*The U.S. Food and Drug Administration (FDA) said on Thursday that the use of Johnson & Johnson's covid-19 vaccine in the United States should be limited to those who cannot be vaccinated with Pfizer or Moderna covid-19 Vaccine * because of the risk of a rare but potentially life-threatening hemagglutination disorder.
The FDA pointed out that the Johnson & Johnson vaccine can also be reserved for those who cannot obtain covid-19 vaccine except Johnson & Johnson, or those who still choose Johnson & Johnson because they do not have Pfizer or Moderna mRNA vaccine. According to the agency, this is because the benefits of covid-19 vaccination still outweigh the rare risks posed by Johnson & Johnson vaccine.
The FDA's move echoes a similar recommendation released by the Centers for Disease Control and Prevention (CDC) last December. The proposal said that people should receive covid-19 vaccine or booster injection from Pfizer and Moderna, rather than Johnson & Johnson's vaccine.
Both the FDA update and CDC recommendations focus on thrombocytopenic thrombosis (TTS). It is understood that this is a rare, dangerous and special blood coagulation disease. In addition to blood clots, it will also lead to low platelets. It may be dangerous to treat it with heparin, a common clotting drug. A CDC panel discussion in the United States concluded before the recommendation was released in December that although women aged 30 to 49 were at the highest risk, cases were also found in both sexes and more age groups. The FDA said that as of March 2022, 60 cases had been found and 9 people died of the disease. The FDA points out that this is about three cases per million doses of Johnson & Johnson vaccine. Nearly one million people died of covid-19 in the United States.
"Today's action demonstrates the strength of our safety monitoring system and our commitment to ensuring that science and data guide our decision-making. We have been closely monitoring the occurrence of Janssen covid-19 vaccine and TTS after its use, as well as using the latest information from our safety monitoring system to revise the EU," Dr. Peter marks, director of FDA's biological products evaluation and research department, said in a press release
According to an FDA briefing, the symptoms of TTS usually begin within one to two weeks after vaccination. This is not the case for people who received the Johnson & Johnson vaccine a few months ago.
Johnson & Johnson our first priority is to ensure the safety and well-being of people using Johnson & Johnson covid-19 vaccine. In close coordination with the FDA, Johnson & Johnson has updated its covid-19 vaccine profile in the United States to raise awareness of the risk of thrombocytopenia syndrome (TTS), a rare but potentially life-threatening situation. "
The company said the data continued to show a favorable benefit risk profile compared to not vaccinating.
When the CDC of the United States recommended Pfizer and Moderna vaccines instead of Johnson & Johnson's vaccines, it gave part of the reason is the wide availability of these two mRNA vaccines. In the early days of the pandemic, when covid-19 vaccines appeared in waves and were scarce in some places, the public health recommendation was to get any vaccine that people could get.
It is understood that Johnson & Johnson is widely used in low - and middle-income countries - usually as the only vaccine available. Data show that only 15.8% of people in low-income countries have received a dose of covid-19 vaccine.