Tag: Johnson & Johnson

FDA expects J&J vaccine pause to last “a matter of days”

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The U.S. FDA on Tuesday recommended an immediate halt of the use of Johnson & Johnson’s COVID-19 vaccine, citing cases of a rare blood clot disorder that six women developed within two weeks of receiving the shot.

The latest: Acting FDA Commissioner Janet Woodcock said at a briefing that she expects the pause to only last “a matter of days,” as health officials investigate the data surrounding the “extremely rare” blood clots.

Driving the news: The FDA’s recommendation was issued “out of an abundance of caution” and to prepare health providers to recognize and treat patients appropriately, since these types of blood clots require a different kind of treatment. Continue reading.

J&J says its one-shot vaccine is 66% effective against moderate to severe COVID

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Johnson & Johnson announced Friday that its single-shot coronavirus vaccine was 66% effective in protecting against moderate to severe COVID-19 disease in Phase 3 trials, which was comprised of nearly 44,000 participants across eight countries.

Between the lines: The vaccine was 72% effective in the U.S., but only 57% effective in South Africa, where a more contagious variant has been spreading. It prevented 85% of severe infections and 100% of hospitalizations and deaths, according to the company.

The big picture: The vaccine is not as effective as some of its two-dose competitors, but still provides strong protection against the most serious COVID-19 symptoms.  Continue reading.

Ellison: Minnesota receiving $3.1 million in settlements with Walgreens, Johnson & Johnson

Credit: Leila Navidi, Star Tribune file

Minnesota was among dozens of states to file suit against the two health companies.

Minnesota will receive $3.1 million through settlements reached in three multi­state health care fraud-related lawsuits filed against Walgreens and Johnson & Johnson.

The largest share of the money, more than $2.1 million, comes from a $120 million settlement reached this month in a lawsuit filed by Minnesota and 45 other state attorneys general against Johnson & Johnson that alleged its subsidiary, DePuy, made misleading claims about how long its metal-on-metal hip-implant devices would last. The devices failed faster than DePuy claimed, according to Minnesota Attorney General Keith Ellison, requiring implant revision surgeries and causing pain, allergic reactions and other adverse health effects.

Minnesota was also part of two lawsuits filed by numerous states against Walgreens that began as whistleblower complaints. One suit, from which Minnesota will recover more than $761,000, alleged that Walgreens knowingly sent “hundreds of thousands” more insulin pens than needed to Medicare, Medicaid and other federal health care beneficiaries — improperly billing the federal health programs in the process.

View the complete January 25 article by Stephen Montemayor on The Star Tribune website here.