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The drugmaker Pfizer said it will not apply for emergency use authorization for its Covid-19 vaccine candidate until at least the third week of November.
Pfizer CEO Dr. Albert Bourla made the announcement in an open letter published Friday. It means the EUA will not come before the presidential election.
“We may know whether or not our vaccine is effective by the end of October,” Bourla wrote. But he went on to note that it will take weeks after that time to make sense of the data collected, determine how effective it is and confirm its safety.
But before any drugmaker can apply for emergency use authorization of a Covid-19 vaccine candidate, the Food and Drug Administration will require two months of safety information following the final dose of vaccine. Pfizer’s vaccine requires two doses, about a month apart.