CDC, FDA Find Possible Link Between Pfizer’s Bivalent COVID Shot and Strokes

CDC, FDA Find Possible Link Between Pfizer’s Bivalent COVID Shot and Strokes

The U.S. Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) said last week that they are investigating a possible link between Pfizer/BioNTech’s bivalent messenger RNA (mRNA) Comirnaty COVID biologic and an increased risk of a type of ischemic stroke among people 65 years of age and older. Data from the […]

VAERS Data Reveal Serious Adverse Event Reports in Babies After mRNA COVID Shots

VAERS Data Reveal Serious Adverse Event Reports in Babies After mRNA COVID Shots

On June 15, 2022, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the U.S. Food and Drug Administration (FDA) advised the FDA to grant an Emergency Use Authorization (EUA) for Moderna/NIAID and Pfizer/BioNTech’s mRNA COVID-19 biologics be given to infants and children under age five and as young as six months old. With […]

FDA Grants EUA for Novavax’s COVID Vaccine

FDA Grants EUA for Novavax’s COVID Vaccine

Opinion | On July 13, 2022, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to Novavax to distribute its experimental two-dose NVX-CoV2373 (also known as “Nuvaxovid” and “Covovax”) COVID-19 vaccine for use by adults. The decision was expected, given the favorable recommendation by the FDA’s Vaccines and Related Biological Products Advisory […]

U.S. Becomes First Country to Give mRNA COVID Vaccine to Babies

U.S. Becomes First Country to Give mRNA COVID Vaccine to Babies

On June 15, 2022 the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the U.S. Food and Drug Administration (FDA) unanimously advised the FDA staff to grant Moderna and Pfizer/BioNTech an Emergency Use Authorization (EUA) amendment to allow their mRNA COVID vaccines to be given to children under age five and as young as […]

FDA Panel Recommends EUA for Novavax COVID-19 Vaccine

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, […]

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, […]

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 […]

Two FDA Officials Resign Over White House Booster Shot Decision

Two FDA Officials Resign Over White House Booster Shot Decision

Two senior officials of the U.S. Food and Drug Administration (FDA) have stepped down from the COVID vaccine review team at a critical time in the approval process. While the FDA did not cite a specific reason for the departure of two veteran officials, Endpoints News reports that widespread frustration in the regulatory agency began […]

Severe Reactions to COVID-19 Vaccine Close Schools in Michigan, Ohio and New York

Severe Reactions to COVID-19 Vaccine Close Schools in Michigan, Ohio and New York

Schools in three states, Michigan, Ohio and New York were forced to close for a day last month after school staff could not work due to severe side effects from COVID-19 vaccinations. Schools in Alma and Ithaca, Michigan were closed on Feb. 16, 2021 because the majority of the teachers had experienced side effects after […]

Moderna, Pfizer Test mRNA Experimental Biologics on Children

Moderna, Pfizer Test mRNA Experimental Biologics on Children

On Dec. 10, 2020, American biotechnology company Moderna, Inc., which is pioneering the development of experimental messenger RNA (mRNA) therapeutics and vaccines, gave a 12-year old a dose of the company’s mRNA-1273 vaccine in a Phase 2/3 study of the new vaccine. Moderna CEO Stephane Bancel said, “Our goal is to generate data in the […]