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 […]
Tamiflu on Track to Be an Over-The-Counter Drug
In July 2019, drug and French vaccine manufacturer Sanofi signed a deal with Roche Pharmaceuticals to obtain exclusive over-the-counter (OTC) rights for Tamiflu (oseltamivir), an antiviral drug licensed for the treatment of influenza infections. Genentech, a member of the Roche Group, currently sells Tamiflu in the United States only for prescription use.1 Tamiflu is a […]