By Stan Deresinski, MD, FACP, FIDSA
Clinical Professor of Medicine, Stanford University
SYNOPSIS: The Food and Drug Administration recently limited the use of the Janssen COVID-19 vaccine.
SOURCE: U.S. Food & Drug Administration. FDA News Release. Coronavirus (COVID-19) update: FDA limits use of Janssen COVID-19 vaccine to certain individuals. May 5, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-limits-use-janssen-covid-19-vaccine-certain-individuals?utm_campaign=Coronavirus+%28COVID-19%29+Update%3A+FDA+Limits+Use+of+Janssen+COVID-1&utm_medium=email&utm_source=govdelivery
On May 5, 2022, the Food and Drug Administration (FDA) restricted the use of the Janssen/J&J COVID-19 vaccine only to individuals ≥ 18 years of age for whom:
- the use of other authorized vaccines is not feasible; or
- it is the only available choice because they have elected its use and would otherwise not receive vaccination.
COMMENTARY
In contrast to the messenger ribonucleic acid (mRNA) vaccines from both Pfizer and Moderna, the Janssen/J&J vaccine contains recombinant replication-incompetent adenovirus 26 expressing the SARS-CoV-2 spike protein. It initially received emergency use authorization in February 2021, but its administration was paused three months later to allow the FDA to investigate six reported cases of thrombosis with thrombocytopenia syndrome (TTS) occurring after receipt of this vaccine. The hold was lifted just 10 days later at a time when a total of 15 cases of TTS occurred after approximately 8 million doses had been identified. Eight months later, in December 2021, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) recommended the preferential use of mRNA vaccines over the Janssen vaccine and indicated circumstances in which it could be considered. These were basically identical to the current recommendation.
As of March 18, 2022, the FDA and CDC had identified 60 confirmed cases of TTS, eight of which were fatal. They calculated a TTS case rate of 3.23 per million administered vaccine doses, with a fatality rate of 0.48 per million.
The FDA provides the following as examples of individuals who still may be candidates for receipt of the Janssen/J&J COVID-19 vaccine. These include those with a history of an anaphylactic reaction to an mRNA vaccine and those who would not otherwise receive vaccination because they decline receipt of an mRNA vaccine because of personal concerns. The FDA has published a revised fact sheet for healthcare providers.1 For patients who fear mRNA vaccines, the Novavax vaccine, comprised of spike protein nanoparticles combined with an adjuvant, is under review at the FDA.
REFERENCE
- U.S. Food & Drug Administration. Fact sheet for healthcare providers administering vaccine (vaccination providers). Revised May 5, 2022. https://www.fda.gov/media/146304/download
The Food and Drug Administration recently limited the use of the Janssen COVID-19 vaccine.
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