Pfizer (NYSE:PFE) may be about to take a major step forward in its coronavirus vaccine development efforts.
"We are very close to submitting for an emergency use authorization," CEO Albert Bourla said during the STAT Summit on Tuesday.
An emergency use authorization (EUA) is not the same as full-scale regulatory approval, but if Pfizer is granted an EUA, the U.S Food and Drug Administration could authorize the use of the drugmaker's experimental vaccine during the COVID-19 crisis.
PFIZER'S CORONAVIRUS VACCINE DEVELOPMENT EFFORTS ARE NEARING AN IMPORTANT MILESTONE. IMAGE SOURCE: GETTY IMAGES.
On Nov. 9, Pfizer and its partner BioNTech (NASDAQ:BNTX) said an interim analysis of their phase 3 clinical trial data found their vaccine candidate, BNT162b2, could be more than 90% effective at preventing COVID-19. Importantly, Pfizer and BioNTech noted that no serious safety concerns had been observed among the more than 43,000 participants in the study.
Bourla's comments echo those made earlier by the companies. In their press release announcing their efficacy data, Pfizer and BioNTech said they planned to request an EUA soon after they collected the required safety data, which they expected would occur in the third week of November.
An EUA could allow Pfizer and BioNTech to beat rival drugmaker Moderna (NASDAQ:MRNA) to market. On Monday, Moderna said its COVID-19 vaccine candidate, mRNA-1273, could be more than 94% effective at combatting the dangerous disease.
Still, Bourla said he welcomed Moderna's announcement and hopes other companies' development efforts are successful, so as to meet the urgent need for safe and effective vaccines worldwide.
