FDA Panel Recommends EUA for Novavax COVID-19 Vaccine
Despite concerns about the risk of developing myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining of the heart) following vaccination with Novavax’s experimental NVX-CoV2373 (also known as “Nuvaxovid” and “Covovax”) COVID-19 vaccine, the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted on June 6, […]
Guillain-Barré Syndrome Linked to COVID-19 Shots
A study by the University College London showed that serious Guillain-Barré syndrome (GBS), which can result in temporary or permanent paralysis, is a “small but significant” risk associated with AstraZeneca/Oxford University’s AZD1222 (or “Vaxzevria”) vaccine. Of the 996 cases of GBS that were recorded in the United Kingdoms’ National Immunisation Management System database between January […]
Pfizer, Moderna Apply for EUA for COVID Shots for Infants, FDA to Decide Quickly
On June 1, 2022, Pfizer and BioNTech submitted an application to the U.S. Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) to distribute their messenger RNA (mRNA) BNT162b2 (also known as “Comirnaty”) COVID-19 biologic for children as young as six months to five years old. The application is for a three-dose regimen, […]
COVID Vaccine-Induced Cardiovascular Events Raise Concerns for Adolescents and Young Adults
A new study published in the peer-reviewed journal Nature found significantly more emergency heart events in adults under 40 that are caused by the COVID-19 vaccines than by SARS-CoV-2 infections. “While not establishing causal relationships, the findings raise concerns regarding vaccine-induced undetected severe cardiovascular side effects and underscore the already established causal relationship between vaccines […]
Pfizer and Moderna COVID-19 Shots Can Trigger Alopecia Areata in Patients with Autoimmune Conditions
Following the granting by the U.S. Food and Drug Administration (FDA) of Emergency Use Authorization (EUA) status for Pfizer/BioNTech’s BNT162b2 and Moderna/NIAID’s mRNA-1273 messenger RNA (mRNA) COVID-19 biologics in December 2020, there have been increasing reports of alopecia areata following vaccination with these products.1 Alopecia areata is an autoimmune disorder characterized by hair loss due […]
Moderna Recalls 764,900 Doses of Spikevax Due to Contamination Problem
Moderna, Inc., developer of the experimental messenger RNA (mRNA) mRNA-1273, or “Spikevax,” biologic, has recalled 764,900 doses in lot #000190A of the product from the European market. On Apr. 8, 2022, the company said that the doses, manufactured under contract to Moderna by Spanish pharmaceutical company ROVI Pharma Industrial Services, SAU, are being pulled out […]