Connect with us

Business

US FDA Asks J&J to Discard Millions of COVID-19 Vaccine Doses

Published

on

US FDA Asks J&J to Discard Millions of COVID-19 Vaccine Doses

Article content

The US Food and Drug Administration said Friday that Johnson & Johnson must discard millions of doses of its COVID-19 vaccine that were manufactured in a troubled Baltimore factory, but have also authorized millions for use.

Two sources familiar with the situation told Reuters that the agency had authorized about 10 million doses. The New York Times said the discarded batches total about 60 million doses, citing people familiar with the matter.

Without disclosing or confirming the number of vaccine doses, the FDA said in a press release that it had authorized the use of two lots of the vaccine, that several other lots were not suitable for use, and that others were being evaluated.

The agency said it was not yet ready to license the Emergent BioSolutions Inc plant to manufacture the J&J vaccine. US authorities halted J&J vaccine production at the Baltimore site in April and J&J took over manufacturing at the plant.

A source familiar with the matter told Reuters that the doses of J&J are expected to be exported to other countries. The doses are already in vials and ready to use, the other source said.

Safety concerns about the J&J vaccine, along with declining US demand for vaccines overall, have slowed the launch of the single-shot vaccine at an accelerating rate. About half of the 21 million doses produced for the United States remain unused.

Commercial

Article content

The FDA said its decision allows the J&J doses to be used in the United States or exported. The agency said the drug manufacturer and Emergent must agree that the FDA can share relevant information about the manufacture of the doses with the regulators where the vaccine is shipped.

J&J, in a statement, confirmed that the FDA authorized the two batches, but did not recognize the doses that regulators decided should be discarded.

“Today’s decisions represent progress in our continued efforts to make a difference in this pandemic on a global scale,” Kathy Wengel, director of global supply chain at J&J, said in the statement.

The FDA declined to comment beyond its statement.

Last month, Emergent CEO Robert Kramer said he understood that there are 100 million doses of the J&J vaccine ready for FDA review and that regulators had begun the review process.

The April stoppage followed the discovery that ingredients in AstraZeneca’s COVID-19 vaccine, which was also produced at the plant at the time, contaminated a batch of J&J vaccine. AstraZeneca shooting is no longer being done there.

An FDA inspection also revealed a long list of sanitary problems and poor manufacturing practices at the Emergent plant.

Separately, the European drug regulator said on Friday that batches of the J&J COVID-19 vaccine made for the region around the time contamination issues were revealed at the Baltimore plant would not be used, as a precaution.

Commercial

Article content

The European Medicines Agency did not say how many injections were affected, but Reuters reported that it involves millions of doses, making it difficult for J&J to meet the target of delivering 55 million to Europe by the end of June.

Later Friday, Canada’s drug regulator said it would not deliver J & J’s shipment of 300,000 doses of COVID-19 vaccine, which were made at the Baltimore plant.

Health Canada said it was planning an on-site inspection this summer and would not accept any products or ingredients made at the plant until the inspection is complete.

(Reporting by Michael Erman in Maplewood, NJ; additional reporting by Mrinalika Roy and Ankru Bannerjee in Bengaluru; edited by Bill Berkrot and Anil D’Silva)

Commercial

In-depth reports on the economics of innovation from The Logic, presented in association with the Financial Post.

Comments

Postmedia is committed to maintaining a lively but civilized discussion forum and encourages all readers to share their views on our articles. Comments can take up to an hour to moderate before appearing on the site. We ask that you keep your comments relevant and respectful. We have enabled email notifications – you will now receive an email if you receive a response to your comment, there is an update from a comment thread you follow, or if a user you follow comments. Visit our Community Principles for more information and details on how to adjust your E-mail settings.

Continue Reading
Advertisement
Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *

Advertisement
Advertisement

Lifestyle

The 7 best epic novels you will want to read and reread over and over again The 7 best epic novels you will want to read and reread over and over again
LifeStyle8 hours ago

The 7 best epic novels you will want to read and reread over and over again

Despite concerns about the early pandemic that eventually run out of good TVHonestly, I don’t feel like we’ve ever done...

6 small patio design ideas to make the most of your space 6 small patio design ideas to make the most of your space
LifeStyle8 hours ago

6 small patio design ideas to make the most of your space

I think we can all agree that this summer More than ever We are excited to do each and every...

