NIH Director: J&J COVID-19 Vaccine Blood Clot Risk ‘Truly Rare’

Dr. Francis Collins, director of the National Institutes of Health, appears before a Senate hearing to discuss vaccines, in Washington, on Sept. 9, 2020. Michael Reynolds/Pool/Getty Images

Blood-clotting issues linked to the Johnson & Johnson (J&J) COVID-19 vaccine are extremely rare, the head of the National Institutes of Health (NIH) said on Sunday as he pushed back against calls for the one-dose vaccine to be paused for women under the age of 50.

NIH director Francis Collins made the remarks in response to advice from physician and CNN medical analyst Leana Wen, who said in a Washington Post op-ed that “the default position should be against administering the Johnson & Johnson vaccine to women under 50.”

Wen’s piece was published after the Centers for Disease Control and Prevention’s (CDC) vaccine advisory committee voted to lift the pause on the J&J vaccine with no restrictions.

In an emergency meeting Friday, members of the Advisory Committee on Immunization Practices (ACIP) said that they recommend resuming the use of the J&J vaccines in persons age 18 and older after a robust discussion and examination of the available data on the severe blood clotting syndrome with low platelet levels associated with taking the vaccine.

“I think [Wen’s] in the minority compared to the decision that was put forward by the Advisory Committee on Immunization Practices of CDC, which met for an entire day on Friday and went over all of the data, documenting a total of some 13 cases of this rare form of blood-clotting out of some eight million doses of the J&J vaccine that had been administered,” Collins said during an interview with NBC’s “Meet the Press.”

“The strong conclusion of that group was that the vaccine should go forward. It should be made available to everybody,” Collins continued. “But there should be a fact sheet that provides the information to everybody to understand what the nature is of this potential very rare side effect so that everyone is aware of the facts.”

“When you consider the nature of this risk, this is truly a rare event,” Collins added. “And when you measure that against the benefits of preventing somebody from dying of COVID, there’s no comparison. We clearly have a situation where the benefits greatly outweigh the risks, even for younger women.”

The CDC and the Food and Drug Administration halted the use of the J&J vaccine on April 13 after reports that six women had died from a blood clotting disorder with low platelet levels within two weeks of being inoculated. A seventh woman was identified at the first emergency meeting held by ACIP to discuss the connection between the J&J vaccine and the clotting disorder on April 14.

The panel decided to allow the pause to continue until more data could be gathered and investigated. Members said they may receive more reports related to the severe and rare blood clotting before they met again.

Prior to the pause, 6.85 million doses of the J&J vaccine had been administered to Americans by April 12.

Collins told host Chuck Todd that people are a “thousand times less likely” to experience blood-clotting episodes after receiving the J&J vaccine than experiencing intestinal bleeding from taking aspirin, an over-the-counter medication.

“All of us who have been taking aspirin for headaches and muscle aches for the last many decades,” the NIH director said. “The risk of aspirin inducing a significant intestinal bleed is much higher than what we’re talking about here, something in the neighborhood of one in 500, one in a thousand for people who regularly take aspirin. We’re talking about something here that’s about a thousand times less likely to happen.”

He said the J&J COVID-19 vaccine is “really low risk,” adding, “You are less likely as a woman taking J&J to have this blood-clotting problem than to get struck by lightning next year.”

According to Dr. Michael Streiff, medical director at The John Hopkins Hospital Special Coagulation Laboratory, typical signs and symptoms of blood clots in the brain are severe headaches, seizures, limb weakness, and reduced consciousness or coma.

Meiling Lee contributed to this report.