“You may choose to look the other way, but you can never say again that you did not know.”
— William Wilberforce
The European Medicines Agency (EMA) held an emergency meeting on Mar. 18, 2021 after many European countries suspended use of the Oxford/AstraZeneca experimental COVID-19 vaccine due to reports of severe side effects including blood clots, low platelet counts and death.1 The EMA conducted a preliminary investigation into potential serious side effects and pronounced the vaccine […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
Kenya has become the third African country, along with Ghana and Malawi, to launch a pilot program for the world’s first malaria vaccine, Mosquirix, which has been developed by GlaxoSmithKline (GSK). The vaccine is available to children from six months of age in specific locations in Kenya due to its phased pilot introduction.1 2 Malaria […]