WHO Pandemic Flu Deal Doesn’t Go Far Enough, NGOs Say

Two civil society groups said the recent World Health Organization agreement on influenza pandemic strategy is an improvement on the present situation but has key shortcomings.

On 16 April, WHO members agreed to a framework to facilitate influenza vaccines access for developing countries. The framework also administers the sharing of virus strains and benefit sharing for countries having shared virus samples (IPW, WHO, 18 April 2011).

According to a joint statement by the Third World Network and the Berne Declaration, the agreement obliges the pharmaceutical industry and other entities “to engage in sharing of benefits,” but it does not go far enough to secure from them a reasonable level of benefits or mandatory commitments to share knowledge, technology, and know-how with developing countries on the production of vaccines.

The framework, they said, also “fails to contain any reference to relevant key international instruments, that is the Convention of Biological Diversity and the Nagoya Protocol on Access and Benefit Sharing that obligates the sharing of fair and equitable benefit sharing once access to biological materials is provided.”

David S. Fedson, MD says

27/04/2011 at 9:11 am

The WHO draft agreement on influenza virus sharing was recently announced with great fanfare and a chorus of approval from vaccine companies. In effect, it codifies WHO program to donate to a select number of developing countries enough doses of swine flu vaccine to cover 10% of their populations. Although the document says that all Member States should share viruses on an equal footing, it does not say that the benefits arising from virus sharing should themselves be shared on an equal footing. This is clear from the language of PP3 and PP8 on page 4 of the draft report.

(PP3) Recognize that Member States have a commitment to share on an equal footing H5N1 and other influenza viruses of human pandemic potential and the benefits, considering these as equally important parts of the collective action for global public health …

(PP8) Recognize that the benefits arising from the sharing of H5N1 and other influenza viruses with human pandemic potential should be shared with all Member States based on public health risk and need …

A global pandemic will inevitably impose equal public health risks and needs on all Member States. Rich countries, especially those that produce vaccines, will surely plan to vaccinate more than 10% of their populations. It is in inconceivable that a WHO commitment to ensure access to enough doses of vaccine to cover 10% of populations of its Member States will be sufficient to reflect equal sharing. The WHO statement represents a gesture, not a realistic commitment to global public health. Developing countries should not be misled into thinking it is anything else.

Anyone reading the WHO draft document should look closely for the following:

1. Does WHO demand that all inactivated pandemic vaccines be formulated at dosages that respond to the needs of populations, not individuals? (See J Public Health Policy 2007; 28: 322-40.) This means that the vaccines must be adjuvanted and contain the lowest dose of hemagglutinen (HA) antigen that is adequately immunogenic for a population, not optimally immunogenic for an individual. For the swine flu pandemic in 2009, this was not achieved. In the first six months of swine flu vaccine production, 66% of the doses produced worldwide were nonadjuvanted (see Vaccine 2010; 28: 4709-12). Had these doses been formulated with adjuvants and the HA dosage been reduced to 3.5 ug HA instead of the conventional dosage of 15 ug HA, the world would have had an extra one billion doses!! Many public health officials and influenza experts believe the principle reason why so many doses of non-adjuvanted vaccines were produced was the decision of the FDA not to allow an adjuvanted vaccine to be used in the US. The WHO draft document does not challenge the FDA position regarding its opposition to adjuvanted pandemic vaccines.

2. Does WHO specify a mechanism for rapidly accelerating the production of live-attenuated and/or adjuvanted recombinant protein influenza vaccines, either of which would allow production of billions of doses within a few months (see JPHP 2007). Success for either approach would most surely require new and radically disruptive arrangements between companies. For example, Novartis, GSK and Sanofi Pasteur would have to be persuaded not to produce their adjuvanted inactivated vaccines and instead produce live-attenuated vaccine viruses from seed strains provided by MedImmune/AstraZeneca. Equally important, regulatory officials would have to be persuaded to accept this. WHO does not have the political authority to make this happen. It is doubtful that national health authorities in vaccine producing countries (especially the US, UK, France and Germany) would be willing to force the issue.

3. Will WHO be able to gain acceptance ahead of a pandemic for a global registration protocol that will allow rapid licensing for all pandemic vaccines? In 2009, there were considerable delays with vaccine registration in many countries and, as noted above, the FDA decision on adjuvanted vaccines was ignored by regulatory authorities in other countries that allowed them to be used.

