Category: FDA

Have People Been Given the Wrong Vaccine?

Commentary Randomized controlled trials show all-cause mortality reduction from the Covid adenovirus-vector vaccines (RR=0.37, 95 percentCI: 0.19-0.70) but not from the mRNA vaccines (RR=1.03, 95 percentCI 0.63-1.71). That is the verdict from a new Danish study by Dr. Christine Benn and colleagues. Have people been given vaccines that don’t work (Pfizer/Moderna) instead of vaccines that do work…


US FDA Issues Warning to Companies Selling Unapproved Skin Lightening Products

The U.S. Food and Drug Administration (FDA) said on Tuesday it sent warning letters to twelve companies for selling certain over-the-counter (OTC) skin lightening products that have not been approved by the agency and pose safety risks. The products from companies including M & M Beauty and Wellness, Ultimark Products, and Genomma Lab USA contain…


FDA Launches Investigation Into Lucky Charms After Reports of Illness

The Food and Drug Administration (FDA) said it is investigating scores of reports from consumers who claimed they got sick after eating Lucky Charms. The agency confirmed to several news outlets this week that it is “is currently reviewing and investigating” reports from thousands of people who complained via a website of vomiting, diarrhea, and…


Facts Matter (April 14): Biden’s Employer Mandate REINSTATED By Appeals Court; Mask Mandate Extended; More Coming

Despite the fact that most Americans are over COVID-19, have gotten back to their regular lives, and just wish to move on, it looks like government officials have some other ideas. Just one week ago, the 5th Circuit Court of Appeals reinstated the vaccine mandate on federal employees. The Department of Defense is currently engaged in…


Pfizer to Ask US Regulators to Authorize COVID Vaccine Booster for 5–11 Age Group

Pfizer and BioNTech plan on asking the U.S. Food and Drug Administration (FDA) to grant emergency use authorization for a booster for their COVID-19 vaccine for children aged 5- to 11-years-old, the companies announced on April 14. The submission will be based on data from a Phase 2/3 clinical trial that showed a boost in…


Florida Hospital Stops Ivermectin Without Telling Family, Fires Nurse for Advocating for It

The children of a 55-year-old Florida woman say the hospital treating their mother for COVID-19 told her, and them, that she would be treated with ivermectin. But the treatment was stopped after she improved because a hospital pharmacist intervened, medical records show. Dianne Spangler, of Titusville, worsened after the ivermectin was stopped early. She was…


Facts Matter (April 7): 10K New Pfizer Docs Reveals FDA Knew Natural Immunity Works, Vaccine Fertility Effects UNKNOWN

Around a week ago, the FDA released its second trove of documents related to its authorization of the Pfizer vaccine. And within them, there are three interesting points that I believe are worth discussing. The first has to do with the fact that according to the data, natural immunity proved to be as effective as…


FDA Warns of Norovirus Outbreak Linked to Oysters

Federal health regulators this week have warned of a norovirus outbreak linked to raw oysters across about a dozen U.S. statements. Potentially tainted raw oysters harvested in British Columbia, Canada, were sent to California, Colorado, Florida, Hawaii, Illinois, Massachusetts, Minnesota, New Jersey, Nevada, New York, Oregon, Texas, and Washington, according to the U.S. Food and Drug Administration…


FDA, CDC Warns of Norovirus Outbreak in 13 States

Federal health regulators this week have warned of a norovirus outbreak linked to raw oysters across about a dozen U.S. states. Potentially tainted raw oysters harvested in British Columbia, Canada, were sent to California, Colorado, Florida, Hawaii, Illinois, Massachusetts, Minnesota, New Jersey, Nevada, New York, Oregon, Texas, and Washington, according to the U.S. Food and Drug Administration…


FDA Advisers Oppose Repeated COVID-19 Vaccine Boosters

Experts who advise the U.S. Food and Drug Administration (FDA) on April 6 came out in opposition to a strategy of repeated COVID-19 vaccine boosters within a short period of time, during a meeting where FDA officials said they plan on deciding on the future vaccination strategy by June. “I do not believe that booster…