A medical examiner prepares a dose of the Novavax vaccine because the Dutch Health Service Organization starts with the Novavax vaccination program on March 21, 2022 in The Hague, Netherlands.
Patrick Van Katwijk | Getty Images
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Novavax can finally breathe a sigh of relief – no less than a small one.
The Food and Drug Administration approved the corporate’s Covid-19 vaccine after greater than a month of delay – however the long-awaited green light comes with unusual restrictions.Â
The choice limits use of the shot, Nuvaxovid, to people ages 65 and older and people ages 12 to 64 who’ve no less than one underlying medical condition that puts them at high risk of severe illness in the event that they contract Covid.Â
Those recent 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’s required to get regulatory approval for shots.Â
Novavax’s shot is now fully approved within the U.S. Since 2022, the vaccine has been used under an emergency use authorization. Health experts consider it a worthwhile alternative to messenger RNA shots from Pfizer and Moderna, which have been way more popular amongst Americans.Â
Those firms’ Covid jabs are already fully approved to be used in anyone 12 and older and authorized to be used in children as young as 6 months.
But all three firms must secure additional approval to update the strain targeted by their respective shots ahead of the autumn and winter vaccination season. FDA vaccine advisors are set to debate strain selection at a gathering later this week.Â
And next month, advisors to the Centers for Disease Control and Prevention are set to debate if yearly Covid vaccines still must be really useful for everybody or just for certain people at higher risk.
Novavax, nevertheless, has much more work to do ahead than its rivals do.Â
The FDA’s approval requires the corporate to finish several studies on whether its vaccine can also be related to several heart conditions, similar to myocarditis, or inflammation of the guts muscle. (Cases of myocarditis amongst individuals who have received Covid shots are rare and mainly reported in teenage boys).
Among the required research may be accomplished with available data. But one recent study would almost certainly require Novavax to follow hundreds of healthy people who find themselves 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 remains to be a win for Novavax.Â
The corporate now expects to be ready for business delivery of the vaccine within the U.S. this fall in partnership with France’s Sanofi. The 2 firms last yr inked an as much as $1.2 billion licensing deal.Â
Analysts said the partnership could boost Novavax’s probabilities 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.Â
The complete approval has also triggered a $175 million milestone payment to Novavax from Sanofi as a part of their deal, which is a meaningful sum for the small vaccine maker.Â
The narrower approval of Novavax’s shot might not be totally bad news, Jefferies analysts added. They said people ages 65 and older represent the most important age group for Covid vaccination anyway.Â
We’ll must wait and see how any changes at federal health agencies impact the rollout of Novavax’s shot later this yr, so stay tuned for our coverage!
Be happy to send any suggestions, suggestions, story ideas and data to Annika at annikakim.constantino@nbcuni.com.
Latest in health-care tech: Virtual solutions for depression and anxiety are effective, but can increase costs, report says
Patients affected by mild to moderate depression and anxiety can meaningfully improve their symptoms through the use of virtual mental health-care tools, in response to a brand new report from the Peterson Health Technology Institute (PHTI) on Tuesday. Nonetheless, a few of these tools increase total health-care costs for employers and plans.Â
Depression and anxiety affect multiple in five adults within the U.S., PHTI said. In 2020, the U.S. spent greater than $240 billion on treatment for these two disorders alone. Virtual mental health tools have develop into increasingly popular lately, and PHTI evaluated a variety of self-guided solutions, prescription digital therapeutics and blended-care solutions for its report on Tuesday.Â
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 variety of firms, including Teladoc Health, Headspace and Spring Health.Â
“As a healthcare system, we should always champion the success of those virtual solutions at improving access and outcomes, and we should be diligent in supporting thoughtful, financially sustainable, and clinically appropriate growth of those solutions for the individuals who need them,” Caroline Pearson, executive director of PHTI, said in a letter.Â
Self-guided solutions offer digital content like lessons and activities that patients can access and personalize to fulfill their individual needs. PHTI found that these tools deliver “clinically meaningful improvements” for patients with depression and anxiety who aren’t already receiving psychotherapy. These tools also decrease net health spending for business payers, the report said.Â
Prescription digital therapeutics are software-based tools which were cleared by the U.S. Food and Drug Administration and should be prescribed to patients. When used along with usual care, these tools can assist patients with depression and anxiety meaningfully improve their symptoms, PHTI said.Â
The organization found that prescription digital therapeutics decreased net health spending for business payers in addition to Medicare at anticipated reimbursement rates.Â
Blended-care solutions mix self-guided content with virtual care teams of licensed therapists and psychiatrists. These tools make up the most important share of the market, and so they are popular with employer purchasers. These tools offer “strong clinical effectiveness,” PHTI said, though there’s more limited comparative data on this category.Â
Despite these large clinical improvements, blended-care solutions increase net health spending for payers, PHTI said. The savings don’t offset the prices, and estimated spending could be higher if the solutions were deployed in Medicare or Medicaid.Â
“Most of those solutions currently charge access fees for all employees— not only those that enroll to make use of the answer,” Pearson said. “Consequently, despite the fact that these solutions deliver strong clinical advantages, the avoided healthcare costs from users cannot offset the general prices charged for the product.”Â
Read the total report here.
Be happy to send any suggestions, suggestions, story ideas and data to Ashley at ashley.capoot@nbcuni.com.