4. Will WHO be able to establish regional or global vaccine purchasing consortia like PAHO’s Revolving Fund? In 2009, the PAHO Revolving Fund was used to purchase pandemic vaccines for many Latin American Countries (LACs). The number of doses purchased through the Revolving fund far exceeded the number donated to LACs by WHO. Nonetheless, even larger numbers of doses were purchased by large LACs (e.g., Brazil, Mexico) through bilateral arrangements with vaccine companies. WHO has no mandate to force Member States to accept a Revolving Fund-type of purchasing mechanism in place of these bilateral arrangements.

For these and other reasons, the WHO virus sharing agreement will not make much difference for a global vaccine response to another influenza pandemic, at least not in the foreseeable future. Efforts are underway to transfer technologies for vaccine production to developing countries, and several developing country vaccine manufacturers can be expected to soon enter international markets with new influenza vaccines, including live-attenuated vaccines. Without question, the global capacity to produce influenza vaccines will gradually increase. In the long-term, an inexpensive “universal” flu vaccine may even become available. Nonetheless, even with new types of vaccines and production in developing countries, the daunting challenges of rapid production and worldwide distribution and administration present huge management and logistical problems, none if which are addressed in the WHO document.

If a vaccine-centered “top down” approach to confronting pandemic influenza won’t work, an alternative “bottom up” approach might be beneficial. This approach is based on widely available inexpensive generic agents that could modify the dysregulated host response of patients at risk of dying. Experimental evidence continues to suggest that this might save lives. For example, an observational study of almost 3000 patients hospitalized with laboratory-confirmed seasonal influenza has shown that inpatient statin treatment reduced mortality by 41%. Experimental studies suggest that other treatment regimens using glitazones, fibrates or biguanides might be better (Influenza Other Respir Virus 2009; 3: 129-42). WHO influenza staff have known about this idea for more than five years, but they have shown no interest in even discussing it. Had they done so, WHO could have taken the lead in advocating a global research effort to determine whether immunomodulatory treatment of severe influenza might reduce mortality. Such an initiative might have prevented the virus sharing impasse that arose between WHO and the Indonesian Minister of Health in early 2007, an impasse that necessitated the virus sharing arrangement finally announced by WHO on April 16th, more than four years later.

Comments

Riaz K Tayob says

21/04/2011 at 2:31 pm

Great reporting and coverage as always!

Aside from the substance of the “deal” on pandemic preparedness, the conduct of WHO as an international civil service needs to be looked at, specifically:

1) Are there ANY documents or research indicating that WHO knew that it was in violation of international agreements (related to the UN like the Convention on Biodiversity) BEFORE the scandal became public?

2) Why did WHO medical professionals, in the face of a pandemic, not ALL push for public health interests to take precedence over commercial interests in a “pandemic” situation? Was it a case of the rich countries are fine, and all the rest be fed to the wolves?

David S. Fedson, MD says

27/04/2011 at 9:11 am

The WHO draft agreement on influenza virus sharing was recently announced with great fanfare and a chorus of approval from vaccine companies. In effect, it codifies WHO program to donate to a select number of developing countries enough doses of swine flu vaccine to cover 10% of their populations. Although the document says that all Member States should share viruses on an equal footing, it does not say that the benefits arising from virus sharing should themselves be shared on an equal footing. This is clear from the language of PP3 and PP8 on page 4 of the draft report.

(PP3) Recognize that Member States have a commitment to share on an equal footing H5N1 and other influenza viruses of human pandemic potential and the benefits, considering these as equally important parts of the collective action for global public health …

(PP8) Recognize that the benefits arising from the sharing of H5N1 and other influenza viruses with human pandemic potential should be shared with all Member States based on public health risk and need …

A global pandemic will inevitably impose equal public health risks and needs on all Member States. Rich countries, especially those that produce vaccines, will surely plan to vaccinate more than 10% of their populations. It is in inconceivable that a WHO commitment to ensure access to enough doses of vaccine to cover 10% of populations of its Member States will be sufficient to reflect equal sharing. The WHO statement represents a gesture, not a realistic commitment to global public health. Developing countries should not be misled into thinking it is anything else.

