vaccines

The state of the hunt:

Pfizer/BioNTech asked the U.S. FDA to expand its authorization of their vaccine to adolescents.
  Numerous countries restricted the use of the AstraZeneca/Oxford shot to older people—or discontinued it altogether—even as regulators concluded the benefits outweighed the risks.
  COVAX affirmed that SII’s supply commitments to the initiative remain “legally binding” amid continued export restrictions from India.

 

Vaccines


Icosavax announced Wednesday the close of $100 million in Series B financing.

The funds will support the development of the biotech’s bivalent RSV and human metapneumovirus vaccine through initial clinical studies, continued evaluation of its virus-like particle (VLP) Covid-19 vaccine candidate, and expansion of its pipeline of other VLP vaccine candidates targeting respiratory diseases, the press release said.

The state of the hunt:

Pfizer and BioNTech plan to seek authorization of their vaccine for adolescents age 12-15 after promising Phase 3 results.
  J&J agreed to supply up to 400 million doses of Janssen’s jab to the African Union.
  Serum Institute of India launched clinical trials of its version of the Novavax vaccine candidate.

 

Vaccines


Approved or authorized vaccines
   
New data show lower efficacy for Pfizer/BioNTech: The…

CARB-X announced Monday an award of up to $2 million and up to $5.3 million more in milestones to the University of Oxford’s Jenner Institute for work on its gonorrhea vaccine candidate (dmGC_0817560 NOMV), currently in lead optimization.

The funds will support optimization, scale-up and production for first-in-human trials of “an affordable vaccine for global use,” the press release said.

Local media reported Monday that Indian companies have inked an agreement with the Council of Scientific and Industrial Research’s Indian Institute of Chemical Technology (CSIR-IICT) to expand the use of mRNA as a vaccine development platform in the country.

The Hindu Business Line named vaccine supplier Bharat Biotech International Limited, animal health company Biovet, and biotech Sapigen Biologix as signatories.

Only Pune-headquartered Gennova Biopharma is currently using mRNA…

Japan’s Global Health Innovative Technology Fund announced $21 million in product development investments on Wednesday.

More than two-thirds of the awards will help advance six ongoing projects, while the rest fund four new investments: a leishmaniasis drug from Takeda and the Drugs for Neglected Diseases initiative; a malaria therapy from Eisai, the Medicines for Malaria Venture and the University of Dundee; a tuberculosis drug from Daiichi Sankyo RD Novare and the TB Alliance; and a…

Takeda has asked the European Medicines Agency to approve its tetravalent dengue vaccine candidate, the company announced last week. In parallel, the agency will consider recommending the shot for countries outside the European Union through the EU-M4all (previously Article 58) procedure, according to the press release.

Takeda said it plans to seek additional approvals for TAK-003 this year in Argentina, Brazil, Colombia, Indonesia, Malaysia, Mexico, Singapore, Sri Lanka and Thailand…

Sanofi announced Wednesday it will invest over $700 million to build a new vaccine facility in Toronto—increasing supply of its market-leading Fluzone high-dose quadrivalent influenza shot in Canada, the United States and Europe.

The press release quoted CEO Paul Hudson as saying that the new facility “will be a key resource to assist against future pandemics.” Sanofi expects the plant to be operational in 2026.

The state of the hunt:

The European Union and India made new moves to curtail vaccine exports.
  COVAX warned of delivery delays.
  Pfizer and BioNTech launched a pediatric trial of their vaccine in children as young as 6 months.

 

Vaccines


Approved or authorized vaccines
   
New data, new questions for AstraZeneca: If AstraZeneca thought higher-than-expected efficacy results this week from the U.S.-based Phase 3 trial of AZD1222 would…

GSK today fired veteran vaccines adviser Moncef Slaoui as board chair of its majority-controlled Galvani Bioelectronics over “substantiated” allegations of sexual misconduct. An investigation remains ongoing, according to the GSK press release.

Per the press release, Slaoui’s behaviors were “wholly unacceptable” and contrary to the “strong values that define GSK’s culture.”

Slaoui became well known in 2020 as chief scientist to the U.S. government’s Operation Warp Speed…