Novavax climbs 9% after clinical trial shows the firm’s COVID-19 vaccine is 90% effective

COVID Shot
  • Novavax shares climbed as much as 9% on Monday following the biotech firm’s upbeat data about its potential COVID-19 vaccine.
  • The study of nearly 30,000 people in the US and Mexico produced an overall efficacy rate of 90.4%.
  • The company is aiming to file for FDA approval in the third quarter of this year.
  • See more stories on Insider’s business page.

Novavax shares climbed as much as 9% on Monday after the company said a late-stage study of its experimental COVID-19 vaccine showed efficacy of more than 90% in nearly 30,000 people. The results move the company closer to seeking authorization for its use in the US.

The company said it plans on filing for regulatory approval of NVX-CoV2373 with the Food and Drug Administration in the third quarter and upon receiving clearance it would remain on track to reach manufacturing capacity of 100 million doses per month by the end of the third quarter. It also foresees hitting manufacturing capacity of 150 million doses per month by the end of the fourth quarter.

Novavax traded 2% higher as of 9:55 a.m. in New York, and has now gained more than 90% year-to-date.

Novavax’s phase 3 study of 29,960 participants in 119 sites in the US and Mexico overall efficacy of 90.4% after observing 77 COVID-19 cases among the participants, with 63 in the placebo group and 14 in the vaccine group. It said the potential vaccine demonstrated 100% protection against moderate and severe disease.

The vaccine is administered in two doses and preliminary safety data from the Prevent-19 study showed the potential product to be generally well-tolerated.

“These data show consistent, high levels of efficacy and reaffirm the ability of the vaccine to prevent COVID-19 amid ongoing genetic evolution of the virus,” said Gregory Glenn, M.D., president of Research and Development at Novavax, in a statement.

The company said further analyses of the trial are ongoing and that data will be submitted to peer-review journals for publication. It also said the placebo-controlled portion of its study of 2,248 adolescents ranging from 12 years to less than 18 years of age continues.

In May, the company’s shares slid to the $121 range after Novavax said it was delaying seeking approval for its COVID-19 vaccine from three regulators, including the Food and Drug Administration, because of manufacturing issues.

Read more: These 5 stocks are prime candidates for an explosive AMC-style short squeeze right now, according to data from Fintel.io

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Novavax surges 12% as its COVID-19 vaccine is found to be 96% effective in preventing the original virus strain

coronavirus vaccine UK
Kate Bingham, Chair of the UK’s Vaccine Taskforce, after starting her Novavax trial at north London’s Royal Free Hospital on October 13, 2020.

  • Novavax shares rose 12% in regular trading Friday after the company announced its vaccine efficacy.
  • The company’s vaccine, NVX-CoV2373, was found to be 96.4% effective against the original strain of COVID-19.
  • It is 86.3% effective against the more contagious virus strain found in the UK.
  • Sign up here for our daily newsletter, 10 Things Before the Opening Bell.

Shares in Novavax rose as much as 20% in pre-market trading Friday after the company announced its coronavirus vaccine candidate is 96.4% effective against the original strain of the COVID-19 virus in a third-stage trial conducted in the UK.

The announcement brings the US-based company closer to getting its vaccine, NVX-CoV2373, approved for use by regulators.

Novavax said its vaccine is 86.3% effective against the more contagious virus variant found in the UK. The study enrolled more than 15,000 participants aged between 18 and 84.

In a smaller trial conducted in South Africa, the company said its vaccine was 55% effective against another contagious variant in volunteers without HIV, but still prevented severe illness. The shot’s effectiveness fell to around 49% when the analysis included data on participants who were HIV-positive, according to Reuters.

“Across both trials, NVX-CoV2373 demonstrated 100% protection against severe disease, including all hospitalization and death,” Novavax said in a statement.

The company’s shares rose 22% in pre-market trading to $235.71 per share. They were trading below $10 in January 2020 when it announced it was developing a vaccine.

Novavax is planning to file for vaccine authorization from UK regulators early in the second quarter of 2021, the company’s chief medical officer Filip Dubovsky told Reuters. It plans to produce its two-shot vaccine in eight locations, including at the Serum Institute of India in Pune.

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Novavax’s COVID-19 vaccine was 89.7% effective in a large trial, and worked against the contagious virus variant first found in the UK

coronavirus vaccine UK
Kate Bingham, Chair of the Government’s Vaccine Taskforce, after starting her Novavax trial at the Royal Free Hospital, north London on October 13, 2020.

