Discrete packaging for authorized dose in 6-11 year-olds is not yet available, so vaccination providers have to use product from a vial labeled for ‘booster doses only’ in adults. ACIP members unanimously endorse use of the mRNA vaccine in individuals ages 6-17 years but urge manufacturers to move away from relying on color to differentiate formulations.

Companies such as Novartis, Roche or Takeda are heavily invested in the advanced therapeutics field, usually spreading their bets across multiple modalities. The remaining challenges offer opportunities for the next wave of innovation to transform the field once again and make a dent in the larger market of common diseases and solid tumors.

FDA’s Doran Fink and CDC’s ACIP members say vaccine manufacturers could conduct a study to determine whether longer intervals between doses would provide greater effectiveness and longer durability. Right now, they are relying on international data.

A rolling review of an adapted version of Moderna’s COVID-19 vaccine Spikevax aimed at variants of SARS-CoV-2 has begun at the European Medicines Agency. The EMA has also given an update on its latest vaccine safety reviews, including reports of heavy menstrual bleeding with Spikevax and Comirnaty.