Is a fourth dose of the covid-19 vaccine necessary?
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(CNN) --
The US Food and Drug Administration (FDA) announced Thursday that it will limit the emergency use authorization of the Johnson & Johnson/Janssen covid-19 vaccine. to persons 18 years of age and older for whom other vaccines are not appropriate or accessible and to those who choose J&J because they would not otherwise be vaccinated.
The FDA said in a statement that the change is motivated by the risk of a rare and dangerous clotting condition called thrombosis with thrombocytopenia syndrome (TTS) that can occur after receiving the vaccine.
The FDA warns people with a history of certain blood clots to avoid Johnson's vaccine.
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"We have closely monitored Janssen's COVID-19 vaccine and the occurrence of TTS following its administration and have used updated information from our safety monitoring systems to review the emergency use authorization," it said in the statement. Dr. Peter Marks, director of the FDA's Center for Biological Evaluation and Research.
"We recognize that the Janssen COVID-19 vaccine continues to have a role in the ongoing response to the pandemic in the United States and throughout the global community...Today's action demonstrates the strength of our safety and security surveillance systems. our commitment to ensuring that science and data guide our actions."
The agency confirmed to CNN that the updated authorization also applies to booster doses.
The FDA says it has determined that the benefits of the J&J vaccine outweigh the risks for certain people.
Some examples of people who can still get the vaccine are:
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Those who have had a severe allergic reaction to an mRNA vaccine such as those from Pfizer/BioNTech or Moderna
Those with personal concerns about mRNA vaccines who would remain unvaccinated if J&J's vaccine were not available
Those with limited access to covid-19 mRNA vaccines
As of Thursday, more than 18.7 million doses of the J&J vaccine have been administered in the United States, according to the US Centers for Disease Control and Prevention (CDC).
"Encouraging" data suggests Johnson & Johnson's vaccine may continue to have an impact against covid-19
Following a meeting in December, the CDC's vaccine advisory committee issued an updated recommendation on Johnson & Johnson's vaccine, saying it makes a "preferential recommendation for the use of mRNA COVID-19 vaccines over vaccine." against the Janssen adenovirus vector COVID-19 in all persons over the age of 18 in the United States.
The committee cited the same concerns about thrombosis with thrombocytopenia syndrome.
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 that move was accompanied by a warning about rare coagulation events.
Johnson & Johnson then said in a statement: "The safety and well-being of people who use our products is our number one priority. We are aware of an extremely rare disorder that affects people with blood clots in combination with low platelets in a small number of individuals who have received our COVID-19 vaccine…. We have worked closely with medical experts and health authorities, and we strongly support open communication of this information to health professionals and the public."
In an updated fact sheet on the vaccine, the FDA states that 15% of TTS cases have been fatal.
The agency's updated analysis of the vaccine includes cases reported to its Vaccine Adverse Event Reporting System (VAERS) database through March 18.
The FDA says it has confirmed 60 cases of TTS, including nine deaths.
In general, the risk of TTS is extremely rare: about three cases for every million doses of vaccine administered.
The highest rate of TTS has been in women 30 to 49 years of age.
About eight cases per million doses of vaccines administered have occurred in women in this age group.
TTS cases usually begin one to two weeks after vaccination.
Symptoms include shortness of breath, chest pain, leg swelling, persistent abdominal pain, neurological symptoms such as headaches or blurred vision, or red spots just under the skin called petechiae away from the site where the vaccine was received.
The new warning in the vaccine information sheet reads: "The Janssen Covid-19 vaccine may cause thrombosis with thrombocytopenia (TTS) which can be life-threatening."
-- CNN's Brenda Goodman and Amanda Sealy contributed to this report.
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