The US Food and Drug Administration announced Thursday that the emergency use of Johnson & Johnson Covid-19 vaccines will be limited to people who are 18 and older for whom other vaccines aren’t appropriate or accessible, as well as those who choose J&J because they wouldn’t otherwise get vaccinated.
The FDA stated in a statement that the adjustment was made due to the risk of thrombosis with thrombocytopenia syndrome (TTS), a rare and fatal blood clotting disorder that can occur after getting the vaccination.
The director of the FDA’s Center for Biologics Evaluation and Research, Dr Peter Marks, mentioned in a statement, “We’ve been closely monitoring the Janssen COVID-19 Vaccine and occurrence of TTS following its administration and have used updated information from our safety surveillance systems to revise the EUA,” He also said, “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. … Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our actions.”
The amended permission also applies to booster doses, according to the FDA.
For certain patients, the FDA has judged that the advantages of the J&J vaccination exceed the dangers. People who may still receive the vaccination include those who have a serious adverse reaction to an mRNA vaccination from Pfizer/BioNTech or Moderna, those who have personal issues about mRNA vaccinations would not get vaccinated if the J&J vaccine was not available and those with restricted mRNA access Vaccines Covid-19.
According to the US Centers for Disease Control and Prevention, more than 18.7 million doses of the Johnson & Johnson vaccine have been provided in the US as of Thursday. 7.7% of those who are deemed completely immunised received this vaccination.
The CDC’s vaccine advisory committee updated its recommendation on Johnson & Johnson’s vaccine after a meeting in December, saying it makes a “preferential recommendation for the use of mRNA COVID-19 vaccines over the Janssen adenoviral-vectored COVID-19 vaccine in all persons aged 18 years in the United States.”
TTS symptoms appear one to two weeks after vaccination. Shortness of breath, chest discomfort, leg swelling, persistent abdomen pain, neurological symptoms such as headaches or confused vision, or red patches just beneath the skin known as petechiae beyond the vaccination site are all possible signs.
“The Janssen Covid-19 vaccine can induce thrombosis with thrombocytopenia syndrome (TTS), which can be life-threatening,” according to the revised warning on the vaccination’s information page.
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