Novavax wins a narrower covid permit after delay
A healthcare staff prepares a dose of the Novavax vaccine, while the Dutch health organization begins on March 21, 2022 in the Haag, the Netherlands, with the Novavax vaccination program.
Patrick van Katwijk | Getty pictures
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Novavax Can finally take relief – at least a small one.
The Food and Drug Administration has the company's Covid 19 vaccine after more than one month delay-but the long-awaited green light is associated with unusual restrictions.
The decision limits the use of the Nuvaxovide shot to people aged 65 and over and older and people between the ages of 12 and 64, who have at least one underlying medical condition, which is a high risk of serious diseases if they contract with covid.
These new restrictions seem to reflect the high degree of skepticism for health and human services, Robert F. Kennedy Jr. and other leaders, whom he has appointed vaccines in the federal health authorities. Remarkably, the Food and Drug Administration should outline its approach to the Covid vaccination in a virtual event on Tuesday, in which the necessary changes in the recording of recordings could be necessary.
Novavax 'shot has been fully approved in the USA since 2022. The vaccine was used as part of an emergency permit. Health experts regard it as a valuable alternative to Messenger -RNA recordings of Pfizer And Modernthat were much more popular with Americans.
The Covid jabs of these companies are already fully for use in Mones and older and for use in children from 6 months.
However, all three companies have to obtain an additional approval in order to update the burden aimed by their respective recordings before the autumn and winter vaccination season. FDA vaccine advisors will later discuss the selection of the stretches this week at a meeting.
And in the next month, consultants of the centers will discuss for the control and prevention of diseases if annual covid vaccines should be recommended for all or only for certain people with a higher risk.
However, Novavax has even more work to do than its rivals.
When admitting the FDA, the company must complete several studies on whether its vaccine is also associated with several heart diseases such as myocarditis or inflammation of the heart muscle. (Cases of myocarditis in people who have received Covid recordings are rare and mainly for boys of teenage age).
Some of the required examinations can be carried out with available data. However, a new study would most likely require that Novavax would take thousands of healthy people who are 50 to 65 years old either, either the vaccine or placebo.
Despite these extra so -called “post -marketing” requirements, some analysts stated that admission was still a victory for Novavax.
The company now expects to be ready for the commercial delivery of the vaccine in the USA in cooperation with France's Sanofi. The two companies concluded a license agreement of up to 1.2 billion US dollars last year.
Analysts said the partnership could increase the chances of Novavax to win more market share of Covid vaccinations. Sanofi is a “Powerhouse partner” with “strong vaccine experts and distribution channels”, said Jefferie's analysts on Sunday in a note.
The complete approval also triggered a milestone payment of 175 million US dollars of Novavax from Sanofi as part of their business, which is a meaningful sum for the small vaccine manufacturer.
The closer approval of Novavax 'shot may not be completely bad news, added Jefferie's analysts. They said people aged 65 and over are the largest age group for Covid vaccination anyway.
We have to wait and see how changes in the federal health agencies affect the introduction of Novavax's shot later this year. So stay up to date on our reporting!
Feel free to send Annikakim.constantino@nbcuni.com tips, suggestions, ideas and data to Annika.
The latest in the healthcare system tech: virtual solutions for depression and anxiety are effective, but can increase the costs, according to report
According to a new report by the Peterson Health Technology Institute (PhTI) On Tuesday, patients who suffer from mild to moderate depression and anxiety can significantly improve their symptoms by using virtual instruments for mental health through health. However, some of these tools increase the total health costs for employers and plans.
Depression and anxiety affect more than every fifth adult in the USA, said Phti. In 2020, the United States spent more than 240 billion US dollars for treatment for these two disorders alone. In recent years, in recent years, a number of self-managed solutions, prescription digital therapeutics and blended-care solutions for his report on Tuesday.
PhTI is a non -profit organization that carries out independent reviews of digital health solutions. For its latest report, the organization assessed 15 different instruments for mental health care from a number of companies, including Teladoc Health, Headspace and spring health.
“As a health system, we should work for the success of these virtual solutions to improve access and results, and we have to be diligent in supporting thoughtful, financially sustainable and clinically appropriate growth of these solutions for the people they need,” said Caroline Pearson, Managing Director of PhTI.
Self -guided solutions offer digital content such as teaching and activities that patients access and meet their individual needs. PhTI found that these tools for patients with depression and anxiety provide “clinically sensible improvements” that do not already receive psychotherapy. These tools also lower health expenditure for commercial payers, the report says.
Prescription digital therapeutic agents are software-based tools that have been deleted by the US Food and Drug Administration and must be prescribed to the patient. In addition to the usual care, these tools can help patients with depression and anxiety to improve their symptoms sensibly, said Phti.
The organization stated that prescription digital therapeutic agents reduced the net health expenditure for commercial payers and medicar to expect reimbursement rates.
Blended-Care solutions combine self-guided content with virtual care teams from licensed therapists and psychiatrists. These tools make up the largest proportion of the market and are popular with employer buyers. These tools offer “strong clinical effectiveness,” said Phti, although there are only limited comparative data in this category.
Despite these major clinical improvements, blended-care solutions increase net health expenditure for payers, said Phti. The savings do not compensate for the costs, and the estimated expenses would be higher if the solutions were used in Medicare or Medicaid.
“Most of these solutions currently charge access fees for all employees – not only those who register for the use of the solution,” said Pearson. “Although these solutions offer strong clinical advantages, the avoided health costs of the users cannot compensate for the total prices calculated for the product.”
Read the full report here.
Feel free to send tips, suggestions, story ideas and data to Ashley at Ashley.capoot@nbcuni.com.
