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Tuesday, May 11, 2021
More J&J troubles: Vaccine manufacturing halted and more possible clot cases

More J&J troubles: Vaccine manufacturing halted and more possible clot cases

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Enlarge / The Emergent BioSolutions plant, a manufacturing partner for Johnson & Johnson's Covid-19 vaccine, in Baltimore, Maryland, on April 9, 2021. Covid-19 Coverage View more stories The US Food and Drug Administration last week asked Emergent BioSolutions to stop making Johnson & Johnson’s COVID-19 vaccine at its troubled facility in Baltimore, according to a…
The very common vaccine ingredient at the center of J&J, AstraZeneca drama

The very common vaccine ingredient at the center of J&J, AstraZeneca...

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Enlarge / Adenoviruses seen via transmission electron microscopy. Covid-19 Coverage View more stories Out of an abundance of caution, US officials on Tuesday recommended pausing use of Johnson & Johnson’s COVID-19 vaccine. Officials linked the vaccine to six peculiar illnesses in which people developed life-threatening blood clots in combination with low levels of blood platelets,…
J&J COVID vaccine use paused due to one-in-a-million complication

J&J COVID vaccine use paused due to one-in-a-million complication

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Enlarge / A nurse practitioner named Heidi Johnson administers a vaccine from Johnson & Johnson. Covid-19 Coverage View more stories On Tuesday morning, the US Centers for Disease Control and Food and Drug Administration issued a release acknowledging an extremely rare clotting disorder was associated with the use of the Johnson & Johnson COVID vaccine.…
Factory mix-up spoils 15 million doses of J&J COVID vaccine

Factory mix-up spoils 15 million doses of J&J COVID vaccine

Enlarge / A sign at the Johnson & Johnson campus on August 26, 2019 in Irvine, California. Covid-19 Coverage View more stories About 15 million doses of Johnson & Johnson’s one-shot COVID-19 vaccine were ruined, and future vaccine shipments will be delayed. This all follows a mix-up at a manufacturing facility in Baltimore, according to…
FDA authorizes J&J COVID vaccine after unanimous vote [Updated]

FDA authorizes J&J COVID vaccine after unanimous vote [Updated]

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Enlarge / A sign at the Johnson & Johnson campus on August 26, 2019 in Irvine, California. Update, 2/27/2021 7:20pm EST: The US Food and Drug Administration on Saturday evening granted emergency use authorization for Johnson & Johnson's COVID-19 vaccine. The vaccine is the third authorized in the US and the first to require only…
FDA panel votes unanimously in favor of authorizing J&J vaccine

FDA panel votes unanimously in favor of authorizing J&J vaccine

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Enlarge / A sign at the Johnson & Johnson campus on August 26, 2019 in Irvine, California. After a day-long meeting Friday, an advisory panel for the US Food and Drug Administration voted 22 to 0 to recommend issuing an Emergency Use Authorization for Johnson & Johnson’s single-shot, refrigerator-stable COVID-19 vaccine. If the FDA accepts…
Johnson & Johnson’s vaccine safe and effective, FDA review concludes

Johnson & Johnson’s vaccine safe and effective, FDA review concludes

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Enlarge / A sign at the Johnson & Johnson campus on August 26, 2019 in Irvine, California. Covid-19 Coverage View more stories Johnson & Johnson’s single-shot COVID-19 vaccine is effective and has a “favorable safety profile,” according to scientists at the Food and Drug Administration. The endorsement comes out of a review released by the…
Pfizer vaccine doesn’t need ultra-cold storage after all, company says

Pfizer vaccine doesn’t need ultra-cold storage after all, company says

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Enlarge / A picture taken on January 15, 2021 shows a pharmacist holding with gloved hands a vial of the undiluted Pfizer-BioNTech vaccine for COVID-19. Covid-19 Coverage View more stories In a bit of good news, Pfizer and BioNTech announced today that their highly effective COVID-19 vaccine does not require ultra-cold storage conditions after all…
Tweaking COVID vaccines to fight variants won’t require big trials, FDA says

Tweaking COVID vaccines to fight variants won’t require big trials, FDA...

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Covid-19 Coverage View more stories With concerning coronavirus variants erupting around the world, the US Food and Drug Administration is ironing out how to rapidly review vaccine tweaks that better protect against the mutants—and the regulatory agency is turning to its experience with annual flu shots to do so. In a statement late Thursday, the…
FDA blindsided as Trump Admin cripples agency on its way out

FDA blindsided as Trump Admin cripples agency on its way out

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Enlarge / Stephen Hahn, commissioner of the US Food and Drug Administration. The US Food and Drug Administration is under siege from the Trump Administration, which is forcing through a steady stream of changes in its final days that threaten the remaining independence of the regulatory agency. Perhaps the most dramatic meddling came on Monday,…

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