The U.S. FDA expanded the age indication of Seqirus’ cell-based seasonal quadrivalent influenza vaccine, Flucelvax, to include children age 6 months and older, the New Jersey-based company announced last week.

Supporting the approval, a Phase 3 study demonstrated that the shot was safe and immunogenic in children ages 6 months to 5 years, according to the Seqirus press release.

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…

The state of the fight: 

  • A U.S. FDA advisory panel recommended booster shots of the J&J and Moderna vaccines for select groups.
     
  • CureVac will abandon development of its first-generation mRNA-based vaccine candidate.
     
  • Brii Bio has submitted its monoclonal antibody cocktail to the U.S. FDA for Emergency Use Authorization.
Approved or authorized vaccines

 
WHO advisory group…

The African Medicines Agency (AMA) cleared a major threshold last week when Cameroon became the 15th country to formally confirm its participation, setting off a 30-day countdown for the agency’s establishment, according to a statement from the African Union.

The AMA aims “to provide support for weak regulatory systems,” promoting harmonized regulatory policies among members, per the statement. In an article on the development, Health…

BD announced last week that it has completed new needle and syringe manufacturing lines in its Holdrege, Nebraska facility more quickly than initially planned in order to meet surging U.S. demand spurred by the Covid-19 pandemic.

The $70 million project included $42 million in funding from the U.S. Biomedical Advanced Research and Development Authority, the press release noted.

Cocrystal Pharma has scored a nod from Australian regulators to begin a Phase 1 trial of its CC-42344 oral PB2 inhibitor for the treatment of pandemic and seasonal influenza A, the Washington state–based company announced last week.

The biotech’s discovery and development pipeline also includes antivirals for treating Covid-19, hepatitis C and norovirus, according to the press release, while the company website says it’s developing an…

Paul Stoffels, J&J’s chief scientific officer, will retire at the end of this year, the company announced Tuesday.

J&J’s press release credited Stoffels with launching Johnson & Johnson Global Public Health and spearheading the development of the company’s Covid-19 vaccine. A Wall Street Journal article on Tuesday said he pushed the company to pursue medicines for LMICs, “including one for multidrug-resistant tuberculosis…

Mentions: J&J, leadership

Moderna said last week that it will invest up to $500 million to build “a state-of-the-art mRNA facility” in Africa with the goal of producing up to 500 million vaccine doses per year, “to include drug substance manufacturing with the opportunity for fill/finish and packaging capabilities at the site.”

The press release said Moderna expects to begin country and site selection soon. However, company chair and co-founder Noubar Afeyan…

Mentions: Moderna

Some 47% of the world’s population has little or no access to basic diagnostics except those for HIV and malaria, according to a report issued last week by the Lancet Commission on Diagnostics. Access to diagnostics is the “single largest gap in the care pathway” and is most severe at the primary healthcare level, where only about 19% of people in LMICs have access to simple tests, the article said.

The Commission proposed 10…

Mentions: diagnostics, LMICs, UHC

The Lancet Microbe published an article last week by European academics arguing that funding for antibiotic innovation remains “insufficient to address the scale of antibiotic resistance.” As an alternative, the authors proposed a “mission-oriented” antibiotic trials infrastructure to protect new drugs from commercial failure.

Through the so-called Networked Institute Model (NIM), a collection of public institutes would conduct all…

WHO’s Strategic Advisory Group of Experts (SAGE) on Immunization gave the go-ahead on Monday to broader use of novel type 2 oral polio vaccine (nOPV2), making more countries eligible to deploy it, the Global Polio Eradication Initiative (GPEI) said in a press release.

The move comes after SAGE and WHO’s independent Global Advisory Committee on Vaccine Safety reviewed data from campaigns earlier this year that used more than 65 million…

Mentions: WHO, SAGE, Polio, vaccines, nOPV2, GPEI

The state of the fight: 

  • Countries raced to order Merck’s molnupiravir antiviral after positive Phase 3 results.
     
  • WHO released an independent strategic review of the Access to COVID-19 Tools Accelerator.
     
  • SII plans to ship bulk substance for its Covishield vaccine to AstraZeneca in the U.K. when it resumes exports.
Approved or authorized vaccines

 
European countries pause…

Seqirus announced on Tuesday that the U.S. Biomedical Advanced Research and Development Authority has picked the CSL subsidiary to develop two influenza A(H2Nx) vaccine candidates through Phase 1.

The $35 million deal will evaluate one cell-based and adjuvanted candidate and one self-amplifying mRNA (sa-mRNA) shot, the New Jersey-based company said in a press release.

Bayer announced Tuesday that it is upping its investment to over $460 million for new manufacturing facilities for long-acting reversible contraceptives (LARCs) and hormonal intrauterine systems (IUS).

The company plans to build a new “state-of-the-art” plant in Costa Rica by 2024 and expand previously announced manufacturing in Finland by 2025.

As part of an earlier sustainability commitment, Bayer is aiming to increase access to…

A therapy for the prevention of recurrent C. difficile infection (CDI) in high-risk patients has met the primary endpoint in a Phase 2 trial, Vedanta Biosciences announced Tuesday. The Massachusetts-based company’s VE303, an orally administered live biotherapeutic, yielded a 31.7% absolute risk reduction in rate of recurrence versus placebo, according to a press release.

Based on the Phase 2 data, the U.S. Biomedical Advanced Research…

GSK issued a press release Wednesday welcoming WHO’s new recommendation for widespread use of the company’s RTS,S malaria vaccine among children in sub-Saharan Africa and other regions with moderate to high P. falciparum transmission.

The shot disappointed in a 2009-2014 trial, showing only 39% efficacy against clinical malaria. But new Phase 3 results in August demonstrated that seasonal RTS,S vaccination in combination with…

Janssen’s RSV vaccine achieved 80% protection against lower respiratory infections in older adults in Phase 2b trials, the J&J subsidiary announced last week at the virtual IDWeek 2021 conference.

The company has started Phase 3 trials of the candidate “throughout North America and a selection of countries across Europe, Asia and the Southern Hemisphere,” according to a press release it issued last week.

J&J is competing…

J&J’s Janssen subsidiary is moving an investigational dengue treatment into clinical development, the company announced Wednesday. New preclinical data published in Nature showed that the compound—an “entirely novel mechanism of antiviral action”—demonstrated efficacy against dengue in a prophylactic setting and “rapid and significant reduction in viral load” in a therapeutic model, according to Janssen’s press release.

The KU…

Mentions: Janssen, J&J, dengue, drugs

Merck and Acceleron Pharma announced last week that the multinational is buying the Massachusetts-based cardiovascular specialist for $11.5 billion.

In the deal, Merck gets Acceleron’s technology for the transforming growth factor (TGF)-beta superfamily of proteins, Phase 3 pulmonary arterial hypertension drug candidate Sotatercept, and licensed anemia treatment Reblozyl, the press release said.

Mentions: Merck, Acceleron, drugs, M&A

Nigeria has launched the first edition of a national vaccine policy, local media reported last week. The framework aims to encourage local production and “ensure self-sufficiency in vaccines availability,” according to a foreword by Minister of Health Osagie E. Ehanire.

At a launch event, Ehanire told reporters that the policy should encourage Biovaccines Nigeria Limited—a joint venture between the government and Ikeja-based May &…