Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Advertise
  • SUBSCRIBE

FDA curtails use of Janssen COVID-19 vaccine over blood clotting concerns

By Brian Buntz | May 6, 2022

FDA logoThe FDA has decided to limit the use of the COVID-19 vaccine to individuals at least 18 years old who cannot receive other authorized or approved COVID-19 vaccines. The agency also will authorize its use for individuals who would “otherwise not receive a COVID-19 vaccine.”

FDA came to the conclusion after reviewing data related to a rare clotting disorder known as thrombosis with thrombocytopenia syndrome (TTS) in a number of Janssen vaccine recipients roughly one or two weeks after vaccination.

FDA has added a warning describing the risk of TTS to the fact sheet for healthcare providers administering the Janssen vaccine.

“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,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a press release.

Janssen COVID-19 vaccine

Janssen COVID-19 vaccine [Image courtesy of Wikimedia Commons]

The FDA temporarily suspended the Janssen vaccine’s use on April 13, 2021, after receiving TTS reports after authorizing its use on February 27 of that same year. After lifting the pause later in April 2021, FDA recommended mRNA vaccines over Janssen’s adenovirus-vectored vaccine in December 2021.

The European Medicines Agency uncovered a possible link between the AstraZeneca Vaxzevria COVID-19 vaccine and rare blood clots last year.

The AstraZeneca COVID-19 vaccine has not been authorized in the U.S.

The AstraZeneca and Janssen vaccines both rely on a viral-vector platform, whereas the vaccines from Pfizer and Moderna are mRNA-based.

To date, U.S. authorities have identified 60 cases of TTS, including nine that were fatal.

FDA concluded that there were 3.23 reports of TTS per million vaccine doses administered.

Janssen notes that current data indicate that the vaccine maintains a favorable benefit-risk profile given its ability to protect against COVID-19.

Unlike the FDA-approved COVID-19 vaccines from Pfizer and Moderna, the Janssen vaccine remains only available under emergency use authorization.

In early afternoon trading, JNJ shares were down about 1% to $175.38.

About The Author

Brian Buntz

The pharma and biotech editor of WTWH Media, Brian is a veteran journalist with more than 15 years of experience covering an array of life science topics, including clinical trials, drug discovery and development and medical devices. Before coming to WTWH, he served as content director focused on connected devices at Informa. In addition, Brian covered the medical device sector for 10 years at UBM. At Qmed, he overhauled the brand’s news coverage and helped to grow the site’s traffic volume dramatically. He had previously held managing editor roles on two of the company’s medical device technology publications. Connect with him on LinkedIn or email at bbuntz@wtwhmedia.com.

Tell Us What You Think! Cancel reply

Related Articles Read More >

Doctor, woman patient and tablet for consulting with results, medical info and talk for healthcare with mockup space. Japanese medic, digital touchscreen or show video for surgery, wellness or advice.
Putting patients first in clinical trials
Confidently navigate the transition from bench to batch
Merck
FDA approves Merck’s Winrevair to treat pulmonary arterial hypertension
kobayashi pharmaceutical logo
Report: Japan health authorities investigate Kobayashi Pharmaceutical factory after five deaths
“ppw
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news, technologies, and developments in Pharmaceutical Processing.

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Pharmaceutical Processing World
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index
  • R&D 100 Awards

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Advertise
  • SUBSCRIBE