The U.S. Food and Drug Administration (FDA) is limiting the use of the Janssen/Johnson & Johnson COVID-19 vaccine, according to a statement published Thursday. The J&J COVID-19 vaccine has been linked to thrombosis with thrombocytopenia syndrome (TTS), a rare, potentially life-threatening condition that causes blood clots. Now, only people 18 years or older in two different groups will be able to get the J&J vaccine.
The first group includes anyone who otherwise wouldn’t get a COVID-19 vaccine (in other words, individuals who will only receive the J&J vaccine due to personal preference). The second includes individuals “for whom other approved COVID-19 vaccines are not accessible or clinically appropriate.” Those affected include people who suffered an anaphylactic reaction (a severe allergic reaction that can cause symptoms like skin rash and difficulty breathing) to either the Pfizer-BioNTech or Moderna COVID-19 vaccines, the only other COVID-19 vaccines approved for use in the U.S. Per the FDA statement, the benefits of getting the J&J vaccine outweigh the risks of remaining unvaccinated for these individuals. The FDA update aligns with guidance from the Centers for Disease Control and Prevention (CDC), which has recommended the use of Pfizer-BioNTech and Moderna over the J&J vaccine since December 2021.
The decision follows an FDA review, which was referenced in its statement of reported cases of TTS occurring after a J&J vaccine. “After conducting an updated analysis, evaluation, and investigation of reported cases, the FDA has determined that the risk…warrants limiting the authorized use of the vaccine,” the statement said.
The J&J COVID-19 vaccine first received emergency use authorization from the FDA in February 2021. Two months later, the FDA and CDC paused the use of the vaccine when six cases of TTS linked to the J&J vaccine were reported. Health care providers were then informed of these risks so they could appropriately plan for the possibility of TTS since it requires specific treatment. The FDA then lifted the pause.
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TTS occurs when blood clots form alongside low platelet counts, according to a 2021 CDC report. (Platelets are a type of blood cell, and low platelet counts can cause internal bleeding.) Blood clots can potentially lead to heart attack, stroke, or death. Symptoms to look out for include pain and swelling in limbs, chest pain, numbness on one side of the body, and an abrupt change in mental faculties, among others. TTS is primarily diagnosed through blood tests and imaging tests, including MRI or ultrasound, and it’s a very rare complication of the J&J COVID-19 vaccine; the FDA estimates that TTS occurs in 3.23 people per every million who receive the vaccine. Even fewer people die from TTS following a J&J vaccine: “The reporting rate of TTS deaths is 0.48 per million doses of vaccine administered,” the FDA statement said.
Experts have also said that SARS-CoV-2, the virus that causes COVID-19, can also cause blood clots: A 2020 systematic review and meta-analysis of 42 studies that included more than 8,000 people found that the risk of thromboembolism (TE), which occurs when blood vessels are obstructed by a blood clot, is significant. “TE rates of COVID-19 are high and associated with a higher risk of death,” the researchers wrote.
The new report highlights the fact that continuous research is being done to determine the safest and best vaccination practices to protect people from severe illness and death from COVID-19.
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Source: SELF
