COVID-19 Quick Takes: EMA to require more stringent safety monitoring for vaccines; plus J&J, Clover-Thousand Oaks, Medicago-GSK, Inovio and Synairgen

EMA details additional safety monitoring requirements for vaccines
EMA announced several additional safety monitoring activities it will require of COVID-19 vaccine manufacturers in addition to the normal pharmacovigilance requirements of all medicines. These include the submission of monthly safety reports, rather than the usual six-month safety reports; post-authorization observational safety studies; and enhanced monitoring of reported adverse events to more quickly detect any emerging safety signals. EMA will also increase its transparency by publishing the full risk management plan for each COVID-19 vaccine.

J&J starts second Phase III vaccine trial
Johnson & Johnson (NYSE:JNJ) said Monday it began evaluating prime-boost administration of JNJ-78436735 in the 30,000-subject Phase III ENSEMBLE 2 study. The pharma will run the new study in parallel with the 60,000-volunteer Phase III ENSEMBLE trial, which began in September, of one vaccination with the adenoviral vector vaccine. On Sunday, the company announced an expanded collaboration with the Biomedical Advanced Research and Development Authority (BARDA), under which the pharma will now commit $604 million and BARDA $454 million to conduct ENSEMBLE...