FDA decided to put strict restrictions on the J&J covid-19 vaccine. The FDA said they made the change because people faced the risk of a rare and risky clotting condition called thrombosis with thrombocytopenia syndrome (TTS) after obtaining the vaccine.
Director of the Center for FDA Evaluation and Analysis of Biological Products, Dr. Peter Marks, said they closely monitored the Janssen COVID-19 vaccine and the occurrence of TTS after its administration. And they have used updated information from our safety surveillance systems to review the EUA. Research, he said in the statement that they recognize that Janssen’s COVID-19 vaccine still has a part in the present pandemic response in the US and throughout the global community. Today’s action demonstrates the strength of our safety surveillance systems and our commitment to ensuring that science and data guide our actions.
The FDA agency confirmed to the media that the revised approval also applies to booster doses.
The FDA says it has decided to put strict restrictions on the benefits of J&J vaccine that outweigh the risks for certain people. Examples of people who can yet get the vaccine include:
- People who had an extreme allergic reaction to an mRNA vaccine such as those from Pfizer/BioNTech or Moderna
- People with personal concerns about mRNA vaccines would remain unvaccinated without the J&J vaccine
- People with limited access to mRNA Covid-19 vaccines
According to the US CDC, More than 18.7 million doses of the J&J vaccine have got administered in the US.
After a meeting in December, the vaccine advisory committee of the CDC issued an updated recommendation on the Johnson & Johnson vaccine. They say it makes a preferential recommendation for using mRNA vaccines over the vaccine against COVID-19 with a Janssen adenoviral vector in all people over the age of 18 in the United States.
The FDA committee noted the same concerns regarding TTS.
Both the CDC and the FDA previously recommended a pause in using this vaccine due to reports of TTS. They lifted the pause, but that move came with a warning about rare coagulation events.
In a statement, Johnson & Johnson company said that the safety and well-being of the people who use their products is their priority. They are conscious of an extremely rare disorder affecting people with blood clots in combination with low platelets in a few people who have received our COVID-19 vaccine. They are working closely with medical experts and health authorities. They strongly encourage this information’s open communication to health professionals and the public.
The FDA says that 15% of TTS cases have been fatal in an updated fact sheet on the vaccine.
The vaccine agency’s updated analysis includes cases reported to its Vaccine Adverse Event Reporting System (VAERS) database until March 18. The FDA says it has verified 60 cases of TTS, including nine deaths.
In general, the risk of TTS is extremely rare, with about three cases per million doses of vaccine administered. The highest rate of TTS has been seen in women 30 to 49 years of age. Nearly eight cases per million vaccine doses administered have occurred in women in this age group.
TTS cases usually start one to two weeks after vaccination. TTS symptoms include shortness of breath, chest pain, leg swelling, and persistent abdominal pain in patients. Also, they face problems with neurological symptoms such as headaches or blurred vision, or red spots just under the skin called petechiae beyond the vaccination site.
The new warning in the vaccine information sheet reads that the Janssen Covid-19 vaccine can cause thrombosis with thrombocytopenia syndrome (TTS), which can be life-threatening.