Emerging: FDA leaving troubled COVID vaccine factory

The Crypto Daily - Movers and Shakers - May 5, 2021

Since April, FDA inspectors have combed the factory and reviewed security camera footage to identify lapses in handling material inside the factory and worked with Gaithersburg, Maryland-based Emergent to resolve a host of problems, including unsanitary conditions and poorly trained workers. The agency also has been reviewing data on months’ worth of vaccine substance made in the factory and has allowed several large batches of vaccine doses made from it to be released for distribution.

The Baltimore factory was shut down by the FDA in mid-April due to contamination problems that forced the company to trash the equivalent of tens of millions of doses of vaccine it was making under contract for Johnson & Johnson. The bulk vaccine was contaminated with an ingredient for AstraZeneca’s COVID-19 vaccine, which was being made in the same factory. The process of restarting operations began Thursday, but it will take time for the factory to ramp up and reach the production level of before the shutdown, according to Emergent spokesman Matt Hartwig. Shares of Emergent rose $1.31, or 2%, to $66.47 in afternoon trading Thursday.

Emergent is one of several J&J contractors that produce its one-shot vaccine in bulk. The concentrated vaccine then is shipped to other factories for final steps, including diluting them to the correct strength, putting them in vials and packaging them up. The lapses at the Bayview factory have hampered J&J’s efforts to be a major player in vaccinating people, particularly in remote areas and poor countries, given that it’s the only drugmaker with an authorized vaccine that only requires one dose and standard refrigeration. It’s also cheaper than some other vaccines.

The productions problems have forced J&J to import millions of doses from its factory in the Netherlands to the U.S. and to miss supply commitments. Emergent Chief Executive Robert Kramer said the company had fallen short of the public’s expectations. Emergent’s factory had a history of FDA citations for problems including mold, dirty walls and floors, poorly trained employees and an inadequate strategy to prevent contamination, yet it was given a huge role in COVID-19 vaccine production by the Trump administration. Emergent was handed a lucrative contract to make many millions of COVID-19 vaccines for both J&J and AstraZeneca at the Bayview factory.

The Biden administration has been working to find a different American manufacturing partner for British drugmaker AstraZeneca, whose COVID-19 vaccine isn’t authorized for distribution in the U.S. ___ Follow Linda A. Johnson at https://twitter.com/LindaJ_onPharma

The News Highlights

  • Emerging: FDA leaving troubled COVID vaccine factory
  • Check the latest update on business news
Disclaimer: If you need to edit or update this news from compsmag then kindly contact us Learn more

For Latest News Follow us on Google News


Latest Headlines
  • Show all
  • Trending News
  • Popular By week
As a result of a new report that beefs up production and supplier details, the Apple Car is once again on the rise
As a result of a new report that beefs up production and supplier details, the Apple Car is once again on the rise
Apple Reportedly Looking At Partnerships With Korean Battery And Powertrain For Purported Apple Car DigiTimes’ report, hidden behind a paywall, states that ...
Before thousands of companies that need employees, migrate to Florida this season
Before thousands of companies that need employees, migrate to Florida this season
“We’re looking for everything right now,” he said. “Servers, cooks, bartenders with experience. But if no experience, we can train.” Augusto Marenco, a manager ...
Waco Region Records Highest COVID-19 Hospitalization Rate in Texas |  local news
Waco Region Records Highest COVID-19 Hospitalization Rate in Texas | local news
McLennan County’s full vaccination rate for residents 12 or older has increased relatively quickly, from 43% to 48%, in the past month, but the pandemic is ...
Samsung Develops a 200-Megapixel Sensor for Phone Cameras in the Future
Samsung Develops a 200-Megapixel Sensor for Phone Cameras in the Future
On Friday, Samsung revealed it’s created the world’s first 200-megapixel image sensor, with a pixel size of 0.64μm.The sensor, dubbed the Isocell HP1, is ...
Sensata Technologies Reports First Quarter 2021 Financial Results
Biden, world leaders promote climate action, promise methane cuts
Biden, in the public opening of the otherwise private talks, hailed a new U.S. agreement with the European Union aiming at cutting the two entities’ ...
WhatsApp is rumoured to be launching the ability to synchronise chats between iOS and Android devices
WhatsApp is rumoured to be launching the ability to synchronise chats between iOS and Android devices
The feature will be available to users of both Android and iOS systems, which means that people will be able to switch from both Android to iOS, and vice ...
Chapter 2 of Deltarune is Now Available on PC and Mac
Chapter 2 of Deltarune is Now Available on PC and Mac
Some of the biggest indie games, like Minecraft, have beat-out titles like Call of Duty and Halo. However, Minecraft was bought out by Microsoft, turning it ...
The NFT market The Block Crypto, an OpenSea mobile app for iOS and Android, is now available
The NFT market The Block Crypto, an OpenSea mobile app for iOS and Android, is now available
The mobile app allows users to connect their OpenSea profile and discover new works, save works to favorites and filter NFT searches based on criteria such ...
Xiaomi shows off its Android smart eyewear concept
Xiaomi shows off its Android smart eyewear concept
Following today’s big reveal, a company spokesperson confirmed to The Verge that Xiaomi has “no plan to actually put them on sale.” For now, the Xiaomi Smart ...
The Xiaomi Pad 5 Resurrects the Android Tablet
The Xiaomi Pad 5 Resurrects the Android Tablet
In Apple’s case, the iPad Mini’s appeal was heightened because, let’s face it, the iPhone 13 and Apple Watch 7 are really just iterations on their ...
Show next
Compsmag - Latest News from tech, business and health
Logo