Newsdeck

Vaccines

Tens of millions of J&J Covid-19 shots sit at Baltimore factory

The J&J vaccine at the Fair Cape Diary Farm on August 05, 2021 in Durbanville, South Africa. (Photo: Gallo Images/Misha Jordaan)

Oct 28 (Reuters) - An estimated 30 million to 50 million doses of Johnson & Johnson's Covid-19 vaccine made early this year sits idle in Emergent BioSolutions Inc's plant in Baltimore awaiting a green light from U.S. regulators to ship, two sources familiar with the matter said.

Emergent, a contract drug manufacturer, is waiting for the U.S. Food and Drug Administration to approve release of those doses. The agency must still inspect and authorize the plant before Emergent can ship newly manufactured drug substance, one of the sources said.

The exact number of doses sitting idle cannot be determined, the source said, because Emergent only makes raw vaccine substance and does not fill vials with finished product.

The FDA in April halted operations at Emergent’s production facility after J&J’s vaccine was found to be contaminated with material from AstraZeneca’s COVID-19 shots, which were also being manufactured there at the time.

The contamination ruined about 15 million J&J doses and set back its U.S. vaccine rollout by weeks.

Material manufactured for the J&J vaccine at the Baltimore plant prior to the April shutdown and awaiting FDA approval could be enough to produce as many as 50 million shots, the two sources said. They asked not to be named because they were not authorized to speak publicly on the issue.

Of the 100 million doses worth of vaccine material Emergent described in an April Congressional hearing as being sidelined, the FDA has so far cleared nine batches of J&J’s vaccine and three batches of AstraZeneca’s. It has not disclosed how many doses were in those batches.

Emergent in late July said it would resume production of J&J’s vaccine at the plant following additional FDA reviews, but has not provided updates on production or timing of potential shipments.

Emergent has begun making new vaccine substance, but the FDA has yet to provide guidance on when it plans to inspect the Baltimore facility, one of the sources said.

The FDA said in a statement that it conducted a limited inspection of Emergent’s facility in July to confirm it had conducted corrective actions following the April production pause. A previous inspection had turned up a raft of sanitary, safety and bad manufacturing practice issues at the plant.

The agency said it has not yet authorized the facility to ship doses and continues to review batches made prior to the production halt. It has based its batch approvals on reviews of facility records and quality testing conducted by the manufacturer.

The FDA typically waits for a drug manufacturing facility to produce multiple batches of its product before conducting an inspection, according to a former FDA official who asked not to be named because she was not authorized to speak with the media.

Following the Emergent plant shutdown, J&J lowered its production target for 2021 to between 500 million and 600 million doses from around 1 billion. It expects to be able to make 1 billion doses annually starting next year.

J&J has not specified whether it needs Emergent to restart production to hit its 2022 target. It has another manufacturing facility in Leiden, Netherlands, and production agreements with other contract manufacturers, including Catalent Inc and India’s Biological E.

The United States contracted with J&J for 100 million shots in 2020 and ordered an additional 100 million in March.

Last week, the FDA authorized J&J’s vaccine as a booster for people who are already vaccinated but desire additional protection against COVID-19, including anyone over age 18 who originally received the company’s single-dose shot.

Use of J&J’s vaccine fell sharply in the United States after it was linked to a rare but potentially lethal blood clotting disorder.

By Carl O’Donnell.

(Reporting by Carl O’Donnell Editing by Caroline Humer and Bill Berkrot).

Information pertaining to Covid-19, vaccines, how to control the spread of the virus and potential treatments is ever-changing. Under the South African Disaster Management Act Regulation 11(5)(c) it is prohibited to publish information through any medium with the intention to deceive people on government measures to address COVID-19. We are therefore disabling the comment section on this article in order to protect both the commenting member and ourselves from potential liability. Should you have additional information that you think we should know, please email [email protected]

Gallery

Please peer review 3 community comments before your comment can be posted

A South African Hero: You

There’s a 99.7% chance that this isn’t for you. Only 0.3% of our readers have responded to this call for action.

Those 0.3% of our readers are our hidden heroes, who are fuelling our work and impacting the lives of every South African in doing so. They’re the people who contribute to keep Daily Maverick free for all, including you.

The equation is quite simple: the more members we have, the more reporting and investigations we can do, and the greater the impact on the country.

Be part of that 0.3%. Be a Maverick. Be a Maverick Insider.

Support Daily Maverick→
Payment options

MavericKids vol 3

How can a child learn to read if they don't have a book?

81% of South African children aged 10 can't read for meaning. You can help by pre-ordering a copy of MavericKids.

For every copy sold we will donate a copy to Gift of The Givers for children in need of reading support.