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, […]
Pharmacists, Pharmacy Interns Given Green Light to Vaccinate Children
Under an amendment to the Public Readiness and Emergency Preparedness Act (PREP), pharmacists and pharmacy interns in the United States are now permitted to administer vaccines recommended by the Centers for Disease Control and Prevention (CDC) to children over three years of age.1 Currently, there are 28 states that allow pharmacists to administer vaccinations to […]
