Brazil Halts and Re-Starts Phase 3 Clinical Trials of Chinese COVID-19 Vaccine
Brazil briefly stopped clinical trials of CoronaVac, the Chinese-made experimental vaccine for COVID-19, after a death among trial participants was reported on Nov 9, 2020. The Bhutantan Institute in San Paulo, Brazil had been conducting Phase 3 trials with more than 10,000 volunteers when the study was halted.1 However, within days, Bhutantan officials announced they […]
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 […]
A Volunteer in AstraZeneca COVID-19 Vaccine Trial Has Died in Brazil
A volunteer in one of the most advanced coronavirus vaccine trials in the world has died and, despite the news, AstraZeneca’s testing continues. … A major setback in the race to develop a coronavirus vaccine. Of course, I’m not going to get a vaccine if they don’t know what the hell you’re working with. A […]
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 […]
Brazilian Doctor Dies Participating in AstraZeneca’s COVID-19 Vaccine Clinical Trial
Story Highlights A COVID-19 vaccine trial participant, who was a physician working with COVID-19 patients at hospitals in Brazil, has reportedly died from coronavirus infection complications. It has not been confirmed, but sources indicate the victim was given the trial “placebo” (a meningococcal vaccine) and not the experimental AZD1222 vaccine developed by pharmaceutical company AstraZeneca […]
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 […]