Five experts on the panel that will vote on whether to lift the pause – a committee of 15 – on Friday spoke with Business Insider. All five want Johnson & Johnson’s one-dose shot to still be used in the U.S.
But several suggested it should come with a warning, advising young women of rare brain blood clots seen in at least nine people, including six women between ages 18 and 48 during the rollout.
Two U.S. officials told the Washington Post that the vaccine will likely carry some kind of a warning about rare, similar to one used in the EU.
Vaccinations with J&J’s shot were paused last week after nine reports of a rare possible reaction to the vaccine involving blood clots. Seven of the reactions were in women under 60.
Regulators are unlikely to place an age limit on who can receive the vaccine in their recommendations, which is expected after their 11am-5pm meeting Friday.
An Oregon woman in her 50s died after developing a rare brain blood clot within two weeks of getting the Johnson & Johnson Covid vaccine, state health officials said Thursday.
She received the shot just days before the Centers for Disease Control (CDC) and Food and Drug Administration (FDA) issued a nationwide pause on the J&J shot amid blood clot concerns that arose after six women under 50 developed the dangerous condition.
No doses made at the plant have been shipped in the U.S. and distribution of the shot is paused amid blood clot concerns
Weekly supply of J&J’s shot was halted after the pause was placed on the vaccine last week. So far, just shy of eight million doses have been given, and 17.6 million have been distributed
‘I think almost surely this is going to turn out to be related to the vaccine because of the clustering and because of the extraordinary, unusual presentation and findings of the patients who have it,’ committee member Dr Sarah Long, a Drexel University professor of pediatrics told Business Insider.
A second committee member, Dr Wilbur Chen, a professor at the University of Maryland, told the outlet he hoped that now that more people are aware of the potential – though rare – for brain blood clots, cases would be more quickly identified and treated.
Dr Long added that if the clots continued to disproportionately affect younger women, then perhaps the committee would recommend it only for men and older women.
But officials who spoke to the Post on the condition of anonymity said it was unlikely that they would recommend an age limit on who should receive the vaccine.
A third panelist, Dr Kevin Ault, a University of Kansas OBGYN, said that the committee hadn’t seen additional data beyond the nine reports (six women under 50 outside the trial, one woman under 50 in the trial and one young man in the trial) identified as of last week.
‘I don’t want to get ahead of the advisory committee tomorrow’s meeting,’ said CDC director Dr Rochelle Walensky on the Today show Thursday (pictured)
Earlier this week, CDC director Dr Rochelle Walensky hinted that there had been some but not many additional reports of blood clots.
Now, the committee members have at least one more data point to consider after the death of the woman in her 50s.
Prior to new report out of Oregon, only one person had died of the brain blood clots, the man who took part in the trial.
That group, the Advisory Committee on Immunization Practices (ACIP), is meeting tomorrow to discuss data on blood clots linked to the vaccine.
Publicly, officials have punted and refused to give Americans an idea of when J&J vaccinations might resume, while the committee deliberates.