The Indian Health Service and some tribes have paused the administering of the Johnson & Johnson COVID-19 vaccine following reports that it could lead to rare but potentially dangerous blood clots.
“IHS would like to stress that these events appear to be extremely rare,” IHS said in a news release. The agency said COVID-19 vaccine safety is a “top priority” for the federal government and it paused the J&J vaccine administration “out of an abundance of caution.”
There have been no cases of the “rare and severe type of blood clot” reported to IHS in individuals who have received the single-dose vaccine, according to IHS. “IHS employees have been advised to reach out to patients that may already have an appointment scheduled to receive the J&J vaccine and offer Pfizer and Moderna vaccines when available and appropriate.”
The Johnson & Johnson shot makes up approximately 1.5 percent of the shots in the arm, IHS said. As of April 12, 1,097,038 doses ofPfizer, Moderna and Johnson & Johnson have been administered.
This J&J vaccination pause will not affect the agency’s goal of vaccinating 44 percent of its active adult patients by the end of April.
The Centers for Disease Control and Prevention and the Food and Drug Administration said Tuesday they were investigating unusual clots that occurred 6 to 13 days after vaccination. The clots occurred in veins that drain blood from the brain and occurred together with low platelets. All six cases were in women between the ages of 18 and 48; there was one death and all remained under investigation.
The Gila River Indian Community in Arizona said the Gila River Healthcare and the Phoenix Area Office of the Indian Health Office will pause administration of the J&J per the CDC and FDA recommendation. The tribe said its health clinic has administered more than 400 J&J vaccinations.
The Bois Forte Band of Chippewa Indians in northern Minnesota also announced its pause of the vaccine as well as clinics it worked with. The tribe will offer the Moderna vaccine.
The Leech Lake Band of Ojibwe is doing the same until further notice, according to a post on Facebook.
“Leech Lake has previously administered the J&J vaccine and encourages any person that has received the J&J vaccine who develops severe headache, abdominal pain, leg pain, or shortness of breath within three weeks of receiving their vaccination to contact their health care provider,” read a statement.
Navajo Nation President Jonathan Nez said in a statement they “fully support pausing” the J&J vaccine on the Navajo Nation at all IHS and tribally-run health facilities until the tribe receives the findings of the investigation. Approximately 4,000 doses of the J&J vaccine have been administered on the Navajo Nation.
The FDA commissioner said she expected the pause to last a matter of days.
The clots were in veins that drain blood from the brain and occurred together with low platelets, the fragments in blood that normally form clots. All six cases were in women between the ages of 18 and 48. One person died.
More than 6.8 million doses of the J&J vaccine have been given in the U.S., the vast majority with no or mild side effects.
The White House’s COVID-19 coordinator, Jeff Zients, said the pause will “not have a significant impact” on the country’s vaccination program. “The J&J vaccine makes up less than 5 percent of the more than 190 million recorded shots in arms in the United States to date.”
Any slowdown in the dissemination of the shots could have broad implications for the global vaccination effort. The J&J vaccine held immense promise because its single-dose regimen and relatively simple storage requirements would make it easier to use, especially in less affluent countries.
The clots, which happened six to 13 days after vaccination in veins that drain blood from the brain, occurred together with low platelets, the fragments in blood that normally form clots.
Authorities stressed they have found no sign of clot problems with the most widely used COVID-19 vaccines in the U.S. — from Moderna and Pfizer.
A CDC committee will meet Wednesday to discuss the cases, and the FDA has launched an investigation into the cause of the clots and low platelet counts.
If you received J&J
Common side effects after getting a COVID-19 vaccine can include arm pain and normal flu-like symptoms for a couple days afterward. Those aren't pleasant, but they aren't what officials are concerned about.
Instead, be on the lookout for different, more severe symptoms associated with the clots, particularly between one and three weeks after the shot. Those include severe headache, backache, abdominal pain, shortness of breath, leg swelling, tiny red spots on the skin or bruising.
If those symptoms show up, seek medical treatment right away. The Centers for Disease Control and Prevention has issued advice to help doctors spot these rare clots and safely treat them.
The Associated Press contributed to this report.