Fighting mpox: promising vaccines to watch – Labiotech.eu

The World Health Organization (WHO) has declared a global public health emergency as the mpox virus ravages the African continent with cases having spiked by 160% this year. As Bavarian Nordic ramps up production of the only marketed mpox vaccine, a few clinical trials are underway to combat the outbreak.

The Danish biotechs vaccine, called Jynneos, was approved for emergency use by the U.S. Food and Drug Administration (FDA) in 2022, and is the only one that has widespread approval to target the virus. This was also the year that a previous mpox outbreak hit parts of the world, such as countries in Europe and North America, where the virus is not endemic.

The viral infection, formerly known as monkeypox, which can spread through close contact with an infected person, animal, or contaminated objects, results in rashes, fever, headache, muscle aches, back pain, low energy and swollen glands. While the severity can vary from person to person, extreme cases can cause death. But this time around, a new, deadlier strain of the mpox virus called clade 1 has been spotted in the Democratic Republic of Congo and has been spreading at an alarming rate, according to the Africa Centres for Disease Control and Prevention (CDC).

Now, Bavarian Nordic is scaling up production to ensure fair access and said that it will work along with the Africa CDC and the WHO to contain the spread. So far, this year, more than 500 deaths have been reported in Africa, crossing 2023 figures. The biotech aims to manufacture 10 million doses of Jynneos by the end of 2025 with plans to supply up to 2 million doses this year.

JYNNEOS is a live, non-replicating vaccine that elicits immune responses to a group of viruses known as orthopoxviruses. It contains a weakened form of the vaccinia virus, which is related to the monkeypox and smallpox viruses, and cannot copy itself in the human body.

However, as countries suffered Jynneos shortages in 2022, more trials are underway at present, to test investigational vaccines and drugs to tackle the epidemic.

A major concern among U.S. legislative leaders and government medical countermeasure operations is the sole dependence on a single non-U.S. supplier for supply of a critically needed medical countermeasure such as the mpox/smallpox vaccine.

There is only one authorized supplier of the MVA vaccine (Bavarian Nordic), which has insufficient production capacity to meet the existing and forecasted needs, said David Dodd, chief executive officer (CEO) of American biotech GeoVax. Health authorities in Africa recently stated that 10 million doses are needed, but only 200,000 doses are available. Unfortunately, Jynneos is produced in a manufacturing process that is constrained in the production yield and speed of production.

GeoVax expects to change this situation, initially as the first U.S.-based supplier of an Modified vaccinia Ankara (MVA) vaccine, and also implement an advanced manufacturing process that provides higher production yield faster at lower cost, added Dodd.

GeoVaxs GEO-MVA is very similar to Jynneos as they are both derived from the same initial MVA parental line. The MVA vaccine provides protective immunity against mpox and smallpox, which is why MVA is used worldwide as the protective vaccine against both mpox and stockpiled by the U.S. government as a medical countermeasure against a potential bioterrorism threat utilizing smallpox, explained Dodd. GEO-MVA and Jynneos are anticipated to provide similar protection against mpox and smallpox, and therefore, an expedited regulatory pathway is expected to be finalized soon.

Due to the current insufficient supply of MVA vaccines, especially with reports of infection outside of Africa, like Sweden, where a case of the new strain was confirmed, GeoVax is in talks with U.S. legislators and global regulators to authorize and boost MVA vaccine supply.

The basic need for manufacturing the mpox vaccine has been met, and we are ready to advance towards the vaccine product manufacturing process. The company is actively engaging with U.S. and global stakeholders to discuss how we can contribute to countermeasure activities, said Dodd.

Moreover, the biotech seeks to accelerate the production of MVA vaccines regardless of GEO-MVA or Jynneos. These vaccines typically use cells derived from specially sourced chickens, which is a lengthy process. The company has validated an advanced MVA manufacturing process that does not depend on these chickens to overcome the limitation of a slower, more complex manufacturing process, at a time when it is challenged to respond promptly to epidemics or pandemics. So instead, an avian cell line will be ten times more efficient, explained Dodd.

While currently the chicken embryonic fibroblasts (CEF)-based manufacturing process remains for GEO-MVA and Jynneos, GeoVax is transitioning to the advanced manufacturing process. The benefit will be to increase the supply of MVA vaccine more quickly, thereby expanding the global supply available, without being dependent upon stockpiling as the manner to develop mpox vaccine supply, said Dodd.

Meanwhile, mRNA giant Modernas vaccine the biotech famed for developing one of the COVID-19 vaccines is being trialed in the U.K. The National Institute for Health and Care Research (NIHR) in the U.K. is calling for healthy people aged between 18 and 49 to take part in the study.

However, it has been a let down on the treatment front. The antiviral pill tecovirimat, also known as TPOXX, has been in the clinic for a while now. It works by interfering with a protein that is present on the surface of the virus to hinder it from replicating, thereby slowing the spread of infection. But last weeks disappointing trial results found that the drug is no better than placebo.

Thus far, the majority of mpox cases has been in the Democratic Republic of the Congo and surrounding areas within that region. The Africa CDC, along with the DRC Ministry of Health and the WHO are leading the counter-effort, explained Dodd. And, smallpox vaccines like American biotech Emergent BioSolutions ACAM2000 will be used to dampen infection rates in the DRC as well as the other impacted countries of Burundi, Kenya, Rwanda, and Uganda. Around 50,000 doses will be sent to the affected regions. With the possibility of more than one MVA vaccine for rollout and expedited manufacture, hopes of controlling the spread of the deadly virus remain.

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Fighting mpox: promising vaccines to watch - Labiotech.eu