Pfizer was “very close” to applying for an emergency use approval, according to the company’s CEO
Pfizer’s CEO on Tuesday said that Pfizer was “very close” to applying for an emergency use approval (EUA) for its COVID-19 vaccine, according to a report.
This, after the company began collecting safety data to submit to regulators in the United States.
Pfizer CEO Albert Bourla told medical news site Stat. that they’re “very close” to submitting for an emergency use authorization (EUA), adding that they will announce it as soon as they’re doing it.
It was last week when Pfizer announced the preliminary results from a late-stage clinical trial showing the COVID-19 vaccine it had co-developed with BioNTech was over 90% effective after the second dose.
Pfizer had previously said that the company expected to contact the United States Food and Drug Administration to apply for an Emergency Use Authorization (EUA) by the third week of November, which means that the company’s announcement could be days away.
The United States Food and Drug Administration had implemented a requirement on COVID-19 vaccine makers of having at least two (2) months of follow-up with volunteers after their second dose – taken 28 days after the first dose – in order to ensure that the vaccines were safe.
Meanwhile, Moderna and the United States National Institutes for Health announced the preliminary results from their own trial, finding their COVID-19 vaccine was “almost 95% effective“.
Moderna had previously said that the company expected to apply for an emergency use approval by November 25, 2020.