Pfizer and BioNTech have cleared one of the last hurdles en route to the first Covid-19 vaccine authorization.

On Tuesday, the FDA released its own internal assessment of the companies’ vaccine and trial data, finding that the inoculation was almost certainly at least 90% effective and worked similarly across different subpopulations, including the elderly and people with co-morbidities.

The agency also found no serious safety concerns, although they did spotlight mild adverse events that cropped up in a significant percentage of participants. These data largely align with what trial participants have previously reported publicly, leading some experts to caution that while the vaccine is safe, public health authorities need to prepare people for symptoms such as headache and fatigue.

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