We Need More Details and Raw Data on Pfizer and Moderna COVID-19 Vaccines
On Nov. 26, 2020, when I raised questions1 about the results of Pfizer’s and Moderna’s COVID-19 vaccine trials, all that was in the public domain were the study protocols2 and a few press releases.3 Now, two journal publications4 and around 400 pages of summary data are available in the form of multiple reports presented by and to the U.S. Food and Drug […]
FDA Opposes COVID-19 Vaccination Dose and Schedule Changes to Vaccinate More People
Only two weeks after the first experimental biologic for SARS-CoV-2 became available, the U.S. was more than 16 millions doses behind Operation Warp Speed’s goal of giving COVID-19 vaccines to 20 million people by the end of 2020.1 Responding to the slow rollout, Operation Warp Speed chief adviser Moncef Slaoui, MD proposed giving half-doses to […]
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 […]
81 Percent of Clinical Trial Volunteers Suffer Reactions to CanSino Biologics’ COVID-19 Vaccine That Uses HEK293 Human Fetal Cell Lines
An experimental vaccine for COVID-19 is being developed by CanSino Biologics, Inc. of Tianjin, China, in partnership with China’s Academy of Military Medical Sciences’ Institute of Biotechnology. A Phase 1 human clinical trial of the COVID-19 vaccine (adenovirus type-5 Ad5-nCoV) has been completed in China involving 108 healthy adults, ranging in age from 45–60 years […]
A Vaccine for Coronavirus by Autumn?
There appears to be a consensus opinion among leading public health authorities that a coronavirus vaccine for COVID-19 would take at least 12-18 months to develop, test and be ready for market distribution. The projection assumes that an aggressive development schedule would produce a licensed vaccine proven safe and effective for use in humans no […]
Cholera Vaccine Recommended by European Medicines Agency
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of the single-dose oral cholera vaccine Vaxchora, developed by multinational biopharmaceutical firm Emergent BioSolutions, Inc. of Gaithersburg, Maryland. On Jan. 30, 2020, the CHMP adopted a “positive opinion” on the granting of a marketing authorization for the bacterial […]