Company says it is pursuing authorization for 2-18 year-olds due to unmet need and lack of an authorized vaccine in the youngest age group; however, the relatively small size of the safety database, the single-arm design of the pediatric immunobridging study conducted solely in India, and lack of authorized use in adults spell trouble for the request.

Dr Reddy’s indicates it is close to break-even between “the investment made and what we gained” for Russian COVID-19 vaccine Sputnik V in India, with Sputnik Light, boosters and pediatric shots seen as the new growth drivers. The company’s fully vertically integrated operations also puts it in prime position for supplies of antiviral molnupiravir.

The US FDA has rejected an emergency use authorization application for NRx Pharmaceuticals’ Zyesami (aviptadil) for use in COVID-19 patients with respiratory failure. The UK has revamped its emergency delivery service for drugs that experience shortages as a result of the pandemic and other factors.

Dr Reddy’s indicates it is close to break-even between “the investment made and what we gained” for Russian COVID-19 vaccine Sputnik V in India, with Sputnik Light, boosters and pediatric shots seen as the new growth drivers. The company’s fully vertically integrated operations also puts it in prime position for supplies of antiviral molnupiravir.