Update (1240ET): As we await the ACIP's recommendation on whether J&J's Janssen COVID-19 vaccine should be allowed to be used on American patients as soon as this weekend, some disturbing new details about rare but deadly side-effects have emerged.
According to slides shared online that were presented to the ACIP team during today's meeting, two more people have died from a rare combination of blood clots and low platelet counts potentially linked to the J&J jab.
This brings the total known deaths to three, among nearly 7 million Americans who have received the shot. Seven more have been hospitalized, including four who landed in the ICU, while five have been discharged home, members of the CDC panel's safety workgroup found Thursday.
As we have reported, federal health officials called for a nationwide pause in use of the shot on April 13 after they received reports about six women between 18 and 48 who had developed the blood clots. When ACIP first met last week to examine the safety concerns around the J&J shot, members decided they didn't have enough data to make any recommendation.
The presentation, prepared by the CDC panel's safety subgroup, asserts that the risk of the clotting syndrome appears to be highest for women under 50, a group that includes about 7M American women. Meanwhile, the risk appears to be less than one in 7 million doses for men and women over 50. So far, cases have been reported in people aged 21 to 77, almost all of them women.
The full committee is expected to vote Friday on its recommendations for use of the vaccine. It is possible that the committee will recommend a warning label be added to the vaccine or suggest its use should be restricted by age, sex or both factors. Biden administration officials have previously said they would look to the CDC’s advisory panel for guidance on lifting the pause in the shot, and they are expected to make a final decision soon. "I think the FDA and I both feel strongly, and the CDC feels strongly that we need to act swiftly after that analysis," CDC Director Rochelle Walensky told reporters in a press briefing Friday. "But I do think that there is plenty of people who are interested in the J&J vaccine if just for convenience as well as for a single-dose option."
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The Advisory Committee on Immunization Practices - the agency that advises the FDA and CDC on vaccines, and will ultimately decide the fate of the Johnson & Johnson COVID-19 jab - is set to meet Friday to decide whether to recommend that the halt on the J&J be lifted, or left in place for now.
While public-health authorities insist the societal benefits of the vaccine outweigh potentially deadly (but extremely rare) side effects like cerebral blood clots, the J&J jab has remained on halt for more than a week, despite assurances from Dr. Anthony Fauci that the halt would be lifted in a few days. At any rate, supplies of the J&J jab dried up shortly before the halt began thanks to a factory accident in Baltimore that spoiled 15M doses.
According to WSJ, a significant issue that the ACIP might consider on Friday is how the clot risk among J&J jab recipients measures up against the risk of clots that come with COVID-19 Blood clotting all over the body is one complication of severe forms of the disease. About 15% to 20% of Covid-19 patients who are admitted to intensive-care units develop blood clots.
A recommendation to lift the pause could prompt the FDA and CDC to put the vaccine back in circulation as early as this weekend, because millions of doses have already been distributed to vaccine sites.
The lifting of the pause could be accompanied by restrictions limiting the vaccine’s use to older adults, as well as possible warnings about the potential clot risk, according to people familiar with the matter.
The ACIP meeting is scheduled to begin at 1100ET, with a potential vote by 1700ET. It will be the ACIP’s second emergency meeting in 10 days to discuss the J&J vaccine. The committee, which advises the CDC, met April 14, one day after use of J&J’s vaccine was paused. But the committee, meeting online, deferred voting on a recommendation because members wanted more information about the vaccine’s risks and benefits.
After EU regulators highlighted a possible link between the J&J (and AstraZeneca-Oxford) jab and rare blood clots, J&J promised to update its packaging information to include a warning about possible clots. Nordic countries remain wary of the adenovirus-vector jabs (which includes not just AstraZeneca and J&J, but Russia's Sputnik V), and on Friday, Sweden's public health agency decided to recommend against using the J&J jab for patients under 65.
US regulators abruptly halted use of the J&J jab earlier this month after determining that at least six women experienced blood clots that were tied to the vaccine. At least one of those cases was fatal. The blood-clot risks are believed to be highest in patients with low blood platelet counts. The FDA initially authorized the J&J jab for use in the US in late February, making it the third jab - and first adenovirus-vector jab - approved in the US.