Food delivery companies are popping up in S’pore, but complaints are on the rise Food delivery companies are popping up in S’pore, but complaints are on the rise
LifeStyle8 hours ago

Food delivery companies are popping up in S’pore, but complaints are on the rise

It seems that negative comments about food delivery companies abound online. A quick glance at the Facebook pages of the...

How are delivery-only food and beverage brands affected in cloud kitchens during MCO? How are delivery-only food and beverage brands affected in cloud kitchens during MCO?
LifeStyle9 hours ago

How are delivery-only food and beverage brands affected in cloud kitchens during MCO?

With dinners banned during closures, many restaurants have had to switch online and offer their wares through delivery and takeout....

Malaysian indie game developer behind The Company Man Malaysian indie game developer behind The Company Man
LifeStyle10 hours ago

Malaysian indie game developer behind The Company Man

At a time when many of us are WFH and lacking office culture (or not, there is no judgment here),...

Coworking and coliving hotel in Gua Musang, Kelantan Coworking and coliving hotel in Gua Musang, Kelantan
LifeStyle13 hours ago

Coworking and coliving hotel in Gua Musang, Kelantan

Only recently have we noticed new coworking space launches in Klang Valley slowing down. Considering the pandemic and travel restrictions,...

4 Nutritionist Approved Healthy Foods on Amazon to Update Your Pantry 4 Nutritionist Approved Healthy Foods on Amazon to Update Your Pantry
LifeStyle24 hours ago

4 Nutritionist Approved Healthy Foods on Amazon to Update Your Pantry

In a dream world, healthy, nutrient-dense meals would be easily accessible to everyone. Buying quinoa, leafy greens, and other superfoods...

Where the magic of Tata Harper happens Where the magic of Tata Harper happens
LifeStyle1 day ago

Where the magic of Tata Harper happens

Tata Harper is famous for doing most of the manufacturing of her clean, natural skincare on her farm in Vermont,...

The Best Summer Pasta Salad Recipe You Must Try This Season The Best Summer Pasta Salad Recipe You Must Try This Season
LifeStyle1 day ago

The Best Summer Pasta Salad Recipe You Must Try This Season

I am currently sitting in my parents’ backyard, an oasis in the heart of Northern California, it is my happy...

Top 9 Dating Apps For 30s – Time To Find The Real Deal! Top 9 Dating Apps For 30s – Time To Find The Real Deal!
LifeStyle1 day ago

Top 9 Dating Apps For 30s – Time To Find The Real Deal!

Even if you’re the type of person who loves the thrill of the hunt, the seemingly endless dating carousel can...

Advertisement

Sport

MLB has a rule to avoid ‘bad faith’ substance testing from Joe Girardi and managers like him MLB has a rule to avoid ‘bad faith’ substance testing from Joe Girardi and managers like him
Sports5 mins ago

MLB has a rule to avoid ‘bad faith’ substance testing from Joe Girardi and managers like him

Joe Girardi, the Phillies manager and lifelong baseball player, inserted himself at the heart of the catchy baseball conversation Tuesday...

Domestic violence charges against Derrius Guice dismissed Domestic violence charges against Derrius Guice dismissed
Sports6 mins ago

Domestic violence charges against Derrius Guice dismissed

Domestic Violence Charges Against Former Washington Runner Derrius guice have been fired, since Justin Jouvenal of the Washington Post write....

Pistons win lottery, land No. 1 pick in NBA draft Pistons win lottery, land No. 1 pick in NBA draft
Sports20 mins ago

Pistons win lottery, land No. 1 pick in NBA draft

FILE – Sekou Doumbouya reacts after being selected with the 15th pick by the Detroit Pistons during the 2019 NBA...

Pete Alonso to defend the title in the 2021 Home Run Derby Pete Alonso to defend the title in the 2021 Home Run Derby
Sports27 mins ago

Pete Alonso to defend the title in the 2021 Home Run Derby

New York Mets slugger Pete Alonso is ready to defend his crown. The 26-year-old announced on Wednesday via Instagram that...

Canadiens signs VP of hockey operations John Sedgwick to three-year extension Canadiens signs VP of hockey operations John Sedgwick to three-year extension
Sports42 mins ago

Canadiens signs VP of hockey operations John Sedgwick to three-year extension

We have sent an email with instructions to create a new password. Your current password has not been changed. We...

