TWN Info Service on Health Issues (Apr24/06)
23 April 2024
Third World Network

WHO: Monkeypox and avian flu outbreaks stress need for equitable access under IHR

New Delhi/Geneva, 23 April (Chetali Rao and K M Gopakumar) – The recent outbreak of diseases with potential to become a Public Health Emergency of International Concern (PHEIC) stresses the need for incorporating provisions in the International Health Regulations 2005 (IHR 2005) to promote equitable access to health products.

However, the discussions on equitable access to health products at the International Negotiating Body (INB) that is developing a pandemic instrument have captured the attention of various stakeholders including civil society organizations compared to parallel discussions at the Working Group that has been mandated to amend IHR 2005.

[The INB has the mandate to negotiate an international legal instrument on pandemic prevention, preparedness and response.]

The issue of equitable access is very critical in the context of IHR 2005 compared to the pandemic instrument. A pandemic outbreak is less frequent compared to PHEIC and often a pandemic emanates from a PHEIC. Therefore, from a public health perspective it is important to facilitate equitable access to health products required for the prevention of and response to a disease that has the potential to become a PHEIC and further escalating to a pandemic.

Further, even if equitable access is addressed effectively in the pandemic instrument this would not ensure access in PHEIC situations because the scope of equitable access would be limited to pandemic situations only. 

A report of the MSF Access Campaign on access to Ebola treatment reveals the non-availability of therapeutics in countries facing the outbreak despite the marketing approval of two monoclonal antibodies viz. Inmazeb and Ebanga. The report states: “In August 2022, WHO sent multiple requests for quotations to Ridgeback and Regeneron for potential orders of different amounts of mAb114 and REGN-EB3 respectively. Discussions on procurement and access were initiated between Ridgeback and the WHO but failed to materialize into any concrete agreement”.

One of the important reasons for such a scenario is the lack of an international framework to facilitate guaranteed access to health products required for PHEIC response. An MSF Briefing Document cites “inadequate global mechanisms to prioritize and ensure equitable allocation of scarce medical products for humanitarian contexts during public health emergencies” as the reason for non-availability of health products at the epicenter of disease outbreaks despite their availability in developed countries. 

Monkeypox (mpox)

The recent outbreak of Monkeypox virus (MPXV) clade I in the Democratic Republic of Congo’s (DRC) South Kivu province is indeed alarming, especially given its transmission through both heterosexual contact and close community-level contact, with children being disproportionately affected. This represents a significant shift from previous observations where children were least affected by the virus.

According to a November 2023 report by the World Health Organization (WHO), the number of suspected mpox cases in the DRC has surged to unprecedented levels, with over 12,500 cases and a case fatality ratio of 4.6%. The outbreak has spread to new geographic areas, including urban centres like Kinshasa, indicating a changing epidemiology of mpox in the region. The risk of further spread, both within neighbouring countries and globally, is significant.

However, only a few countries maintain stocks of vaccines against smallpox and mpox, despite the global outbreak since 2022. This stockpiling trend, reminiscent of responses to the COVID-19 pandemic, highlights disparities in access to essential vaccines and therapeutics. The prioritization of testing, treatment, and vaccination outside the outbreak countries in Africa underscores the urgent need for resources to combat the outbreak in the DRC.

A Geneva-based organisation working on mpox has emphasized the importance of mobilizing resources to contain the outbreak in the DRC, warning that failure to do so may lead to the virus spreading to other countries. It states that “Like the COVID-19 pandemic, the people that are being prioritized for tests, treatment and vaccination are not in the outbreak countries in Africa. We can either mobilize resources and fight the deadly mpox outbreak now in the DRC, or we can let the virus continue to spread and fight it when it is imported into other countries.”

Response to mpox include 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.

JYNNEOS, is a newer third generation live virus vaccine produced from the strain Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), an attenuated, non-replicating orthopoxvirus. The modified vaccinia Ankara (MVA) is unable to replicate effectively in mammalian cells, thus reducing the risk of dissemination and transmission. It was originally developed to prevent smallpox but is also protective against mpox in adults 18 years and older. The 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, but they exhibit significant side effects.  Though the effectiveness of ACAM2000 against mpox is unknown, it is suggested by at least one study that reported that its precursor, the first-generation smallpox vaccine Dryvax, demonstrated protection against mpox among 1555 vaccinated contacts of 338 patients in the DRC.

Antiviral therapies provide an excellent complement to vaccination in that they reduce virus titres quickly, regardless of immune status, and lower transmission rates by diminishing the virus reservoir. However, currently there are no treatments approved by the Food and Drug Administration (FDA) specifically for mpox, but antiviral drugs approved for treatment of smallpox may help to treat mpox. An antiviral drug, tecovirimat (TPOXX™) has been found to be effective for treating mpox. Tecovirimat is an orally bioavailable, low molecular weight compound and is active against multiple species of orthopox viruses in-vitro including variola.

