Instead of the bivalent COVID-19 vaccines comprising both the original and omicron BA.4/BA.5 SARS-CoV-2 strains that have been in use in the U.S. since April, the CDC’s Advisory Committee for Immunization Practices voted 13-1 Sept. 12 to recommend the universal use of updated monovalent XBB-containing COVID-19 vaccines as authorized or approved by the FDA.
Moderna Inc. has more than COVID-19 vaccines in the hopper, and the company aims to add still more oomph by way of an oncology deal with Immatics NV that could be worth more than $1.7 billion for the latter, which banks $120 million up front and stands to collect research funding as well.
Brii Biosciences Ltd.’s therapeutic vaccine for hepatitis B (HBV), BRII-179 (VBI-2601), induced functional immune responses – inducing broad antibody and T-cell responses – in patients with chronic HBV in a phase II trial that evaluated the vaccine in combination with pegylated interferon-alfa, according to interim results.
Messenger RNA, or mRNA, represents a relatively new class of therapeutics with the potential to prevent and treat a wide range of diseases. A well-known success story is of the mRNA vaccines that controlled the COVID-19 pandemic, which has fueled enthusiasm for the field. But biotechs are also developing mRNA candidates for several other infectious diseases, including malaria, tuberculosis and HIV, as well for cancer, autoimmune and allergic diseases. However, delivering nucleic acid therapeutics can be challenging, since mRNA cannot get into cells on its own. “Nucleic acid therapeutics can be incredibly fragile,” Thomas Madden, CEO of Acuitas Therapeutics, told BioWorld. “When injected into the body without a delivery system, messenger RNA, for example, is rapidly destroyed.”
Biontech SE and Pfizer Inc. filed a petition with the U.S. Patent Trial and Appeal Board for an inter partes review against Moderna Inc., the latest move in an ongoing patent battle over the mRNA technology used to develop COVID-19 vaccines.
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.