RT yosoymario (@yosoymario91)My wife, who’s a doctor looked at me while injecting myself with grey market Chinese peptides and said “but you didn’t get the fucking Covid vaccine”. You bet I didn’t girl. ...

Healthcare Access - Covid vaccine availability may vary based on location or pharmacy [1]

A week of shifting rules and escalating political rhetoric has left millions of Americans grappling with a simple health-care question: Can I get the Covid vaccine or not? https://t.co/t02DnWLrHr ...

Company Response - Pfizer defended the evidence supporting its Covid vaccine [1] - Pfizer responded to President Donald Trump's questioning of drug companies' transparency around the shots [1]

An influential vaccine panel’s task force will be led by a member who has previously expressed distrust in the Covid vaccine, weeks after a shooting on the US Centers for Disease Control and Prevention was fueled by Covid misinformation https://t.co/YczVp7bkv6 ...

.@MikeBloomberg: The president who sped the development of the Covid vaccine might do the same for a cancer cure — if his health secretary gets out of the way (via @opinion) https://t.co/g1nOXDmzX7 ...

The Food and Drug Administration is considering revoking Pfizer Inc.’s authorization to sell its Covid vaccine for children under the age of 5, a move that would leave healthy kids with no available shots https://t.co/epTXYQQ1Ei ...

Core Viewpoint - Moderna has lowered its 2025 revenue outlook due to delays in vaccine shipments to the U.K., while still beating Wall Street expectations for the second quarter as it implements cost-cutting measures [1][2]. Revenue Outlook - The company now expects full-year revenue to be between $1.5 billion and $2.2 billion, a decrease of $300 million at the top end of the range [2]. - The delay in shipping spring Covid boosters to the U.K. has shifted deliveries to the first quarter of 2026, but the overall contract value remains unchanged [3]. Second Quarter Performance - Moderna reported second-quarter sales of $142 million, a 41% decline from the same period last year, primarily due to decreasing Covid vaccine sales [4]. - The revenue from the Covid vaccine accounted for $114 million of the total, surpassing analysts' expectations of $89 million [5][7]. - The company's vaccine for respiratory syncytial virus had negligible sales, falling short of the expected $5.9 million [5]. Financial Losses - Moderna posted a net loss of $825 million, or $2.13 per share, for the second quarter, an improvement from a net loss of $1.3 billion, or $3.33 per share, in the same quarter last year [5][6]. - The loss per share was better than the expected loss of $2.97 [7]. Cost Management - The company's efforts to cut costs resulted in a 27% reduction in second-quarter operating expenses, which fell to $1.1 billion from $1.6 billion year-over-year [6].

Company Restructuring - Moderna is reducing its workforce by approximately 10% [1] - The company aims to cut spending due to declining Covid vaccine sales [1]

FDA Initiatives & Goals - FDA aims to streamline drug approval process by addressing inefficiencies and reducing the time to market, which currently takes over ten years [2][3][8] - FDA is releasing decision letters to enhance transparency and predictability for drug makers and investors [5] - FDA is standardizing review processes to avoid reviewer autonomy and is modernizing processes with AI, including using AI as an organizing tool for scientific reviews [7][8] - FDA is considering page limits for drug applications to streamline the review process [8] - FDA is exploring a "plausible mechanism pathway" for rare diseases, potentially reducing the need for extensive studies [22] Challenges & Criticisms - Concerns exist regarding inconsistent application of standards, as highlighted by the complete response letters issued to Replimune and Capricor [6] - FDA faces criticisms about resource allocation, with ongoing debates about whether more funding is the solution to improve efficiency [10][11] - The departure of key personnel, such as Peter Marks and Vinay Prasad, has raised concerns about potential disruptions to streamlining efforts [12][15] Drug Safety & Regulation - FDA temporarily held the use of Sarepta's gene therapy for Duchenne muscular dystrophy in ambulatory patients due to safety signals, but has since been restored [20][21] - FDA is addressing the emergence of synthetic kratom byproducts, specifically 708, which is a potent opioid found in vape stores [34][36] - FDA acknowledges the existence of vaccine injuries and the need for further studies by HHS and NIH [25][28] Leadership & Personnel - George Tidmarsh, MD, PhD, has been appointed as the top drug regulator, bringing experience as a drug developer from La Jolla Therapeutics [18] - FDA is seeking a replacement for Doctor Vinay Prasad, who departed after a short tenure [19]