FDA Restricts Johnson & Johnson COVID-19 Vaccine—What to Know

The U.S. Food and Drug Administration (FDA) is limiting using the Janssen/Johnson & Johnson COVID-19 vaccine, in line with a assertion revealed Thursday. The J&J COVID-19 vaccine has been linked to thrombosis with thrombocytopenia syndrome (TTS), a uncommon, doubtlessly life-threatening situation that causes blood clots. Now, solely folks 18 years or older in two completely different teams will be capable to get the J&J vaccine.

The first group contains anybody who in any other case wouldn’t get a COVID-19 vaccine (in different phrases, people who will solely obtain the J&J vaccine as a consequence of private choice). The second contains people “for whom other approved COVID-19 vaccines are not accessible or clinically appropriate.” Those affected embrace individuals who suffered an anaphylactic response (a extreme allergic response that may trigger signs like pores and skin rash and problem respiratory) to both the Pfizer-BioNTech or Moderna COVID-19 vaccines, the one different COVID-19 vaccines accredited to be used within the U.S. Per the FDA assertion, the advantages of getting the J&J vaccine outweigh the dangers of remaining unvaccinated for these people. The FDA replace aligns with steering from the Centers for Disease Control and Prevention (CDC), which has beneficial using Pfizer-BioNTech and Moderna over the J&J vaccine since December 2021.

The resolution follows an FDA assessment, which was referenced in its assertion of reported circumstances 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 assertion mentioned. 

The J&J COVID-19 vaccine first obtained emergency use authorization from the FDA in February 2021. Two months later, the FDA and CDC paused using the vaccine when six circumstances of TTS linked to the J&J vaccine had been reported. Health care suppliers had been then knowledgeable of those dangers so they may appropriately plan for the potential for TTS because it requires particular therapy. The FDA then lifted the pause. 

TTS happens when blood clots kind alongside low platelet counts, in line with a 2021 CDC report. (Platelets are a kind of blood cell, and low platelet counts could cause inner bleeding.) Blood clots can doubtlessly result in coronary heart assault, stroke, or loss of life. Symptoms to look out for embrace ache and swelling in limbs, chest ache, numbness on one facet of the physique, and an abrupt change in psychological schools, amongst others. TTS is primarily recognized via blood exams and imaging exams, together with MRI or ultrasound, and it’s a really uncommon complication of the J&J COVID-19 vaccine; the FDA estimates that TTS happens in 3.23 folks per each million who obtain the vaccine. Even fewer folks 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 assertion mentioned. 

Experts have additionally mentioned that SARS-CoV-2, the virus that causes COVID-19, can even trigger blood clots: A 2020 systematic assessment and meta-analysis of 42 research that included greater than 8,000 folks discovered that the danger of thromboembolism (TE), which happens when blood vessels are obstructed by a blood clot, is critical. “TE rates of COVID-19 are high and associated with a higher risk of death,” the researchers wrote. 

The new report highlights the truth that steady analysis is being executed to decide the most secure and finest vaccination practices to guard folks from extreme sickness and loss of life from COVID-19.


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