US Health Panel Recommends Restarting Johnson & Johnson COVID-19 Vaccinations
PITTSBURGH (KDKA) - The Advisory Committee on Immunization Practices met emergently for the second time in just over a week to discuss the Johnson & Johnson COVID-19 vaccine, recommending to restart the use.
The vaccine was paused after the last meeting due to a concern about rare, but serious clots, a condition called Thrombosis with Thrombocytopenia Syndrome, in other words clotting along with a low level of clotting cells called platelets.
"I have no doubt the pause was the right thing to do. It gave the committee and the CDC and the FDA more time to acquire information," says AHN primary care internist Dr. Marc Itskowitz.
The low platelets are a unique feature. The clots can occur in the veins of the brain and in other parts of the body.
"It seems to affect people younger in age, and it seems to affect women more than men," says Dr. Michael Streiff of Johns Hopkins University.
"You can focus in on the 30 to 39 age group," says Dr. Tom Shimabukuro, of the Centers for Disease Control and Prevention. "This is where we saw the most cases."
Usually clots can be treated with a blood thinner called heparin, but that can be dangerous in this case. Attention to the special treatment required, as well as to symptoms of headache, nausea, vomiting and abdominal pain six days after vaccine, was part of why the pause was put in place.
"Those two pieces I think will improve outcomes, because it's clear that at least in some of the cases where people, the published cases, they tried to treat their symptoms at home for a number of days before they presented, and when they presented they were severely ill," says Dr. Streiff.
The committee reviewed 15 reported cases.
"The cases occurred in predominantly young women," says Dr. Itskowitz. "They were very rare. Only 15 cases out of 6 or 7 million doses of this vaccine. So overall, it's a very safe vaccine."
Presenters pointed out these clots are similar to what has been seen with the AstraZeneca vaccine in Europe, which is similar in design. The syndrome has not been noted with the 5.2 million doses of the Pfizer or Moderna vaccines.
During the public comment period, people brought up worries about not having a choice of vaccines, and expressed hesitation at the newness of these shots.
Johnson & Johnson agreed to a warning label about the potentially fatal cases. Three of the 15 cases died.
The CDC used computer models to predict 26 serious clots for every 10 million vaccinated people, but up to 3,500 fewer ICU hospitalizations and 1,400 fewer deaths.
"Five-hundred-thousand Americans have died, 3 million people have died worldwide. What else do we need to wait for in terms of deciding the benefit outweighs the risk?" says Dr. Itskowitz. "I don't anticipate they will not bring back the J&J vaccine, but I think they will bring it back with some level of restriction."
The committee voted 10 to 4 with one abstention in favor of resuming the Johnson and Johnson vaccine for all adults, men and women, but with a warning statement about the serious clots added to the FDA's emergency use authorization.
The CDC now has to sign off on these recommendations. It doesn't have to follow the advice of its advisory panel, but it typically does.