Adams: Packers players don’t talk about Rodgers situation Adams: Packers players don’t talk about Rodgers situation
Sports50 mins ago

Adams: Packers players don’t talk about Rodgers situation

Apparently, Packers players aren’t discussing the Aaron Rodgers situation and what it will mean if the reigning MVP doesn’t return...

Settlement reached in Kobe Bryant helicopter crash lawsuit Settlement reached in Kobe Bryant helicopter crash lawsuit
Sports1 hour ago

Settlement reached in Kobe Bryant helicopter crash lawsuit

FILE – Investigators work at the scene of the helicopter crash, where former NBA star Kobe Bryant and his 13-year-old...

Euro 2021: Portugal vs France and Germany vs Hungary, Euro 2020 LIVE: Preview, expected line-up, team news and where to watch Euro 2021: Portugal vs France and Germany vs Hungary, Euro 2020 LIVE: Preview, expected line-up, team news and where to watch
Sports1 hour ago

Euro 2021: Portugal vs France and Germany vs Hungary, Euro 2020 LIVE: Preview, expected line-up, team news and where to watch

HHello everyone and welcome to this blog live for the night of this Wednesday. Euro 2020 Group F games, between...

Watch Live: Canucks Introduces Sedins as GM Special Advisers Watch Live: Canucks Introduces Sedins as GM Special Advisers
Sports1 hour ago

Watch Live: Canucks Introduces Sedins as GM Special Advisers

Following Tuesday’s announcement that Henrik and Daniel Sedin will rejoin the Vancouver Canucks as special advisers to the general manager,...

MLB has a rule to avoid ‘bad faith’ substance testing from Joe Girardi and managers like him MLB has a rule to avoid ‘bad faith’ substance testing from Joe Girardi and managers like him
Sports2 hours ago

Phillies manager Joe Girardi explains decision to have Max Scherzer searched for sticky material

Say it’s not like that, Joe. Max Scherzer was checked for sticky material three times Tuesday night, the second day...

Advertisement

Entertainment

Entertainment1 second ago

Alexander Skarsgard to star in Brandon Cronenberg’s thriller

Neon is getting ready to dip his toes back into dark waters with Brandon Cronenberg’s infinity pool. Ready to slip...

Tamar Braxton Praises Nigerian Culture – See Her Message Tamar Braxton Praises Nigerian Culture – See Her Message
Entertainment1 min ago

Tamar Braxton Praises Nigerian Culture – See Her Message

Tamar braxton is promoting Nigerian culture. Look at the message he shared on social media. ‘Everyone who knows me knows...

Lizzo has the funniest reaction to her super short bob Lizzo has the funniest reaction to her super short bob
Entertainment9 mins ago

Lizzo has the funniest reaction to her super short bob

Courtesy of Lizzo / TikTok Well mishap! Lizzo is revealing U.S exactly how you feel about your new ‘do and...

Khloe Kardashian Likes Tweet About Coolest Bitch Amid Tristan Split Khloe Kardashian Likes Tweet About Coolest Bitch Amid Tristan Split
Entertainment19 mins ago

Khloe Kardashian Likes Tweet About Coolest Bitch Amid Tristan Split

Khloe Kardashian she seems to be taking on her inner confidence in her latest breakup with temporary boyfriend Tristan Thompson…...

Chris Pratt talks about time travel in a new feature Chris Pratt talks about time travel in a new feature
Entertainment21 mins ago

Chris Pratt talks about time travel in a new feature

THE WAR OF TOMORROW It will be released exclusively on Amazon Prime Video globally on July 2, 2021, and in...

Gunpowder, Supersonic and Blue Hawk added to ‘the Boys’ season 3 Gunpowder, Supersonic and Blue Hawk added to ‘the Boys’ season 3
Entertainment22 mins ago

Gunpowder, Supersonic and Blue Hawk added to ‘the Boys’ season 3

Boys Season 3 will feature heroes Gunpowder, Supersonic, and Blue Hawk. The third season of Boys is set to be...

Harrison Ford is injured while filming Indiana Jones 5 Harrison Ford is injured while filming Indiana Jones 5
Entertainment30 mins ago

Harrison Ford is injured while filming Indiana Jones 5

Even Indiana Jones it is susceptible to bumps and bruises. star Harrison ford suffered a shoulder injury on the set...

