PCV

The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of Pfizer’s 20-valent pneumococcal conjugate vaccine in adults, the company announced last week. Prevnar 20—to be marketed in Europe as Apexxnar—scored its U.S. FDA nod in June.

Pfizer remains locked in a next-gen PCV race with Merck, whose 15-valent shot crossed the regulatory finish line after Pfizer’s in the U.S. but took first place in the E.U.

Sanofi shared substantial growth expectations in immunization during its vaccine investors day last week.

Through a combination of new vaccines and increased sales of existing products, Sanofi "expects to more than double its vaccine sales by the end of the decade," for a total vaccines business size of almost $57 billion by 2030, FiercePharma reported.

The company sees mRNA, pneumococcal conjugate vaccines (PCVs), and RSV as three areas of opportunity going forward, its press…

The U.S. FDA has granted priority review to Merck’s 15-valent pneumococcal conjugate vaccine (PCV) as the agency evaluates the shot for children and adolescents ages 6 weeks to 17 years, the company announced Wednesday.

Marketed as Vaxneuvance, the jab won FDA approval for use in adults in July, just weeks after Pfizer’s 20-valent vaccine became the first next-gen PCV to cross the finish line.

Washington state-based startup Inventprise revealed Wednesday that it has won up to $90 million from the Gates Foundation to advance its pediatric 25-valent pneumococcal conjugate vaccine candidate (IVT-25) through Phase 2.

The company will make IVT-25 “available and accessible at an affordable price” to LMICs and make its proprietary “linker” platform technology available for future global health vaccine development, the press release said.

Shanghai’s Fosun Pharma is racking up majority ownership of Antejin Biotech through a $628 million deal combining Fosun’s vaccine unit with the Chengdu-based biopharma, Bloomberg reported Tuesday.

Antejin has a 13-valent pneumococcal vaccine in early-stage trials, according to Bloomberg, and a 24-valent pneumococcal conjugate shot in an earlier stage of development, according to Endpoints News. Fosun will have the option to boost its 73% Antejin stake to as high as 92% if those…

Both Pfizer’s and Merck’s next-generation pneumococcal conjugate vaccines (PCVs) got the nod for routine use from the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP) last week.

The decision surprised Wall Street analysts, who had expected ACIP to favor Pfizer’s single-dose 20-valent Prevnar “one-and-done” vaccine over Merck’s 15-valent Vaxneuvance (which requires the company’s 23-valent polysaccharide Pneumovax as a booster), according to FiercePharma.

Both…

Regulators delivered good news to Merck last week.

Firstly, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of the company’s 15-valent pneumococcal conjugate vaccine in adults. The U.S. FDA approved the shot in July.

Meanwhile, the FDA approved Merck’s blockbuster cancer immunotherapy, Keytruda, to be used in combination with chemotherapy, with or without bevacizumab (Roche’s Avastin), for the treatment of patients with persistent, recurrent…

Pfizer enjoyed three boosts over the past week to its booming vaccine portfolio, already buoyed by global sales of Covid-19 shots.

Firstly, the company settled a patent dispute last week with Merck over their rival pneumococcal conjugate (PCV) shots. Under the settlement, Merck will pay Pfizer 7.25% of its worldwide net sales of all PCV products through the end of 2026, and 2.5% of net sales of PCV products from 2027-2035, according to Bloomberg Law.

On Tuesday, Pfizer and…

Scarcely a month after notching U.S. FDA approval of its 15-valent pneumococcal conjugate vaccine (PCV) in adults, Merck announced Wednesday that the shot has also met key immunogenicity and safety endpoints in a Phase 3 trial in infants.

Vaxneuvance had a safety profile “generally comparable” to PCV13, according to Merck’s press release. On immunogenicity, the shot was shown non-inferior to PCV13 for all 13 shared serotypes at two intervals: at 30 days following the third dose (based…

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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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