FDA limits J&J COVID vaccine as dose shortage looms

The US Meals and Drug Administration (FDA) yesterday severely restricted use of the Johnson & Johnson (J&J) COVID-19 vaccine as federal price range paperwork herald a vaccine scarcity this fall if second boosters are extensively inspired.

Blood clots with the J&J vaccine

Within the 14 months after gaining an emergency use authorization, the J&J one-dose vaccine yesterday hit one other, when the FDA restricted its use to sure people, citing uncommon however critical blood clotting occasions following vaccination.

The FDA mentioned the company has now recognized 60 confirmed circumstances of thrombosis with thrombocytopenia syndrome (TSS), together with 9 deadly circumstances, amongst 18 million recipients of the vaccine. The company now recommends that solely individuals who wouldn’t get a COVID-19 vaccine in any other case, or who could also be allergic to mRNA vaccines, obtain the J&J shot.

“We acknowledge that the Janssen COVID-19 Vaccine nonetheless has a job within the present pandemic response in america and throughout the worldwide neighborhood. Our motion displays our up to date evaluation of the chance of TTS following administration of this vaccine and limits using the vaccine to sure people,” mentioned Peter Marks, MD, PhD, director of the FDA’s Middle for Biologics Analysis and Analysis, in an FDA press release.

The adenovirus-based vaccine was as soon as thought-about a game-changer, because it was simpler to manage and retailer than the mRNA vaccines, and required just one go to to a vaccine supplier. However with weeks of gaining FDA authorization final spring, the company mentioned they have been conscious of 9 circumstances of TSS. Use of the vaccine was then paused for 10 days, and the vaccine shortly fell out of favor with People—200 million of which have obtained both the Pfizer or Moderna vaccine merchandise.

The Facilities for Illness Management and Prevention (CDC) COVID Data Tracker exhibits 66.3% of People are absolutely vaccinated in opposition to COVID-19, 77.7% have obtained not less than one dose of vaccine, and 45.9% of these eligible have obtained their first booster dose.

The US reported 72,158 new COVID-19 circumstances yesterday, and 242 deaths, in response to the Johns Hopkins COVID-19 tracker. The 7-day common of latest every day circumstances is 67,827, with 286 every day deaths, in response to the Washington Submit tracker.

Potential Sep 1 cutoff for vaccines

In funding information, price range paperwork point out that the Biden administration may run out of COVID-19 vaccines by Sep 1 if it strikes ahead with plans to encourage all adults to get a second booster shot, Stat studies.

At the moment, adults 50 and older and people immunocompromised are really helpful to get a second booster—or 4 photographs complete for mRNA vaccines—however many specialists consider that suggestion will widen earlier than this fall.

In different federal information, over 260 journey trade and enterprise organizations are calling on the Biden administration to finish its COVID-19 testing requirement for vaccinated worldwide passengers coming into the nation, Axios studies.

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