Pharmaceutical Processing World

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

Factory error ruins 15M J&J COVID-19 vaccine doses

By Brian Buntz | March 31, 2021

Johnson & JohnsonEmployees at an Emergent BioSolutions (NYSE:EBS) facility in Baltimore made a mistake several weeks ago when formulating the ingredients for Johnson & Johnson’s COVID-19 vaccine, requiring 15 million doses of it to be discarded.

A quality control process revealed that one batch of a drug substance for the J&J COVID-19 vaccine “did not meet quality standards,” according to a statement from Johnson & Johnson.

The batch did not reach the fill-and-finish stage of manufacturing.

Emergent BioSolutions is a contract manufacturer for both Johnson & Johnson (NYSE:JNJ) and AstraZeneca (LON:AZN).

The mistake could delay the FDA’s authorization of Emergent BioSolutions production lines for the Johnson & Johnson COVID-19 vaccine.

The error also led Johnson & Johnson to increase its oversight over the vaccine production at the Emergent BioSolutions site.

Current shipments of J&J vaccines, which were produced in the Netherlands, remain unaffected.

Robert Kramer, Emergent BioSolutions president and CEO, stressed that the error was not a result of a mixing of ingredients of vaccines from Johnson & Johnson and AstraZeneca, as the Washington Post and others had reported.  “It wasn’t the case where an ingredient from one vaccine contaminated or impacted another,” Kramer told CNBC. “It was more simply the fact that one production run — one batch of product — was determined to be inconsistent with our quality specifications.”

Johnson & Johnson still expects to produce more than one billion doses of the COVID-19 vaccine by the end of the year.

Emergent BioSolutions was also the focus of a recent exposé from The New York Times, which described its efforts to lobby the U.S. government to buy millions of anthrax vaccine doses. As a result, the paper argued, the U.S. had relatively little money left over for pandemic response.

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 >

Great Point Partners logo.
Great Point Partners acquires majority stake in Eutecma to fuel sustainable cold chain growth
Antheia_Logo (1)
Pharma ingredient manufacturer Antheia raises $56M Series C
Prolific Machines logo.
Prolific Machines enters FDA program to enhance therapeutics manufacturing platform
Genentech roche
Roche, Genentech to build $700M drug manufacturing plant in North Carolina
“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
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE