A two-in-one mRNA vaccine developed by Moderna that targets seasonal influenza and COVID-19 produced robust and durable immune responses without safety concerns in a small mid-stage trial, the company... ...

Core Viewpoint - The FDA's refusal to review Moderna's application for its new mRNA flu vaccine has left the company's president in shock, citing confusion over the agency's decision regarding trial adequacy and control measures [1][6][7]. Group 1: FDA's Decision - The FDA stated that Moderna's application lacked an "adequate and well-controlled" trial, specifically not comparing the new vaccine to the best-available standard of care at the time of the study [2][9]. - The FDA indicated that the trial should have used a high-dose flu vaccine as a comparator, particularly for individuals over 65, as these are considered more effective for older adults [10][11]. - The FDA's letter did not express concerns about the safety or efficacy of the vaccine, but emphasized that the trial design did not meet their guidelines [6][9]. Group 2: Moderna's Response - Moderna's president expressed surprise and confusion over the FDA's decision, noting that the company had previously discussed trial designs with regulators and received written confirmation that their approach was acceptable [5][9]. - The company reportedly invested over a billion dollars in the clinical trial, which involved more than 40,000 participants and reached the pivotal Phase 3 stage [5][14]. - Moderna warned that the FDA's decision could deter future investments in new medicines and cures, suggesting a significant impact on innovation in the pharmaceutical industry [6]. Group 3: Implications and Reactions - The Health and Human Services spokesperson criticized Moderna for not following FDA guidance, stating that the trial exposed older participants to increased risks by using a substandard control [11][12]. - The recent policy changes under Health and Human Services Secretary Robert F. Kennedy, Jr. have led to the termination of nearly $500 million in federal funding for mRNA vaccine development, affecting multiple companies including Moderna [12][13]. - The decision has drawn criticism from health officials, who argue that it undermines the potential of mRNA vaccines in pandemic preparedness [13].

Core Viewpoint - Pfizer has seen a significant decline in its coronavirus vaccine market, which previously contributed to over $100 billion in annual sales, and faces challenges in replacing this revenue stream moving forward [1][2]. Vaccine Development - Pfizer is developing new mRNA vaccines, including one for influenza, which could improve efficacy compared to traditional flu vaccines that have variable effectiveness [4][5]. - In a phase 3 clinical trial, Pfizer's mRNA influenza candidate showed significantly fewer flu-like illnesses compared to a leading competitor, with potential regulatory submissions expected next year [6]. Cancer and Weight Loss Candidates - Pfizer is advancing two promising candidates: PF-4404, an investigational cancer medicine with a dual mechanism of action, and MET-097i, a weight loss medicine acquired through Metsera [7][9]. - PF-4404 is set to initiate seven new clinical trials and target 10 new indications by the end of next year, which could be a long-term growth driver if approved [8]. - MET-097i has shown competitive weight loss potential and favorable tolerability, with phase 3 studies anticipated to start in 2026 [10]. Financial Outlook - Pfizer is facing patent cliffs, particularly with the immunosuppressant Xeljanz losing exclusivity, which may hinder sales growth in the near term [11]. - Despite a 2% year-over-year revenue decline to approximately $45 billion in the first nine months of 2025, net income has benefited from cost-cutting measures [13]. - The stock is currently undervalued at 8.7 times forward earnings compared to the healthcare sector average of 18.3, and offers a forward dividend yield of 6.6%, making it attractive for long-term investors [14].

