FDA Revokes EUA for Johnson & Johnson/Janssen’s COVID Vaccine
On June 1, 2023, the U.S. Food and Drug Administration (FDA) withdrew the Emergency Use Authorization (EUA) Johnson & Johnson/Janssen’s adenovirus vectored Ad26.COV2.S (also known as JNJ-78436735) COVID-19 vaccine that had been granted to the companies on Feb. 27, 2021. The FDA noted that Janssen requested the voluntary withdrawal of the EUA in a letter […]
RSV Vaccine Approved by FDA for Adults 60 and Older
The U.S. Food and Drug Administration (FDA) has approved a license for the world’s first respiratory syncytial virus (RSV) vaccine to be given to people 60 years of age and older. Pharmaceutical and biotechnology company GSK (formerly GlaxoSmithKline) has already begun manufacturing doses of the vaccine, which will be sold as early as this fall […]
“The Big Catch-Up”
In response to the marked decline in childhood vaccination rates around the world during the COVID-19 pandemic of the past three years, the World Health Organization (WHO), the United Nations Children’s Fund (UNICEF), Gavi, the Vaccine Alliance, the Bill & Melinda Gates Foundation, the Clinton Health Access Initiative (CHAI) and other organizations are partnering in […]
Government Buys 1.5 Million More Doses of Novavax’s COVID Vaccine
Biotechnology company Novavax announced that it has made a modification to an existing contract with the U.S. Department of Health and Human Services (HHS) and the Department of Defense (DoD) to provide up to 1.5 million more doses of its Nuvaxovid COVID-19 vaccine (also known as “NVX-CoV2373” and “Covovax”), in addition to the 3.2 million […]
FDA Approves U.S. Babies and Young Children to Get Omicron COVID Booster Shots
In early December 2022, the U.S. Food and Drug Administration (FDA) amended the Emergency Use Authorization (EUA) for the Pfizer/BioNTech and Moderna/NIAID mRNA COVID-19 shots to include administration of the Omicron COVID booster shots to children as young as six months old. The action allows everyone over the age of six months to get the […]
Pfizer’s New RSV Vaccine for Pregnant Women on Fast Track
Amongst frantic media coverage of increases in cases of (RSV) among children, Pfizer has announced the development of an experimental bivalent RSV vaccine for pregnant mothers in an attempt to protect newborns from being infected with the virus. The pharmaceutical giant plans to submit the results of their RSV vaccine clinical trials to the U.S. […]
