Members of the Immunization Practices Advisory Committee said they did not have enough information to make their recommendations, or even suggest that the vaccine should be discontinued.
The CDC and the U.S. Food and Drug Administration have recommended that the United States suspend the use of the Johnson & Johnson vaccine on Tuesday after six cases of a rare but dangerous and difficult-to-treat form of blood clot in people recently vaccinated has. .
On Wednesday, CDC advisers also heard of a possible seventh case and the details of one case in a volunteer during trials with the vaccine – a case that J&J initially said was not linked to the vaccine.
ACIP staff said they would quickly look into a time within the next week to ten days for the committee to meet again so that the vaccine is not unnecessarily delayed if they decide it is safe to proceed.
“We will find a time to get back together,” said Dr. Amanda Cohn, executive secretary of ACIP, told the meeting. “We will try to determine what the date is by Friday of this week so that people have a little more time to get it on the agenda.”
Federal regulators are eager to get more information about the blood clots, called cerebral venous sinus thrombosis (CVST), which are found in combination with a deficiency of blood clotting cells called platelets. The combination makes the condition extra dangerous because the use of blood thinners commonly used to treat blood clots can cause bleeding in these patients.
At least four of the six cases were treated with the blood thinner heparin when they first developed symptoms, Dr. Aran Maree, chief medical officer for pharmaceutical products at J & J’s Janssen vaccine, told the meeting.
He gave details of what is known about the cases, including: a 45-year-old woman who died; a 38-year-old woman who has not recovered; an 18-year-old woman who has not recovered; a 48-year-old woman who has not recovered; a 26-year-old woman who has recovered and a 28-year-old woman whose status is unknown.
It also contains a possible seventh case – a 59-year-old woman who has not yet recovered and whose blood clots may not fit the same profile as the others.
Maree said the company still feels the vaccine is safe enough to use.
“I want to reiterate that Janssen believes that the overall benefit-risk profile of our vaccine is positive in the population for which it is authorized,” Maree told the meeting.
“We support ensuring awareness of the signs and symptoms of this very rare event, as well as making recommendations to ensure the correct diagnosis, treatment and reporting by healthcare professionals.”
ACIP staff said the committee could consider recommending changes to who gets the vaccine – for example, men only, as most cases of blood clots are among women, or only people over 50, as most cases are among people under 50 was.
But members said they may not yet know enough to make such recommendations.
“I do not want to vote on this issue today. I do not want to vote not to recommend the vaccine – I think it is not really something I necessarily believe,” said Dr. Beth Bell, a clinical professor at the University of Washington, said. in Seattle, the meeting said.
“I just do not feel that there is enough information to make an evidence-based decision. We will not have all the information, but I think there are things we can gather relatively quickly, all of which have to do with the benefit / risk balance, ”Bell said.
“We do need to better understand the risk, which we know is going to be very rare, very low, but we really do not know exactly how low and how to characterize it correctly,” Bell added.
“I think we do not have to vote and gather the necessary information so that we can make an evidence-based decision.”
Bell, who chairs the ACIP working group, said earlier it was also unclear whether the blood clots seen in people who received the Janssen vaccine were the same as those seen in people in the UK and Europe who received the AstraZeneca vaccine, which is not yet authorized in the US.
Both vaccines use adenoviruses, a type of cold virus, to carry genetic material from the coronavirus to the body to bring about immunity. One theory is that these adenoviruses somehow elicit an immune response that causes the low platelet count and the blood clots.
“The extent to which the cases seen after each of these adenoviral vector vaccines represent exactly the same syndrome is not entirely clear at this time,” Bell said.
The group has a scheduled meeting over three weeks – on May 5 – or can plan another emergency meeting.
But Dr Nirav Shah, director of Maine’s Center for Disease Control and Prevention and representative of the Association of State and Territorial Health Officials, said waiting was equally bad.
“We are in a situation where a decision is not the same as making a decision,” Shah said. He noted that people who benefit from taking a vaccine will be vaccinated as a result of further delays.
Dr. Camille Kotton of Massachusetts General Hospital and Harvard Medical School, said the country needs the one-shot vaccine.
“It’s very devastating to keep this vaccine quiet for those of us who are front-line health workers,” Kotton said at the meeting.
‘I generally agree that at the moment we do not have the information to make a decision. But we were planning to use this vaccine in the state of Massachusetts for people who are homebound and otherwise unable to get a vaccine.
“We intended to use it for our vulnerable population within patients, often with many disease conditions and with a high risk of disease, but which could not yet be vaccinated otherwise. And then it would certainly be used in which may otherwise be underserved populations or populations unable to obtain mRNA vaccines, “Kotton added.
The mRNA vaccines manufactured by Moderna and Pfizer / BioNTech require special cooling and are given in two doses.
“So I definitely want us to be careful and very careful with our decision-making, but I also just want to emphasize that this one-and-done vaccine that does not require the cold chain that the mRNA vaccines do, it’s a significant loss is, ‘Kotton said.
Dr. Paul Offit, a member of the U.S. Food and Drug Administration Advisory Committee, calls it “an unfortunate non-decision.”
“One thing they could have said was, ‘Just explain to people that there is this very rare but very real side effect, and remember that out of every million people who get Covid, 1,850 will die,'” Offit said. “There are no risk-free choices, just choices to take different risks,” said director of the vaccine. Education Center at Philadelphia Children’s Hospital.
Earlier, the director of CDC, dr. Rochelle Walensky, said it was not clear that her agency had heard of every blood clot associated with the vaccine. “At present, we believe that these events are extremely rare, but we are also not yet sure that we have heard about all possible cases, as this syndrome cannot be easily recognized as one associated with the vaccine,” he said. she said at a media conference.
She said that although people should be aware of the possible symptoms, the vaccine monitoring system works. “Together, CDC and FDA were able to identify these rare incidents and act quickly to alert healthcare providers and the public. It shows that the safety systems we have in place are working,” she said.
The symptoms that people should pay attention to when they get the Janssen vaccine include severe headaches, abdominal or leg pain or shortness of breath, Walensky said.