How COVID-19 Vaccine Trials are Designed
There’s been a lot of talk lately about whether or not the fast-tracked COVID-19 vaccine will in fact be safe and effective. While vaccine makers insist that any vaccine reaching the market will have undergone rigorous testing, the way trial protocols are designed suggests these vaccines may leave a lot to be desired. As reported1 by […]
CDC Gives States COVID-19 Vaccination Program “Playbook”
The U.S. Centers for Disease Control (CDC) created a national COVID-19 Vaccine Program Playbook for state, territorial and local public health officials and their partners and issued directions for how to plan and operationalize COVID-19 vaccine programs in their jurisdictions. State health departments throughout the United States submitted comprehensive drafts of their COVID-19 vaccine distribution […]
Pharma’s Public Pledge On COVID-19 Vaccines
On Sept. 8, 2020, nine pharmaceutical companies working on COVID-19 vaccines signed a pledge saying they would not submit their experimental vaccines to the U.S. Food and Drug Administration (FDA) unless they were shown to be both safe and efficacious in the Phase 3 human clinical trials.1 2 3 4 5 The pledge, signed by […]
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 […]
Johnson & Johnson Pauses Phase 3 COVID-19 Vaccine Trial Following ‘Unexplained Illness’
Story Highlights Weeks after Johnson & Johnson announced that their experimental COVID-19 vaccine was in final, Phase 3 testing, the company has paused the study to evaluate an unexplained illness in a study participant. AstraZeneca’s late-stage vaccine trial is also still on pause in the U.S. after two cases of a neurological illness arose in […]
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, […]