Source: CNN health
The U.S. FDA issued a statement on May 5 saying that it will limit the emergency use authorization of Johnson & Johnson’s new crown vaccine to those over 18 years old who are not suitable or unable to obtain the mRNA vaccine Population vaccination because it may cause a rare high-risk coagulation state, thrombosis with thrombocytopenia syndrome (TTS).
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation, said the J&J vaccine is still in play in the U.S. and global pandemic response The benefits for some people outweigh the risks. The following three groups of people are recommended to be vaccinated:
1. People with severe allergic reactions to mRNA vaccines;
2. Concerned about mRNA vaccines of people who would not be vaccinated without the J&J vaccine;
3. People who have difficulty getting mRNA vaccination.
TTS usually occurs one to two weeks after vaccination, and symptoms include shortness of breath, chest pain, swollen legs, neurological symptoms such as persistent abdominal pain, headache or blurred vision, or blood on the skin outside the vaccination site. petechiae.
In its latest note on the vaccine, the FDA said 15 percent of TTS cases were fatal. The latest analysis of the vaccine includes cases reported to its Vaccine Adverse Event Reporting System (VAERS) database as of March 18. The FDA said it had confirmed 60 cases of TTS, including nine deaths. Overall, the risk of TTS is extremely rare: about 3 cases per 1 million vaccine doses, and mortality is about 1 case per 2 million doses. The highest incidence of TTS is in women between the ages of 30 and 49. Among women in this age group, there are about 8 cases per 1 million vaccine doses.
Therefore, most people do not need to take this risk, it is necessary to indicate on the product insert that this is not a first-line vaccine, and the authorization update also applies to booster vaccinations.
Marks noted that Johnson & Johnson said it had updated product labeling in response to FDA restrictions. “The Janssen COVID-19 vaccine can cause thrombosis with thrombocytopenia syndrome (TTS), which may be life-threatening,” says a new warning on the vaccine’s labeling.