The Food and Drug Administration (FDA)-approved COVID-19 vaccine from Pfizer and BioNTech should not be prescribed off-label for children under 12, as no data exists on proper dosing or safety in youth, an FDA official said on Monday. Acting FDA Commissioner Dr. Janet Woodcock told reporters that the federal agency does not believe it would…
FDA Discourages Off-Label Use of FDA-Approved Pfizer Vaccine in Kids
FDA Discourages Off-Label Use of FDA-Approved Pfizer Vaccine in Children
The Food and Drug Administration (FDA)-approved COVID-19 vaccine from Pfizer and BioNTech should not be prescribed off-label for children under 12, as no data exists on proper dosing or safety in youth, an FDA official said on Monday. Acting FDA Commissioner Dr. Janet Woodcock told reporters that the federal agency does not believe it would…
Facts Matter (Aug 23): Worlds First DNA-Based Vaccine Given Emergency Authorization in India, No Trial Data
Earlier Monday, the Food and Drug Administration released a statement and officially approved the Pfizer vaccine—making it the first fully authorized vaccine in America. This means that very likely, more businesses will be mandating vaccination as a term of employment. Meanwhile, on Friday, India became the first country in the world to approve a different…
NTD Business Full Broadcast (Aug. 23)
U.S. regulator grants full approval to the Pfizer vaccine. It’s the first to get such a clearance. But not everyone agrees with the decision. What are the concerns? Business growth slowing in July as supply chain problems persist and demand cools off. We talk to an American manufacturer. And two vital money-transfer firms have stopped all…
US Drug Regulators Approve Pfizer’s COVID-19 Vaccine
U.S. drug regulators on Monday approved the COVID-19 vaccine from Pfizer and BioNTech for people 16 and older, making it the first such shot to receive approval in the country. The Food and Drug Administration (FDA) said the vaccine, which will be known as Comirnaty, proved effective in a clinical trial of approximately 44,000 people….
Why Testing Your Immunity to COVID-19 is as Important as Vaccination—Feat. Dr. Hooman Noorchashm
Antibody testing is the gold standard for determining immunity, says immunologist and physician Dr. Hooman Norchashm. Yet, the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) are actively deterring people from testing their immunity. Why? Additionally, the Delta variant of COVID-19 is currently being used by the government to explain the…
FDA Declines to Approve Sesen Bio’s Bladder Cancer Treatment, Shares Plunge
The Food and Drug Administration (FDA) has declined to approve Sesen Bio Inc’s lead therapy candidate for a type of bladder cancer, the company said on Friday, sending its shares down more than 80 percent. The FDA notified the drug developer that it cannot approve the marketing application for the drug, Vicineum, in its present…
The Case Against Naming Ezekiel Emanuel to Lead the FDA
Commentary If you think Dr. Anthony Fauci is a controversial figure in the fight against COVID-19, you may not have seen anything yet. Politico—the Democrats’ favorite publication for leaking their future plans—just reported that President Joe Biden is seriously considering nominating bioethicist Ezekiel Emanuel to lead the Food and Drug Administration (FDA). This politically maladroit…
Fauci Expects ‘Flood’ of COVID Vaccine Mandates After FDA Approval
Biden administration COVID-19 advisor Anthony Fauci over the weekend said he hopes CCP (Chinese Communist Party) virus vaccines will be fully approved by federal drug regulators in “the next few weeks,” adding in another interview that he believes a “flood” of vaccine mandates will be handed down after that. With the full FDA approval, it’s…
FDA Classifies Philips Ventilator Recall Due to Low Oxygen Risk
The U.S. Food and Drug Administration (FDA) on Tuesday classified the recent recall of some of Philips’ ventilators as Class 1, or the most serious type of recall, saying the use of these devices may cause serious injuries or death. This is the second Class 1 recall initiated by the company this year. In June,…
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