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 […]
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 […]
Makers of Experimental COVID-19 Vaccines Lobby EU for Liability Protection
Vaccines Europe, a pharmaceutical industry lobbying group, has issued a memo to its member companies saying it would seek liability protection from the European Union (EU) for corporations manufacturing COVID-19 vaccines. The memo, obtained by the Financial Times, expressed concern about the “inevitable risks” of rushing the development and global marketing of COVID-19 vaccines.1 2 3 […]
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 […]
Children Recruited in U.K. for COVID-19 Vaccine Trial
The University of Oxford’s Jenner Institute and Oxford Vaccine Group in the United Kingdom has announced that its researchers have begun recruiting children aged five to 12 years for phase II and phase III clinical trials testing an experimental COVID-19 vaccine the university is developing in partnership with AstraZeneca plc.1 Oxford’s ChAdOx1 nCov-19 (“chimpanzee adenovirus […]
COVID-19 Vaccine Will Likely Be Given Multiple Times, Perhaps Annually
In an interview with the JAMA on June 2, 2020, Anthony Fauci, MD, director of the U.S. National Institute of Allergy and Infectious Diseases (NIAID) said that while he was “cautiously optimistic” about the effectiveness of the vaccines being developed for COVID-19, he was concerned that any protection the vaccines may provide might only be temporary. […]
Pfizer/BioNTech Target Fall 2020 for COVID-19 Vaccine Availability
In recent weeks Inovio Pharmaceuticals of Pennsylvania and representatives of the German biotechnology firm CureVac AG and the University of Oxford in the United Kingdom have announced that their experimental COVID-19 vaccines will be ready for use by September 2020. On Apr. 29, 2020, Pfizer, Inc. of New York stated in a news release that […]
