Pfizer CEO Albert Bourla says company crossed safety milestone for Covid-19 vaccine, EUA submission imminent
Pfizer won’t say when they’ll send their Covid-19 vaccine to the FDA, except that it’s going to be very soon.
Speaking at New York Times and STAT summits Tuesday, CEO Albert Bourla said that, in their Phase III trial with BioNTech, they have already passed the minimum two-month follow-up the agency requires that developers reach to obtain emergency use authorization. With news last week that an interim analysis showed the vaccine was “over 90% effective,” that would appear to give the Big Pharma and their biotech partner most of the data required to achieve the first US OK for a Covid-19 vaccine.
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