The Food and Drug Administration (FDA) in the United States (U.S), on May 5, declared a temporary ban or restriction of the administration of the Johnson & Johnson COVID-19 vaccine on adults who can’t receive mRNA vaccines. The FDA explained that the restriction was considered following the detected risk of potentially life-threatening side effects with the J&J shot.
FDA, therefore, approved that COVID-19 vaccine can only be administered at the moment to people aged 18 years of age and older who can’t receive either the Moderna or Pfizer vaccines, both of which are two-dose vaccines and use mRNA technology. It was disclosed that J&J’s single-shot vaccine uses adenovirus technology.
The FDA in a statement, however, indicated that persons of 18 years and older who want to receive the J&J vaccine “because they would otherwise not receive a COVID-19 vaccine” can also take it.
FDA in the statement explained that the agency made the decision to restrict J&J’s vaccine after reevaluating the data on the risk of life-threatening blood clots that may occur within two weeks of vaccination.
Director of the FDA’s Center for Biologics Evaluation and Research, Peter Marks, declared: “We recognize that the Janssen COVID-19 Vaccine still has a role in the current pandemic response in the United States and across the global community.
“Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals.”
TTS refers to thrombosis with thrombocytopenia syndrome, a rare form of blood clotting.
The FDA disclosed that after an analysis, the agency discovered that the risk of TTS in combination with low levels of blood platelets between one and two weeks after the J&J vaccine is administered warrants placing limitations on the use of the vaccine.
The director stated that FDA officials have been “closely monitoring” the J&J vaccine and the occurrence of TTS, as the Agency expressed optimism in the time of tragedies that the “known and potential benefits of the vaccine” still currently outweigh the negatives.
Director of the FDA’s Center for Biologics Evaluation and Research, Peter Marks, promised that “the agency will continue to monitor the safety of the Janssen COVID-19 Vaccine and all other vaccines and, as has been the case throughout the pandemic, will thoroughly evaluate new safety information.”