FDA and CDC pause on the use of Janssen COVID-19 vaccine (updated information)


Following a thorough review of the safety of the Johnson & Johnson (Janssen) COVID-19 vaccine in the United
States, including two meetings of the CDC's Advisory Committee on Immunization Practices (ACIP), the U.S. Food
and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC) have determined that
the recommended pause in vaccine use should be lifted, and use of the vaccine resumed. The pause was
recommended on 13 April 2021, following reports of six cases of a rare and severe type of blood clot in individuals
following administration of the Janssen COVID-19 vaccine.

Beginning on 23 April 2021, medical and scientific teams from the FDA and CDC examined available data to assess
the risk of cerebral venous sinus thrombosis, or CVST (thrombosis in large blood vessels in the brain), and thrombosis
at other sites in the body (including but not limited to large blood vessels in the abdomen, and veins in the leg),
along with thrombocytopenia, or low blood platelet counts (TTS). The two agencies confirmed that a total of 15
cases of TTS had been reported to VAERS, including the original six reported cases. All of these occurred in women
between the ages of 18 and 59, with a median age of 37. Reports indicated that symptoms appeared between 6
and 15 days after vaccination.

In their report, the two agencies concluded that:
• Use of the Janssen COVID-19 vaccine should be resumed in the United States.
• The FDA and CDC are confident that this vaccine is safe and effective in preventing COVID-19.
• The FDA determined that available data show that the known and potential benefits of the vaccine outweigh its
known and potential risks in individuals age 18 and older.
• At present, available data suggest that the likelihood of TTS occurring is very low; however, the FDA and CDC
will continue to investigate this risk.
• Health care providers who are administering vaccines should read the Janssen COVID-19 vaccine “Fact Sheet for
Health Providers,” and people who are to be vaccinated should read the “Fact Sheet for Recipients and
Caregivers,” both of which have recently been revised to include information on the risk of this syndrome, which
has occurred in a very small number of people who received the Janssen COVID-19 vaccine.

Source: https://www.fda.gov/news-events/press-announcements/fda-and-cdc-lift-recommended-pause-johnsonjohnson-janssen-covid-19-vaccine-use-following-thorough


In tandem with this, on 20 April 2021 the Pharmacovigilance Risk Assessment Committee (PRAC) of the European
Medicines Agency (EMA) concluded that a warning regarding unusual blood clots with low platelet counts should be
added to the product information for the Janssen COVID-19 vaccine. PRAC also determined that these events should
be listed as very rare side effects of the vaccine.

Source: https://www.ema.europa.eu/en/news/covid-19-vaccine-janssen-ema-finds-possible-link-very-rare-casesunusual-blood-clots-low-blood


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