CDC ENTEBBE

The FDA has lifted the clinical hold on Novavax's Phase III trials for a COVID-19-influenza Combination vaccine and standalone influenza vaccine, allowing recruitment to resume. The hold was due to a serious adverse event in a prior trial, which was later deemed unrelated to the vaccine. Novavax plans to start the Phase III trial as soon as possible, utilizing its Matrix-M adjuvant technology.

Mount Sinai Health System awarded $7 million by NIH to lead NY coalition to create diverse health database, aiming to inform individualized treatment and increase participants, particularly in opioid use disorder, through collaboration with Weill Cornell Medicine, NYC Health + Hospitals, Institute for Family Health, and NYU Langone.

Mount Sinai awarded $7M by NIH to lead NY coalition for diverse health database, aiming to inform personalized treatments and address opioid crisis through increased participant recruitment.

Robert F. Kennedy Jr. is being considered by Trump allies for the role of HHS Secretary, with hopes rising after Republicans secured Senate majority. Kennedy's anti-science stances pose challenges, but his supporters argue his 'Make America Healthy Again' proposals align with Trump's agenda. Other potential candidates include Florida's Dr. Joseph Ladapo, former Louisiana Gov. Bobby Jindal, and ex-deputy HHS Secretary Eric Hargan. Kennedy's platform includes FDA reforms, restricting pharma ads, and ending water fluoridation, though some of his goals fall outside HHS jurisdiction.

Robert F. Kennedy Jr. is being considered by Trump allies for the role of HHS Secretary, with his chances improving after the Republican Senate majority. Kennedy's anti-science stances, including his claim that 'there's no vaccine that is safe and effective,' have been criticized. Despite this, Kennedy remains noncommittal about the possibility of heading HHS, which includes agencies like the CDC and FDA. Other potential candidates for the role include Florida's Dr. Joseph Ladapo and former Louisiana Gov. Bobby Jindal.

Ms Anderson, a 36-year-old with a history of major depressive disorder and recurrent pregnancy losses, experienced a stillbirth at 34 weeks, leading to increased anxiety and sadness. Perinatal loss is common, affecting 15% of pregnancies, with disparities among racial and ethnic groups. Psychiatric sequelae include grief, postpartum depression, anxiety, and PTSD. Treatment strategies involve nonpharmacologic approaches like support groups and psychotherapy, with pharmacologic options considered for severe cases.

Robert F. Kennedy Jr., a longtime vaccine skeptic, may influence U.S. vaccine regulation under Trump, potentially slowing approvals and spreading disinformation. Kennedy seeks more transparency and data on vaccines, but his actions could face backlash from the public, Congress, and the drug industry. The CDC's Advisory Committee on Immunization Practices, vulnerable to influence, could be stacked with skeptics, impacting vaccine recommendations and affordability. Kennedy's soft power, already discouraging vaccine use, may grow with a federal position.

Moderna's Q3 COVID-19 vaccine sales exceeded expectations at $1.8B, but full-year guidance remains unchanged, suggesting a potential decline in Q4. mResvia, Moderna's RSV vaccine, generated $10M in revenue, significantly below projections. Moderna plans to cut R&D expenses by 20% and prioritize investments in new vaccines and rare disease drugs.

The Ministry of Health launched a 4-day Polio Vaccination campaign in 49 districts from Nov 7-10, 2024, targeting 8.7 million children aged 0-5. Health workers will administer two drops of the vaccine door-to-door in regions including Busoga, Bugisu, Bukedi, Teso, Sebei, and Karamoja. The campaign is part of the Global Polio Eradication Initiative supported by WHO, UNICEF, CDC, Rotary International, and others.

FDA publishes 'Catching Up with Califf: One Health' by Commissioner Robert M. Califf, updates 2022 Food Code, announces first pre-harvest agricultural water treatment, authorizes LumiThera's Valeda Light Delivery System for dry AMD, and arrests Massachusetts spa owner Rebecca Fadanelli for illegal injections.