More Young Children Ingested Drugs and Illicit Substances During COVID Pandemic Period
A new study published in the Journal of the American Medical Association (JAMA) shows an increase in ingestion of illicit substances such as cannabis, opioids and ethanol among children under six years old in the COVID-19 pandemic period compared with the pre-pandemic period.1 “This is an important study, with a clear indication of the ongoing and […]
Shortage of Adderall Affecting Behavior in Children and Adults
On October 12, 2022, the U.S. Food and Drug Administration (FDA) announced a shortage of a drug formulation of amphetamine mixed salts, commonly referred to by the brand name Adderall. Adderall is an FDA approved drug for the treatment of narcolepsy and attention deficit hyperactivity disorder (ADHD), including anger, anxiety, forgetfulness and trouble focusing.1 Adderall […]
FDA Authorizes COVID Bivalent Shots for Children as Young as Five Years Old
On Oct. 12, 2022, the U.S. Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) of the COVID bivalent booster versions of messenger RNA (mRNA) Comirnaty and Spikevax biologics developed by Pfizer/BioNTech and Moderna/NIAID for children as young as five or six years old, respectively. The FDA’s decision on Aug. 31 to grant […]
FDA, CDC Green Light Pfizer’s Experimental COVID Biologic for Children 5 to 11 Years Old
One Oct 29, 2021, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for the experimental messenger RNA (mRNA) Pfizer/BioNTech COVID-19 biologic BNT162b2 for children five to 11 years old. The FDA’s decision, which is based on a clinical trial earlier this year involving 2,268 kindergartners and elementary school-aged kids and an […]
White House Reveals Plans to Give COVID Shots to All 5 to 11 Year Old Children
On Oct. 20, 2021, the Biden administration outlined plans to begin giving COVID-19 vaccinations to children between five and 11 years old. Pending the results of reviews of the plan by the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) over the […]
With Little Safety Data, CDC Recommends Pfizer COVID Vaccine for 12-Year-Old Children
Opinion | I monitor meetings of the Advisory Committee on Immunization Practices (ACIP) of the U.S. Centers for Disease Control and Prevention (CDC) for the National Vaccine Information Center (NVIC). On May 10, 2021, the U.S. Food and Drug Administration (FDA) expanded the Emergency Use Authorization (EUA) granted Pfizer/BioNTech to distribute its experimental mRNA vaccine in […]
J&J to Test COVID-19 Vaccine on Babies, Pregnant Women and the Immunocompromised
Pharmaceutical and medical device giant Johnson & Johnson, Inc. (J&J) announced on Feb. 28, 2021 plans to test its experimental Ad26.COV2.S vaccine for COVID-19 on infant children (including newborns), pregnant women and people with compromised immune systems. J&J did not include infants, pregnant women or the immunocompromised in the U.S. population in clinical trials on […]
Moderna, Pfizer Test mRNA Experimental Biologics on Children
On Dec. 10, 2020, American biotechnology company Moderna, Inc., which is pioneering the development of experimental messenger RNA (mRNA) therapeutics and vaccines, gave a 12-year old a dose of the company’s mRNA-1273 vaccine in a Phase 2/3 study of the new vaccine. Moderna CEO Stephane Bancel said, “Our goal is to generate data in the […]
Pfizer Wants to Use Children in COVID-19 Vaccine Clinical Trial
On Oct. 14, 2020, Pfizer, Inc. of New York City, New York announced it had received approval by the U.S. Food and Drug Administration (FDA) to enroll children in the Phase 3 human clinical trial on its experimental messenger RNA (ribonucleic acid) BNT162b1 vaccine for COVID-19. The trial, which last month was expanded to include adolescent […]
AAP Wants Children Enrolled in COVID-19 Vaccine Clinical Trials
The American Academy of Pediatrics (AAP) is asking federal officials to include children in COVID-19 vaccine trials.1 On September 29, 2020, Sara Goza, MD, president of the AAP, wrote a letter addressed to U.S. Department of Health and Human Services (HHS) Secretary Alex Azar and Food and Drug Administration (FDA) Commissioner Steven Hahn, MD stating, […]
