The European Medicines Agency (EMA) announced yesterday that AstraZeneca should include the risk of very rare blood clots on the list of possible side effects of its COVID-19 vaccine — and a UK vaccines advisory committee said it would be “preferable” not to give the vaccine to individuals under age 30. Read More

The U.S. Army this week began phase 1 testing of a COVID-19 vaccine it developed, which is aimed at protecting against many coronavirus variants. Read More

Moderna has expanded its existing agreement with Catalent to boost COVID-19 vaccine production at Catalent’s fill-and-finish facility in Bloomington, Ind., to supply the U.S. market. Read More

The University of Oxford said it has paused a trial evaluating its COVID-19 vaccine co-developed with AstraZeneca in children and teenagers while it awaits additional information on the risk of blood clots from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). Read More

The FDA released Q&A guidance yesterday on bioequivalence (BE) studies for generic drugs and abbreviated new drug application (ANDA) submissions during the COVID-19 pandemic. Read More

The U.S. government has stepped in to address a serious manufacturing error at Emergent BioSolutions’ Baltimore, Md., facility that wasted 15 million Johnson & Johnson (J&J) vaccine doses. However, putting J&J in charge of the site and barring production of AstraZeneca (AZ)’s vaccine there isn’t likely to halt AZ’s production schedule, a White House official said Monday. Read More

The FDA has identified five main activities it will focus on for improving its COVID-19 Pandemic Recovery and Preparedness Plan (PREPP), including two on its reviews of Emergency Use Authorization (EUA) processes and its approaches to inspections, public communications and supply-chain monitoring. Read More

New EU restrictions are slowing Pfizer’s ability to transport its COVID-19 vaccine across borders, a company executive said. Read More