On July 12, 2021, the FDA added a warning to the Fact Sheet for the Johnson & Johnson (Janssen) adenovirus-based COVID-19 vaccine about an increased risk of Guillain-Barré syndrome (GBS) following administration of the product.1

The warning is based on 100 cases of GBS that were reported to the Vaccine Adverse Events Reporting System (VAERS) following administration of the Johnson & Johnson vaccine. Most of the cases occurred within 42 days of vaccination; 95 of the 100 persons who developed GBS required hospitalization, and 1 died. About 12.5 million doses of the Johnson & Johnson vaccine had been administered at the time the warning was issued.Continue reading

More from Issue 1630
Previous Issue: 1629      July 26, 2021
Coming Soon
Treatment of Clostridioides difficile Infection
Dasiglucagon (Zegalogue) for Severe Hypoglycemia
Ozanimod (Zeposia) for Ulcerative Colitis
Apoaequorin (Prevagen) Dietary Supplement for Cognitive Impairment/Memory
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Advance Release

The FDA has licensed the adjuvanted, recombinant varicella zoster virus (VZV) vaccine Shingrix (GSK) for prevention of herpes zoster (shingles) in adults of any age who are or will be at elevated risk because of disease- or therapy-induced immunodeficiency or immunosuppression. Shingrix has been licensed for herpes zoster prevention in adults ≥50 years old since 2017.Continue reading