Over 26,000 cases of monkeypox have been confirmed globally as of Thursday and the number is only growing. However, there are only 16.4 million doses of the vaccine currently available.
The manufacturer of the world’s only vaccine approved for monkeypox, Bavarian Nordic, faces a planned closure of its European production plant until late 2022. With only 16.4 million doses of the MVA-BN vaccine available worldwide, it is unclear how the company plans to meet rising demand for its monkeypox vaccine, following the global health emergency of international concern recently declared by the World Health Organization (WHO).
With no new doses expected to leave the facility until early 2023, donations from the few high-income countries that have stockpiled the vaccine, notably the United States, will be crucial to the world’s ability to respond to the outbreak.
Without a new licensing deal to speed up production of their vaccine, Bavarian Nordic risks catalysing a preventable repeat of the inequities seen in the early global response to the Covid pandemic.
Vaccine inequity exposed again?
Currently, the Danish-based company holds the patent to the only European Medicines Agency and US Food and Drug Administration approved monkeypox vaccine.
With the rights to the manufacture and distribution of the vaccine solely in Bavarian Nordic’s hands, and more than a dozen countries inquiring about doses, it is the US government that will be in possession of, or contracted to receive, the overwhelming majority of MVA-BN doses due to be delivered in 2022 – roughly adding up to about 14.4 million doses.
The US Defence Department, through the Biomedical Advanced Research and Development Authority (BARDA), financed key elements of the vaccine’s development with contracts amounting to nearly $2bn between 2003 and 2020, a review of those contracts by Health Policy Watch shows.
This means that, either via donations, or by persuasion of Bavarian Nordic to scale up its production, Washington, once more, could be called upon to take the lead in ensuring equitable access to monkeypox treatments.
Bavarian Nordic plans unclear
Bavarian Nordic’s European vaccine production line, key to its generation of new volumes of the MVA-BN monkeypox vaccine, was closed this spring and will not be reopened until the third quarter of 2022, according to a 9 May investor report. Once re-opened, the company will only begin producing new volumes of the vaccine in early 2023, global health sources in Geneva told Health Policy Watch.
Of the roughly 16 million doses of MVA-BN vaccine said to be available now, most – about 15 million – are still in bulk form (a drug in large quantities before it is put in individual vials and becomes a vaccine - ed.), according to statements this week by WHO.
Most of the available one to 1.4 million finished and delivered doses are held in the strategic stockpile of the US, which heavily financed the development of the vaccine, according to the global health forecasting firm Airfinity.
Virtually all of the 15 million remaining doses are already promised to a tiny handful of high-income customers – mostly the United States.
According to the Airfinity data, as of 20 July 2022, the US had another 13 million doses on order for 2022, with another two million doses spread between Canada, the United Kingdom, the European Union, Germany and another “undisclosed European country”.
Nearly 30 million more doses delivered in earlier years to the US have already expired.
In an exchange with Health Policy Watch, a source at Bavarian Nordic pointed to the recent conclusion of a deal with the US government to fill-and-finish 2.5 million more doses from bulk supplies available, with a US-based firm.
But despite the current closure of the company’s European manufacturing line, there are no current plans to outsource or out-licence the bulk manufacturing of MVA-BN, the source indicated.
The company is scaling up production of the MVA-BN vaccine, based on “customer demand” and has “planned our production to satisfy the demand for our vaccine in both the short and the medium term”, the source added, without referring to impacts of the plant closure.
However, without more external licensing agreements, it is unclear how Bavarian Nordic indeed expects to meet increasing demand.
‘Not enough’ doses ready
Company executives have so far remained silent in the face of offers by the WHO, as well as individual pharma firms, to support more production scale-up, or more rapid “fill-and-finish” of the 15 million vaccines available right now in bulk at a critical point for the global response to the spread of monkeypox.
Speaking at a press briefing on Wednesday, WHO’s Tim Nguyen noted:
“When it comes to the supply, we know that there is not enough in fill-and-finish form. So the key is what are their [Bavarian Nordic’s] plans for gearing up on fill and finish capacity.”