Anyone reading the WHO draft document should look closely for the following:

1. Does WHO demand that all inactivated pandemic vaccines be formulated at dosages that respond to the needs of populations, not individuals? (See J Public Health Policy 2007; 28: 322-40.) This means that the vaccines must be adjuvanted and contain the lowest dose of hemagglutinen (HA) antigen that is adequately immunogenic for a population, not optimally immunogenic for an individual. For the swine flu pandemic in 2009, this was not achieved. In the first six months of swine flu vaccine production, 66% of the doses produced worldwide were nonadjuvanted (see Vaccine 2010; 28: 4709-12). Had these doses been formulated with adjuvants and the HA dosage been reduced to 3.5 ug HA instead of the conventional dosage of 15 ug HA, the world would have had an extra one billion doses!! Many public health officials and influenza experts believe the principle reason why so many doses of non-adjuvanted vaccines were produced was the decision of the FDA not to allow an adjuvanted vaccine to be used in the US. The WHO draft document does not challenge the FDA position regarding its opposition to adjuvanted pandemic vaccines.

2. Does WHO specify a mechanism for rapidly accelerating the production of live-attenuated and/or adjuvanted recombinant protein influenza vaccines, either of which would allow production of billions of doses within a few months (see JPHP 2007). Success for either approach would most surely require new and radically disruptive arrangements between companies. For example, Novartis, GSK and Sanofi Pasteur would have to be persuaded not to produce their adjuvanted inactivated vaccines and instead produce live-attenuated vaccine viruses from seed strains provided by MedImmune/AstraZeneca. Equally important, regulatory officials would have to be persuaded to accept this. WHO does not have the political authority to make this happen. It is doubtful that national health authorities in vaccine producing countries (especially the US, UK, France and Germany) would be willing to force the issue.

3. Will WHO be able to gain acceptance ahead of a pandemic for a global registration protocol that will allow rapid licensing for all pandemic vaccines? In 2009, there were considerable delays with vaccine registration in many countries and, as noted above, the FDA decision on adjuvanted vaccines was ignored by regulatory authorities in other countries that allowed them to be used.

4. Will WHO be able to establish regional or global vaccine purchasing consortia like PAHO’s Revolving Fund? In 2009, the PAHO Revolving Fund was used to purchase pandemic vaccines for many Latin American Countries (LACs). The number of doses purchased through the Revolving fund far exceeded the number donated to LACs by WHO. Nonetheless, even larger numbers of doses were purchased by large LACs (e.g., Brazil, Mexico) through bilateral arrangements with vaccine companies. WHO has no mandate to force Member States to accept a Revolving Fund-type of purchasing mechanism in place of these bilateral arrangements.

For these and other reasons, the WHO virus sharing agreement will not make much difference for a global vaccine response to another influenza pandemic, at least not in the foreseeable future. Efforts are underway to transfer technologies for vaccine production to developing countries, and several developing country vaccine manufacturers can be expected to soon enter international markets with new influenza vaccines, including live-attenuated vaccines. Without question, the global capacity to produce influenza vaccines will gradually increase. In the long-term, an inexpensive “universal” flu vaccine may even become available. Nonetheless, even with new types of vaccines and production in developing countries, the daunting challenges of rapid production and worldwide distribution and administration present huge management and logistical problems, none if which are addressed in the WHO document.

If a vaccine-centered “top down” approach to confronting pandemic influenza won’t work, an alternative “bottom up” approach might be beneficial. This approach is based on widely available inexpensive generic agents that could modify the dysregulated host response of patients at risk of dying. Experimental evidence continues to suggest that this might save lives. For example, an observational study of almost 3000 patients hospitalized with laboratory-confirmed seasonal influenza has shown that inpatient statin treatment reduced mortality by 41%. Experimental studies suggest that other treatment regimens using glitazones, fibrates or biguanides might be better (Influenza Other Respir Virus 2009; 3: 129-42). WHO influenza staff have known about this idea for more than five years, but they have shown no interest in even discussing it. Had they done so, WHO could have taken the lead in advocating a global research effort to determine whether immunomodulatory treatment of severe influenza might reduce mortality. Such an initiative might have prevented the virus sharing impasse that arose between WHO and the Indonesian Minister of Health in early 2007, an impasse that necessitated the virus sharing arrangement finally announced by WHO on April 16th, more than four years later.

WHO Pandemic Flu Deal Doesn’t Go Far Enough, NGOs Say

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