine-program.html
Subsequent documents are as follows:
April 6, 2008. Message on the need for full transparency to Secretary Leavitt through his online blog. http://archive.hhs.gov/secretarysblog/my_weblog/2008/03/pandemic-exerci.html
June 2, 2008 "Commentary: Pandemic flu vaccine program needs help," by Ned Feder. Article in Federal Times.
April 28, 2009. Online commentary, "Pandemic Flu Threat Raises Question: Is U.S. Ready to Protect the Public?"
July 20, 2009. Online commentary, "Flu Vaccine Shortage? The Whole Truth, Please."
July 20, 2009. Letter to Secretary Sebelius.
August 26, 2009. Online article, "Lives at Risk in Swine Flu Pandemic: POGO Asks DHHS Secretary Sebelius to Disclose Deficiencies in Government Plans for Vaccine Production."
August 26, 2009. Letter to Secretary Sebelius.
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