pneumo

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…

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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Beijing-based Sinovac announced last week that the China National Medical Products Administration has approved its 23-valent pneumococcal polysaccharide (PPSV23) shot—the company’s first bacterial vaccine licensure, according to the press release.

According to lot release data, Sinovac will compete for PPSV23 market share in China against Beijing Minhai, Chengdu Institute of Biological Products, Merck and Walvax.

In other Chinese vaccine news, Shenzhen Kangtai (BioKangtai)…

The novel, 24-valent pneumococcal vaccine candidate from Affinivax proved safe, well-tolerated and highly immunogenic in Phase 1, according to data the Massachusetts-based company shared last week at the IDWeek infectious disease conference.

The study compared ASP3772—based on the biotech’s proprietary Multiple Antigen Presenting System (MAPS)—to Pfizer’s Prevnar 13 in adults ages 18-64. Affinivax has also completed enrollment in the Phase 2 portion of its study (in adults over 65),…

Institute of India (SII) has spun off its Covid-19 vaccine portfolio into a new company, per local media.

According to its website, Serum Institute Life Sciences will “leverage Serum Institute’s current manufacturing capabilities” and has begun construction of a new, billion-dose-capacity GMP facility. The company currently has five Covid-19 vaccines in its pipeline, including two developed in-house and three more from partnerships with AstraZeneca, Codagenix and Novavax.

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