Baltimore vaccine maker hid potential problem, House report says
Cross-contamination of coronavirus vaccines being made for Johnson & Johnson and AstraZeneca was discovered in March 2021. The company had more than $1.3 billion worth of contracts from the federal government and from Johnson & Johnson and AstraZeneca to make the vaccines. The hold tags indicated a potential quality problem with the vaccine in the containers, the House panel found. After discovery of cross-contamination, the Biden administration suspended the plant’s production of the Johnson & Johnson vaccine in April and permanently halted production of the AstraZeneca vaccine at the plant. But even after the restart in August, problems continued, according to the House report.
washingtonpost.comRegulators limit use of J&J COVID vaccine, citing rare blood clots
Federal regulators are limiting the use of Johnson & Johnson’s COVID-19 vaccine to cases where mRNA vaccines aren’t an option. An exception will be made if an adult elects to receive the J&J shot and would otherwise not receive a COVID-19 vaccine. After further review by the CDC’s advisory committee, and time for physicians to learn how to treat the condition, regulators allowed use of the Johnson & Johnson vaccine to resume. Among them, 393,366 residents received a Johnson & Johnson shot, including only 10,221 since Jan. 1. Spring surge pushes beyond metro Detroit: Michigan COVID data for Thursday, May 5Fire Watch issued for parts of Michigan with warm, dry weekend ahead
mlive.comJ&J lowers 2022 revenue and earnings expectations, stops giving Covid vaccine sales guidance
Johnson & Johnson on Tuesday lowered its full-year sales and earnings outlook, and stopped providing Covid-19 vaccine sales guidance due to a global supply surplus and demand uncertainty. J&J is now forecasting 2022 sales of $94.8 billion to $95.8 billion, about one billion dollars lower than the guidance provided in January. J&J reported first-quarter sales of $23.4 billion, slightly missing Wall Street expectations but growing 5% over the same quarter last year. The company's medical devices business grew by 5.9% to $6.97 billion in sales compared to the first quarter of 2021. "Looking ahead, I remain confident in the future of Johnson & Johnson as we continue advancing our portfolio and innovative pipeline."
cnbc.comJ&J's Janssen settles with WVa for $99M in opioid lawsuit
West Virginia will receive $99 million in a settlement finalized with Johnson & Johnson’s subsidiary Janssen Pharmaceuticals Inc. The state filed a lawsuit accusing the drugmaker of contributing to the opioid crisis in the state that's led the nation in overdose deaths.
Michigan considers how to spend $776 million in opioid settlement money
Michigan is set to receive $776 million from three opioid distributors and an opioid manufacturer, as part of a $26 billion nationwide settlement for their role in the opioid epidemic. The money comes from pharmaceutical distributors Cardinal, McKesson and AmerisourceBergen as well as opioid manufacturer Johnson & Johnson. It’s one of the largest multi-state agreement in U.S. history, second only to the tobacco settlement of 1998. Nessel said the payout could top $1 billion once Purdue Pharma’s still-pending settlement money is added to the pot. RELATED STORIESNew vending machine at Ann Arbor library offers free kits to stop opioid overdosesOne of Michigan’s top payouts from national opioid lawsuits settlement could come to Washtenaw CountyGenesee County to receive nearly $16M from historic opioid settlement
mlive.comUnable to sue, Michigan woman files claim in her mom’s COVID-19 vaccine-related death
Tatum Strieter-Byron is asking the federal government to compensate her for her mother Sandra Jacobs’ death in April of a confirmed complication of the Johnson & Johnson COVID-19 vaccine. It was established because COVID-19 vaccine manufacturers and others are granted liability protections through the Public Readiness Emergency Preparedness Act, enacted in 2005. In 2020, the U.S. Health and Human Services secretary invoked the act and declared COVID-19 a public health emergency, warranting Johnson & Johnson and others immunity from lawsuits. About 18.5 million Johnson & Johnson doses have been administered in the United States, making the side-effect rare. The CDC now recommends the Pfizer and Moderna vaccines over the Johnson & Johnson vaccine because of the risk of serious adverse events.
mlive.comFDA fully approves the Moderna COVID-19 vaccine for adults
The U.S. Food and Drug Administration on Monday, Jan. 31, fully approved the Moderna COVID-19 vaccine. Updated analyses to determine the effectiveness of the Moderna vaccine included 14,287 vaccine recipients and 14,164 placebo recipients 18 and older who did not have evidence of coronavirus infection before receiving their first dose. The Moderna vaccine is the second most commonly administered vaccine in Michigan. Fewer than 400,000 people received the Johnson & Johnson and about 43,000 got the booster. The Pfizer and Moderna mRNA vaccines are preferred to the Johnson & Johnson vaccine, linked to deaths from a rare, but serious blood clotting disorder.
