Rapid Development of an Integrated Network Infrastructure to Conduct Phase 3 COVID-19 Vaccine Trials.

Importance: The COVID-19 pandemic has caused millions of infections and deaths and resulted in unprecedented international public health social and economic crises. As SARS-CoV-2 spread across the globe and its impact became evident, the development of safe and effective vaccines became a priority. Outlining the processes used to establish and support the conduct of the phase 3 randomized clinical trials that led to the rapid emergency use authorization and approval of several COVID-19 vaccines is of major significance for current and future pandemic response efforts.

The march toward rational therapeutics in children.

Although children suffer from many of the same diseases as adults, the majority of drugs are not approved for pediatric use. This places children at risk, either that they will not be treated adequately because of the lack of approved agents or that their physician will be lacking the necessary labeling information to treat appropriately with a given agent. This paper details the slow progress over the last 25 years toward providing pediatric labeling and thus providing children with optimal protection and range of treatment options.