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The FDA is using a temporary process during the pandemic for communicating issues it finds after reviewing records or other information requested in lieu of or in advance of pre-approval or pre-license inspections for Center for Drug Evaluation and Research (CDER)-regulated products. Read More
The COVAX vaccine program aims to distribute almost 340 million vaccine doses during the first half of the year, according to its latest distribution plan unveiled yesterday. Read More
GlaxoSmithKline (GSK) and Germany-based CureVac announced that they will co-develop a messenger-RNA-based COVID-19 vaccine to protect against multiple emerging variants of the SARS-CoV-2 virus. Read More
Chinese researchers have reported that two vaccines developed in China can elicit an immune response against the COVID-19 variant first identified in South Africa but at reduced levels. Read More
Moderna said it is in discussions with the FDA over a proposal to fill its COVID-19 vaccine vials with up to 50 percent more doses to help increase the pace of inoculations in the U.S. Read More
AstraZeneca and the University of Oxford said they are working “as rapidly as possible” to tailor their COVID-19 vaccine for significant new coronavirus mutations and believe the revamped vaccine will be ready in the fall — and that their existing vaccine has been shown to reduce transmission of disease. Read More
The FDA’s Center for Biologics Evaluation and Research (CBER) has published its list of draft and final guidances that it aims to develop in 2021. Read More
The COVID-19 vaccine Covaxin, which was approved for emergency use in India ahead of late-stage trial results, may be coming to the U.S., as its manufacturer, Bharat Biotech, has secured a U.S. partner and plans to seek Emergency Use Authorization (EUA) from the FDA for distribution in the U.S. Read More
The Pharmaceutical Research and Manufacturers of America (PhRMA) is calling on the World Trade Organization (WTO) to reject a proposal that would temporarily revoke patents for COVID-19 vaccines and treatments, ahead of a WTO meeting on intellectual property scheduled for tomorrow. Read More