  • Novavax’s vaccine was 89.7% effective at preventing symptomatic COVID-19 in a late-stage trial.
  • Novavax said the vaccine was 86.3% effective against B.1.1.7, the variant first found in the UK.
  • US biotech Novavax’s COVID-19 shot has not yet been approved by regulators.

Novavax’s COVID-19 vaccine was 89.7% effective at preventing COVID-19 with symptoms in a trial of more than 15,000 people, the US biotech announced Thursday.

The shot held up against the highly contagious coronavirus variant circulating in the UK and the US, called B.1.1.7, Novavax said. The vaccine worked 86.3% of the time against this particular variant, Novavax said in a press release.

The shot was 96.4% effective against the original virus strain, it said.

The company said that its vaccine was 48.6% effective in a smaller trial of around 2,600 participants in South Africa, where another variant, called B.1.351, is circulating. Its efficacy was slightly higher in those who were HIV-negative, at 55.4%.

There is some evidence that B.1.351, which is circulating in 48 countries and 23 states in the US, can partially evade antibodies.

The company said that the shot provided 100% protection across both trials against severe disease, including all hospitalization and death. But the numbers were small – there were five people with severe disease in the group that received a placebo instead of the vaccine.

“Importantly, both studies confirmed efficacy against the variant strains,” Stanley Erck, chief executive officer at Novavax, said.

Read more: COVID Vaccine Tracker: J&J’s shot joins Moderna and Pfizer, AstraZeneca and Novavax up next

There are more than 113,000 reported cases of B.1.1.7 in the UK, and more than 3,700 reported cases in the US, where it has been detected in all 50 states, according to the Centers of Disease Control and Prevention (CDC).

The CDC has predicted that the variant will become the most common coronavirus variant in the US by the end of March.

There are currently 108 reported cases in the US of B.1.351, the variant first detected in South Africa, according to the CDC.

The trial results were announced in a press release, and are yet to be scrutinized by experts or published in a medical journal.

Novavax’s vaccine combines an engineered form of the virus with a plant-based ingredient to generate an immune response. The vaccine can be stored at normal temperatures.

The shot is yet to receive a regulatory greenlight. The company said in the press release Thursday that it expected the data from the UK and South Africa trials to underpin its submission to regulators worldwide.

Erck has said before that the company would probably file for approval in the UK first, in about April, before submitting data to the US Food and Drug Administration as soon as May. Novavax’s US trial is ongoing.

Novavax has said previously that it hopes to produce its shot at a rate of 2 billion doses a year by the middle of 2021, though it’s not clear how many shots the company could actually make this year.

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What we know about vaccines and variants

Pills 2 (2)

Hello, 

Man, what an end to the week. The coronavirus variant first identified in South Africa was found in the US, and we got vaccine results from Novavax, and from Johnson & Johnson’s one-shot coronavirus vaccine.

We’ll get into all that and more, but first – new to our newsletter? You sign up here for daily dispatches from the healthcare team.

Also – we’re hiring another reporter for the team! Are you a journalist looking to dig deep on digital health, break news, and make sense of what’s ahead for the industry? Be sure to apply here!


vaccines
A pharmacist fills a syringe to prepare a dose of the Pfizer-BioNTech Covid-19 vaccine for front-line health care workers at a vaccination site at Torrance Memorial Medical Center on December 19, 2020 in Torrance, California.

We’re learning more about how vaccines work against variants

It’s been a mixed bag of vaccine news this week, kicking off with the news that Merck is dropping out of the race.

With the pharma giant tapping out, all eyes have been on the next wave of results, with more than 200 vaccines still in the works.

Andrew Dunn mapped out what the year ahead looks like for those candidates.

Read the full breakdown here>>

And as new, more infectious variants have emerged around the world, a big question has been around how they’ll interact with vaccines. 

On Monday, Moderna said that it is designing a new version of its COVID-19 shot to fight the variant first found in South Africa

Then on Thursday, Novavax shared results from its UK and South Africa trials, finding that its coronavirus vaccine was highly effective in the UK, but didn’t work nearly as well in South Africa, where a new variant is circulating widely.

The news was followed shortly after on Friday morning with the long-awaited results from Johnson & Johnson’s one-dose vaccine. The company said its vaccine is 66% effective against COVID-19 based on a global trial run in places including the US, Latin American and South Africa. 

The results – while not as high as Pfizer and Moderna’s – come with some big questions. For one, having only one dose could be a game-changer. J&J shared that its vaccine was 85% effective at preventing severe disease, across all variants, which would be a big help in curbing the pandemic. 