Alex Rodriguez has no plans to date Alex Rodriguez has no plans to date
Entertainment42 mins ago

Alex Rodriguez has no plans to date

June 23, 2021 Alex Rodriguez has no plans to date “for a while.” Jennifer Lopez and Alex Rodriguez The 42-year-old...

Laurence Fishburne and Amber Midthunder! Laurence Fishburne and Amber Midthunder!
Entertainment44 mins ago

Laurence Fishburne and Amber Midthunder!

Friday, Liam Neeson Returns For Some Action In New Netflix Thriller THE ICE ROAD. Directed by Jonathan Hensleigh, the new...

Big Tech Antitrust Legislation Arrives Before House Judiciary Committee – News Block Big Tech Antitrust Legislation Arrives Before House Judiciary Committee – News Block
Entertainment44 mins ago

Big Tech Antitrust Legislation Arrives Before House Judiciary Committee – News Block

UPDATE, 9:57 AM PT: The House Judiciary Committee advanced the first half dozen bills targeting big technologies, passing a bill...

Advertisement

Tech

The Peloton Tread + treadmill requires a membership fee after safety issues and recall The Peloton Tread + treadmill requires a membership fee after safety issues and recall
Tech4 mins ago

The Peloton Tread + treadmill requires a membership fee after safety issues and recall

Peloton has found an interesting solution to its treadmill safety issues, which have been linked to the death of a...

Nvidia Canvas can turn your digital doodles into near-real images Nvidia Canvas can turn your digital doodles into near-real images
Tech8 mins ago

Nvidia Canvas can turn your digital doodles into near-real images

In Word: A couple of years ago, Nvidia introduced an artificial intelligence tool that could take a rough drawing and...

‘IPhone 13’ to impress with new features, iPhone SE 5G coming in early 2022, says Kuo ‘IPhone 13’ to impress with new features, iPhone SE 5G coming in early 2022, says Kuo
Tech18 mins ago

‘IPhone 13’ to impress with new features, iPhone SE 5G coming in early 2022, says Kuo

Beyond an impressive “iPhone 13” in late 2021, Apple will launch a new iPhone SE 5G in the first half...

Ant trapped in ancient amber with a parasitic fungus trapped in its butt Ant trapped in ancient amber with a parasitic fungus trapped in its butt
Tech25 mins ago

Ant trapped in ancient amber with a parasitic fungus trapped in its butt

About 50 million years ago, this ant got stuck in the resin of a tree that also preserved the parasitic...

Scammer arrested for phishing operation, sent 25,000 text messages in one day Scammer arrested for phishing operation, sent 25,000 text messages in one day
Tech29 mins ago

Scammer arrested for phishing operation, sent 25,000 text messages in one day

Police arrested an individual last week for fraudulently texting thousands of people to obtain bank details and defraud them. It...

PairTree, a platform that facilitates adoptions, raises $ 2.25 million to help launch a corresponding app PairTree, a platform that facilitates adoptions, raises $ 2.25 million to help launch a corresponding app
Tech41 mins ago

PairTree, a platform that facilitates adoptions, raises $ 2.25 million to help launch a corresponding app

PairTree CEO Erin Quick and her adopted son and daughter. (Photo courtesy of Quick) New financing: ParaTree, a platform that...

What is Facebook?  – The New York Times What is Facebook?  – The New York Times
Tech48 mins ago

What is Facebook? – The New York Times

This article is part of the On Tech Newsletter. You can sign up here to receive it during the week....

FI Scouts is an iPhone application to gain your financial independence FI Scouts is an iPhone application to gain your financial independence
Tech52 mins ago

FI Scouts is an iPhone application to gain your financial independence

Source: Christian Mitteldorf FI Scouts is a new iPhone application designed to help you on your path to financial independence....

Apple TV + shares the first trailer for ‘Watch the Sound With Mark Ronson’ Apple TV + shares the first trailer for ‘Watch the Sound With Mark Ronson’
Tech1 hour ago

Apple TV + shares the first trailer for ‘Watch the Sound With Mark Ronson’

The first trailer for the Apple TV + documentary series “Watch the Sound With Mark Ronson” features Angel Olsen, Charli...

Warren Buffett resigns from Gates Foundation board Warren Buffett resigns from Gates Foundation board
Tech1 hour ago

Warren Buffett resigns from Gates Foundation board

Warren Buffett announced Wednesday that he will donate $ 4.1 billion of Berkshire Hathaway stock to five foundations, and that...

Advertisement
Advertisement