That means more complete data is needed to showcase how well the two-dose vaccine regimen works in the elderly and other vulnerable groups. In order to approach US regulators for an emergency-use authorization, Pfizer and BioNTech must also report safety data. The companies anticipate they will have accumulated the FDA-requested two months of safety data for people in the trial by this coming week. US regulators and outside experts will assess the data and hold a hearing intended to increase public confidence. Though the trial resumed in late October, J&J now expects to have an initial readout of results from the trial early next year, rather than by the end of 2020.

Source: Mint November 15, 2020 10:41 UTC