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Several high-profile U.S. Food and Drug Administration officials are resigning from their positions within the federal agency in protest of the Biden administration’s overreach when it comes to COVID-19-related scientific decisions such as booster shots...Despite the lack of clear evidence in support of booster shots, the Biden administration plans to move forward with supplemental jabs for adults beginning as early as the White House’s Sept. 20 deadline, pending the FDA’s approval. This pressure from the Democrat president and his administration to offer “premature and unnecessary” consent to something that scientific data does not conclusively back up, reports indicate, is causing strife within the regulatory agency...READ MORE

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

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

The U.S. FDA has awarded the first full approval for a COVID-19 vaccine to Pfizer and its German partner BioNTech, a historic decision that comes weeks ahead of its previously expected Labor Day deadline...Pfizer’s jab, now approved for people aged 16 and older, will remain under an emergency nod for adolescents aged 12 to 15...The agency’s full approval for Pfizer’s mRNA shot, now marketed as Comirnaty, is expected to spark a wave of vaccine mandates from companies, universities and organizations awaiting the agency’s final sign-off...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

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 New York Times reports that the Pfizer shot will be the first of the coronavirus jabs to be cleared by the FDA...According to the report, the FDA originally had planned to approve the vaccine before Labor Day, but decided to accelerate its ruling...The full approval of the shot also paves the way for employers and private companies to mandate employees and patrons to be vaccinated...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