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 […]
The Declining Standards of FDA Drug Approvals
The U.S. Food and Drug Administration (FDA) has a legal obligation to protect the public and ensure that the benefits of medicines outweigh the harms before being marketed to people. But the agency’s increasing reliance on pharmaceutical industry money has seen the FDA’s evidentiary standards for drug approvals significantly decline. The Need for Speed Since the enactment of […]
Developers of mRNA COVID Shots Spar Over Intellectual Property Rights
Pfizer and BioNTech will have to answer in court to legal claims by Moderna that they copied its innovative messenger RNA (mRNA) technology in the making of their COVID-19 biologic, Comirnaty. The patent infringement lawsuit filed in U.S. District Court for the District of Massachusetts and the Regional Court of Dusseldorf in Germany alleges that […]
Study: Natural Immunity Offers More Protection Than Three mRNA COVID Shots
As the debate continues surrounding the issue of bodily autonomy being violated by school and workplace COVID-19 vaccine mandates, a new research study that analyzed more than one million people has found that natural immunity to SARS-CoV-2 offers longer lasting protection than vaccination.1 The study, which was published in The New England Journal of Medicine […]
FDA Reports Systemic Health Problems in Women With Breast Implants
Breast implant surgery is the most common cosmetic surgical procedure in the United States, with more than 313,000 surgeries performed in 2018—a 48 percent increase since 2000.1 Silicone implants are the most common reconstructive breast surgery. In 2018, the American Society of Plastic Surgeons (ASPS) reported 101,657 breast reconstruction procedures, of which 78,814 used silicone […]