PHILADELPHIA (KYW Newsradio) — The Pennsylvania Department of Health is extending the pause on the Johnson & Johnson vaccine until April 24 or until updated guidance comes from the CDC or FDA.
The CDC's vaccine advisory committee will meet again in the next week or two for further discussion. They decided Wednesday, after several hours of discussion, that they don’t have enough information to make a recommendation.
Typically, the CDC's Advisory Committee on Immunization Practices, would end a meeting by voting on a recommendation. However, after in-depth presentations on what is known and unknown about the six cases of rare but serious blood clots linked to the vaccine, they boiled the meeting down to two questions: Do they have enough information to make a decision? What would the appropriate recommendation be?
It was pointed out several times during the meeting that safety is paramount, and that the review system is working, bringing to attention a small number of cases of a very rare but serious blood-clotting disorder. Those six cases are a very small fraction of a percentage of the 7 million doses administered.
The committee also tried to make clear that their intent is not to send a message that the J&J vaccine is inherently bad, but they do want to figure out what groups might be at higher risk, and what might cause that risk.
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Authorities have studied the clots for only a few days and have little information to judge the shot.
"It’s a very rare event. Nothing in life is risk-free. But I want to be able to understand and defend the decision I’ve made based on a reasonable amount of data," said adviser Dr. Beth Bell of the University of Washington.
Fellow committee member Dr. Sara Long with St. Christopher's Hospital and a professor of pediatrics at Drexel University voiced her support for a continued pause. With more data, they may be able to determine, for example, if the vaccine is safer for men, or for a certain age group, she said.
"And we might be able to make some risk-related, more definitive, potential use of the vaccine in a month," she said.
Dr. Tom Shimabukuro with the CDC says it is possible more cases will come to light in the coming days.
"There may be cases out there which have not come to our attention but might come to our attention now this information is out there. That’s a reporting bias called stimulated reporting," he said.
Dr. Grace Lee from Stanford pointed out they’ll never have perfect information, but she hopes in the coming days or weeks they could have risk factors broken down.
Side effects too rare to have occurred in studies of thousands of people sometimes pop up once shots are used in millions, and Shimabukuro said spotting such a rare potential risk amid the nation’s huge vaccine rollout "is an example of a success story for vaccine safety."
However, some vaccine specialists who were closely watching the deliberations expressed dismay that the public will have to wait for more advice.
"What they did was they punted," said Dr. Paul Offit, a vaccine expert at the Children's Hospital of Philadelphia. "I just don’t think waiting is going to give you a critical amount of information that is going to help you make a decision."
One question brought up, but not answered, is if the risk of clotting is small enough, and the issue publicized enough, to allow the resumption of the vaccine, letting people decide if they were willing.
Offit noted that many European countries are dealing with a similar uncertainty with the AstraZeneca vaccine without stopping its use.
While the advisers said an indefinite pause isn’t a good idea, it was determined there is not enough information yet to make a decision, and they will reconvene in the coming weeks.
Committee members say we’re lucky in the U.S. that vaccination efforts an continue with Moderna and Pfizer alternatives. The government says there are no signs of similar clots after vaccination with the Pfizer and Moderna shots.