Jakarta, CNBC Indonesia – The United States Food and Drug Administration (USFDA) has restricted the authorization for emergency use of the Johnson & Johnson/Janssen Covid-19 vaccine to persons 18 years of age and older.
The FDA said the change was made because of the risk of a rare and dangerous clotting condition called thrombosis with thrombocytopenia syndrome (TTS) after receiving the vaccine.
“We have been closely monitoring the Janssen COVID-19 Vaccine and the emergence of TTS after its administration and have used the latest information from our safety surveillance system to revise the EUA,” said Dr. Peter Marks, director of the FDA’s Center for Biological Evaluation and Research, said in a statement Thursday (5/5/2022), quoted by CNN International.
“We recognize that the Janssen COVID-19 Vaccine still plays a role in the current pandemic response in the United States and throughout the global community. …Today’s actions demonstrate the robustness of our safety surveillance system and our commitment to ensuring that science and data guide our actions. “
Even so, the FDA has determined that the benefits of the J&J vaccine outweigh the risks for certain people.
Here are the requirements for people who may still get the J&J vaccine:
– People who have had a severe allergic reaction to mRNA vaccines such as those from Pfizer/BioNTech or Moderna
– People who have personal concerns about the mRNA vaccine who will remain unvaccinated without the J&J vaccine
– People who have limited access to the Covid-19 mRNA vaccine.
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Photo: Participants take part in the COVID-19 booster vaccination at the Booster Vaccination Center, Pondok Indah Mall 3, Jakarta, Wednesday (23/3/2022). The Provincial Government of DKI Jakarta continues to boost vaccination programs, especially boosters. (CNBC Indonesia/ Andrean Kristianto) Participants take part in the COVID-19 booster vaccination at the Booster Vaccination Center, Pondok Indah Mall 3, Jakarta, Wednesday (23/3/2022). The Provincial Government of DKI Jakarta continues to boost vaccination programs, especially boosters. (CNBC Indonesia/ Andrean Kristianto)- – |
As of Thursday, more than 18.7 million doses of the J&J vaccine had been administered in the US, according to the US Centers for Disease Control and Prevention (CDC). Of those who were fully vaccinated, 7.7% got this vaccine.
Following a meeting in December, the CDC’s vaccine advisory committee issued updated recommendations on Johnson & Johnson’s vaccine. They made “preferential recommendations for the use of the COVID-19 mRNA vaccine over Janssen’s adenoviral vector COVID-19 vaccine in all persons aged 18 years in the United States.”
Both the CDC and the FDA previously recommended a pause in the use of this vaccine due to reports of TTS. The pause was lifted, but the move later came with a warning in a rare case of freeze.
Overall, the risk of TTS is very rare. Only about three cases for every million doses of vaccine given. The highest TTS rate occurred in women aged 30 to 49 years. About eight cases per 1 million doses of vaccine administered have occurred in women in this age group.
Cases of TTS usually begin a week or two after vaccination. Symptoms include shortness of breath, chest pain, swollen legs, persistent abdominal pain, neurological symptoms such as headache or blurred vision, or red spots just under the skin called petechiae outside the vaccination site.
A new warning on the vaccine fact sheet says “Janssen’s Covid-19 vaccine can cause thrombosis with possibly life-threatening thrombocytopenia syndrome (TTS).
(tfa / tfa)
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