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
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.
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 […]
Harvard Study’s Goal: Identifying Messages That ‘Break Through’ to Vaccine Skeptics
“If only there were a message that could break through skepticism and persuade unvaccinated people to get their shots. What a world that would be. But over the past year, this really did happen,” reads a February 2022 Vox article1 that continues on to describe a Harvard Business School publication2 which offers new evidence on […]
Pfizer, BioNTech Seek COVID Biologic Emergency Use Authorization for Infants as Young as Six Months Old
Pfizer and BioNTech have requested emergency use authorization (EUA) for doctors to administer two doses of their mRNA COVID-19 biologic to infants as young as six months old. A statement from Pfizer states that the “rolling submission” application was submitted on Feb. 1, 2022 at the request of the U.S. Food and Drug Administration (FDA) […]
Novavax’s Protein COVID-19 Vaccine Now Available in Europe
Novavax’s experimental NVX-CoV2373 (also known as “Nuvaxovid” and “Covovax”) COVID-19 vaccine has been authorized for distribution in the European Union (E.U.), making it the fifth COVID vaccine available for use in the E.U. Approved for people over 18 years old, Nuvaxoid is the first protein subunit COVID vaccine to be approved for use.1 2 The […]