Science & Tech

FDA puts the brakes on J&J vaccine after 9th clotting death reported

Boxes of Johnson & Johnson's Janssen COVID-19 vaccine at a vaccination site in Florida.
Enlarge / Boxes of Johnson & Johnson’s Janssen COVID-19 vaccine at a vaccination web site in Florida.

The US Food and Drug Administration restricted using the Johnson & Johnson (Janssen) COVID-19 vaccine late Thursday, citing the chance of a really uncommon however extreme clotting dysfunction referred to as thrombosis with thrombocytopenia syndrome (TTS).

From now on, the J&J vaccine is simply for use in folks ages 18 and up who’re unable or unwilling to obtain an alternate COVID-19 vaccine. That consists of individuals who have had a life-threatening allergic response (anaphylaxis) to an mRNA COVID-19 vaccine, individuals who have private considerations about mRNA COVID-19 vaccines and would in any other case not get vaccinated, and individuals who haven’t got entry to mRNA COVID-19 vaccines.

The limitation comes because the FDA and the Centers for Disease Control and Prevention have been intently monitoring individuals who acquired J&J COVID-19 vaccinations for TTS. To date, the businesses have recognized and confirmed 60 instances of TTS linked to the vaccine, together with 9 deaths. That represents a price of three.23 TTS instances per million doses of J&J vaccine administered, and a price of 0.48 TTS deaths per million doses of vaccine administered, the FDA stated Thursday.

Though the dangers are small, the FDA decided that they are pointless dangers for most individuals to take, given the extensive availability of mRNA vaccines (made by Moderna and Pfizer-BioNTech) which are equally efficient and don’t carry such dangers of extreme illness and demise.

The FDA’s choice follows a downgraded suggestion from the Centers for Disease Control and Prevention final December, which said that the mRNA COVID-19 vaccines are most popular over the J&J vaccine. The CDC outlined particular cases through which the J&J vaccine might be thought-about, which match the makes use of listed by the FDA.

Limits and dangers

In an announcement Thursday, high vaccine regulator Peter Marks defined the timing of the FDA’s transfer. “We recognize that the Janssen COVID-19 vaccine still has a role in the current pandemic response in the United States and across the global community. Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals,” he stated, and “demonstrates the robustness of our security surveillance techniques and our dedication to making sure that science and information information our choices. … The company will proceed to observe the protection of the Janssen COVID-19 Vaccine and all different vaccines, and as has been the case all through the pandemic, will completely consider new security data.”

TTS is a extreme situation marked by the bizarre mixture of blood clots blocking a blood vessel, aka thrombosis, and thrombocytopenia, an general low rely of blood platelets, which assist blood clot. The situation could be notably harmful if the blood clot impacts the mind, corresponding to in cerebral venous sinus thrombosis (CVST), which is a uncommon however life-threatening sort of stroke that forestalls blood from draining out of the mind.

The danger of TTS from the J&J vaccine—which makes use of an adenovirus-based vaccine design—was first recognized in early April 2021, at which level the CDC paused use of the vaccine. The FDA and CDC lifted the pause later that month after figuring out that the vaccine’s advantages in stopping COVID-19 outweighed the small danger of growing TTS. It nonetheless stays unclear how the vaccine might set off the situation in uncommon cases, nonetheless researchers hypothesized that one thing in regards to the adenovirus-based vaccine might set off an immune response that results in platelet activation and low platelet ranges. Another adenovirus-based COVID-19 vaccine, made by AstraZeneca, has additionally been linked to uncommon instances of TTS.

Amid the TTS experiences, the CDC’s pause, and early medical trial information exhibiting that mRNA vaccines outperformed the J&J vaccine, use of the troubled adenovirus-based vaccine plummeted within the US. Of the 577 million doses administered thus far, solely 18.7 million had been J&J vaccines.

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