Thursday, June 13, 2024

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Group B Strep Vaccine for Pregnant Women on Fast Track for FDA Approval

pregnant woman

Pfizer is conducting phase 2 trials for the development of a vaccine that will target pregnant women to prevent newborns from infection with Group B Streptococcal (GBS). The vaccine was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) in September and the agency has indicated it will fast track the product’s […]

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 […]

Guillain-Barré Syndrome Linked to COVID-19 Shots

Guillain-Barre Syndrome

A study by the University College London showed that serious Guillain-Barré syndrome (GBS), which can result in temporary or permanent paralysis, is a “small but significant” risk associated with AstraZeneca/Oxford University’s AZD1222 (or “Vaxzevria”) vaccine. Of the 996 cases of GBS that were recorded in the United Kingdoms’ National Immunisation Management System database between January […]

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