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The COVID-19 vaccine from Novavax Inc (NASDAQ:NVAX) is moving toward obtaining US clearance after the company claimed that solved the manufacturing problems that had delayed its application.
FDA clearance is not imminent as the agency has to analyze a large amount of study data from multiple countries, the Wall Street Journal reports, citing a person familiar with the matter.
However, a decision is getting closer since Novavax formally submitted an application for authorization at the end of January. In July 2020, the US awarded the company a $1.6 billion contract to develop and deliver 100 million doses of its vaccine.
The FDA will review Novavax’s application “as soon as possible,” according to a spokeswoman for the agency. She also added that the agency plans to hold an advisory committee hearing before authorizing the drugmaker’s vaccine. No specific date has been scheduled.
Novavax’s drug 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 the virus.
Novavax has had to demonstrate that its peak protein and adjuvant were the same in each manufacturing batch to obtain FDA clearance.
The process has taken longer than expected, but the company has managed to resolve it, according to Novavax medical director Filip Dubovsky.
Novavax Dosage lost some of its potency against the Omicron variant after two dosesbut announced that a third booster injection should provide further protection.
In February, Health Canada approved Novavax’s COVID-19 vaccine for application in people over 18 years of age.
The movement of prices
Shares of NVAX were trading 1.91% lower at $70.35 in premarket when last checked Monday.
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