The Food and Drug Administration (FDA) said on Wednesday that it will add a warning of heart inflammation to the fact sheet for the Pfizer and Moderna mRNA COVID-19 vaccines that are given to patients prior to vaccination. At a meeting of the Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices…
Heart Inflammation Warning to Be Added to mRNA Vaccine Fact Sheet: FDA
June 23, 2021
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Federal Health Officials Investigate Origins of Rare Multi-State Tuberculosis Outbreak
Federal health authorities are investigating a rare multi-state outbreak of tuberculosis (TB) infections in patients who have recently undergone spinal surgery, according to reports. The investigation follows an outbreak that happened this past spring and has since possibly affected more than 100 people who may have been infected after undergoing spinal surgery that used a…
FDA Warns Doctors to Stop Using Heart Pump Tied to Deaths
WASHINGTON—U.S. health regulators warned surgeons Thursday to stop implanting a heart pump made by Medtronic due to power failures recently tied to cases of stroke and more than a dozen deaths. Medtronic said earlier in the day it would stop selling its Heartware assist device, which is intended to boost blood circulation in patients with…
Pfizer/BioNTech Ask US Regulators for Full Approval of COVID-19 Vaccine
Pfizer and BioNTech are asking drug regulators in the United States for full approval for their COVID-19 vaccines. The two companies announced on Friday that they initiated a rolling submission for a biologics license application by submitting nonclinical and clinical data, including the most recent analyses from a Phase 3 clinical trial, to the Food and…
US Lawmakers Announce Bill to Cut Toxic Metals in Baby Food
WASHINGTON—A group of Democratic U.S. lawmakers presented legislation Thursday which will set new maximum levels of toxic heavy metals in baby food and require manufacturers to comply within one year. The bill will be formally introduced Friday. The Baby Food Safety Act of 2021 would set maximum levels of inorganic arsenic, lead, cadmium, and mercury…
Former FDA Commissioner Says Social Distancing Mandate ‘Wasn’t Based on Clear Science’
Former Food and Drug Administration Commissioner Scott Gottlieb said that the six-foot social distancing mandate that was employed across much of the United States and the world to deal with the CCP virus pandemic “wasn’t based on clear science.” “This six-foot distancing requirement has probably been the single costliest mitigation tactic that we’ve employed in…
Former FDA Chief Says Social Distancing Mandate ‘Wasn’t Based on Clear Science’
Former Food and Drug Administration Commissioner Scott Gottlieb said that the six-foot social distancing mandate that was employed across much of the United States and the world to deal with the CCP virus pandemic “wasn’t based on clear science.” “This six-foot distancing requirement has probably been the single costliest mitigation tactic that we’ve employed in…
Johnson & Johnson Vaccine Expected in Orange County ‘Any Day’
March 2, 2021
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A new COVID-19 vaccine that requires just a single injection could simplify and expedite the inoculation process for Orange County residents, officials say. “There are some people who said, ‘I want the one dose and I want to get it over with, I don’t want to come back for a second dose,’” Orange County Health Officer Dr. Clayton…
Advisory Panel Endorse J&J COVID-19 Vaccine For FDA Authorization
A panel of expert advisers to the U.S. Food and Drug Administration on Friday voted in favor of authorizing Johnson & Johnson’s one-dose COVID-19 vaccine for emergency use, bringing it an important step closer to a U.S. rollout. The FDA is likely to authorize the vaccine for emergency use within a day or so, making…
FDA Allows Pfizer Vaccine to Be Stored at Standard Freezer Temperature
The U.S. Food and Drug Administration (FDA) announced Thursday it is allowing the mRNA vaccine by Pfizer-BioNTech to be stored at the standard freezer temperature for a period of up to two weeks. Pharmaceutical freezers and refrigerators can facilitate the standard freezer temperatures of -25 to -15 degrees Celsius (-13 to 5 degrees Fahrenheit). The approval comes several…
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