To Fight Mpox, Release Vaccine Stockpiles [Guest Essay]
Newsletter Edition #227 [The Files In-Depth]
Hi,
The response to the Mpox emergency is following a familiar trajectory.
Parts of the world where the disease is endemic is struggling to address the outbreak with inadequate vaccines or diagnostics. Whatever vaccines are available, have mostly been stockpiled in a few countries in the developed world. Manufacturers of these vaccines are also located in the developed world. There is a monopoly over production, prices are high.
In today’s edition, experts from Third World Network, are calling for a release of vaccine stockpiles to address the emergency. They also describe the current failings that are making it difficult to immediately boost production. The structural deficiencies in our response mechanisms are yet to be fixed, while another crisis is blowing up in our faces. And yes, they also remind us of the international obligations to assist in situations like this.
Watch this space.
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I. GUEST ESSAY
To Fight Mpox, Release Vaccine Stockpiles [Guest Essay]
By Chetali Rao & K M Gopakumar
The authors are experts affiliated with Third World Network. Write to them at chetali.rao@gmail.com.
The World Health Organization (WHO) declared Mpox as a Public Health Emergency of International Concern (PHEIC ) under the International Health Regulations (IHR). WHO’s decision comes at a time when Mpox cases continue to ravage the Democratic Republic of the Congo (DRC) and a growing number of countries in Africa. Prior to WHO’s announcement, the Africa Centres for Disease Control and Prevention (Africa CDC) also declared Mpox as a Public Health Emergency of Continental Security (PHECS). However, any qualitative change on the ground from these declarations depends on the access to vaccines.
With the new variant (clade 1b), spreading more easily through routine close contact, and affecting women and children, vaccines will once again be the cornerstone in managing the emergency. However, it appears that the access to vaccines would remain bleak unless there is immediate release from stockpiles.
Vaccines for Mpox: The Gap in Supply and Demand
Response to Mpox includes both vaccines and therapeutics. A smallpox vaccine, called JYNNEOS or IMVANEX or MVA-BN, has been approved in Canada, the European Union, and the United States for use against Mpox. In addition to its use in adult population, this vaccine has also been granted an Emergency Use Authorization for people younger than 18 years of age and at high risk of infection. While JYNNEOS is the preferred vaccine for mpox, alternative approaches include second-generation small-pox vaccines like LC16 and ACAM2000. WHO’s Strategic Advisory Group of Experts on Immunisation (SAGE) recommends using these vaccines for Mpox.
From a therapeutic viewpoint - a new antiviral drug TECOVIRIMAT – which was in trials in DRC since 2022 has failed to meet its primary endpoint.
Presently, Africa faces a severe shortfall of health products including vaccines and diagnostics. African CDC estimates that at least 10 million doses of vaccines are needed across Africa, as against the 200,000 doses currently available.
To meet the shortfall, Africa CDC has signed a tripartite agreement with the EU's Health Emergency Preparedness and Response (HERA), and Bavarian Nordic - the manufacturer of JYNNEOS for the procurement and supply of 200,000 doses. However, this is still just 2 per cent of the required doses. According to a report Bavarian Nordic has stated that it has a current stock of 500000 doses. It could produce another 2 million doses in 2024 and 10 million doses by 2025.
This clearly shows a massive shortage of supply and once again highlights the perils of dependency on monopoly production and underlines the need for a decentralised production through diverse manufacturers. In the case of Mpox the situation is exacerbated as Bavarian Nordic is the only supplier of an effective Mpox vaccine and holds patent monopoly rights.
The Lack of Abbreviated Pathway for Biosimilars
Furthermore, unlike biosimilars, vaccines lack an abbreviated pathway for non-originator production. This creates a situation where, in the event of pandemic or PHEIC, it is impossible to rapidly bring a vaccine to market.
Furthermore, the absence of an abbreviated pathway renders TRIPS flexibilities, such as issuing compulsory licenses, ineffective, as vaccine manufacturers will take months, if not years to bring a non-originator version.
The Need for Access and Benefits Sharing Mechanism for PHEICs
Concurrently, the current situation also exposes the lack of an effective access and benefit-sharing (ABS) system to facilitate guaranteed access to vaccines and other health products during PHEIC. While the vaccine developers have benefited from the access to virus samples or their digital sequences, there is no mechanism to share the benefits emerging from accessing such samples.
Currently WHO's Pandemic Influenza Preparedness (PIP Framework) creates an obligation on vaccine manufacturers to share, but this framework is restricted to only influenza vaccines. In the case of PHEICs like Mpox there is no obligation to share the health products. Therefore, it is important to include PHEIC within the scope of mandatory sharing of vaccines and other health products under the Pathogen Access and Benefit Sharing (PABS) system, which is currently being negotiated under the aegis of a new Pandemic Agreement.
The Demand to Release Stockpiles of Vaccines
Currently, there are no manufacturers of Mpox who are prequalified by WHO, although WHO has now invited vaccine manufacturers to submit dossiers for the emergency use listing (EUL), allowing organisations like UNICEF and Gavi to procure and distribute vaccines more efficiently, but this may take months for the vaccines to reach Africa.
