Healthy Returns: Novavax scores narrower Covid vaccine approval after delay

CNBC

20-05-2025

Novavax can finally breathe a sigh of relief – at least a small one.
The Food and Drug Administration approved the company's Covid-19 vaccine after more than a month of delay – but the long-awaited green light comes with unusual restrictions.
The decision limits use of the shot, Nuvaxovid, to people ages 65 and older and those ages 12 to 64 who have at least one underlying medical condition that puts them at high risk of severe illness if they contract Covid.
Those new restrictions appear to reflect the high degree of skepticism Health and Human Services Secretary Robert F. Kennedy Jr. and other leaders he has appointed across federal health agencies have about vaccines. Notably, the Food and Drug Administration is slated to outline its approach to Covid vaccination at a virtual event Tuesday, which could spell major changes to what is required to get regulatory approval for shots.
Novavax's shot is now fully approved in the U.S. Since 2022, the vaccine has been used under an emergency use authorization. Health experts consider it a valuable alternative to messenger RNA shots from Pfizer and Moderna, which have been far more popular among Americans.
Those companies' Covid jabs are already fully approved for use in anyone 12 and older and authorized for use in children as young as 6 months.
But all three companies must secure additional approval to update the strain targeted by their respective shots ahead of the fall and winter vaccination season. FDA vaccine advisors are set to discuss strain selection at a meeting later this week.
And next month, advisors to the Centers for Disease Control and Prevention are set to debate if yearly Covid vaccines still should be recommended for everyone or only for certain people at higher risk.
Novavax, however, has even more work to do ahead than its rivals do.
The FDA's approval requires the company to complete several studies on whether its vaccine is also associated with several heart conditions, such as myocarditis, or inflammation of the heart muscle. (Cases of myocarditis among people who have received Covid shots are rare and mainly reported in teenage boys).
Some of the required research can be completed with available data. But one new study would most likely require Novavax to follow thousands of healthy people who are 50 to 65 years old who take either the vaccine or a placebo.
Despite those extra so-called "post-marketing" requirements, some analysts said the approval is still a win for Novavax.
The company now expects to be ready for commercial delivery of the vaccine in the U.S. this fall in partnership with France's Sanofi. The two companies last year inked an up to $1.2 billion licensing deal.
Analysts said the partnership could boost Novavax's chances of winning more Covid vaccine market share. Sanofi is a "powerhouse partner" with "strong vaccine expertise and distribution channels," Jefferies analysts said in a note on Sunday.
The full approval has also triggered a $175 million milestone payment to Novavax from Sanofi as part of their deal, which is a meaningful sum for the small vaccine maker.
The narrower approval of Novavax's shot may not be totally bad news, Jefferies analysts added. They said people ages 65 and older represent the largest age group for Covid vaccination anyway.
We'll have to wait and see how any changes at federal health agencies impact the rollout of Novavax's shot later this year, so stay tuned for our coverage!
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Patients suffering from mild to moderate depression and anxiety can meaningfully improve their symptoms by using virtual mental health-care tools, according to a new report from the Peterson Health Technology Institute (PHTI) on Tuesday. However, some of these tools increase total health-care costs for employers and plans.
Depression and anxiety affect more than one in five adults in the U.S., PHTI said. In 2020, the U.S. spent more than $240 billion on treatment for these two disorders alone. Virtual mental health tools have become increasingly popular in recent years, and PHTI evaluated a range of self-guided solutions, prescription digital therapeutics and blended-care solutions for its report on Tuesday.
PHTI is a nonprofit that conducts independent evaluations of digital health solutions. For its latest report, the organization assessed 15 different mental-health care tools from a range of companies, including Teladoc Health, Headspace and Spring Health.
"As a healthcare system, we should champion the success of these virtual solutions at improving access and outcomes, and we must be diligent in supporting thoughtful, financially sustainable, and clinically appropriate growth of these solutions for the people who need them," Caroline Pearson, executive director of PHTI, said in a letter.
Self-guided solutions offer digital content like lessons and activities that patients can access and personalize to meet their individual needs. PHTI found that these tools deliver "clinically meaningful improvements" for patients with depression and anxiety who are not already receiving psychotherapy. These tools also decrease net health spending for commercial payers, the report said.
Prescription digital therapeutics are software-based tools that have been cleared by the U.S. Food and Drug Administration and must be prescribed to patients. When used in addition to usual care, these tools can help patients with depression and anxiety meaningfully improve their symptoms, PHTI said.
The organization found that prescription digital therapeutics decreased net health spending for commercial payers as well as Medicare at anticipated reimbursement rates.
Blended-care solutions combine self-guided content with virtual care teams of licensed therapists and psychiatrists. These tools make up the largest share of the market, and they are popular with employer purchasers. These tools offer "strong clinical effectiveness," PHTI said, though there is more limited comparative data in this category.
Despite these large clinical improvements, blended-care solutions increase net health spending for payers, PHTI said. The savings do not offset the costs, and estimated spending would be higher if the solutions were deployed in Medicare or Medicaid.
"Most of these solutions currently charge access fees for all employees— not just those who sign up to use the solution," Pearson said. "As a result, even though these solutions deliver strong clinical benefits, the avoided healthcare costs from users cannot offset the overall prices charged for the product."
Read the full report here.
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