He added that WHO has already “received offers” from other manufacturers to help the Danish firm to “scale up the fill and finish” – and passed those onto the manufacturer.
South Africa’s Aspen Pharmacare is one such firm that came forward recently with a public offer to support the fill and finish of monkeypox vaccines.
Paradoxically, Aspen’s COVID-19 facility, whose opening was touted last year by WHO officials as a “transformative moment” in the mission to drive down stark vaccine inequalities, is also at risk of closure due to lack of demand for its version of the Johnson & Johnson vaccine “Aspenovax”, which was a flagship product of Africa’s aspirations to localise more vaccine capacity on the continent. So a contract to fill-and-finish Monkeypox could be a perfect match – if only the suitor was interested.
Approached by Health Policy Watch, Bavarian Nordic’s spokesperson Thomas Duschek declined to provide further details of the company’s vaccine production and distribution plans – or whether the company would negotiate with Gavi to sell Monkeypox vaccines in bulk for low- and middle-income countries.
Rich countries urged to donate vaccines
While vaccine demands are spread among those countries now reporting cases, only a handful of nations, and primarily the United States, hold the keys to available supplies that could be used right away to stem the pandemic tide.
This has left the WHO and its associates asking for vaccine donations, another striking replay of the early days of the Covid vaccine rollout.
“We urge countries with stockpiles – or supplies on order – to be generous and flexible in releasing doses to countries with cases that do not have access to ensure equality,” a spokesperson for the Vaccine Alliance (GAVI) told Health Policy Watch.
WHO’s Chief Scientist, Soumya Swaminathan also speaking at last Wednesday’s WHO briefing, echoed that, saying: “We are in discussions with the manufacturers to get an idea of availability of doses. Many of them have already been committed to countries, so we would like to explore the possibility of a donation from countries that do have doses, to put them in a stockpile.”
But the United States also announced last week that it will begin deploying some 800,000 doses of its available MVA-BN stock to vaccinate at-risk groups at home. That leaves little in its strategic stockpile for donations – until at least the 2.5 million doses of fill-and-finish are delivered.
Replay of Covid playbook?
Despite the emerging tensions between vaccine demand and supply, leading global health officials have so far tread gently in their comments about the Danish vaccine company, perhaps due to the world’s dependence on this single company’s policies to get the pandemic under control.
“I look at Bavarian Nordic, and it’s a good company,” GAVI CEO Seth Berkley noted in a press briefing Thursday.
But, he added, Bavarian Nordic “doesn’t have a large fill finish production facility, so it may be that if four doses are needed, then moving towards a fill and finishing approach as Aspen or the few other manufacturers have offered would be a way to move forward”.
Anne Simon, Unit Chief of the EU’s Health Emergency and Preparedness Response Authority (HERA), told Health Policy Watch: “The European Commission, notably through HERA and the European Medicines Agency, stand ready to support Bavarian Nordic to scale up vaccine production as is needed.”
The Global Fund was more blunt: “The global Covid-19 response demonstrated structural global health inequities which left low and middle-income countries exposed to harmful vaccine nationalism,” a spokesperson told Health Policy Watch.
What about other vaccines?
In theory, there are two other vaccines available against smallpox – and thus potentially effective against monkeypox. But neither are licensed for monkeypox as such.
First is the LC16, manufactured by Japanese pharmaceutical KM Biologics, the only second or third-generation smallpox vaccine to be licensed for use in children by the WHO. Officials at the WHO, however, have noted that Japan views the vaccine as a national asset, and the country has no plans to share its stockpiles.
When KM Biologics was asked about plans for production scaling and prospects of working with WHO or GAVI to provide vaccines for distribution in low and middle-income countries, the company told Health Policy Watch: “we are afraid we cannot be of help in the matters described in your email.”
The world also possesses around 100 million doses of the older generation ACAM2000 vaccine that contributed to the eradication of smallpox, but experts deem the risk of adverse effects too high to deploy unless absolutely necessary.
“This is a global challenge,” GAVI CEO Seth Berkley explained at a press conference on Thursday. “If you have rare diseases, or small producers for disease, there’s not enough attraction to have them produced by many different manufacturers.”