IO Biotech ApS will discuss this fall with the U.S. FDA the data package related to Cylembio (imsapepimut and etimupepimut, adjuvanted) after the off-the-shelf therapeutic cancer vaccine prospect missed “by a hair” the primary endpoint in a pivotal phase III melanoma trial, said CEO Mai-Britt Zocca.
The Nipah virus (NiV) from the Henipavirus genus is a bat-borne zoonotic pathogen that causes encephalitis and acute respiratory distress syndrome in humans. NiV infections have a very high fatality rate. No approved vaccine or therapeutics against NiV infection exist for use in humans despite its dangerous potential for causing larger epidemics.
Cancel culture continues at the U.S. Department of Health and Human Services (HHS) as it observes National Immunization Awareness Month with another strike against vaccines. This time, a $500 million strike specifically targets 22 mRNA vaccine R&D programs at the Biomedical Advanced Research and Development Authority (BARDA), marking the beginning of the end of BARDA’s funding for mRNA vaccines.
Chinese vaccine company Ab&B Bio-tech announced an IPO listing on the Hong Kong Stock Exchange (HKEX:2627) under which it hopes to raise up to HK$518.36 million (US$66 million) to commercialize its influenza and human rabies vaccines in China and internationally.
The other shoe dropped on the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) when at least nine liaison organizations were informed by email late July 31 that they would no longer be involved in ACIP’s process of reviewing scientific evidence and informing vaccine recommendations.
Chinese vaccine company Ab&B Bio-tech announced an IPO listing on the Hong Kong Stock Exchange (HKEX:2627) under which it hopes to raise up to HK$518.36 million (US$66 million) to commercialize its influenza and human rabies vaccines in China and internationally.
The threat of another influenza pandemic arising from bird-to-human and then human-to-human transmission drives continuing efforts to develop effective vaccines against avian influenza. In the latest advance in this area, researchers at Novavax Inc. have reported a new vaccine against avian influenza strain A(H5N1) clade 2.3.4.4b.
The news that Vinay Prasad has stepped down as CBER director at the U.S. FDA had some biotech stocks literally jumping in joy as the market opened July 30. Meanwhile, Prasad’s decisions regarding vaccine development, as well as actions by Makary and HHS Secretary Robert Kennedy, are coming under fire.
Danish vaccines manufacturer Bavarian Nordic A/S is to be taken private in a DKK233 per-share deal valuing the company at DKK19 billion (US$2.97 billion). The deal needs the support of 90% of Bavarian Nordic shareholders to go through, and as things stand may not reach that target because it does not have the support of the largest shareholder, the Danish pension fund ATP, which owns 10.17%.
It’s not surprising that, of all the recommendations the U.S. CDC’s vaccine advisory board made at its June meeting, the first one Health and Human Services Secretary Robert Kennedy signed off on would essentially remove thimerosal from influenza vaccines in the U.S. What is surprising is the time it took for him to do so, given his long-held position on the preservative used in multidose vials and his insistence that a thimerosal presentation and vote be added to the agenda.
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