iter for the average American to get an updated COVID vaccine. On Friday, a CDC advisory panel unanimously recommended limiting the COVID shot to people 65 and older or those with underlying health conditions. This days after the former CDC chief medical officer, Dr.. Deborah Howry, warned Congress about changes in the AY's decision-making process. I resigned because CDC leaders were reduced to rubber stamps. supporting policies not based in science, and putting American lives at risk.Secretary Kennedy cens ...

Core Viewpoint - The U.S. government has terminated its contract with Moderna for the late-stage development of an mRNA-based bird flu vaccine, impacting the company's funding and development plans [1][2]. Group 1: Contract and Funding - The Biden administration had awarded Moderna two contracts totaling $766 million, including $590 million for advancing vaccine development and $176 million to expedite vaccine development [2]. - The termination of the contract was anticipated due to a review of agreements made during the Biden administration by the Trump administration [3]. Group 2: Clinical Data and Future Plans - Despite the funding setback, Moderna reported positive interim data from a phase I/II study of its mRNA-1018 vaccine, showing an increase in protective antibody levels from 2.1% to 97.8% after the second dose among 300 participants [4]. - The company plans to present further clinical findings at an upcoming scientific conference and is exploring new paths for pandemic preparedness in light of the funding loss [5]. Group 3: Stock Performance and Market Sentiment - Year-to-date, Moderna's stock has decreased by 37%, contrasting with a 5% decline in the industry [6]. - Negative sentiment surrounding Moderna's stock has been exacerbated by recent FDA guidance limiting COVID-19 booster eligibility and the voluntary withdrawal of a regulatory filing for its COVID-19/influenza vaccine [8][9]. - The company is also working to reduce operating expenses and streamline its R&D pipeline amid these challenges [10].

Core Viewpoint - Traws Pharma is advancing the development of tivoxavir marboxil (TXM) as a treatment for bird flu and seasonal influenza, with recent FDA feedback guiding their regulatory strategy and clinical study plans [1][2][3]. Group 1: FDA Interaction and Development Plans - The FDA provided written responses regarding the development paths for TXM, including the potential use of the Animal Rule for approval [1][2]. - Traws Pharma is requesting a Type D meeting with the FDA to clarify next steps in the development process for TXM [2]. - The company aims to conduct a combined clinical study involving subjects infected with seasonal and bird flu [2]. Group 2: Therapeutic Efficacy and Urgency - Positive therapeutic effects of TXM have been observed in three animal models of bird flu, reinforcing the need for rapid progression towards stockpiling and pandemic readiness [3]. - Traws Pharma has initiated discussions with the Biomedical Advanced Research and Development Authority (BARDA) for stockpiling TXM in preparation for potential pandemics [3]. - The historical context of H5N1 virus outbreaks, which have had death rates up to 50%, underscores the urgency of these actions [3]. Group 3: Product Overview and Market Opportunity - TXM is an investigational oral small molecule designed as a single-dose treatment for bird flu and seasonal influenza, showing potent in vitro activity against various influenza strains [4]. - The seasonal influenza market represents a multi-billion dollar opportunity, driven by global health organizations and government tenders, with additional potential from pandemic outbreaks [4]. - The data supporting TXM's development as a treatment for both bird flu and seasonal flu is considered robust [4].