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The Food and Drug Administration is preparing to announce a new warning for the Johnson & Johnson coronavirus vaccine saying the shot has been linked to a serious but rare side effect called Guillain-Barré syndrome, in which the immune system attacks the nerves...About 100 preliminary reports of Guillain-Barré have been detected after the administration of 12.8 million doses of Johnson & Johnson vaccine in the United States, the Centers for Disease Control and Prevention said in a statement Monday. The cases have largely been reported about two weeks after vaccination and mostly in men, many aged 50 and older...READ MORE

Use of the anti-parasitic drug ivermectin could reduce COVID-19-related deaths, data from a peer-reviewed study shows...The study, published last week in the American Journal of Therapeutics, analyzed data from multiple clinical studies assessing ivermectin as a potential treatment for COVID-19. Ivermectin, which is approved by the U.S. Food and Drug Administration as a treatment for intestinal strongyloidiasis and onchocerciasis...The latest assessment of those multiple studies seems to confirm the potential of ivermectin against COVID-19. However, the FDA currently maintains a web page warning against the unauthorized use of ivermectin to treat the virus...The FDA notes that clinical studies are underway assessing ivermectin against COVID-19, but until those are reviewed and confirmed, it will warn against taking unauthorized medication...READ MORE

The AstraZeneca COVID-19 vaccine takes another hit to its safety profile as the European Medicines Agency adds a new side effect to the label of its shot…The EMA identified a rare blood condition, capillary leak syndrome, as a potential side effect of AstraZeneca’s Vaxzevria. The condition causes plasma leaks from blood vessels into neighboring body cavities and muscles. Blood pressure experiences a sharp drop as a result, and, left untreated, the disorder can lead to organ failure and death…READ MORE

A former pharmacist in Wisconsin who intentionally tampered with more than 500 doses of a COVID-19 vaccine was sentenced to three years in prison on Tuesday. Steven Brandenburg, 46, pleaded guilty in February to two felony counts of attempting to tamper with a consumer product...He had admitted to intentionally removing the doses manufactured by Moderna from a refrigerator for hours at Aurora Medical Center in Grafton, located just north of Milwaukee...READ MORE

Nevada Air Guard Capt. Caleena Longworth knew at the age of 10 that she wanted to be a doctor, and by January of this year, in the final semester of her medical doctorate program, she was one class away...With the class not set to begin until April, UNLV’s Kirk Kerkorian School of Medicine offered her a two-month vacation. Instead, Longworth, an Air Force veteran and native of Reno, started administering thousands of vaccinations to Nevadans at Cashman Center...READ MORE

South Africa's president said...the "selfish, unjust" refusal of pharmaceutical companies and allied Western governments to entertain emergency patent waivers on COVID-19 vaccines was endangering the entire world...In unusually impassioned remarks, Cyril Ramaphosa lambasted a resistance to calls by India and South Africa for temporary patent waivers to ramp up production...The proposed waiver from the WTO's agreement on Trade-Related Aspects of Intellectual Property Rights has support in principle from U.S. President Joe Biden and French President Emmanuel Macron...But the pharmaceutical industry is against the waiver, as are Germany, Switzerland and the World Bank. They argue it would stifle innovation and that vaccine supplies are constrained by a lack of manufacturing capacity...READ MORE

The AstraZeneca COVID-19 vaccine takes another hit to its safety profile as the European Medicines Agency adds a new side effect to the label of its shot...The EMA identified a rare blood condition, capillary leak syndrome, as a potential side effect of AstraZeneca’s Vaxzevria. The condition causes plasma leaks from blood vessels into neighboring body cavities and muscles. Blood pressure experiences a sharp drop as a result, and, left untreated, the disorder can lead to organ failure and death...READ MORE

The U.S. drug regulator...added a warning to the literature that accompanies Pfizer Inc/BioNTech and Moderna COVID vaccine shots to indicate the rare risk of heart inflammation after its use...For each vaccine, the fact sheets for healthcare providers have been revised to include a warning that reports of adverse events suggest increased risks of myocarditis and pericarditis, particularly after the second dose and with onset of symptoms within a few days after vaccination, the FDA said...READ MORE

Many of the underlying causes of vaccine-related errors are ongoing issues, so health care providers who plan to stock and/or administer COVID-19 vaccines should anticipate the types of errors that can and do happen and take the necessary steps to prepare and mitigate the risk for COVID-19 vaccine–related errors…A recent analysis of more than 160 COVID-19–related event reports submitted to the Institute for Safe Medication Practices National Vaccine Errors Reporting Program from December 14, 2020, through April 17, 2021, underscores that more needs to be done to reduce the risk for vaccination errors because they can lead to inadequate immunity, increased cost, and reduced confidence in the health care delivery system…READ MORE

1. Shoulder injury related to vaccine administration.
2. Not checking/documenting administration in the immunization information system.
3. Wrong diluent.
4. Wrong diluent volume.
5. Errors related to vaccine storage.
7. Administration of air in empty vaccine syringe.
8. Wrong dose.
9. Age-related events.
10. Vaccine competency.

Dozens of Nevadans fully vaccinated against COVID-19 have been hospitalized after contracting rare breakthrough cases of the disease, state health officials reported in new data...The majority of the 51 cases were white, male, and age 70 and older, among those most at risk of severe infections. But 32 of the patients showed no symptoms of COVID-19 infection, according to the Nevada Department of Health and Human Services data...health officials had reported at least two deaths among 186 breakthrough cases...READ MORE