Novavax, one of the first players in the race to vaccinate the world against Covid, delivered disheartening news on Monday, saying that its highly protective vaccine would not be authorized in the United States or Britain until at least July, and that it would not reach peak production until the end of the year.
The delays, announced during an earnings call with investors, are the latest setback for the little-known Maryland company, which was granted up to $1.6 billion from the U.S. federal government last year and whose product has shown robust results in clinical trials. Despite these wins, the company has struggled to demonstrate that it can deliver on its promise to supply the world with 2 billion doses this year. Novavax has never brought a vaccine to market in its 34-year history.
On the call, the company’s president and chief executive, Stanley C. Erck, said that the regulatory and manufacturing hurdles causing the delay have now been resolved. “Nearly all of the major challenges have been overcome, and we can clearly see the light at the end of the tunnel,” he said.
Investors did not appear to agree: By Tuesday morning, the company’s stock had fallen to $133.86, down nearly 17 percent, although it rebounded somewhat later in the day.
finalized a deal with Gavi, a public-private global vaccine partnership, to supply 1.1 billion doses of its shot to low- and middle-income countries. Novavax has struck other deals with countries like South Korea, Japan and Australia, and has set up agreements with eight production plants around the world.
In January, the company estimated that it would hit its full production capacity of 150 million doses a month by the middle of this year, a prediction it later revised after facing a shortage of supplies like filters and the giant single-use bags that are used in vaccine manufacturing. On Monday, the company delayed its estimate again, saying it expected to reach production of 100 million doses a month by the end of the third quarter, and to make 150 million a month by the fourth quarter.
One of its major manufacturing partners, the Serum Institute in India, has faced its own production and geopolitical challenges. A fire at the facility earlier this year reduced its capacity, and in April, Serum’s chief executive, Adar Poonawalla, called out the United States for restricting access to raw vaccine ingredients. And though Novavax’s deal with Serum is intended to supply the rest of the world through its arrangement with Gavi, the Indian government has banned exports of vaccines from the country as it struggles with a deadly second wave of Covid-19.
which is tracking global vaccine deals. “I think particularly for countries in South and Southeast Asia, as well as countries in Africa, it is hard to overstate the impact that this is having.”
Regulatory hurdles have also set Novavax back. On Monday, company executives said that a now-resolved issue with an “assay” — a test that was needed to confirm that their product can be consistently manufactured at commercial scale across multiple production plants — was delaying regulatory approvals around the world, and that countries like Britain and the United States would not grant authorization until at least July. Company officials once said they hoped to gain authorization for their vaccine in April.