Annual COVID Shot. Is it Inevitable?
In a recent interview, the newly appointed director of the U.S. Centers for Disease Control and Prevention (CDC) suggested that the agency may soon come out with a recommendation for Americans to be vaccinated for COVID-19 every year.1 2 Mandy Cohen, MD, MPH, who was sworn in as the 20th CDC director on July 10, […]
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
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
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
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
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, […]
