Novavax has enlisted a brace of manufacture heavyweights connected the quest to propulsion its recombinant COVID-19 vaccine hopeful crossed the decorativeness line.
The biotech’s caller elder vice president of prime assurance, Nasir Egal, Ph.D., hails from Sanofi, portion Jim Kelly, Novavax’s caller main fiscal serviceman and treasurer, joins from Supernus Pharmaceuticals. Novavax volition channel the execs’ prime and commercialized know-how toward its experimental COVID-19 vaccine NVX-CoV2373, which it plans to file for an exigency usage authorization (EUA) successful the U.S. successful the 4th quarter.
The quality comes aft Novavax reported bid of vaccine manufacturing and proviso issues this year, which forced it to hold its FDA filing timeline from May to July, and past into the last 3 months of the year.
Egal spent astir 10 years astatine Sanofi, moving up to the relation of caput of planetary prime outer affairs. Before Sanofi, he worked successful planetary and determination prime and compliance astatine pharma heavyweights Novartis and Merck & Co. He’s besides served astatine the U.S. Food and Drug Administration arsenic a probe scientist, Novavax said.
For his part, Kelly served arsenic CFO Supernus and had a ten-year tally arsenic Vanda Pharmaceuticals’ CFO and treasurer earlier that. His resume besides includes fiscal roles astatine Biogen and MedImmune.
Novavax volition number connected Kelly’s fiscal and strategical expertise arsenic it “quickly matures into a planetary commercialized company,” Novavax CEO Stanley Erck said successful a statement. The biotech, which formed successful 1987, has ne'er brought a vaccine to market.
Throughout 2020, Novavax’s changeable ranked among the large 5 expected to comprise the United States' vaccine effect successful 2021 alongside shots from Pfizer, Moderna, Johnson & Johnson and AstraZeneca. Pfizer and Moderna were the archetypal to triumph U.S. exigency nods with their mRNA vaccines, followed by Johnson & Johnson with its single-dose prophylactic. AstraZeneca’s changeable has not been authorized stateside.
But Novavax’s changeable hasn’t had the easiest way to a filing. While the vaccine precocious posted 90.4% efficacy successful a pivotal signifier 3, putting it successful a akin league to Pfizer and Moderna’s vaccines, Novavax has stumbled connected manufacturing.
The biotech had primitively hoped to use for an EUA successful the 2nd quarter, but successful May, Novavax said it would propulsion backmost filings successful the U.K., U.S. and European Union into the 3rd quarter. At the time, the institution flagged accumulation issues related to an assay needed to beryllium cross-site manufacturing consistency information to regulators. The institution has besides had occupation sourcing earthy materials similar bioreactor bags, extent filters and maturation media, though a institution spokesperson told Fierce Pharma successful precocious July that those problems person “generally been resolved.”
In an August regulatory filing, Novavax disclosed different delay, stating that the U.S. wanted it to enactment with the FDA connected issues related to analytic methods earlier advancing further U.S. manufacturing. “We’re talking weeks here, we’re not talking months,” Novavax CEO Stanley Erck said connected an expert telephone astatine the time.
Meanwhile, Novavax precocious finalized a woody to merchantability the European Commission 200 cardinal doses of its vaccine. Under the deal, Novavax is connected platform to proviso 100 cardinal doses, positive an enactment for 100 cardinal more, done 2023. It says it aims to implicit its rolling submission to the European Medicines Agency successful the 3rd quarter.
Elsewhere, Novavax has pledged 100 cardinal doses to the U.S. and 1.1 cardinal doses to low- and middle-income countries.