mlive.comJ&J expects more than $3 billion in Covid vaccine sales this year in mixed quarterly report
Johnson & Johnson on Tuesday projected that its Covid vaccine would generate $3 billion to $3.5 billion in sales in 2022, after posting a mixed fourth-quarter report that slightly beat on earnings' estimates but missed on revenue. Revenue: $24.8 billion, vs. $25.29 billion expectedCFO Joseph Wolk told CNBC a strengthening dollar negatively impacted top line sales by $150 million to $200 million. Hospital staffing shortages caused by the omicron Covid variant also generated uncertainty in the company's medical devices business, particularly with elective procedures, Wolk said. J&J reported $93.77 billion in sales in 2021, a 13.6% increase over the prior year. J&J said it expects to generate $10.40 to $10.60 in earnings per share this year and $98.9 billion to $100.4 billion in revenue.
cnbc.comCDC endorses Pfizer, Moderna COVID-19 vaccines over Johnson & Johnson
Individuals unable or unwilling to receive an mRNA vaccine will continue to have access to the Johnson & Johnson vaccine, approved in February for American adults, the CDC reported. There is not an increased risk of the disorder after doses of the Pfizer and Moderna vaccines, according to the CDC. In April, the Johnson & Johnson vaccine brought about the death of a Michigan woman, 60-year-old Sandra Jacobs of Saline. Johnson & Johnson is the least commonly administered of the three vaccines. In April, when distribution of the Johnson & Johnson vaccine resumed after a pause to explore the reports of TTS, it was said to be 90% effective against hospitalization.
mlive.comAdvisory committee recommending Pfizer, Moderna vaccines over J&J vaccine, linked to 9 deaths
A federal vaccine advisory committee is now recommending the Pfizer and Moderna vaccines over the Johnson & Johnson vaccine, linked to rare but serious blood clotting disorder, according to the Associated Press. In April, the Johnson & Johnson vaccine brought about the death of a Michigan woman, 60-year-old Sandra Jacobs of Saline. RELATED: Michigan woman’s death caused by rare Johnson & Johnson COVID vaccine side effect, autopsy report saysJust five days earlier, federal health agencies temporarily paused the vaccine administration while they examined the vaccine and TTS. Federal heath authorities already have said that those receiving the Johnson & Johnson vaccine could get a Moderna or Pfizer booster shot. Early data indicated a dose of mRNA vaccine after the Johnson & Johnson vaccine would be better than a second dose of the Johnson & Johnson shot, providing a greater rise in antibodies.
mlive.comCDC reports heart inflammation cases among young kids who got Pfizer COVID-19 shot
The U.S. Centers for Disease Control and Prevention said on Thursday it had received reports of eight cases of myocarditis, a type of heart inflammation, in children aged 5-11 years who received Pfizer and BioNTech's COVID-19 vaccine.
news.yahoo.comCDC expert panel prefers Pfizer, Moderna vaccines over J&J shots for adults due to rare blood clot cases
The Advisory Committee on Immunization Practices voted unanimously to recommend Pfizer and Moderna over the Johnson & Johnson vaccine. Seventeen men developed TTS. A week later, the FDA and the CDC lifted the pause on J&J shots after the independent advisory panel said the benefits of the shots outweighed the risks. In October, the FDA and CDC authorized J&J boosters for all adults at least two months after receiving their initial J&J shot. People who received their primary vaccination with the J&J shot can also get boosted with the Pfizer or Moderna vaccines.
cnbc.comReport: US cancels vaccine maker’s multimillion dollar deal
The federal government has canceled a multimillion dollar deal with Emergent BioSolutions, a Maryland- based vaccine manufacturer with facilities in Baltimore that were found to have produced millions of contaminated vaccine doses this spring.
Reports: FDA expected to OK ‘mix-and-match’ COVID vaccine boosters
The Food and Drug Administration is expected to announce this week people will be able to receive a COVID-19 vaccine booster shot with a vaccine from a different manufacturer than their original doses, according to reports in the New York Times, Washington Post and Wall Street Journal.
Michigan business groups urge Biden to reconsider vaccine, testing mandate
Michigan business groups are urging President Joe Biden to reconsider a plan to require most workers to get vaccinated or regularly tested for COVID-19 but say, if it is enacted, Gov. Gretchen Whitmer should ensure related state rules are no stricter.
FDA advisory panel to meet on Moderna, Johnson & Johnson COVID vaccine booster shots
The Food and Drug Administration’s vaccine advisory panel is set to meet Thursday and Friday, Oct. 14-15, and we are getting our first look at the data the panel will be using to make its recommendation on booster shots for Moderna and Johnson & Johnson.