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Pfizer, Moderna Apply for EUA for COVID Shots for Infants, FDA to Decide Quickly

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

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

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 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 […]

FDA Approves Fourth COVID Shot. Fifth Shot Considered.

FDA Approves Fourth COVID Shot. Fifth Shot Considered.

On Mar. 29, 2022, the U.S. Food and Drug Administration (FDA) approved a second booster dose (a fourth shot) of the Pfizer/BioNTech messenger RNA (mRNA) biologic BNT162b2 (“Comirnaty”) and Moderna/NIAID mRNA-1273 (“Spikevax”) for people 50 years of age and older, as well as younger individuals who are immunocompromised. The second booster would be given no […]

Vaccinologist Develops Tinnitus After COVID Shot, Calls for More Research

Vaccinologist Develops Tinnitus After COVID Shot, Calls for More Research

Vaccinologist and director of the Mayo Clinic’s Vaccine Research Group, Gregory M. Poland, MD, who is a leading vaccine developer and pro-mandatory vaccination proponent, has called for further research into the link between COVID-19 vaccination and hearing loss, as well as other auditory conditions such as tinnitus (ringing in the ears). Dr. Poland experienced a […]

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