Novavax to apply for FDA emergency use authorization in third quarter

Novavax to apply for FDA emergency use authorization in third quarter
© Getty Images

Vaccine manufacturer Novavax said Monday that it plans to apply for Food and Drug Administration (FDA) emergency use authorization in the third quarter, pushing back previous predictions it could get approval in May.

As part of its first quarter earnings report, Novavax announced that it intends to apply for emergency use authorization from the FDA, the U.K. Medicines and Healthcare products Regulatory Agency and the European Medicines Agency in the third quarter.

The U.S. company’s announcement comes after Novavax’s CEO Stanley Erck told CNBC in March that he was hopeful the vaccine would receive emergency use authorization from the FDA in May. 

ADVERTISEMENT

Novavax expects to produce 100 million doses per month by the end of the third quarter and reach 150 million doses per month before the end of the year. Previously, the company was aiming for 150 million doses per month in the third quarter. 

The vaccine maker received $1.6 billion from the U.S. for its vaccine development and manufacturing. But because it took longer than competitors’ shots, the U.S. has already secured enough vaccine doses for its population. 

The Novavax vaccine could instead have more of an impact on the worldwide vaccination effort as many other countries still need vaccines. The manufacturer has committed 1.1 billion doses to COVAX, a World Health Organization program designed to get doses to low- and middle-income nations. 

If approved in the U.S., Novavax would become the fourth authorized COVID-19 vaccine after the Pfizer-BioNTech, Moderna and Johnson & Johnson vaccines.

Novavax’s COVID-19 vaccine was found to be almost 90 percent effective against the virus in a U.K. trial, but its effectiveness plummeted to about 50 percent against the variant that was originally identified in South Africa. 

In its first quarter report, Novavax also released that an early study in animals of a combination vaccine for COVID-19 and the flu led to a positive immune antibody response.