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The FDA has released the final batch of documents related to the approval of Pfizer’s Comirnaty COVID-19 vaccine, more than 800 days after the vaccine was approved. The release comes as a result of a Freedom of Information Act (FOIA) lawsuit. The documents reveal that the FDA acknowledged its safety monitoring system was “not sufficient” to assess the risks of heart conditions associated with the vaccine, specifically myocarditis and pericarditis.

Title: Study Reveals Unintended Immune Responses in mRNA COVID Vaccines Summary: A recent study conducted by researchers at the University of Cambridge’s Medical Research Council (MRC) Toxicology Unit found that over 25-30% of individuals receiving mRNA COVID vaccines experienced unintended immune responses due to a glitch in the vaccine’s code.

Leon C. Hirsch, founder of U.S. Surgical and inventor of the modern-day surgical stapler, died Sunday at the age of 96. Hirsch was known for his dedication and impact on the industry, and is credited with the invention of the modern day surgical stapler. Under his leadership, USSC (founded in 1963) revolutionized surgery and became the largest manufacturer of surgical staplers and laparoscopic instruments.

The latest batch of documents released as part of a Freedom of Information Act (FOIA) lawsuit against the U.S. Food and Drug Administration (FDA) reveals that the FDA knew its safety monitoring system was inadequate for assessing the risk of heart problems associated with Pfizer’s COVID-19 vaccine when it approved the vaccine.

MIT engineers have created a realistic robotic replica of the heart’s right ventricle, combining real heart tissue with synthetic, balloon-like artificial muscles. The model, known as the robotic right ventricle (RRV), allows scientists to control contractions and study natural valves and structures. The RRV can simulate healthy and diseased states, aiding in the development of heart implants and the understanding of understudied heart disorders.

Summary: The U.S. Centers for Disease Control and Prevention (CDC) has reported that the JN.1 COVID-19 subvariant is rapidly spreading across the country, constituting approximately 15 to 29 percent of cases as of December 8. The variant, originating from the BA.2.86 lineage of the Omicron sub-variant, is now the second-most common variant in the U.S., following the HV.1 variant.

The modern healthcare system is facing a significant challenge— a growing shortage of physicians. According to the American Medical Association (AMA) and the Association of American Medical Colleges, the expected physician shortage in the United States is between 54,100 and 139,000 physicians by 2033. This crisis is attributed to various factors such as a lack of quality medical residency seats, physician burnout, and attrition.

Summary: Henry Schein, a dental and medical products supplier, has reported a data breach affecting 29,112 people, with personal information accessed in a September 27 cyber incident. The breach impacted the company’s manufacturing and distribution businesses, leading to a system shutdown. The ransomware group AlphV/BlackCat has claimed responsibility for the breach. The compromised data includes names, financial information, and account details with security codes.

In a recent groundbreaking study, scientists at the Center for Immune-Oncology, a division of the U.S. National Cancer Institute, have developed an experimental vaccine showing promise in preventing a rare airway cancer linked to human papillomavirus (HPV). The study focused on recurrent respiratory papillomatosis (RRP), a debilitating disorder caused by chronic HPV infection that results in the growth of obstructive tumors in the upper airways.

The 12th annual survey, conducted by the Enterprise Risk Management Initiative and Protiviti, sheds light on the concerns of over 1,143 board members and C-suite executives globally. The study assesses 36 macroeconomic, strategic, and operational risks on one-year (2024) and one-decade (2034) time horizons. Key findings include: Top Risk Themes: Economic pressures and persistent inflation surpass the war for talent as the top near-term risk for business leaders.