Cansino Biologics Inc. has received marketing approval from the NMPA for its ACYW-135 meningococcal conjugate vaccine, Menhycia, making it the first of its kind to be authorized in China. The approval marks “an important step in accelerating the development of China’s meningococcal vaccine immunization strategy,” the company said.
Where’s the plan? That was the underlying question Jan. 11 as Biden administration health officials faced frustration and tough questions from both Democrats and Republicans on the Senate Health, Education, Labor and Pensions (HELP) Committee about how the U.S. government is responding to the surge of COVID-19 infections caused by the omicron variant.
A raft of potentially high-value drug development collaborations, most for gene and RNA therapies, led the first day of the 40th Annual J.P. Morgan Healthcare Conference Monday. Pfizer Inc. enlisted Beam Therapeutic Inc. to advance in vivo base editing programs for up to $1.35 billion, while Bayer AG tapped Mammoth Biosciences Inc.’s in vivo CRISPR systems expertise in a potential $1 billion-plus deal. Selecta Biosciences Inc. inked a new $1.1 billion partnership with Ginkgo Bioworks Inc. to develop next-generation gene therapy capsids, while Acadia Pharmaceuticals Inc. agreed to pay Stoke Therapeutics Inc. as much as $967 million to develop RNA-based medicines. Work on new mRNA vaccines and therapies is also proceeding, with both Pfizer and Biontech SE announcing new collaborations in the space.
LONDON – T cells generated as a result of infection with common cold coronaviruses provide cross-protection against being infected with SARS-CoV-2, according to a new study.
Within hours of a Jan. 5 vote on COVID-19 boosters for adolescents, U.S. CDC Director Rochelle Walensky endorsed the Advisory Committee on Immunization Practices’ (ACIP) recommendation that all adolescents aged 12-17 years should receive a booster dose five months after their primary series. The recommendation applies to the Pfizer Inc.-Biontech SE COVID-19 vaccine, as it’s the only one authorized in the U.S. for use in adolescents.
Once the CDC accepts the recommendation of its Advisory Committee on Immunization Practices (ACIP), the COVID-19 vaccine regimen, at least for the Pfizer Inc.-Biontech SE vaccine, will include a booster dose for everyone 12 and older. ACIP voted 13-1 at a Jan. 5 emergency meeting to recommend the booster dose for 12- to 17-year-olds at least five months after a primary series of the Pfizer vaccine.
Just as the world appeared to be winning the battle against COVID-19, the rules of the game changed. Omicron and concerns about future variants flipped the board. Vaccines and monoclonal antibodies are attracting fresh scrutiny as SARS-CoV-2 evolves. Cases are climbing closer to the highest levels recorded since the pandemic began. Antivirals are aiming to fill treatment gaps, but whether they will or not is about as clear as the virus’ next move.
With Omicron spreading rapidly, U.S. COVID-19 vaccine producers are facing increasing pressure to up their production and to do more to ensure their vaccines are accessible globally.
Astrazeneca plc has confirmed it is working with Oxford University to produce a vaccine against the Omicron variant of the SARS-CoV-2 virus. The Cambridge, U.K.-based pharma was one of the first to get a COVID-19 vaccine okayed by regulators, after acquiring rights to the shot from Vaccitech plc, a spin-out from Oxford University’s Jenner Institute specialist vaccine unit.
Aridis Pharmaceuticals Inc. is one of two companies posting COVID-19 data just days before Christmas. Its fully human monoclonal antibody cocktail, AR-701, was shown to be broadly reactive against COVID-19 variants, including Omicron, in preclinical research. Moderna Inc. also posted new data that showed preliminary neutralizing data against Omicron following 50-mg doses of its vaccine, which is currently authorized, and 100-mg dose boosters, which increased neutralizing antibody levels 83-fold from the pre-boost levels.
RSS
