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Emergent BioSolutions ruined 15 million of Johnson & Johnson COVID-19 vaccine doses back in March. Photo: Saul Loeb/AFP via Getty Images

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.

Go deeper

Tina Reed, author of Vitals
Sep 17, 2021 - Health

Key FDA committee takes on the big booster question

Illustration: Sarah Grillo/Axios

A key FDA advisory committee is meeting today to discuss Pfizer's proposal for a COVID vaccine booster — but it will set the stage for the entire booster debate.

The big question: Not only whether experts believe there’s enough evidence to support boosters, but also whether they believe additional shots should be made available for everyone or limited to older Americans and the immunocompromised.

Sep 17, 2021 - Health

FDA advisory panel recommends Pfizer boosters for those 65 and older

A healthcare worker prepares a dose of the Pfizer-BioNTech Covid-19 vaccine at the Key Biscayne Community Center on Aug. 24, 2021. Photo: Eva Marie Uzcategui/Bloomberg via Getty Images

A key Food and Drug Administration advisory panel on Friday overwhelmingly voted against recommending Pfizer vaccine booster shots for younger Americans, but unanimously recommended approving the third shots for individuals 65 and older, as well as those at high-risk of severe COVID-19.

Why it matters: While the votes are non-binding, and the FDA must still make a final decision, Friday's move pours cold water on the Biden administration's plan to begin administering boosters to most individuals who received the Pfizer vaccine later this month.

Updated 10 hours ago - Politics & Policy

Omicron dashboard

Illustration: Shoshana Gordon/Axios

  1. Health: It's very difficult to get access to antiviral COVID treatments — Axios-Ipsos poll: Omicron's big numbersAnother wave of death — FDA limits use of Regeneron and Lilly antibody treatments.
  2. Vaccines: Pfizer begins clinical trial for Omicron-specific vaccine — The shifting definition of fully vaccinated.
  3. Politics: New York Supreme Court grants stay for indoor mask mandate — Neil Young demands Spotify take down music over vaccine misinformation — Biden admin withdraws temporary vaccine-or-test mandate for large employers.
  4. World: U.K. to lift travel testing requirement for fully vaccinated — Beijing Olympic Committee lowers testing threshold ahead of Games.
  5. Variant tracker