CDC Advisory Panel Recommends Adding COVID Shots to Child Vaccination Schedule Without FDA License for Use in Children Under 12
On Oct. 20, 2022, the Advisory Committee on Immunization Practices (ACIP) voted 15-0 to add the mRNA COVID-19 shots to the list of vaccines recommended by the U.S. Centers for Disease Control and Prevention (CDC) for children as young as six months old, even though no COVID vaccine has been officially licensed by the U.S. […]
Paxlovid May Interact With Common Heart Drugs and Cause Blood Clots, Bleeding, Arrhythmia and Muscle Weakness
Findings from a new study published in the Journal of American College of Cardiology found that administration of the anti-viral drug Paxlovid can interact with several commonly prescribed cardiovascular drugs and be associated with an increased risk for blood clots and bleeding, which are termed clinically relevant drug-to-drug interactions (DDI).1 Manufactured by Pfizer, Paxlovid is […]
FDA Authorizes COVID Bivalent Shots for Children as Young as Five Years Old
On Oct. 12, 2022, the U.S. Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) of the COVID bivalent booster versions of messenger RNA (mRNA) Comirnaty and Spikevax biologics developed by Pfizer/BioNTech and Moderna/NIAID for children as young as five or six years old, respectively. The FDA’s decision on Aug. 31 to grant […]
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 […]
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 […]