To include the information about an observed increased risk of a rare neurological disorder, the United States Food and Drug Administration updated its warning labels for the Johnson and Johnson coronavirus vaccine on Monday, as per a report released by The Times of India.
Although the vaccine has played a minor role in America’s immunization campaign, the news has proved to be a further blow for the shot which was granted and emergency use authorisation in February.
After approximately 12.5 million doses administered, around 100 preliminary reports of Guillain-Barre Syndrome (GBS) has been identified by the officials based on analysis of a federal vaccine safety monitoring system, stated by the people who are familiar with the matter. While there was one reported death, among these reports, 95 of them were serious and required hospitalization.
Causing muscle weakness or, in most severe cases, paralysis, GBS is a neurological disorder in which the body’s immune system damages nerve cells. Each year in the United States it affects an estimated 3,000 to 6,000 people and most go on to recover.
Including certain seasonal influenza vaccines along with a vaccine to prevent shingles, at an increased rate with certain vaccines GBS has also been observed.
Based on contamination issues, a Baltimore plant responsible for its manufacture has been shut for 3 months while the Johnson and Johnson vaccine has suffered severe production issues.
Involving a rare form of clotting, after a heightened risk was identified, the shot was also subject to a safety pause in April.