Pfizer and BioNTech’s experimental Covid-19 vaccine candidate prevented more than 90% of infections in healthy volunteers. Based on these data, the companies plan to apply for emergency use authorization (EUA), which would grant FDA authorization to an unapproved medical product during a state of emergency. Despite the current crisis facing the world, this well-intentioned approach may be misguided as an EUA would allow an unapproved and unlicensed vaccine to be deployed to millions of people before proof of safety and efficacy have been fully established. At this stage of development, an emergency use authorization would not require detailed, cautious reporting of adverse events–potentially undermining the ongoing and future clinical trials necessary to establish safety and efficacy. Read more here.
(Source: Matt McCarthy; Stat News; 11/10/20)