The World Health Organisation (WHO) has endorsed a new test for tuberculosis (TB) to fasten efforts to eradicate one of the deadliest and dangerous infectious disease.

The test is called Xpert MTB/RIF Ultra and uses analysis of molecules to detect genetic markers and presence of Mycobacterium tuberculosis, the bacteria that causes TB, in the saliva of people suspected to be infected by the disease, according to the United Nations.

The new test is the first to receive endorsement from the UN health agency earning the “prequalification status” meaning that it has passed the stringent quality checks.

“This first prequalification of a diagnostic test for tuberculosis marks a critical milestone,” said WHO Assistant Director-General for Access to Medicines and Health Products Dr Yukiko Nakatani.

“It underscores the importance of such groundbreaking diagnostic tools in addressing one of the world’s deadliest infectious diseases,” he added.

The global health body added that accurate results from the test can be expected “within hours” and while the test is running, it can also detect genetic mutations from the saliva of the people who resist first-line TB drugs such as rifampicin.

This advancement can help doctors in prescribing “second-line” treatments to the sufferers.

“It is intended for patients who screen positive for pulmonary tuberculosis and who have either not started anti-tuberculosis treatment or received less than three days of therapy in the past six months,” the UN health agency said.

Tuberculosis remains one of the world’s leading fatal diseases, resulting in over a million deaths annually.

“High-quality diagnostic tests are the cornerstone of effective TB care and prevention,” said WHO Director for Regulation and Prequalification Dr Rogerio Gaspar.

“Prequalification paves the way for equitable access to cutting-edge technologies, empowering countries to address the dual burden of TB and drug-resistant TB,” he added.

Moreover, seven more TB tests are in the assessment status by WHO as the organisation aims to expand access to quality-assured testing technology for the disease.

The World Health Organisation (WHO) said on Monday it had approved Bavarian Nordic’s mpox vaccine for adolescents aged 12 to 17 years, an age group considered especially vulnerable to outbreaks of the disease that has triggered global concern.

The WHO said in a statement that it gave the Jynneos vaccine prequalification for adolescents on October 8.

The WHO declared mpox a global public health emergency for the second time in two years in August after a new type of the virus spread from the Democratic Republic of Congo to its neighbours.

The United Nations agency approved the use of the vaccine in September as the first shot against mpox in adults, making it easier for badly hit African countries to access the vaccine.

Children, adolescents and those with weakened immune systems have been particularly vulnerable to mpox, a viral infection that typically causes flu-like symptoms and skin lesions filled with pus.

WHO’s latest decision comes after the EU approved the drug for the vaccine for adolescents in September.

The Danish biotech firm is also preparing to conduct a clinical trial to assess the vaccine’s safety in children aged two to 12, potentially extending its use.

The trial, partially funded by the Coalition for Epidemic Preparedness Innovations, is expected to start in October.

The US Food and Drug Administration has also approved Bavarian’s shot, but only for use in adults 18 years and older, although it granted Emergency Use Authorisation for its use in adolescents during the mpox outbreak of 2022.

Another mpox vaccine, LC16, made by Japan’s KM Biologics, can already be given to children, according to the Japanese regulator, although it requires a special kind of needle.

Bavarian Nordic did not immediately respond to a request for comment on the prequalification.

Confirmed cases of new mpox strain have been detected in Democratic Republic of Congo, Sweden, Thailand, Burundi, Kenya, Rwanda and Uganda.

The World Health Organisation (WHO) has approved MVA-BN as the first pre-qualified vaccine against monkeypox virus.

“This first pre-qualification of a vaccine against mpox is an important step in our fight against the disease, both in the context of the current outbreaks in Africa and in future,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus.

The development comes as the United Nations’ health centric-body had declared the mpox outbreak as an “international health emergency” in July.

Vaccine development has been in focus in recent times with the WHO also allowing its partners Gavi and the United Nations International Children’s Emergency Fund (Unicef) to buy mpox vaccines even before the UN’s approval last month.

Traditionally, organisations like Gavi, an alliance which helps lower-income countries buy vaccines, can only start purchasing shots once they have approval from the WHO.

Two vaccines, made by Denmark’s Bavarian Nordic BAVA.CO and Japan’s KM Biologics, have already been approved by regulators around the world, including the United States and Japan, and have been in widespread use for mpox since 2022.

