FDA Issues New Warning of Cancers Linked to Breast Implants
The U.S. Food and Drug Administration (FDA) issued a safety communication on Sept. 8, 2022 warning that certain cancers may develop in scar tissue “capsules” that form around breast implants. Cancers cited in the report include squamous cell carcinoma and various lymphomas. The malignancies are not exclusive to a certain type of implant and have […]
Getting a Flu Shot and COVID Bivalent Booster Together
Despite President Biden’s recent admission that the COVID-19 pandemic is over, the White House is making another big push to encourage Americans to get yet another COVID booster shot. This time, the Biden administration is marketing the COVID Bivalent versions of messenger RNA (mRNA) Comirnaty and Spikevax biologics developed by Pfizer/BioNTech and Moderna/NIAID respectively.1 2 […]
Phillips Ventilators and BiPAP and CPAP and Breathing Machines Recalled Due to Health Risks
On Aug. 16, 2022 the U.S. Food and Drug Administration (FDA) issued an update on a June 2021 recall of certain ventilators, BiPAP (Bi-level Positive Airway Pressure), and CPAP (Continuous Positive Airway Pressure) breathing machines manufactured by Philips Respironics because of “potential health risks.”1 A list of the recalled devices made between 2009 and April […]
South Africa Confirms Second Guillain-Barré Syndrome Death Due to COVID Vaccine
The South African Health Products Regulatory Authority (SAHPRA) confirmed on Sept. 12, 2022 that another person in South Africa has died of a polio-like neurological disorder that causes paralysis known as Guillain-Barré syndrome (GBS) due to receiving Johnson & Johnson/Janssen’s adenovirus vectored Ad26.COV2.S COVID-19 vaccine. SAHPRA said the National Immunization Safety Expert Committee (NISEC) performed […]
Study Reveals Much Higher Risk for Serious Adverse Events With mRNA COVID Shots in Clinical Trials
A new study published in the journal Vaccine revealed there was a much higher risk of serious adverse events of special interest for randomized clinical trial participants who received a messenger RNA (mRNA) COVID-19 biologic when compared to participants, who received a placebo for both the Pfizer/BioNTech mRNA BNT162b2 (also known as “Comirnaty”) COVID shot […]
Safety and Effectiveness of New COVID Bivalent Boosters Based on a Study of Eight Mice?
With no safety and efficacy evidence from human clinical trials, on Aug. 31, 2022, the U.S. Food and Drug Administration (FDA) amended the Emergency Use Authorizations (EUAs) for Pfizer/BioNTech’s Comirnaty and Moderna/NIAID’s Spikevax messenger RNA (mRNA) COVID-19 biologics to distribute “bivalent formulations” (two-in-one) of the shots to use as a “single booster dose.”1 2 The […]