Read the full story here>>

J&J’s single-dose coronavirus vaccine is 66% effective against COVID-19, raising worries that some variants may lower protection


California COVID vaccine rollout Six Flags Magic Mountain
At a mass vaccination site set up in a California Six Flags, a nurse administers the COVID vaccine. The state has delivered 45% of its allotted vaccines, compared to North Dakota’s 84% and South Dakota’s 75%.

Vaccine rollout is going well – depending on what state you’re in

Meanwhile, Moderna and Pfizer/BioNTech’s shots are still rolling out across the US. In some places, usage has been better than others. 

On Capitol Hill, members of Congress have received shots, but essential Hill workers have not, Kimberly Leonard reports. 

Patricia Kelly Yeo spoke to experts in the Dakotas about how they’re approaching administering vaccines. For the more rural areas, having a centralized systems has been a big help.  

For states and cities with bigger populations, she found there are two big takeaways from North Dakota and South Dakota’s experiences. Collaboration is key, and so is keeping the rollout system centralized. 

Read the full story here>>

How the Dakotas are successfully rolling out COVID vaccines – and 2 major lessons for larger states


Rosalind Brewer
In March, Rosalind Brewer will become the third Black woman in modern history to lead a Fortune 500 company.

Walgreens has tapped a new CEO 

On Tuesday, The Wall Street Journal broke the news that Walgreens had found its next top exec.

Starbucks COO Roz Brewer is leaving the coffee giant to become Walgreens CEO. She’ll be the only Black woman leading a Fortune 500 company.

It’s a move most Wall Street analysts are cheering on, saying Walgreens “nailed” the choice for a successor to Stefano Pessina who will stay on as executive chairman. 

Shelby Livingston has a full look at what analysts think is ahead for the company with the pick. 

Read the full story here>>

‘Nailed it’: 4 Wall Street analysts lay out why Roz Brewer is the best pick to turn around Walgreens


Humana CEO Bruce Broussard
Humana CEO Bruce Broussard

A conversation with Humana CEO Bruce Broussard

Last Friday, Shelby had a chat with Humana CEO Bruce Broussard. 

Broussard told her about competing with some of the health-insurance startups taking on the red-hot Medicare Advantage market, like Oscar and Devoted. 

Humana for its part has its own answer: a new venture called Author. It launched in 2021 in South Carolina, and already has 15,000 members, Broussard told Shelby. 

Read the full scoop here>>

Speaking of the insurance upstarts, Shelby and the graphics team here at Insider took a closer look at Medicare Advantage enrollment heading into 2021. 

While health-insurance startups are gaining a bigger foothold in the lucrative Medicare Advantage market, they’re still no match for established insurers.

(It’s pretty striking to see the enrollment numbers for giants like UnitedHealthcare stacked next to some of the tiny younger players.)

As part of Shelby’s conversation with Broussard, they discussed what led Humana to invest heavily in primary care. The conversation turned into one about the future of health insurers, medicine, and Humana itself. 

Read the full story here>>

The CEO of major health insurer Humana laid out why he’s betting big on primary care


fitbit sense

The latest on Big Tech’s healthcare ambitions

Tech giants are keeping busy, as Blake Dodge has been reporting over the past few weeks. 

That’s especially the case for companies as part of the Alphabet umbrella. She and Alphabet reporter Hugh Langley teamed up over the past week on some dispatches from Google’s parent company. 

One of the pockets of the healthcare industry tech companies seem to be focused on is monitoring health at home. Blake mapped out how those strategies are playing out so far at Apple, Amazon, Verily, and Google (hint: it’s a lot of smart watches). 

Read the full story here>>

Big tech wants to monitor your health at home. From Verily to Amazon, here’s where they’re placing their bets.


insider events future of healthcare 2x1

Talking the future of digital health and biotech

Over in the land of startups and funding, things are always a-buzz. Here’s what you need to know.

With that all in mind, I wanted to let you know about an event Megan is moderating on February 10 at 3 p.m. ET. She’ll be talking to top healthcare VCs about the year ahead for startups trying to make a dent in the $3.8 trillion healthcare industry.

Tune in>>

SIGN UP HERE: Hear from healthcare’s biggest VCs on the future of digital health, biotech, and startups


I hope you all have great weekends! I’ll be spending mine outside, probably double-masking to stay extra safe. 

