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, […]
DES Tragedy Offers Cautionary Tale for COVID-19 Vaccine Mandates
The synthetic estrogen Diesthylstilbestrol (DES) was prescribed to pregnant women in the U.S. from 1938 to 1971 for the prevention of miscarriages and premature births. In 1953, published research showed that DES did not in fact prevent miscarriages or premature births. However, physicians continued to prescribe it until 1971, when the FDA warned that the […]
How Will Unhealthy Americans React to COVID-19 Vaccines?
If you look at the human clinical trials that have been conducted this year by drug companies developing experimental vaccines for COVID-19, the participants in those trials have all been “healthy adults.” Take, for example, Moderna’s Phase 1 clinical trial for its mRNA-1273 vaccine, which included 45 healthy adults 18 to 55 years old. The same […]