Pfizer Expected To File For FDA Emergency Approval on Friday, Followed Closely By Moderna, Azar Says

Pfizer Expected To File For FDA Emergency Approval on Friday, Followed Closely By Moderna, Azar Says

Pfizer Inc PFE is likely to file an application with the United States Food and Drug Administration for emergency use of its COVID-19 vaccine on Friday, with Moderna Inc MRNA to do the same shortly after.

What Happened: The disclosure on Pfizer’s COVID-19 vaccine was made by Health and Human Services Secretary Alex Azar on Thursday, CNBC reported.

Azar pointed out that Pfizer’s partner BioNTech SE BNTX has announced that “they intend to file for emergency use authorization at the FDA” on Friday.

“We would expect Moderna filing soon also,” the official disclosed at a White House coronavirus task force meeting held after a gap of months.

Why It Matters: Pfizer and its german partner’s mRNA vaccine was the first to report over 90% efficacy against COVID-19 — later confirming 95% efficacy for the vaccine candidate.

Moderna’s vaccine has also shown 95% effectiveness against the disease as per Phase 3 trial results.

BioNTech CEO Ugur Sahin told CNN on Wednesday that the company and Pfizer would seek the emergency use authorization on Friday.

Sahin said he expects the vaccine approval process to be completed and distribution to commence within this year — provided everything goes to plan.

The CEO revealed that  COVID-19 could be under control halfway through 2021.

Price Action: Pfizer shares closed almost 0.1% lower at $36.19 on Thursday and gained 0.72% in the after-hours session. On the same day, BioNTech shares closed almost 5% higher at $94.93 and gained 3.34% in the after-hours session.

Posted In: CNBCCovid-19Emergency Use AuthorizationVaccinesBiotechNewsFDAMediaGeneral

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