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, […]
20 Volunteers Suffer Serious Reactions to Johnson & Johnson’s COVID-19 Vaccine
On Sept. 23, 2020, U.S. pharmaceutical and medical devices company Johnson & Johnson, Inc. announced the start of the Phase 3 human clinical trial for its experimental Ad26.COV2.S vaccine for COVID-19. The New Jersey-based company, which is partnering with its subsidiary Janssen Pharmaceutica NV of Belgium on development of the vaccine, is planning to enroll […]
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 […]
2005 PREP Act and 1986 Act Shield Vaccine Manufacturers from Liability
Story Highlights Most countries that have supply contracts with AstraZeneca have granted the drug company liability protection for their COVID-19 vaccine. In the U.S., vaccine manufacturers and administrators are shielded from liability under the PREP Act of 2005 for a vaccine or drug that is developed in response to a declared public health emergency, including […]
A Grade 3 Vaccine-Related Adverse Event is Serious
When Moderna, Inc. announced on May 18, 2020 the results of a Phase 1 human clinical trial for its experimental mRNA-1273 vaccine for COVID-19, the biotechnology company said the vaccine had produced no “serious adverse events” (SAEs) among the 45 people who participated in the trial and that it considered the vaccine to be “generally […]