Core Insights - Moderna is planning to launch up to 10 new marketed products over the next four years, targeting a market opportunity exceeding $30 billion, which is crucial for driving revenue growth and reducing reliance on the COVID-19 vaccine Spikevax [1][8] Product Portfolio and Market Strategy - Spikevax, Moderna's first marketed product, significantly boosted its profitability but has seen a sharp decline in sales as pandemic demand wanes. The company introduced a second product, the RSV vaccine mResvia, but its uptake was weaker than anticipated. Recently, Moderna received approval for a third product, mNexspike, a next-generation version of Spikevax [2][8] - To counteract declining COVID-19 vaccine sales, Moderna is advancing a late-stage pipeline focused on respiratory, infectious diseases, and oncology. Key vaccine programs include mRNA-1647 for CMV, mRNA-1083 for COVID-19 plus influenza, and mRNA-1010 for standalone influenza, with data expected from the CMV study and a regulatory resubmission for the COVID/flu combination vaccine by the end of 2025 [3][8] Cancer Therapy Development - A significant candidate in Moderna's pipeline is intismeran autogene (formerly mRNA-4157), a personalized cancer therapy developed in collaboration with Merck. This therapy is undergoing evaluation in three pivotal phase III studies for melanoma and non-small cell lung cancer, with additional mid-stage studies for high-risk bladder cancers and other indications. A potential launch is targeted for 2027 [4][8] Competitive Landscape - Moderna faces stiff competition from Pfizer and BioNTech, both of which have experienced revenue fluctuations due to declining demand for their jointly developed COVID-19 vaccine, Comirnaty. These companies are also diversifying into adjacent vaccine and therapeutic areas, including a COVID-19 and influenza combination vaccine [5][6] - BioNTech is focusing on oncology as a long-term growth driver, with key candidates like BNT327, an investigational antibody targeting PD-1 and VEGF, being evaluated across various cancer indications [7]

Public Health & Politics - The Trump administration's efforts to reshape public health are causing mass resignations at the Centers for Disease Control (CDC) [1] - HHS Secretary Robert Kennedy Jr is facing calls for his immediate termination due to the politicization of public health [1] - CDC Director Susan Manarez is reportedly being targeted for refusing to support unscientific directives regarding COVID-19 vaccines [1] - Key CDC officials resigned in protest against the weaponizing of public health [1] - The FDA sharply narrowed COVID-19 vaccine eligibility, restricting it to adults 65 and older and those with underlying conditions [1] - There is concern that the dismantling of the CDC leadership leaves the country vulnerable to biological threats [3] Gun Violence & Policy - A mass shooting at Annunciation Catholic School in Minneapolis resulted in the deaths of two students (aged 8 and 10) and injuries to 14 other children (between ages 6 and 15) and three adults in their 80s [8] - Gun violence is described as the leading cause of death for children in America [24] - Congressman Maxwell Frost criticizes the lack of action on gun violence prevention and the removal of the Office of Gun Violence Prevention by the Trump administration [14][16] Political Landscape & Elections - An Iowa Democrat, Caitlyn Dre, flipped a state senate district blue for the first time since 2011, winning by 11 percentage points in a district that Donald Trump carried by 10 percentage points in the 2024 election [30] - This victory broke the GOP's supermajority in the Iowa Senate for the first time in three years [30] - The Iowa election result is seen as a potential sign of shifting voter sentiment and frustration with the direction of politics [30][31] Judiciary & Executive Power - A Trump-appointed federal judge dismissed a Trump administration lawsuit against federal judges in Maryland, calling it a threat to the constitutional order [26] - The judge accused the Trump administration of taking a confrontational approach with the judicial system over a two-day stay of deportation for immigrants [27] - Former Judge Michael Ludig characterized the lawsuit as an attempt by the executive branch to intimidate the judiciary [28]

Pharmaceutical Industry Trends & Future Directions - The pharmaceutical field is dynamic, with innovations like hydrogels for prolonged drug effects and biodegradable implants for long-term drug delivery [20] - Micro needles, similar to nicotine patches, offer a less invasive drug delivery method [21] - Personalized medicine, driven by AI, is an upcoming trend, tailoring therapies based on individual genetic codes [21] - Nanoparticles are being explored for targeted cancer treatment, aiming for better therapeuticity and reduced harm to normal cells [19] - Lipid nanoparticles are crucial for mRNA vaccines, delivering RNA to help the body battle diseases [17] Drug Development & Treatment Advancements - The development of anti-retroviral therapy (ART) for the first pandemic (likely referring to HIV/AIDS) took 15 years [16] - The development of mRNA vaccines for the COVID-19 pandemic took less than a year [16] - Nanoparticles can be functionalized in various shapes to reach inaccessible parts of the body, potentially revolutionizing medicine [18] Personal Journey & Passion in Pharmaceutics - Passion is defined as being fascinated by something to the point of losing track of time [3] - The speaker's initial plan was not pharmaceutics, but a desire to help people and save lives, influenced by family experiences with breast cancer, led to this path [5][6] - The speaker shifted from wanting to be in corporate to wanting to be in the lab, focusing on the scientific aspects of drug creation [8] - Pursuing a master's in the US was chosen due to better funding and infrastructure compared to India [9]

