PCV

Merck’s next-generation 15-valent pneumococcal conjugate vaccine (PCV) earned U.S. FDA approval in adults last week, crossing the finish line for people age 18 and older nearly six weeks after rival Pfizer’s 20-valent shot.

Even so, Merck’s Vaxneuvance seems poised to beat Pfizer in the race for the lucrative pediatric market. Merck said in May that it plans to seek FDA approval for the shot’s use in children this year.

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The novel 24-valent pneumococcal polysaccharide vaccine (PPSV) candidate from Affinivax and Astellas has notched U.S. FDA Breakthrough Therapy designation on the strength of new Phase 2 data, the companies announced Tuesday.

The results showed that ASP3772—based on Affinivax’s proprietary Multiple Antigen Presenting System (MAPS)—was well tolerated and induced antibody responses to each of its 24 serotypes, according to the press release. The study compared the shot to two market…

The U.S. FDA approved Pfizer’s 20-valent pneumococcal conjugate vaccine (PCV) on Tuesday, handing the company a win over rival Merck for the world’s first next-generation PCV authorization. The shot, Prevnar 20, is also under EMA review, the company’s press release said.

Merck’s 15-valent PCV candidate (V114) may win the pediatric race, however, as the multinational plans to file for a pediatric indication by the end of the year. An FDA decision on Merck’s V114 for adults is expected…

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Merck announced positive topline results last week for its investigational 15-valent pneumococcal conjugate vaccine (PCV), which met primary endpoints in two Phase 3 pediatric studies. The data suggested that V114 protects against 13 serotypes in infants who previously received one or multiple doses of Pfizer’s 13-valent shot and against 15 serotypes in children age 7 months to 17 years in a catch-up setting, according to a Merck press release.

The company said it’s on track to file…

CanSino Biologics has started enrollment in a Phase 3 trial of its 13-valent pneumococcal conjugate vaccine candidate (PCV13i), the Tianjin-based company disclosed Tuesday in a regulatory filing.

Meanwhile, in an apparent attempt to distance itself from safety concerns over AstraZeneca’s and J&J’s Covid-19 shots, CanSino claimed Wednesday that “no blood clot related serious adverse events” had been reported to date in approximately one million immunizations with its adenovirus type…

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).…

Affinivax announced last week that it has raised $226 million in Series C financing to advance its pipeline of MAPS (Multiple Antigen Presenting System) infectious disease vaccines—including its lead pneumococcal candidates and first-in-class shots targeting healthcare-acquired infections.

The Massachusetts-based company received an initial seed and Series A equity investment from the Gates Foundation in 2014 to launch its proprietary MAPS as a broad protection technology, and added…

Merck announced Tuesday that the U.S. FDA has granted priority review to V114, its investigational 15-valent pneumococcal conjugate vaccine (PCV15) for adults—with a target action date of July 18.

The agency awarded Pfizer’s rival 20-valent shot the same designation last month.

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Pfizer announced Tuesday that the U.S. FDA has granted priority review to the biologics license application for its 20-valent pneumococcal conjugate vaccine (PCV) for adults.

The company expects to make an application for the shot to the European Medicines Agency in early 2021.

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The race between Merck and Pfizer for the world’s first approved next-generation pneumococcal conjugate vaccine (PCV) continued this week with Merck’s announcement Monday that it has submitted licensure applications to the U.S. FDA and the European Medicines Agency (EMA) for its V114 15-valent PCV for use in adults.

Pfizer filed an FDA application for its 20-valent PCV in adults just last month, saying it planned an EMA application in early 2021.

The Global Vaccine Market…

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