Core Viewpoint - The article discusses serious adverse events related to COVID-19 vaccines, particularly focusing on the Pfizer/BioNTech and Moderna trials, highlighting issues with trial protocols and regulatory oversight [1][2][3]. Group 1: Vaccine Trials and Regulatory Oversight - The Pfizer and Moderna vaccines received Emergency Use Authorization (EUA) after only 20 weeks of testing, which is atypical for vaccine trials [2]. - A forensic review of 38 deaths during the Pfizer vaccine trial revealed that regulators were not informed of two deaths, including one possibly linked to "sudden cardiac death," which could have influenced the approval process [3]. - The authors argue that had accurate data been presented to the FDA's Advisory Committee, it would have been evident that the vaccine did not save lives [3]. Group 2: Data Discrepancies and Health Risks - The article highlights a 3.7-fold increase in cardiac events among subjects receiving the BNT162b2 vaccine compared to the placebo, indicating significant data discrepancies [4]. - By the time the FDA and CDC acknowledged increased risks of myocarditis and pericarditis, many teenagers had already been vaccinated, with the risks downplayed to parents [5]. Group 3: Recommendations for Regulatory Reform - The authors conclude that restoring public trust in regulatory agencies requires significant policy changes, including the repeal of the PREP Act to prevent inadequately tested treatments from being administered [6].

Core Insights - CROSSJECT reported its financial results for the first half of 2025, highlighting progress in regulatory activities and financial performance [3][4][9]. Financial Performance - The company recorded revenues of €8,038,000 for H1 2025, an increase from €5,766,000 in H1 2024 [13]. - R&D reimbursements from BARDA rose significantly to €6,584,000 in H1 2025, compared to €3,064,000 in H1 2024, reflecting increased R&D activities [13][19]. - The operating loss improved to €5,139,000 in H1 2025 from €6,719,000 in H1 2024, indicating better cost management [14]. - The net loss for the period was €4,868,000, down from €6,402,000 in the same period last year [14]. Regulatory and Development Activities - CROSSJECT continued its regulatory efforts with BARDA to obtain Emergency Use Authorization (EUA) for ZEPIZURE® in the U.S. [4][9]. - The company produced validation batches in collaboration with its CDMO partner EUROFINS, which are part of the EUA dossier [5]. - In September 2025, CROSSJECT secured an €11.3 million extension of R&D funding from the U.S. government [5]. Production and Innovation - The company finalized the development of the ZENEO® Nest module to enhance aseptic filling operations, preparing for increased production volumes [7]. - CROSSJECT maintained a cash position of €6.3 million as of June 30, 2025, down from €7.0 million at the end of 2024, reflecting effective resource management [9]. Strategic Collaborations - The company strengthened its marketing strategy for ZEPIZURE® by collaborating with opinion leaders in epilepsy and emergency medicine [8]. - In preparation for potential FDA inspections, BARDA conducted mock audits during the summer [10].

Core Insights - CROSSJECT is advancing the Emergency Use Authorization (EUA) filing process for ZEPIZURE®, an injectable treatment for epilepsy crises, in collaboration with BARDA [3][5][6] - The company has successfully completed critical aseptic filling steps for ZEPIZURE® and is on track with final assembly and packaging [4][9] - Initial feedback from the FDA is anticipated within one month of the submission, with the final manufacturing data expected to be delivered by June 2025 [5][9] Company Overview - CROSSJECT is a specialty pharmaceuticals company focused on developing emergency medications using its needle-free auto-injector ZENEO® platform [7] - The company has a $60 million contract with BARDA to support the development of ZEPIZURE® [7][8] - Other products in development include solutions for allergic shocks and adrenal insufficiencies, as well as various emergency therapies [7]