Ironically, Bavarian Nordic has said that it has no plans to sell the vaccines in Africa let alone, planning for manufacturing it in Africa.
In the current situation – donations and the immediate release of stockpiles from the US, Canada, EU, Switzerland, appear to be the only way to make the shots available to the continent.
Many countries like US, Canada and EU have maintained a steady stockpile of millions of doses of JYNNEOS. It has been reported that Bavarian Nordic has already signed deals to supply the vaccine to US, Canada and the EU stockpiles.
While the U.S. Biomedical Advanced Research and Development Authority (BARDA), issued a fresh contract of $156.8 Mn to Bavarian Nordic in August 2024 to replenish its stock, the company also extended the contract with Health Canada in 2022, which expanded its earlier supply contract for up to $470 Mn. Additionally, the European Union also signed a contract for 2 million doses in November 2022, allowing 14 participating countries to purchase doses to address their medium- and long-term needs and build stockpiles.
While the world looks to vaccines donations for relief, reports have emerged that countries are refusing to share their stockpiles. It has been reported that Canadian Health Officials have stated that they have no plans to share Canada Mpox stockpiles with the African countries. Switzerland has also refused to share its stockpile with Africa. While African countries facing the brunt of Mpox infections are yearning for vaccines for those scourged by the disease, news reports suggest that Canadian agencies (like Toronto Public Health) are advising eligible people to get vaccinated for Mpox.
Thus, while developed countries prioritize eligible or their at-risk populations and ensure vaccine supply to their population, vaccines have not reached countries where the disease is endemic. This skewed approach of vaccinating eligible persons versus those suffering from the disease has completely undermined global health needs.
International Obligations to Assist
The International Health Regulations (Amended in 2024)
The current version of IHR 2005 does not create an obligation on WHO or State Parties to take measures to facilitate equitable access.
On the other hand, the new amendment, which is not currently in force does create an obligation under the new Paragraphs 7, 8 and 9 of Article 13. While Para 7 and 8 create obligations on WHO to take measures to assist countries in their response activities including equitable access, Para 9 creates clear obligations on State Parties to assist WHO to carry out its functions under Article 13.
Para 9 (a) states: “Pursuant to paragraph 5 of this Article and paragraph 1 of Article 44 of these Regulations, and upon request of other States Parties or WHO, States Parties shall undertake, subject to applicable law and available resources, to collaborate with, and assist each other and to support WHO-coordinated response activities, including through: (a) supporting WHO in implementing actions outlined in this Article;..”
Obligation on international cooperation in Human Rights Law
However, international human rights law clearly creates an obligation on WHO Member States to release part of the stockpiles because it imposes an obligation on international cooperation.
General Comment No. 14 states: "To comply with their international obligations in relation to article 12, States parties have to respect the enjoyment of the right to health in other countries, and to prevent third parties from violating the right in other countries, if they are able to influence these third parties by way of legal or political means, in accordance with the Charter of the United Nations and applicable international law. Depending on the availability of resources, States should facilitate access to essential health facilities, goods and services in other countries, wherever possible and provide the necessary aid when required.”
Further, it states “Moreover, given that some diseases are easily transmissible beyond the frontiers of a State, the international community has a collective responsibility to address this problem. The economically developed States parties have a special responsibility and interest to assist the poorer developing States in this regard.”
Though the General Comment is not binding but the writing on the wall is very clear that there is an international obligation to share part of the stockpile of Mpox vaccines. Similarly, Article 56 of the UN Charter also creates an obligation to cooperate at the international level.
Refusal to share part of the stockpiles without any public health rational is a violation of the obligations under the international human rights law and the UN charter.
The PHEIC declaration of Mpox once again brings forth the persisting inequities in the international health emergency regime, which does not offer any legal guarantee to facilitate the access to health products. Further, the refusal to share the stockpiles also exposes the double standards of developed countries on human rights. This is a learning for developing countries to ensure that there should be a legally binding obligation on WHO and all parties to facilitate equitable access during pandemics and, create obligations during PHEICs in the new pandemic instrument, currently under negotiation.
Also see from WHO: First meeting of the International Health Regulations (2005) Emergency Committee regarding the upsurge of mpox 2024
In case you missed it:
II. PODCAST CORNER
Dialogues: a conversation with Peter Hotez
In this episode of Dialogues, host Garry Aslanyan speaks with Peter Hotez, an internationally-recognized physician-scientist in neglected tropical diseases and vaccine development. In 2022, Hotez and his colleague Maria Elena Bottazzi were nominated for the Nobel Peace Prize for “their work to develop and distribute a low-cost COVID-19 vaccine to people of the world without patent limitation.” He is also one of the leading defenders of vaccines in the United States and the author of several books, including Preventing the next pandemic, The deadly rise of anti-science and Vaccines did not cause Rachel’s autism.”
Listen here
Garry Aslanyan is the host and moderator of the Global Health Matters podcast. You can contact him at: aslanyang@who.int
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