Novavax, one of the earliest players in the world’s vaccination race against Covid, delivered disheartening news Monday, saying its highly protective vaccine would not be approved in the US or UK until July and would not reach peak production by the end of the year.
The delays announced during a profit call with investors are the most recent setback for the little-known Maryland company that received up to $ 1.6 billion from the federal government last year and its product is in clinical trials has shown robust results. Despite these achievements, the company has struggled to show it can deliver on its promise to bring 2 billion doses to the world this year. Novavax has never launched a vaccine in its 34-year history.
Speaking on the conference call, the company’s President and Chief Executive Officer Stanley C. Erck said the regulatory and manufacturing hurdles causing the delay have now been resolved. “Almost all of the major challenges have been overcome and we can clearly see the light at the end of the tunnel,” he said.
Investors didn’t seem to agree: by Tuesday morning, the company’s stock had fallen to $ 133.86, down nearly 17 percent, although it rebounded a little later in the day.
“I don’t see much good for them right now,” said Rob Smith, general manager of Capital Alpha Partners, an investment research firm.
The company’s delay is unlikely to affect wealthy countries like the US, which are being flushed with vaccines from Moderna, Pfizer-BioNTech, and Johnson & Johnson.
It’s likely that this will have a significant impact on the rest of the world, however, as Novavax only signed a deal with Gavi, a public-private global vaccine partnership, last week to sell 1.1 billion doses of its shot at low and medium levels – to deliver. Income Countries. Novavax has other contracts with countries such as South Korea, Japan and Australia and has agreements with eight manufacturing facilities around the world.
In January, the company estimated it would reach its full production capacity of 150 million cans per month by the middle of this year. This forecast was later revised after a lack of supplies such as filters and the huge disposable bags used in vaccine production. On Monday, the company delayed its estimate again, anticipating production of 100 million cans per month by the end of the third quarter and production of 150 million cans per month by the fourth quarter.
One of its key manufacturing partners, the Serum Institute in India, has faced its own manufacturing and geopolitical challenges. A fire at the facility earlier this year reduced capacity, and in April Adar Poonawalla, director of Serum, urged the United States to restrict access to raw vaccine ingredients. And although Novavax’s contract with serum aims to serve the rest of the world through its agreement with Gavi, the Indian government has banned the export of vaccines from the country as it grapples with a deadly second wave of Covid-19.
“Serum is the backbone of global vaccine supplies,” said Andrea Taylor, associate director of the Duke Global Health Innovation Center, which pursues global vaccine businesses. “I think for countries in South and Southeast Asia in particular, as well as for countries in Africa, it is difficult to overestimate the impact this will have.”
Novavax has also thrown back regulatory hurdles. On Monday, company executives said a problem now resolved with an “assay” – a test that was required to confirm that their product could be consistently manufactured on a commercial scale at multiple factories – was gaining regulatory approvals around the world Delayed countries like the UK and the United States would not give approval until July. The company’s employees once said they were hoping to get approval for their vaccine in April.
The delay is particularly noticeable in the UK, where Novavax reported positive results from its clinical trial in January.
British officials convinced Novavax to set up a study there last year, partly because they promised rapid clinical development and regulatory approval. But time is running out: around two-thirds of UK adults have received an initial dose of a coronavirus vaccine, largely made by AstraZeneca, and each adult is expected to be offered one by the end of July.
Updated
May 11, 2021 at 4:32 p.m. ET
The role of the vaccine in the UK depends in part on how quickly Novavax can start distributing its vaccine. A UK factory that makes the vaccines has announced that they will be ready by the summer. The country recently turned away from AstraZeneca intake in younger people because of the risk of very rare blood clots, so Novavax may be an alternative for people under 40.
The country is also investigating the effects of giving a second dose of the Novavax vaccine to people who have already received a first dose of Pfizer or AstraZeneca.
In the US, the Novavax setback sheds new light on the massive deal with the US government. As recently as 2019, the company was on the verge of closing after another vaccine made a major trial and had to sell its manufacturing facility to raise money.
Last year, the Trump administration placed a big bet on the tiny company as part of its Operation Warp Speed project, signing a $ 1.6 billion contract earlier this year to supply 110 million cans. In April, the total amount of the deal increased to $ 1.75 billion, according to Novavax. The company’s major study in the United States and Mexico is still ongoing, despite executives on Monday that they expected the results of that study “in a few weeks.”
Novavax officials said they now didn’t expect to deliver these doses by the end of this year or early 2022. A Novavax spokeswoman said there was no penalty for later delivery in her contract with the U.S. government.
Novavax’s spotty track record offers no confidence in the challenge of producing billions of cans, said Les Funtleyder, healthcare portfolio manager at E Squared Capital Management, which invests in domestic and emerging markets. “It seems they really weren’t prepared for a challenge of this magnitude,” he said.
Recent news about internal sales – such as the departure of Novavax’s chief financial officer last month, five months after he took office for personal reasons – doesn’t help, Funtleyder said. “It’s a bad look,” he said.
But even if there’s a challenging path to follow as a straggler, Novavax’s vaccine could fill important loopholes, some experts said. In the United States, it could be used as a booster shot to bolster dwindling immunity, or the Biden government could choose to donate the vaccine to other countries in need, as it does with the unused supply of AstraZeneca doses .
Novavax has announced that it will develop a new version of its vaccine to address the variant circulating in South Africa. And it was recently announced that it would be investigating the shot in children over the age of 12 to catch up with Moderna and Pfizer, who have already tested their products in that age group.
The vaccine can also be stored at normal refrigeration temperatures without the freezing temperatures required for Pfizer and Moderna vaccines.
“By the end of 2021, there will still be a great need for safe, effective vaccines that can travel well,” said Ms. Taylor of Duke University. “Novavax seems to fit that description.”
Dr. Saad B. Omer, director of the Yale Institute for Global Health, noted that countries with multiple vaccines available were able to switch to other options when concerns about Johnson & Johnson and AstraZeneca vaccines were raised due to blood clot association.
“It’s good to hedge our bets,” he said. “For example, if we want to avoid one body blow after another in low-income countries in many parts of the world that affects everyone, we have to vaccinate a large part of the world.”
Benjamin Mueller and Noah Weiland contributed to the reporting.
