Half a Million Sharks Could Die to Produce Squalene Adjuvants for COVID-19 Vaccines

Half a Million Sharks Could Die to Produce Squalene Adjuvants for COVID-19 Vaccines

Story Highlights A shark conservation group is calling for alternatives to using squalene harvested from the liver of sharks as an adjuvant in COVID-19 vaccine candidates. Shark conservation advocates estimate that an additional 500,000 sharks will be killed every year should squalene adjuvanted coronavirus vaccines become licensed for global general use. The group is asking […]

ACIP Updates Influenza Vaccine Guidelines for Seniors

ACIP Updates Influenza Vaccine Guidelines for Seniors

The Advisory Committee on Immunization Practices (ACIP) for the U.S. Centers for Disease Control and Prevention (CDC) has issued new updates for influenza vaccines for 2020–2021 “flu season,” primarily for Fluzone and Fluad vaccines. In November 2019, U.S. Food and Drug Administration (FDA) licensed inactivated injectable Fluzone High-Dose Quadrivalent (HD-IIV4) for use in persons aged […]

GSK and Sanofi COVID-19 Vaccine Produced in Insect Cells with Squalene Adjuvant

GSK and Sanofi COVID-19 Vaccine Produced in Insect Cells with Squalene Adjuvant

Story Highlights GlaxoSmithKline and Sanofi Pasteur are partnering to develop an experimental COVID-19 vaccine. The two global vaccine manufacturers are using existing recombinant DNA vaccine technology and a squalene adjuvant for their COVID-19 vaccine. Clinical trials are scheduled to begin in the second half of 2020 and, if successful, the vaccine will be available in […]

Novartis Manipulated Data in FDA Biologics License Application

Novartis Manipulated Data in FDA Biologics License Application

On Aug. 6, 2019, the U.S. Food and Drug Administration (FDA) issued a statement saying that Swiss pharmaceutical company Novartis AG submitted a biologics license application (BLA) for the spinal muscular atrophy (SMA) gene therapy Zolgensma (onasemnogene abeparvovec-xioi) with manipulated data and failed to inform regulators until June 28, 2019—more than a month after the […]