Novavax (NVAX) shares soared Wednesday after an advisory panel to the U.S. Food and Drug Administration recommended granting Emergency Use Authorization for the group's Covid vaccine to patients over the age of eighteen.
If ultimately approved by the FDA, NVX-CoV2373 will become the fourth Covid vaccine authorized for use in adult patients in the United States. The drugmaker said late last year that trial data indicates solid immune responses against both existing Covid strains as well as the Omicron variant. More than 40 countries, including Canada, Britain and all 27 European Union nations, have already authorized the Novavax vaccine.
Cantor Fitzgerald analyst Charles Duncan said the FDA approval in the United States is important given that many vaccine-hesitant patients may feel more comfortable with Novavax's traditional two-shot regime as opposed to the MRNA technology-based treatments made by Pfizer (PFE) and Moderna (MRNA).
"The advisory committee's positive recommendation acknowledges the strength of our data and the importance of a protein-based COVID-19 vaccine developed using an innovative approach to traditional vaccine technology," said CEO Stanley Erck.
"Consistent with submissions to regulatory authorities worldwide, we have already submitted an amendment with updated manufacturing information for the EUA to the FDA for review," he added. "We look forward to collaborating with the FDA as it makes its final decision."
Novavax shares were marked 3.8% higher in early Wednesday trading to change hands at $49.29 each.
Novavax said early last month that it sees 2022 revenues in the region of $4 billion to $5 billion, and repeated its view that it will deliver 2 billion shots of its vaccine worldwide before the end of the year.
NVX-CoV2373 for the three months ending in March were pegged at $586 million.
Cantor's Duncan, who carries an 'overweight' rating with an improved $168 price target on the stock, notes that while there remains "some potential commercial risk" linked to the small amount of incidents of myocarditis in male patients, which could limit penetration into vaccine-hesitant markets, "we believe should be viewed as de minimis"
"We don’t see this as a distinctive characteristic of ‘2373, and note the Committee acknowledged a host of safety signals have been observed with other vaccine technology platforms authorized for Covid," he added.
