Feb 24, 2021 | News, Regulatory
Sinopharm, a unit of the China National Pharmaceutical Group, and CanSinoBiologics Inc both have applied in China for the public use of their COVID-19 vaccines. Currently, China has two approved vaccines that were developed within the country, and has yet to approve...
Feb 5, 2021 | FDA, News, Regulatory
Janssen Biotech, a Johnson & Johnson company, submitted an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for its single dose COVID-19 vaccine. The submission is based on topline safety and efficacy data from the Phase...
Feb 2, 2021 | News, Regulatory
Despite facing much public scrutiny for rushing the Sputnik V vaccine, the efficacy of Russia’s vaccine has been validated in a peer-reviewed study that was published in The Lancet. The Lancet published an interim analysis of Phase III data that Sputnik V has...
Jan 29, 2021 | EMA, News, Regulatory
The European Medicine’s Agency (EMA) announced today (1/29) it’s approval of the AstraZeneca and University of Oxford’s COVID-19 vaccine. The approval marks the third vaccine passed by the EMA. The vaccine is administered as two doses, with the second coming between 4...
Jan 26, 2021 | News, Regulatory
Yesterday (1/25), Australia’s Therapeutic Good Administration (TGA) authorized Pfizer and BioNTech’s COVID-19 vaccine. The provisional approval is the first for COVID-19 vaccines in Australia’s market for individuals 16 years and older and is expected to be...