Show an ad over header. AMP

I am the FIRST

FDA clears 10 million J&J vaccine doses from contaminated Baltimore plant

The Food and Drug Administration said Friday that it's allowing for the release of two batches of the Johnson & Johnson COVID-19 vaccine made at the Emergent BioSolutions facility in Baltimore, where 100 million doses had been set aside for review after an accidental contamination.

Why it matters: The two authorized batches amount to approximately 10 million doses of J&J's single-shot vaccine, according to AP. The doses could end up being used in the U.S. or exported to other countries.


The state of play: The FDA said it conducted a "thorough review of facility records" provided by Emergent — one of several contractors used by J&J to produce the vaccine in bulk — and concluded that the batches are "suitable" for use.

  • The agency noted that the authorization for use of those specific doses does not mean the Emergent BioSolutions plant will be included as an authorized manufacturer for the J&J vaccine.
  • The FDA identified some batches that were not suitable for use and said that others are still under review. The New York Times reported that the FDA determined 60 million doses must be thrown out.

Background: In March, workers at the Baltimore plant, which had been producing Johnson & Johnson and AstraZeneca vaccines, conflated the ingredients of the two vaccines, destroying 15 million doses of the J&J vaccine.

  • J&J said at the time that it identified a vaccine batch that "did not meet quality standards."
  • The plant had to cease making J&J vaccines altogether while the FDA conducted an investigation of the facility. Inspectors reported "unsanitary conditions, poorly trained employees and other problems," according to AP.

The big picture: The FDA also authorized an extension of the J&J vaccine's shelf life from three months to 4.5 months, after state health officials raised concerns that a slowdown in vaccine uptake could cause hundreds of thousands of doses to expire.

Southwest heat wave intensifies, 40 million likely to see 100-degree temperatures

A punishing and long-enduring heat wave is intensifying in parts of the West and Southwest, with heat warnings and advisories in effect across seven states Wednesday. The heat will not relent until late in the weekend.

Threat level: In the coming days, 40 million are likely to see temperatures reach or exceed 100 degrees.

Keep reading... Show less

Lordstown Motors: A tale of hubris, political pandering and regulatory failure

Lordstown Motors is the quintessential business fiasco. Equal parts hubris, political pandering and regulatory failure.

Why it matters: There's no indication that anyone will learn their lesson, except perhaps for some random retail investors who didn't diversify.

Keep reading... Show less

GM boosts investment in electric, autonomous vehicles by $8 billion

General Motors plans to boost its cumulative investment in electric and autonomous vehicles to $35 billion from 2020-2025, a significant jump from a $27 billion target.

Driving the news: GM said this morning that the initiative will include building two new battery cell manufacturing plants in addition to the two already under construction in Tennessee and Ohio.

Keep reading... Show less

Biden administration buys 200 million additional doses of Moderna’s COVID vaccine

The Biden administration has purchased an additional 200 million doses of Moderna’s coronavirus vaccine, the biotech company announced Wednesday.

Why it matters: Moderna says the additional doses could be used to vaccinate children or — if necessary — as a booster shot.

Keep reading... Show less

Live updates: Biden and Putin land in Geneva ahead of summit

President Biden is set to meet with Russian President Vladimir Putin in Geneva for five hours of talks on Wednesday, a highly anticipated summit that comes as both sides say U.S.-Russia relations have sunk to a new post-Cold War low.

The latest: Putin arrived in Geneva shortly before 7 a.m. ET and traveled via motorcade to Villa La Grange, a mansion set in a 75-acre park overlooking Lake Geneva. Biden arrived at around 7:20 a.m. ET. The two leaders are expected to take a photo with Swiss President Guy Parmelin before the meeting begins.

Keep reading... Show less

Biden-Putin summit: What to expect when you're not expecting much

After a bitter blast from Putin and tough talk from Biden, both sides agree: Don't count on much from Wednesday's summit between President Biden and Russian President Vladimir Putin.

What they're saying: "We’re not expecting a big set of deliverables out of this meeting," a senior Biden administration official told reporters on Air Force One from Brussels to Geneva. "No breaking of bread."

Keep reading... Show less

Florida's early reopening could make it a business travel mecca

As post-pandemic business travel comes back, experts say Florida's reopening policies should allow it to lock in a significant share of returning corporate events and meetings.

Why it matters: There's a lot of money to be made — with a lot of people itching to travel — after the sector lost $97 billion in spending last year, according to a new Tourism Economics analysis by the U.S. Travel Association.

Keep reading... Show less

There isn’t a worker shortage in the U.S. — there’s been a worker awakening

Many politicians, pundits and business owners have said pandemic-era enhanced unemployment benefits are keeping would-be workers at home. But that's a much too simplistic explanation of today's employment situation.

The big picture: Many hard-hit sectors are rebounding faster than anecdotal evidence would suggest. And when jobs are hard to fill, a broader worker awakening over the past year is part of the reason.

Keep reading... Show less

Insights

mail-copy

Get Goodhumans in your inbox

Most Read

More Stories