Pfizer is “very close” to applying for an emergency use approval for its COVID-19 vaccine after collecting safety data to submit to US regulators, the company’s CEO said on Tuesday, according to a report.
Pfizer had announced last week preliminary results from a late-stage clinical trial showing the injections it had co-developed with Germany’s BioNTech was more than 90 percent effective after the second dose.
“We are very close to submitting for an emergency use authorization,” Albert Bourla told medical news site Stat. “We will announce it as soon as we are doing it”.
On Tuesday, Pfizer CEO said that a key safety milestone had been reached in the study of its COVID-19 vaccine. Pfizer previously said it expects to contact the US Food and Drug Administration to apply for an Emergency Use Authorization by the third week of November.
Speaking at a virtual conference hosted by the New York Times on Tuesday, Bourla said the company was preparing to submit its data to the U.S. Food and Drug Administration.“We are preparing now for submissions,” Bourla said at the conference without specifying when it anticipated filing for an emergency use authorization. Bourla added that Pfizer would soon release more detailed efficacy results.
To ensure the drugs are safe, the FDA had imposed a requirement on COVID-19 vaccine makers of having at least two months of follow-up with volunteers after their second dose, taken 28 days after the first.
On Monday, another drugmaker Moderna and the US National Institutes for Health announced similar preliminary results from their own trial, finding their vaccine was almost 95% effective.