Tips? Feedback? Find me at lramsey@businessinsider.com. You can reach the entire healthcare team at healthcare@businessinsider.com

– Lydia

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Novavax says its coronavirus vaccine was highly effective in a UK trial, but it didn’t work nearly as well against the variant first found in South Africa

coronavirus vaccine UK
Kate Bingham, Chair of the Government’s Vaccine Taskforce, after starting her Novavax trial.

  • Novavax on Thursday said that its vaccine was 89% effective at preventing cases of COVID-19, based on results from a UK trial.
  • In a trial in South Africa, the vaccine was far less effective, likely because of a coronavirus variant that has emerged there.
  • Novavax is still signing up volunteers for a trial of its experimental shot in the US and Mexico.
  • Visit Business Insider’s homepage for more stories.

An experimental coronavirus shot developed by the biotech company Novavax was highly effective at preventing COVID-19 in a trial enrolling 15,000 British volunteers, a critical validation of a leading COVID-19 vaccine candidate, the company said Thursday. 

Despite the success in the UK, weaker results from a smaller study in South Africa raise a warning about the potential for virus variants to evade efforts to defeat them.

Novavax’s vaccine was 49% effective at preventing disease in the South Africa trial, where more than 9 in 10 illnesses were caused by a troubling viral strain called B.1.351. On Thursday, the US confirmed the first cases of that strain

The company published the trial results in a press release, and said it plans to submit them to a scientific journal for review. 

Novavax’s stock jumped 30% in after-market trading. Overall, the clinical success caps an arduous, three-decade-long history of vaccine research for the company, which has never developed a commercial medicine.

The UK and South Africa studies are both ongoing, with Thursday’s announcement detailing interim results from both trials. That means the actual efficacy of the vaccine is likely to change, as more infections are recorded in the studies. Both studies randomized volunteers to receive either two doses of Novavax’s shot or a placebo.

South Africa study results is a troubling, yet caveated, finding

The variant, B.1.351, was first discovered in December in South Africa and has since spread to at least 30 countries. 

By the time Novavax’s study began counting COVID-19 cases among volunteers, B.1.351 was the dominant strain in South Africa, making up roughly 80% of cases, according to data from Nextstrain.org presented by Novavax

The study’s key finding was that the vaccine was 49% effective in South Africa. The trial tallied 44 COVID-19 cases, with 15 among volunteers getting Novavax’s shots and 29 from the placebo group.

That’s far smaller than the final-stage trials ran by Pfizer and Moderna, which each respectively tallied more than 150 cases. 

Still, the 4,406-person study provides the most solid evidence to date that COVID-19 vaccines can be less effective against certain variants of the virus, particularly B.1.351. 

Given the small number of cases, the actual efficacy of the vaccine in South Africa could vary wildly. The interim analysis determined a 95% chance that the shots are between 6% and 73% effective. 

The concern is evident in a change in Novavax’s strategy. The company will start researching a new version of its vaccine that specifically includes B.1.351, aiming to start human testing in the second quarter of 2021. 

Some preliminary research raised concerns this week that other coronavirus vaccines may not work as well against this variant. Moderna’s vaccine, for instance, showed more than a six-fold reduction in neutralizing antibodies, the virus-killing proteins at the heart of the immune response, when exposed to B.1.351.

Both Moderna and Pfizer have still said they expect that their shots will work against the new variant. But both vaccine developers have also started developing variant-specific vaccines out of caution. 

Even with success, Novavax is still likely months away from starting to vaccinate the public

An effective vaccine from Novavax would be a welcome addition to the world’s arsenal of tools to fight the pandemic, which has infected more than 100 million people. Western regulators have so far authorized vaccines from Pfizer-BioNTech, AstraZeneca-Oxford, and Moderna, and several others have gained approval as well, but supplies remain severely limited.

Novavax has said that by the middle of 2021, it aims be able to make shots at a rate of 2 billion doses per year, though it’s not clear how many shots the company could actually make this year.

Despite the clinical success in the UK, Novavax CEO Stanley Erck said it would likely take two or three months for the company to actually file for an emergency OK with that country’s regulators.

The US government struck a $1.6 billion funding deal with Novavax last year, prioritizing its vaccine candidate for large-scale testing in the US and Mexico. That 30,000-person study has so far enrolled more than 16,000 volunteers. The company expects to finish enrollment in the middle of February. 

It’s not clear whether US regulators would require results from the US trial before making a decision on whether to allow the vaccine to be given more widely. Erck said the company was in discussions with the Food and Drug Administration.

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