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.
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.
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%.
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.
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.
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.
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.
(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.
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.
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.
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.
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.
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.