Novartis Manipulated Data in FDA Biologics License Application
On Aug. 6, 2019, the U.S. Food and Drug Administration (FDA) issued a statement saying that Swiss pharmaceutical company Novartis AG submitted a biologics license application (BLA) for the spinal muscular atrophy (SMA) gene therapy Zolgensma (onasemnogene abeparvovec-xioi) with manipulated data and failed to inform regulators until June 28, 2019—more than a month after the […]
‘Too Sick to Get Vaccinated’?
One of the more common reasons some people in the United States give for why they believe everyone has an obligation to vaccinate their children and themselves with all of the vaccines recommended by the Centers for Disease Control and Prevention (CDC) and mandated by state governments is that it protects those who are too […]
Infant Girl in India Dies Day After Receiving Oral Polio and Pentavalent Vaccines
Two-month-old Priyanka Biswal died on Sept. 5, 2019, a day after receiving the live attenuated oral polio vaccine (OPV), pentavalent (diphtheria, pertussis, tetanus, hepatitis B and Haemophilus influenzae type B) vaccine and vitamin supplements at a Community Health Center (CHC) in Naranapur, India.1 2 A report by the Orissa Post noted, “after intake of the polio […]
American Academy of Neurology Recommends Routine Vaccination for MS Patients
New guidelines released by the American Academy of Neurology (AAN) recommend that patients with multiple sclerosis (MS) should get routine vaccinations, including annual influenza vaccinations. Multiple sclerosis is an autoimmune disease that can affect a person’s brain, optic nerves and spinal cord. Patients with MS often experience muscle weakness and have difficulty with balance and […]
Pfizer Fined Again for Violating Drug Laws
Colombia’s national regulatory agency, the Superintendency of Industry and Commerce (SIC), has fined pharmaceutical company Pfizer $25,000 for allegedly inflating the price of several prescription drugs it sold in that country.1 2 On July 31, 2019, the agency stated: The decision was taken after verifying information related to PFIZER SAS’ commercial operations between July and December […]
Skin Inflammation in Elderly Obstructs Vaccine Efficacy
Story Highlights It is known that people over 65 do not respond well to vaccination because aging immune systems do not mount a robust immune response to pathogens. A 2018 study showed that that an excessive inflammatory response at the skin level in elderly patients obstructs immune system function and diminishes a vaccine’s efficacy. The […]