China’s National Medicinal Products Administration has approved Walvax’s bivalent HPV vaccine for the prevention of cervical cancer caused by HPV 16 and HPV 18, Chinese media sources reported last week.
The shot will compete for domestic market share against GSK, Merck, and China’s Xiamen Innovax.
Xiamen Innovax’s bivalent HPV vaccine has won WHO prequalification, PATH announced Tuesday.
The quality mark allows UNICEF and other international agencies to buy the shot—and breaks Merck’s and GSK’s hold over Gavi supply.
PATH—which provided technical assistance to China-based Innovax during the WHO review process—is also sponsoring a Phase 3 trial (underway in Bangladesh and Ghana) to evaluate regimens of the shot with fewer doses.
Médecins Sans Frontières (MSF), Save the Children, UNICEF and WHO issued a press release last week welcoming the addition of GSK’s rotavirus vaccine, Rotarix, to their Humanitarian Mechanism, which allows civil society organizations in countries not otherwise eligible for Gavi support to buy shots at manufacturers’ lowest available price for use in emergencies.
Founded in 2017, the Humanitarian Mechanism was previously limited to pneumococcal conjugate vaccines (from GSK and Pfizer).…
Inovio announced Monday that its VGX-3100 DNA-based HPV immunotherapy has met primary and secondary endpoints among all evaluable subjects in Phase 3 trials.
Administered using the Pennsylvania-based biotech’s proprietary Cellectra 5PSP “smart device,” VGX-3100 reduced cervical high-grade squamous intraepithelial lesions caused by HPV-16 and HPV-18 and cleared infection in 23.7% of people with endpoint data.
However, those results excluded eight trial subjects with missing…
Local media reported on Wednesday that SK Bioscience has won a contract to co-promote and distribute five GSK vaccines in South Korea. The agreement includes Boostrix (tetanus, reduced diphtheria and acellular pertussis), Menveo (meningitis ACVYW-135), Havrix (hepatitis A), Priorix (measles, mumps, rubella) and bivalent HPV shot Cervarix.
WHO’s Market Information for Access (MI4A) to Vaccines initiative released its annual update Tuesday on the state of global HPV vaccine markets.
The market study reported that 57% of member states have introduced one of the four available HPV vaccines into their routine national immunization schedules, with demand expected to continue to rise due to WHO’s Global Strategy to Accelerate the Elimination of Cervical Cancer, launched Tuesday. The study said a “combination of factors,”…
UNICEF Supply Division published reports this month on vaccine markets for HPV and seasonal influenza.
On HPV, the international procurement agency said global vaccine supply is currently insufficient to meet demand—meaning Gavi-supported countries will need to postpone their plans for multi-age cohort vaccinations. Self-financing middle-income countries (MICs) lacking an existing agreement will also not be able to access supply through UNICEF, per the report, until availability…
PATH announced last week that it will conduct post-licensure Phase 3 trials of Xiamen Innovax’s bivalent human papillomavirus vaccine, Cecolin, to boost evidence for future WHO prequalification (PQ). The studies, testing different regimens against Merck’s Gardasil, are planned for the fourth quarter in Bangladesh and Ghana.
WHO accepted the shot for review in March, two months after Chinese regulators approved it.
Innovax said in June that it expects to begin supplying “…
Becton Dickinson (BD) announced last week that the U.S. FDA has approved an expanded version of its human papillomavirus (HPV) assay. The new BD Onclarity test is the first FDA-approved diagnostic to individually identify and report genotypes beyond 16, 18 and 45, the press release said.
Changchun Zhuoyi Biological announced a deal last week with the Chinese Academy of Medical Sciences’ Institute of Basic Medical Sciences for the exclusive use, development and commercialization of a universal human papillomavirus (HPV) vaccine.
According to the company’s press release, the hybrid HPV L1-based chimeric virus-like-particle candidate induced broad cross-neutralizing antibodies against at least 20 HPV serotypes in animal models—suggesting potential for a pan-HPV shot.
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