Meningococcal Vaccine: Protection, Risk, Schedule

MSD Aims To Plug Dengue Fever Vaccine Gap In US

Nearly two years after Takeda pulled its US marketing application for a vaccine against dengue fever, MSD has advanced a rival shot into phase 3.

The international MOBILIZE-1 trial is looking at a single dose of MSD's quadrivalent dengue vaccine V181 – covering all four of the virus' serotypes (DENV-1, DENV-2, DENV-3, and DENV-4), with the first patients now being recruited in Singapore.

While Takeda's Qdenga (TAK-003) shot is approved as a two-dose regimen to protect people from the disease in dozens of countries around the world, the drugmaker withdrew its FDA filing in mid-2023 after a request for additional information from the regulator that the company was unable to provide.

Qdenga was cleared by the World Health Organization (WHO) last year, and sales rocketed to JPY 35.6 billion (around $250 million) in the fiscal year to the end of March 2025, en route to what Takeda has suggested could be a peak of $2 billion or more.

There is one dengue vaccine approved by the FDA – GSK's Dengvaxia – but the jab is restricted to young people aged six to 16 in areas where dengue is endemic and who have previously been infected with the virus, which disqualifies it from being used as a travel vaccine.

MSD is hoping that V181 could offer an option for a much broader population, including those who have not been exposed to dengue before.

"Approximately half of the world's population lives in areas with a risk for dengue, making it a serious public health threat," said Dr Paula Annunziato, head of infectious disease and vaccine clinical development at MSD's Merck Research Laboratories.

If successful, V181 could provide "an important single-dose option for at-risk populations, regardless of previous exposure to dengue, to help reduce the significant burden around the globe," she added.

The WHO has estimated that the mosquito-borne disease infects around 390 million people each year and results in 20,000 deaths. It is endemic in more than 125 countries, including the US territories of Puerto Rico, the US Virgin Islands, and American Samoa, and is a leading cause of fever among travellers to Latin America, the Caribbean, and Southeast Asia.

MOBILIZE-1 has a target enrolment of 12,000 healthy individuals from two to 17 years of age who will be randomised to receive either V181 or placebo at more than 30 trial sites in dengue endemic areas in the Asia-Pacific region, including Indonesia, Malaysia, Philippines, Singapore, Thailand, and Vietnam.

Photo by Towfiqu barbhuiya on Unsplash

WOAH Adopts ASF Vaccine Standard

The World Organization for Animal Health recently adopted an African Swine Fever vaccine standard as a means to help control the disease. The agreement was reached during the Organization's 92nd General Session in Paris last week. The Organization feels ASF control is possible.

Key elements of the new standard include that vaccines must be manufactured with the highest quality and be proven to be effective and safe for use. The Organization warned that poor quality or non-compliant ASF vaccines may make the disease situation worse instead of improving it.

To comply with the new standard, evidence will be required proving the vaccine's efficacy, including in terms of reducing the severity of the symptoms and further transmission of the virus. WOAH (WHOA-ah) says vaccination alone, even if it meets these standards, won't be enough without high levels of biosecurity, control of animal movements, and import restrictions.

The decision to vaccinate ultimately rests with veterinary authority.

Source: NAFB news service

Lassa Fever: Vaccine Produced By Nigerian Shows High Potency –Virologist

Renowned virologist, Dr Simeon Agwale, has hinted that Lassa fever vaccine produced by a Nigerian has scaled through preclinical trials involving mice and non-human primates.

Agwale, the Chief Executive Officer of Innovative Biotech, disclosed this in an interview with newsmen yesterday in Abuja,

He said that this development has raised the hope for controlling the deadly viral disease.

NAN reports that Lassa fever is among deadly viral disease which is sometimes recorded in Nigeria.

Agwale said that the vaccine, licensed from the University of Melbourne by Pac-Man Biologics demonstrated 100 per cent protection during trials.

"This vaccine by a Nigerian is the only one so far demonstrating efficacy against the Nigerian strain of the Lassa virus, which differs from the widely used Josiah strain originating from Senegal.

"We have the exclusive license for the vaccine for use in Africa. We pay royalties to the University of Melbourne and that's how the innovation ecosystem works.

"'They did the foundational work and we are building on it," he said.

He explained that five out of five unvaccinated mice died after being challenged with the virus, while all vaccinated mice survived.

"Similar results were recorded in a non-human primate study, where all unvaccinated animals died on day 22, but all vaccinated ones survived.

"This is 100 per cent protection. It shows great promise and we hope to complete the Phase 1 clinical trials soon," he added.

He also stated that the vaccine doses for clinical trials are being produced in the United States, under a technology transfer arrangement, pending the completion of Nigeria's vaccine production facility.

"Beyond the vaccine success, the experts strongly criticised Nigeria's outdated academic system, especially in postgraduate training and research.

"We spent millions sending lecturers abroad for postdoctoral trainings without results.

"Every postdoctoral position in the U.S. Is funded already, so why send people with extra funds and no structure back home to apply their skills?" he queried.

He warned that unless Nigeria revamps its university curricula to focus on specific, market-relevant training like "vaccinology and drug development," the country would continue to lag in science and innovation.

"We still run masters in Microbiology with nine courses per semester, what's the purpose of that? We need focused programmes.

"A graduate in vaccinology should understand how vaccines are developed, tested and manufactured," he said.

He urged universities to take ownership of research by generating funds through problem-solving innovations rather than relying solely on government support.

"We must build research centres and retain talent. Innovation must solve national issues, not just earn foreign degrees," he said.

He said that collaboration with global partners and deployment of local capacity was critical to achieving health security and scientific self-reliance.

"This is not about being a local champion. You must compete with the best globally because health emergencies don't wait," he said. (NAN)

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