About two weeks after chikungunya virus (CHIKV) vaccine contender Bavarian Nordic A/S provided phase III data with its prospect, rival Valneva SE rolled out positive phase III safety findings in adolescents with its single-dose candidate VLA-1553. Results from the Saint-Herblain, France-based company’s first trial in an endemic area with people previously infected with CHIKV showed the product was generally safe and well-tolerated in subjects aged 12-17 years, regardless of previous infection by the mosquito-borne disease, carried mainly by Aedes aegypti and Aedes albopictus. Immunogenicity data from the study are expected in November.

SK Bioscience Co. Ltd.  and Vaxxas Pty. Ltd. have entered into a joint development agreement that could revolutionize vaccines by developing a vaccine-delivery device combination product using Vaxxas’ high-density microarray patch (HD-MAP) coupled with SK Bioscience’s typhoid vaccine, Skytyphoid.

The COVID-19 pandemic might be officially over, but future variants could still pose a threat, and serious health consequences of the causative virus continue to arise, a fact that has prompted the U.S. government to offer Regeneron Pharmaceuticals Inc. about $326 million to develop and manufacture a next-generation COVID-19 monoclonal antibody therapy.

The U.S. FDA approved Pfizer Inc.’s respiratory syncytial virus (RSV) prophylactic, Abrysvo (RSVpreF) for maternal use, providing pregnant women with the option of protecting their newborns up to the age of 6 months against RSV for the first time. The regulator’s Vaccines and Related Biological Products Advisory Committee voted 14-0 in favor of approving the BLA for maternal use of the vaccine in May, a few weeks before the agency gave it the go-ahead for use in older adults (those ages 60 and older).

Novavax Inc. has signed off 6.5 million shares to SK Bioscience Co. Ltd. for an $85 million equity investment from the South Korean pharmaceutical firm, which also wrote off some of Novavax’s manufacturing liabilities, as part of their continuing vaccine alliance. Seongnam-si, South Korea-based SK Bioscience purchased Novavax shares at $13 each, reflecting a 59% premium over the 90-day trading value, to gain a 6.45% stake in the Gaithersburg, Md.-based mRNA vaccine company, an SK Bioscience spokesperson confirmed to BioWorld.

The dent made in Bavarian Nordic A/S’ future revenues after it dropped development of late-stage respiratory syncytial virus (RSV) contender MVA-BN-RSV could be offset by potential sales of its chikungunya virus vaccine, PXVX-0317, if recent phase III immunogenicity data manage to persuade the U.S. FDA that it’s as worthy as Valneva SA’s VLA-1553, the other chikungunya vaccine racing to be first to market.

South Korea’s antitrust agency on July 20 imposed fines of ₩40.9 billion (US$31.9 million) to crack down on 32 pharmaceutical firms charged with colluding on production, distribution and wholesale of vaccines in the country’s immunization program.

Sanofi SA and Astrazeneca plc had a lot to celebrate July 17 when the FDA approved Beyfortus (nirsevimab) ahead of schedule, making it the first respiratory syncytial virus (RSV) prophylactic for infants in the U.S. “This is just really an historic day,” Michael Greenberg, a Sanofi vice president and medical head of the company’s North America vaccines unit, told BioWorld. The companies had been expecting the FDA decision later this quarter. The earlier approval suggests the FDA appreciated the urgency of having time for health systems and doctors to get the drug ahead of the next RSV season, Greenberg said.

Takeda Pharmaceutical Co. Ltd. has voluntarily withdrawn its U.S. BLA for its dengue fever vaccine, Qdenga (TAK-003), following discussions with the FDA centered on “aspects of data collection, which cannot be addressed within the current BLA review cycle,” the company said in a statement. News of the withdrawal comes more than a month after the May 23 Qdenga PDUFA date. The future plan for Qdenga in the U.S. will be further evaluated given the need for travelers and those living in dengue-endemic areas of the U.S., such as Puerto Rico.