In developed countries like the US, efforts are being made to ensure broad access to mpox vaccines. According to a news report “the key is getting more of the 1.6 million people at risk in the United States fully vaccinated against the virus”.

The US CDC pages read: “… the manufacturer of the vaccines Bavarian Nordic has told the US Government it plans to put the vaccine on the commercial market around April 1, 2024. Federal agencies are working with Bavarian Nordic to ensure that people will continue to have broad access to this vaccine, including people who are uninsured and underinsured.”

Such stockpiling has undermined the global needs and has unfortunately led to delayed or no access to vaccines, therapeutics and diagnostics. Thus while developed countries prioritize at-risk populations and ensure vaccine supply to their population, it is crucial to address the limited or non-existent access to mpox therapeutics for those suffering from the disease in Africa.

An affordable supply of vaccines is needed for people who are suffering from the disease. While price estimates are difficult to garner, the JYNNEOS vaccine is estimated to cost USD 115 (complete vaccination cost per person) while a single dose of 0.0025 ml of ACAM 2000 costs USD 139. Such excessive pricing challenges for low-and middle-income countries (LMICs) will likely continue as LMICs cannot enforce price control on such vaccines to ensure access for their populations. Thus, these countries mostly have to depend on charities from higher income countries which enter into bilateral deals with the vaccine manufacturers. In the case of mpox the situation is exacerbated as Bavarian Nordic is the only supplier for an effective mpox vaccine and holds patent monopoly rights over it.

Avian influenza

The emergence of the H5N1 strain of bird flu, also known as avian influenza, among dairy cows in the US, alongside a confirmed human case in Texas, has understandably raised significant concerns. Experts have warned that this virus has the potential to cause a pandemic and could be significantly more severe than COVID-19.

According to WHO statistics, from 1 January 2003 to February 2024, there have been 887 reported cases of human infection with avian influenza A (H5N1) in 23 countries globally. Unlike COVID-19, which has a mortality rate of around 3% for even the most severe variants, avian influenza has a much higher fatality rate, estimated at 52%, with 462 fatalities out of the 887 reported cases. Given the high fatality rate and the potential for widespread transmission, various agencies have emphasized the importance of closely monitoring the situation. Early detection, surveillance, and rapid response measures are crucial to prevent the spread of the virus and mitigate its impact on public health.

Prioritizing the development and distribution of vaccines and antiviral treatments for H5N1 is critical for enhancing preparedness against potential PHEIC or pandemic scenarios.

As of today, the only instrument that guarantees access to medical products is the WHO’s Pandemic Influenza Preparedness (PIP) Framework. The PIP Framework serves as a comprehensive strategy for global collaboration in influenza preparedness, with a specific focus on sharing influenza viruses, access to vaccines and other pandemic-related products, and building capacity for response and control measures.

The PIP framework obligates manufacturers who signed the Standard Material Transfer Agreement (SMTA) to donate 10% of the real time vaccine production or X number of treatment courses to WHO as well to reserve 10% of the real time vaccine production or X number of treatment courses at affordable price. If the manufacturer is not ready to take this obligation then they have to undertake the obligation to grant manufacturing licenses to manufacturers in the developing countries. However, the scope of the PIP Framework is limited to  H5N1 and other influenza viruses with human pandemic potential and therefore there is no assured access to health products required for other PHEIC responses.

It is concerning to hear that the new draft negotiating text of the pandemic instrument has removed the benefit sharing obligations of health products through donations or affordable prices during a PHEIC. Equitable access to vaccines and other essential health products is crucial, especially for African countries and other LMICs. Without mechanisms in place to ensure affordability and accessibility, these countries may struggle to obtain an adequate supply during global health crises including PHEICs and pandemics like COVID-19.

The current manufacturing scenario poses significant challenges to equitable access. Many LMICs rely heavily on vaccine imports, which can be subject to supply chain disruptions, export restrictions, and high prices. Enhancing local manufacturing capacity and promoting technology transfer could help mitigate these challenges in the long term.

It is quintessential for stakeholders to continue advocating for a framework that prioritizes equitable access to health products, especially during a PHEIC. Thus, it is crucial that proposals to amend the IHR 2005, which is a legally binding instrument with the membership of 196 countries, include provisions on equitable access and these must be given the utmost priority. In this way IHR 2005 would be better equipped to address not only the immediate challenges posed by PHEICs but also the underlying systemic issues that perpetuate health inequities.