Medical Testing

FDA new guidance: Vaccines Adapted for Variants Will Not Need Lengthy Testing

Tue, 2021-02-23 10:04 — mike kraft

The Food and Drug Administration said on Monday that vaccine developers would not need to conduct lengthy randomized controlled trials for vaccines that have been adapted to protect against concerning coronavirus variants.

The recommendations, which call for small trials more like those required for annual flu vaccines, would greatly accelerate the review process at a time when scientists are increasingly anxious about how the variants might slow or reverse progress made against the virus.

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TheHill.com Johnson & Johnson ready to provide doses for 20M Americans by end of March

Mon, 2021-02-22 20:14 — mike kraft

Johnson & Johnson ready to provide doses for 20M Americans by end of Johnson & Johnson said Monday that it plans to have enough doses of its vaccine for more than 20 million Americans by the end of March if its vaccine is authorized by the Food and Drug Administration. Peter Sullivan TheHill

Johnson & Johnson said Monday that it plans to have enough doses of its vaccine for more than 20 million Americans by the end of March if its vaccine is authorized by the Food and Drug Administration.

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FDA issues alert on ‘limitations’ of pulse oximeters, which have accuracy problems with darker skin personsth

Mon, 2021-02-22 19:48 — mike kraft

FDA issues alert on the 'limitations' of pulse oximeters Experts and lawmakers have expressed concern about potential racial disparities in the readings of pulse oximeters. Erin Brodwin STAT

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Although US Covid-19 numbers may be slowing experts project tens of thousands more deaths in next 3 months

Sun, 2021-02-21 11:13 — mike kraft

US Covid-19 numbers may be slowing but experts project tens of thousands more deaths in next 3 months Covid-19 trends may be encouraging in recent weeks -- but a new forecast offered a grim reminder the US is not in the clear. Christina Maxouris, CNN CNN

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Analysis

ANALYSIS: Most vaccine clinical trials fail to report data on participants’ ethnicity or race

Fri, 2021-02-19 12:33 — mike kraft

Most vaccine trials fail to report data on participant ethnicity or race - STAT Of the 230 trials researchers examined, more than 40% did not record participants’ race and about 65% did not report their ethnicity. Nicholas St. Fleur STAT

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The difficulties in enrolling teenagers for vaccine test trials.

Thu, 2021-02-18 11:06 — mike kraft

Teenagers contract the novel coronavirus almost twice as often as younger children but vaccines authorized in the United States are mostly for adults — Moderna’s for 18 and older, Pfizer’s for 16 and up.

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