US Regulators Meet To Discuss Lifting Halt On J&J Jab Despite Blood-Clot Fears

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.

Tyler Durden Fri, 04/23/2021 - 08:35