Novavax reports more delays for its Kovid-19 vaccine

Novavax, one of the first players in the world to be involved in the vaccination race against Kovid, gave a disappointing 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 by the end of the year.

Announced delays during earnings calls with investors, are Latest shock For the little-known Maryland company, which received a grant of up to $ 1.6 billion last year from the US federal government and whose product is Show strong results In clinical trials. Despite these victories, the company has struggled to demonstrate that it can deliver on its promise to supply 2 billion doses to the world this year. Novavax has never brought the vaccine to market in its 34-year history.

On the call, the company’s president and chief executive, Stanley C. Erk said regulatory and manufacturing bottlenecks due to delays have now been resolved. “Almost all 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: As of Tuesday morning, the company’s stock had fallen by nearly 17 percent to $ 133.86, although it later improved somewhat later in the day.

“I don’t see very good for them at this point,” said Rob Smith, managing director of Capital Alpha Partners, an investment research firm.

The company’s delay is unlikely to affect wealthy countries such as the United States, which is loaded with modern, Pfizer-BioNotech and Johnson & Johnson vaccines.

But it is likely to have significant consequences for the rest of the world, given that Novavax only last week Finalized a deal Gavi, with a public-private global vaccine partnership, to supply 1.1 billion doses of its shot to low and middle-income countries. Novavax has made other deals with countries such as South Korea, Japan and Australia, and has agreements with eight production plants worldwide.

In January, Company estimates That it would affect its full production capacity of 150 million doses a month by the middle of this year, a prediction that would later come after facing a shortage of huge single-use bag supplies used in filter and vaccine manufacturing Was revised. On Monday, the company again delayed its estimate, stating that it expected to reach 100 million doses of production a month by the end of the third quarter and 150 million per month by the fourth quarter.

One of its major manufacturing partners, the Serum Institute in India, Have faced their own production and geopolitical challenges. Earlier this year a fire at the facility reduced its capacity and in April, Serum chief executive Adar Poonawala, Called the United States To restrict access to raw vaccine material. And although Novavax’s deal with the serum is to supply the rest of the world through its arrangement with Gavi, the Indian government has banned the export of vaccines from the country as it struggles with the deadly second wave of Kovid-19 is.

“Serum is the backbone of vaccine supply to the world,” said Andrea Taylor, assistant director of the Duke Global Health Innovation Center. Who is tracking Global Vaccine Deals. “I think it is difficult to minimize its impact, especially for countries in South and Southeast Asia, as well as countries in Africa.”

Regulatory constraints have also overtaken Novavax. On Monday, company officials said a now-resolved issue with an “assay” – a test that was required to confirm that their product could be manufactured continuously on a commercial scale at several production plants – Regulatory approvals around the world were delayed, and countries like Britain and the United States would not grant authorization until at least July. Company officials once said that they hoped to get authorization for their vaccines in April.

The delay is particularly striking in the UK, as Novavax reported positive results of its clinical trial in January.

British officer Persuaded Novavax to set up a test there last year Partly by promising momentum in clinical development and regulatory approval. But time is running out: About two-thirds of British adults have received their first dose of the coronovirus vaccine, made by AstraZeneca, and each adult is expected to be offered one by the end of July.

The role of the vaccine in the UK depends on how soon Novavax can begin distributing its shots. A british factory Has said that it will be ready by summer. The country has recently shied away from the AstraZeneca shot in young people because of the risk of very rare blood clots, leaving room for Novavax to be an option for people under 40 years of age.

The country is also studying the effects of giving its second dose. Novavax vaccine In those who have already received the first dose from Pfizer or AstraZeneca.

In the United States, Novavax’s setback sheds new light on its large-scale deal with the US government. As recently as 2019, The company was on the verge of closure After a major test failure for another vaccine, and it was forced to sell its manufacturing facility to raise funds.

Last year, the Trump administration Made a big bet The small company, as part of its Operation Warp Speed ​​project, signed a $ 1.6 billion contract for delivery of 110 million doses by the beginning of this year. According to Novavax’s financial filing, the total amount of the deal was raised to $ 1.75 billion in April. The company’s big test in the United States and Mexico is still not complete, although officials said Monday that they expected results from that study “in a few weeks”.

Novavax officials said they no longer expected to deliver those dosages by the end of this year or by early 2022. A NovaWax spokesperson said that in its contract with the US government, there was no penalty for later delivery.

Novavax’s spotty track record does not give credence that it could pose the challenge of producing billions of doses, said Les Funtleder, a health care portfolio manager at E Square Capital Management, which invests in domestic and emerging markets. “It seems that they were not really ready for a challenge of this magnitude,” he said.

Recent news of internal business – such as Last month departure Five months after taking the role of chief financial officer of Novavax, for personal reasons – does not help, Mr. Funtleder said. “It’s a bad eye,” he said.

But even though it has a challenging path as a latecomer, the Novavax vaccine can fill critical gaps, some experts said. In the United States, it can be used as a booster shot to enhance weakened immunity, or the Biden administration may choose to donate the vaccine to other needy countries, as it has an unused supply of AstraZeneca supplements.

Novavax has stated that it is developing a new version of its vaccine to address the version to be broadcast in South Africa. And it recently announced that it would start studying the shot. 12. Children older than, In an effort to catch Moderna and Pfizer, who have already tested their products in that age group.

Vaccines can also be stored at normal refrigeration temperatures, without the freezing temperatures required for Pfizer and Modern vaccines.

“By the end of 2021 there will be a great need for safe and effective vaccines that can travel well,” said Ms. Taylor of Duke University. “Novavax looks like it might fit that description.”

Dr. Saad B. Omer, director of the Yale Institute for Global Health, said that when concerns were raised about Johnson & Johnson and AstraZeneca vaccines because of the link to blood clots, many vaccine-available countries were able to switch to other options.

“It’s good to hedge our bets,” he said. “If we want to avoid, for example, in many parts of the world, in low-income countries, everyone is affected by body shock after body shock, then we need to vaccinate a large part of the world . “

Benjamin Muller and Noah Weiland contributed reporting.

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