FDA expands Novavax EUA to include children 12 and older

Novavax today announced the Food and Drug Administration expanded the emergency use authorization for its Adjuvanted (NVX-CoV2373) COVID-19 vaccine. Under the expanded EUA, the two-dose primary series can be administered for adolescents between the ages of 12 and 17. The vaccine was previously subject to an EUA for adults over the age of 18. FDA’s decision was based on data from Novavax’s ongoing pediatric expansion of its phase 3 clinical trial, which indicated a clinical efficacy of 78.29% in preventing SARS-CoV-2 infections, Novavax said. Novavax notes that its pediatric trial culled data during a period in which the SARS-CoV-2 delta variant was the predominant strain in the U.S.