Around 1.2 million people have had Bavarian Nordic’s vaccine in the United States alone.

It is to be noted that Pakistan has reported six mpox cases in 2024 and five since the outbreak was declared a public health emergency of international concern by the WHO.

The MVA-BN’s pre-qualification approval is expected to facilitate timely and increased access to this vital product in communities with urgent needs, to reduce transmission and help contain the outbreak.

WHO’s assessment for pre-qualification is based on information submitted by the manufacturer, Bavarian Nordic A/S, and review by the European Medicines Agency, the regulatory agency of record for this vaccine

“We now need urgent scale up in procurement, donations and roll-out to ensure equitable access to vaccines where they are needed most, alongside other public health tools, to prevent infections, stop transmission and save lives,” remarked the WHO chief.

The vaccine — which can be stored at 2–8°C for up to 8 weeks after prior cold storage — can be administered in people over 18 years of age as a 2-dose injection given four weeks apart.

Available data showing that a single-dose MVA-BN vaccine given before exposure has an estimated 76% effectiveness in protecting people against mpox, with the two-dose schedule achieving an estimated 82% effectiveness.

Meanwhile, the WHO has also recommended single-dose use in supply-constrained outbreak situations.

Speaking on the vaccine’s approval, WHO Assistant Director-General for Access to Medicines and Health Products Yukiko Nakatani said: “The WHO pre-qualification of the MVA-BN vaccine will help accelerate ongoing procurement of the mpox vaccines by governments and international agencies such as Gavi and Unicef to help communities on the frontlines of the ongoing emergency in Africa and beyond”.

She also remarked that decision could also help national regulatory authorities to fast-track approvals, ultimately increasing access to quality-assured mpox vaccine products.

The WHO Strategic Advisory Group of Experts (SAGE) on immunisation reviewed all evidence and recommended the MVA-BN vaccine in the context of the mpox outbreak for persons at high risk of exposure.

While MVA-BN is currently not licensed for persons under 18 years, this vaccine may be used “off-label” in infants, children and adolescents, and in pregnant and immune-compromised people meaning that the vaccine’s use is recommended in outbreak settings where the benefits of vaccination outweigh the potential risks.

For the second time since 2022, the World Health Organization (WHO) on Wednesday raised the highest alert by declaring Mpox a global health emergency as 14,000 cases have been reported with 524 deaths in Africa with the potential to reach other continents.

What is Mpox?

Mpox, formerly known as monkeypox, is a viral illness caused by the monkeypox virus, which is part of the same family as smallpox.

Originally identified in monkeys, the disease can infect various animals and humans.

Although historically rare, recent outbreaks have demonstrated its potential for widespread transmission.

While generally less severe than smallpox, MPOX can still pose significant health risks, particularly to vulnerable populations.

Global surge in cases

Between January and July 2024, approximately 14,500 MPOX cases and over 450 related deaths were reported, according to the Africa Centers for Disease Control and Prevention (CDC).

This marks a 160% increase in infections and a 19% increase in mortality compared to the same period in 2023.

While the Democratic Republic of the Congo accounts for 96% of these cases, the disease has also spread to other nearby nations, including Burundi, Kenya, Rwanda, and Uganda, where it is not typically endemic.

How does Mpox spread?

Mpox is primarily transmitted through close contact with an infected person or animal.

Transmission can occur through direct contact with skin lesions or bodily fluids, respiratory droplets from close or prolonged exposure, and contaminated objects such as bedding or clothing.

Recognising symptoms

The symptoms of Mpox can initially mimic other viral infections but typically progress through distinct stages.

Early signs include fever, headache, muscle aches, and swelling of the lymph nodes.

As the infection advances, a rash develops, starting on the face and spreading to other parts of the body.

This rash evolves into raised, fluid-filled blisters that eventually scab over.

The disease can also cause fatigue, backache, and sometimes gastrointestinal symptoms like nausea or vomiting.

Global Health Response

As MPOX remains a concern for global health officials, understanding its transmission and symptoms is crucial for managing and preventing its spread.

Public health measures, including awareness and early detection, are key to controlling outbreaks.

Those who suspect infection or exposure to MPOX are urged to seek medical advice and follow recommended preventive measures.

Health authorities and the WHO continue to work towards navigating this ongoing health challenge.