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 […]