Politico reported Wednesday that Novavax has fallen short of production targets thanks in part to issues linked to testing the 'purity' of its NVX-CoV2373 coronavirus vaccine candidate.
Earlier this summer, the Gaithersburg, Maryland-based drugmaker said it expects to seek regulatory approval from the U.S. Food & Drug Administration for NVX-CoV2373 in the fourth quarter -- a few months behind its prior estimate -- but insisted that it remains on track to reach manufacturing capacity of 100 million doses per month by October and 150 million does per month by the end of the year.
Novavax also noted that the U.S. government -- which has invested $1.6 billion into the group -- had been "instructed to prioritize alignment” with FDA testing procedures, noting the government “further indicated that [it] will not fund additional US manufacturing” until the firm has done so."
"In response to a recent news article citing anonymous sources, Novavax confirms our confidence in our ability to deliver our high-quality vaccine," the company said in a statement. "Further, we underscore our ongoing commitment to the stringent standards of production and manufacturing for our recombinant nanoparticle protein-basedCOVID-19 vaccine candidate with Matrix-M™ adjuvant."
"We are confident that our vaccine will soon play a significant role in the global COVID-19 vaccine arsenal, differentiated by its potential to help address two major issues slowing the world's ability to end the pandemic: global distribution challenges and vaccine hesitancy," said CEO Stanley Erck.
Novavax shares closed 14.76% lower, after earlier trading as much as 27% in the red, to end the session at $136.86 each, a move that would extend the stock's six-month decline to around 35.7%.