Novavax (NVAX) is poised to be one of the next vaccines to receive emergency use authorization (EUA) in the U.S.
CEO Stanley Erck has been busy expanding manufacturing capacity for several countries, and expects the U.K.'s regulatory body to grant authorization in a matter of weeks. Erck said he is ready to roll out vaccines not just in the U.K., but also in Australia and Canada, as the two will accept the U.K. green light as a signal the vaccine is safe to use.
"Many regulatory agencies are going to be inclined to follow the [Medicines and Healthcare products Regulatory Agency] very shortly," Erck said.
But what will happen in the U.S. market remains unclear. Erck has made no secret about his hopes that the U.S. Food and Drug Administration (FDA) will grant an EUA based on the U.K. data — which showed the vaccine was 89.7% efficacious in the U.K., which is dominated by the B.1.1.7 variant, and 96% efficacious against the original virus strain.
Erck told Yahoo Finance Monday that it is clear now the FDA will use the data from the Phase 3 trial in the U.K. and Phase 2b trial in South Africa as part of its decision.
"It’s clear that they will use the U.K. and South Africa data as part of their decision process. What’s not clear is whether we also need the U.S. data," Erck said.
The U.S. Phase 3 trial is already fully enrolled and has already begun to count cases — a metric used to determine when to end the trial. Erck said based on how many cases are being counted, the trial could end "earlier than we originally thought. So those data could be available without terrible delay."
Meanwhile, the company is already busy scaling up production between now and expects to reach an output target of 150 million doses per month by summer. The company has relied on partners like the Serum Institute of India and Takeda (TAK), in Japan, to help it produce doses in addition to eight plants.
Even then, the company has not been immune to some of the manufacturing struggles the other companies have run into.
"We all, the industry, are all trying to scale up unprecedented scale across the globe, and some of our processes use the same raw materials," Erck said.
Even some things as simple as filters, which are being used by every vaccine company right now, are in short supply.
"What we have to do is, if you have eight plants, you can't have one plant have 6 or 12 months of inventory ... you have to start doing just-in-time inventory," Erck said, noting that all companies are employing the same strategy to avoid shutdowns.
And with global demand continuing to outpace supply, there won't be a break anytime soon for the plants — an industry-wide concern.
“We don’t see the day, anytime soon where there’s not going to be a strain on our manufacturing capacity," Erck said.
For equitable access, globally, “We need to have our plants running for quite some time.”
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