Novavax COVID Vaccine Clears Key Step on Path to FDA Authorization After Committee Endorses the Shot

Novavax COVID Vaccine Clears Key Step on Path to FDA Authorization After Committee Endorses the Shot
Novavax’s two-dose dose COVID-19 vaccine for adults ages 18 and older cleared a key step on the path toward Food and Drug Administration authorization on Tuesday. The FDA’s committee of independent vaccine experts voted 21 to 0 with one abstention to recommend authorization of the shot for use in the U.S. after an all-day public meeting in which they weighed safety and effectiveness data.… Read the rest

FDA Flags Heart Inflammation Risk Over Novavax COVID-19 Vaccine

FDA Flags Heart Inflammation Risk Over Novavax COVID-19 Vaccine
A vial of the Phase 3 Novavax coronavirus vaccine prepared for use in a trial at St. George’s University hospital in London, on Oct. 7, 2020. (Alastair Grant/AP Photo)   Staff with the U.S. Food and Drug Administration (FDA) on Friday flagged the risk of heart inflammation following the administration of the Novavax COVID-19 vaccine, although they concluded the shot reduces the risk of mild-to-severe COVID-19.… Read the rest

$9.8 Million Awarded Last Year by Fauci’s Agency to Test Monkeypox Treatment

$9.8 Million Awarded Last Year by Fauci’s Agency to Test Monkeypox Treatment
The National Institute of Allergy and Infectious Diseases, directed by Dr. Anthony Fauci, last year paid $9.8 million to government researchers to test a monkeypox treatment. Some called the timing “curious” given the recent outbreak of the virus.   By Susan C. Olmstead for The Defender The National Institute of Allergy and Infectious Diseases (NIAID), directed by Dr. Anthony Fauci, last year paid $9.8 million to government researchers to test a monkeypox treatment, the National Pulse reported.… Read the rest

Biden’s outrageous comments as FDA Placed Under Investigation as Baby Formula Crisis Rages

Biden’s outrageous comments as FDA Placed Under Investigation as Baby Formula Crisis Rages
With a documented five-month gap between the first findings of contamination at a major infant formula plant and the Food and Drug Administration’s action to close the plant, the FDA is now under the microscope itself to determine what went wrong. The Health and Human Services Office of Inspector General is beginning an audit of the actions that began with a September 2021 report of contamination and ended with a massive February recall of infant formula.… Read the rest

Novavax Hopes Its COVID Shot Wins Over FDA, Vaccine Holdouts

Novavax Hopes Its COVID Shot Wins Over FDA, Vaccine Holdouts
Lauran Neergaard | June 03, 2022 Americans may soon get a new COVID-19 vaccine option — shots made with a more traditional technology than mRNA versions. The big question: Why should they care? After long delays, the Food and Drug Administration is expected to decide within weeks whether to authorize Novavax’s vaccine. It’s late in the pandemic for a new choice, with about three-quarters of U.S.… Read the rest

Pfizer Asks FDA to Authorize COVID Vax for Children Younger Than 5

Pfizer Asks FDA to Authorize COVID Vax for Children Younger Than 5
STOP IT HERE: https://inhere.salsalabs.org/kidsvaxxapproval Carolyn Crist | June 02, 2022 The FDA has accepted Pfizer’s application for a COVID-19 vaccine for children under age 5, which clears the way for approval and distribution in June. Pfizer announced Wednesday that it completed the application for a three-dose vaccine for kids between 6 months and 5 years old, and the FDA said it received the emergency use application.… Read the rest

FDA gives green light to Pfizer COVID booster for kids 5 to 11, disregards questionable efficacy data

FDA gives green light to Pfizer COVID booster for kids 5 to 11, disregards questionable efficacy data
OPPOSE VAX FOR KIDS https://inhere.salsalabs.org/kidsvaxxapproval Sara Middleton, | May 30, 2022 Are we adding yet another series of pokes to the already bursting-at-the-seams childhood vaccine schedule? The U.S. Food and Drug Administration’s recent decision to grant Pfizer yet another emergency use authorization (EUA) for its massively profitable COVID shot – this time affecting young children. Government agency okayed COVID booster for young kids based on questionable evidence derived from fewer than five dozen trial participants On May 17, 2022, the U.S.… Read the rest

FDA sparks anger with decision on ‘phthalates’ — a chemical in fast-food packaging

FDA sparks anger with decision on ‘phthalates’ — a chemical in fast-food packaging
BY SHARON UDASIN – 05/19/22 4:42 PM ET The Food and Drug Administration (FDA) said Thursday that it will not impose a total ban on a set of dangerous chemicals commonly found in fast-food packaging, angering scientists and environmental groups who have long pressed for their removal. The decision came in response to three separate petitions requesting that the FDA limit the use of compounds called phthalates, which are known to disrupt hormone function and have been linked to birth defects, infertility, learning disabilities and neurological disorders.… Read the rest

FDA Authorizes Pfizer Booster COVID Shot for Children Between the Ages of 5 and 11

FDA Authorizes Pfizer Booster COVID Shot for Children Between the Ages of 5 and 11
Today (May 17, 2022), the U.S. Food and Drug Administration (FDA) amended the emergency use authorization (EUA) and authorized a booster dose of the Pfizer-BioNTech COVID-19 shot for children 5 through 11 years of age. The booster shot is 10 micrograms, which is the same dosage for this age group in their primary series and a third of that given to people aged 12 and older.… Read the rest