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 […]
Doctors Link Shortage of Children’s Medications to Spike in Respiratory Infections
In the last few months, parents and caregivers of children have struggled to find over-the-counter and prescription medications used to treat common childhood illnesses like influenza, ear infections and sore throats for their sick children.1 2 The four medications reportedly in short supply are Amoxicillin (an antibiotic), Tamiflu (an antiviral), Albuterol (a bronchodilator) and children’s Tylenol […]
South Africa Confirms Second Guillain-Barré Syndrome Death Due to COVID Vaccine
The South African Health Products Regulatory Authority (SAHPRA) confirmed on Sept. 12, 2022 that another person in South Africa has died of a polio-like neurological disorder that causes paralysis known as Guillain-Barré syndrome (GBS) due to receiving Johnson & Johnson/Janssen’s adenovirus vectored Ad26.COV2.S COVID-19 vaccine. SAHPRA said the National Immunization Safety Expert Committee (NISEC) performed […]
Death in South Africa Causally Linked to Johnson & Johnson COVID Vaccine
On Aug. 4, 2022, the South African Health Products Regulatory Authority (SAHPRA) reported the death of an individual in South Africa shortly after receiving Johnson & Johnson/Janssen’s adenovirus vectored Ad26.COV2.S COVID-19 vaccine. The agency stated that the death was causally linked to the vaccine.1 2 3 4 5 The name and age of the person […]
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 […]
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 […]
