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 […]
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 […]
Kenya Launches Malaria Vaccine Pilot Program
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 […]