Pfizer and BioNTech have requested a revised Emergency Use Authorization for their COVID-19 vaccine, allowing its use in adolescents 12 to 15 years old. Read More

In more bad news for AstraZeneca, the European Medicines Agency (EMA) announced that its safety committee is investigating reports of capillary leak syndrome, a rare, potentially life-threatening disorder, in individuals inoculated with the company’s COVID-19 vaccine. Read More

Emergent BioSolutions’ beleaguered Baltimore, Md., facility, which Johnson & Johnson has taken over to exclusively produce its vaccine, may be cleared to start shipping out J&J doses before the month is over, according to the White House’s COVID-19 response leader. Read More

Eli Lilly’s and Incyte’s Janus kinase (JAK) inhibitor Olumiant (baricitinib) proved unable to significantly reduce progression to noninvasive ventilation for COVID-19 patients in a phase 3 trial, though the drug still managed to significantly reduce the risk of death. Read More

The NIH’s National Institute of Allergy and Infectious Diseases (NIAID) has begun a phase 2 study to evaluate the risk of allergic reactions to the Moderna and Pfizer/BioNTech COVID-19 vaccines in patients who are severely allergic or have a mast-cell disorder. Read More

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