US Food and Drug Administration (FDA) staff said on Tuesday that data on Pfizer Inc's coronavirus vaccine was in line with its guidance on emergency use authorisation, raising hopes it could soon be available to Americans aged 16 and above.
The comments were made in documents released ahead of Thursday's meeting of outside experts to discuss whether the shot developed with German partner BioNTech SE should be authorised for emergency use.
The FDA is expected to decide on whether to authorise the vaccine within days or weeks.
The documents released by the FDA said safety data on the vaccine from nearly 38,000 participants suggests a favourable safety profile, with no specific safety concerns identified that would preclude the issuing of emergency use authorisation.
One dose
They said there is currently insufficient data to make conclusions about the safety of the vaccine in children less than 16 years of age, pregnant and immunocompromised individuals.
The documents said the vaccine appears to provide some protection against Covid-19 after one dose, with efficacy after Dose 1 but before Dose 2 around 52 per cent in a Phase 3 trial.
They noted patients who had previously had Covid-19 may still be at risk of reinfection and could still benefit from vaccines.