Funding & Policy Changes - HHS (美国卫生与公众服务部) 决定 mRNA 技术对呼吸道病毒的风险大于收益，因此 BARTA (生物医学高级研究与发展管理局) 已开始终止总额近 5 亿美元（约合 5 亿美金）的 22 份合同 [2] - 美国卫生部长 Robert F Kennedy Jr 宣布撤回 5 亿美元（约合 5 亿美金）的联邦资金，这些资金原本用于 mRNA 疫苗的研究和开发 [1] - Kennedy 采取了一系列措施，包括解雇数千名公共卫生部门的员工，在 HHS (美国卫生与公众服务部) 安排反疫苗盟友，削减州和地方卫生部门数十亿美元的资金，取消数十亿美元的疫苗研究资金，解散联邦疫苗咨询小组，并退出一项拯救了数百万儿童生命的全球疫苗计划 [6] Scientific & Public Health Concerns - 科学家和医生谴责了这一举动，指出 Kennedy 错误地认为 mRNA 疫苗不能预防呼吸道疾病 [2] - 公共卫生专家警告说，现在停止资助将使美国在未来面临更大的健康威胁 [4] - mRNA 疫苗在疫情期间拯救了数百万人的生命，降低了 COVID 的严重程度，并防止了住院 [3] - Kennedy 散布关于 COVID 疫苗的谎言，声称它们无效，会改变 DNA，导致不孕，并导致广泛的伤害和死亡 [5] Organizational Impact - Kennedy 成立的美国最大的反疫苗组织 Children's Health Defense 正在庆祝 Kennedy 的最新举动 [7] - HHS (美国卫生与公众服务部) 内部的科学家和研究人员对 Kennedy 的最新举动感到震惊 [6]

The health department is pulling the plug on a half a billion dollars in funding specifically for mRNA vaccine development. Health Secretary Robert F. Kennedy Jr.. calling the technology behind current COVID and RSV vaccines quote ineffective. mRNA vaccines don't perform well against viruses that infect the upper respiratory tract. mRNA only codes for a small part of the viral proteins, usually a single antigen.one mutation and the vaccine becomes ineffective. Scientists and vaccine experts are now coming o ...

Vaccine Development - RFK Jr 取消了在美国的 5 亿美金 mRNA 疫苗开发项目 [1]

Core Insights - Moderna's experimental mRNA-based flu vaccine has shown a stronger immune response compared to the currently available vaccine in late-stage trials, paving the way for further development of both the flu vaccine and a combination flu and Covid jab [1][3]. Company Developments - In May, Moderna voluntarily withdrew its application for the combination vaccine targeting Covid-19 and influenza, planning to resubmit it with efficacy data from the phase three trial of its standalone flu vaccine [2]. - The company intends to resubmit the application for the combination vaccine and seek approval for its standalone flu shot later this year, with expectations for regulatory approvals for both products next year [3]. Market Position - Moderna is currently a frontrunner against competitors Pfizer and Novavax in the race to market a combination vaccine, with the potential for significant revenue from the multi-billion-dollar markets of Covid, flu, and respiratory syncytial virus [4][5]. Efficacy Data - The phase three trial involved over 40,000 adults aged 50 and above, showing that Moderna's mRNA-1010 vaccine was 26.6% more effective than the standard competitor vaccine [5]. - The mRNA-1010 vaccine demonstrated strong efficacy against major influenza strains, with a 27.4% higher effectiveness in adults aged 65 and older compared to the standard flu vaccine [6]. Public Health Context - Moderna's CEO highlighted the importance of effective vaccines, especially given that flu-related hospitalizations reached a 15-year high during the 2024 to 2025 season, with over 600,000 hospitalizations reported [7]. Safety and Regulatory Engagement - The safety data for the mRNA-1010 vaccine aligns with previous phase three study results, indicating a consistent safety profile [8]. - Moderna is actively engaging with the FDA to clarify regulatory requirements and believes it has a clear path regarding flu vaccine approval [9].