FDA is concerned that Novavax’s COVID-19 vaccine candidate may be directly linked to cases of heart inflammation in people who received the shot in clinical trials, but Novavax says there’s not enough evidence to establish a direct link. The company says it will continue to monitor all adverse events, including myocarditis and pericarditis, associated with its shot should it be authorized. FDA highlighted its concerns in a briefing document posted online Friday (June 3) . The agency’s Vaccines and Related...