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FDA Revokes EUA for Johnson & Johnson/Janssen’s COVID Vaccine

Janssen 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

boy being examined by doctor

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

J&J 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

shot in the arm

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

Nuvaxovid

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.

four COVID shots

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 […]

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