- Anthony Fauci said that the Pfizer-BioNTech COVID-19 booster shot will likely be ready by September 20. Regulators will need more time to review Moderna’s submission. The Biden administration requested that Moderna submit data for boosting with both the full, 100-microgram dose and a 50-microgram dose, but Moderna focused only on the later. A senior white house official said that while the 50-microgram increases supply, it also means Moderna could make a lot more money. If a third Pfizer shot is authorized before Moderna, Moderna could be left behind and boosting efforts could be complicated. (Articles here, here, and here)
- Health groups and lawmakers are pushing the FDA to speed its authorization of COVID-19 vaccines for children under 12 amid a rise in pediatric hospitalizations and the return to school. However, regulators don’t yet have enough safety and efficacy data on the shots. Pfizer expects to submit clinical trial results for 5- to 11-year-olds to the FDA later this month, while Moderna has said its data won’t be ready until closer to the end of 2021. (Article here)
September 7, 2021
Life Sciences