Editor’s note: FDA and CDC he paused on the Johnson & Johnson vaccine on Friday evening, just hours after the ACIP decision.
The use of the Johnson and Johnson COVID-19 vaccine should be resumed in the United States for all adults over the age of 18, an advisory group from the Centers for Disease Control and Prevention (CDC) decided on Friday.
The Advisory Committee on Immunization Practices (ACIP) voted in favor of this recommendation 10-4 with one abstention. The announcement comes with an updated warning in the US Food and Drug Administration (FDA) Emergency Use Authorization (US) language aimed at women under the age of 50 who have a increased risk of a rare but severe blood clot disorder called thrombosis with thrombocytopenia syndrome (TTS).
As of April 21, 15 cases of TTS have been confirmed, with three deaths, all in women and 13 in women under the age of 50, between 7.98 million doses of the Johnson and Johnson vaccine administered in the United States. Units.
The single-dose vaccine was given pause on April 13 by the FDA and the CDC after reporting that six women developed a rare blood clotting disorder after receiving the Johnson and Johnson vaccine.
William Schaffner, MD, an infectious disease expert at Vanderbilt University in Nashville, Tennessee, and a non-voting member of the ACIP, said Medscape Medical News that the group made the appropriate recommendation.
He applauded both the decision to restart the vaccine and the updated warning information in the US that “will explain [TTS] more fully to people, particularly women, who get vaccinated. “
As for women in the risk group who need to choose vaccines, Schaffner said they will be treated differently across the United States.
“Not all providers will have alternative vaccines to their location, so there will be many different ways to do this. You may need to get this information and select where to go based on the vaccine available if this issue is important. for you, ”he noted.
ACIP has made the decision today after a 6-hour emergency meeting to hear evidence on the benefit of Johnson and Johnson’s protective benefits against COVID-19 against the risk of TTS.
Tom Shimabukuro, MD, of CDC, explained that TTS is a rare but serious and potentially fatal side effect.
It appears that the onset of symptoms occurs 1 to 2 weeks after vaccination. The clinical features appear to be similar to those seen after the AstraZeneca COVID-19 vaccine in Europe.
Patient characteristics with cases include a mean age of 37 years and a mean onset time of 8 days. Twelve of the cases were cerebral venous sinus thrombosis cases.
“There were no pregnant or postpartum cases,” Shimabukuro said. “There were no patients with known coagulation disorders.”
He pointed this out, though headache is a common symptom after COVID-19 vaccines, headaches with TTS usually appear after 6 days instead of one day after injection.
Shimabukuro said that while no cases of TTS have been documented in men, it does not mean there is no risk to men. There may be cases that go unreported, he notes.
Age comparison of TTS after the J&J vaccine in women a
|Age group||TTS cases||Doses administered||Reports|
|18-29||3||579,709||5.2 per million|
|30-39||7||594,215||11.8 per million|
|40-49||3||692,370||4.3 per million|
|50-64||2||1,367,529||1.5 per million|
|More than 65 years||0||757,710||0|
|aCDC COVID-19 Vaccine Follower|
Pros and cons of four options considered
Sara Oliver, MD, MSPH, who leads the ACIP Working Group on CDC COVID-19 Vaccines, outlined the thinking process and modeling of the working group in each of the four scenarios they studied.
It is recommended not to use it for anyone. While there would be no more cases of TTS after the Johnson and Johnson vaccine, it would eliminate the election, cause more cases and deaths from COVID-19 and could disproportionately harm populations at risk of access or difficulty returning a second dose of an mRNA vaccine.
It is recommended for all adults regardless of age or gender with an FDA warning statement in the US. This would allow flexibility in choice and allow use in more difficult-to-access populations. However, the burden would fall on the person to understand the risk and on the departments or health care providers that transmit that risk.
Recommended only for adults over 50 years. This would eliminate the vaccine from the most at-risk population and drastically reduce TTS cases. An individual age limit is also easy to communicate. However, it would probably be difficult to implement and vaccination sites would have to store more than one vaccine. It would eliminate an option in a low-risk population (men under 50) and could disproportionately affect at-risk populations.
Reaffirm recommendations for use, but women under the age of 50 should be aware of the increased risk of TTS and may choose another COVID-19 vaccine (i.e., mRNA vaccines). This allows for more flexible choice and use of the vaccine in hard-to-reach populations, while recognizing the risk of young women. It could be difficult to implement and communicate.
Oliver shared the risk / benefit analysis at the group population level.
For more than 6 months in the current conditions, he said, if the vaccine was resumed for all adults “we expect two cases of TTS among young people aged 50 to 64 and 24 cases among those aged 18 to 49 and a reduction In general, if vaccination with the Johnson and Johnson vaccine was resumed in all adults, the model predicts that 26 cases of TTS would occur between 9.8 million vaccinated people and that there would be approximately 2200 deaths and 1400 ICU admissions would be avoided “.
If the vaccine were to be resumed only for people 50 years of age or older, there would be two cases of TTS planned among children aged 50 to 64, Oliver said.
The number of deaths and admissions to the ICU was avoided if restarting only in this age group would be much lower, but the benefits would outweigh the risks of not restarting.
“The model predicts two cases of TTS and 3.6 million vaccinations, which would prevent some 250 deaths and 800 admissions to the ICU,” he said.
In the end, the wording that the group approved for its recommendation was simply: “The Janssen COVID-19 vaccine is recommended for people 18 years of age or older in the U.S. population under emergency use authorization. of the FDA “.
One of the two non-votes was from Pablo Sanchez, MD, a professor of pediatrics at Ohio State University, who said he thought the final “general recommendation” was not enough, given the risk and severity of TTS.
“I think we need to have stronger language and make sure people are properly informed,” he said.
The abstention came from a member who had a conflict of interest with participation in a clinical trial.
Michael Streiff, MD, a coagulation expert at Johns Hopkins University School of Medicine in Baltimore, Maryland, advised physicians on the management of TTS.
He urged to suspect if anyone has any thrombotic event associated with thrombocytopenia. Confirm the thrombotic event with images and test simultaneously heparin-induced thrombocytopenia, He said.
Physicians should consult a hematologist to confirm the diagnosis and rule out others. He treated with a non-heparin anticoagulant, he said, and treated thrombocytopenia with intravenous immunoglobulin, which blocks the activation of platelets and accelerates platelet recovery.
“Avoid platelet transfusions because it seems to fuel the fire of this syndrome,” Streiff said.
Last week, ACIP members took no action after an emergency meeting on whether to end the pause against the Johnson and Johnson vaccine imposed on April 12 without acting and leaving the pause instead, as members said they needed more information about possible links to the clots and more data about affected patients.
The decision of the ACIP mimics that of the European Medicines Agency, which dit shipment of the vaccine to Europe will resume on Tuesday, but a warning about a possible connection with blood clots is recommended.
Marcia Frellick is a Chicago-based freelance journalist. He has previously written for the Chicago Tribune, Scientific news, and Nurse.com, and was editor at Chicago Sun-Times, el Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick.