Novavax's COVID-19 Shot Inches Up To FDA Authorization: WSJ

Novavax Inc's NVAX COVID-19 vaccine is moving toward U.S. authorization after the Company said it resolved manufacturing problems that had held up its application.

FDA clearance isn't imminent as the agency has to go through a large amount of study data from several countries, the Wall Street Journal reported citing a person familiar with the matter. 

However, a decision is getting closer since Novavax formally submitted an authorization request in late January. In July 2020, the U.S. awarded the Company a $1.6 billion contract to develop and deliver 100 million doses of its vaccine candidate.

Related: Novavax Tumbles On Reports Of Underdelivering COVID-19 Vaccine Commitments.

The FDA will review Novavax's application "as expeditiously as possible," an FDA spokeswoman said. She added that the agency plans to hold an advisory-committee hearing before authorizing Novavax's vaccine. A date hasn't been scheduled.

The Novavax jab is a recombinant protein vaccine that directly delivers a version of the spike protein that the coronavirus uses to infect human cells, training the immune system to fight off the virus. 

Novavax had to show that its spike protein and adjuvant were the same in every manufacturing batch to win FDA authorization. 

The process took longer than expected, but Novavax has resolved it, said Novavax Chief Medical Officer Filip Dubovsky.

Novavax's shot did lose some of its potency against the omicron variant after two doses, but it said that a third booster shot should provide strong protection. 

In February, Health Canada approved Novavax's COVID-19 vaccine for individuals 18 years of age and older.

Price Action: NVAX shares are down 1.91% at $70.35 during the premarket session on Monday's last check.