Novavax to submit COVID-19 vaccine EUA request to U.S. FDA next month

 Novavax Inc will submit a request to the U.S. Food and Drug Administration to authorize its COVID-19 vaccine next month, further delaying the submission it had expected by the end of this year.

The company's announcement on Friday follows submission of final data related to the vaccine's manufacturing processes to the regulator, which is a prerequisite for the emergency use authorization application (EUA).

Novavax has had to delay its U.S. submission multiple times due to development and manufacturing setbacks. A report earlier this year said the methods Novavax used to test the efficacy of its vaccine had fallen short of regulators' standards.

Data released in June from a late-stage U.S. trial showed the vaccine was more than 90% effective against a variety of concerning coronavirus variants, including Delta.

The company has said https://www.reuters.com/business/healthcare-pharmaceuticals/novavax-says-covid-vaccine-boosts-response-omicron-variant-2021-12-22 its vaccine is effective in generating an immune response against the Omicron variant, according to early data, suggesting that the existing COVID-19 vaccine can help combat the new variant.

But it will continue to develop a vaccine tailored for Omicron, and expects to begin clinical studies in the first quarter of 2022.

The biotech company in 2020 received $1.6 billion from the U.S. government to cover testing and manufacturing of a potential COVID-19 shot, with the aim of delivering 100 million doses. (https://reut.rs/3yHnJLr)

The two-dose, protein-based vaccine has so far got authorizations from European Union regulators and the World Health Organization.

It has also secured authorizations in India, Indonesia and the Philippines, where Novavax's partner Serum Institute of India will supply.

Novavax is also awaiting approval in Japan, where its vaccine would be manufactured and distributed by Takeda Pharmaceutical.

https://finance.yahoo.com/news/1-novavax-submit-covid-19-173815458.html

Can We Limit the Consequences of FDA's Aduhelm Approval?

 On July 22, 2021, Michael Gusmano, PhD, MA, and Karen J. Maschke, PhD, shared their perspective on FDA's controversial aducanumab (Aduhelm) decision and discussed whether Medicare would pay for the drug. As part of MedPage Today's review of the past year's top events, Gusmano follows-up with his insights on what has happened since the approval and the ongoing drug coverage disputes.

A drug developed by Biogen for the treatment of Alzheimer's disease, aducanumab (Aduhelm), was approved in June using the FDA's accelerated approval pathway. The vast majority of experts, including the agency's own advisory committee, have raised concerns about the drug's safety and effectiveness, and the quality of clinical trial data on which the approval was based. Along with the potential clinical and social implications of the FDA's decision, the financial consequences are enormous. Biogen's preliminary charge for the drug was $56,000 a year per patient -- although they have just announced they will cut this in half. Even with this reduction, given the large number of Medicare beneficiaries with Alzheimer's disease, the drug could add billions of dollars in additional Medicare spending each year.

Despite these concerns, there is hope that public and private payers may act as checks on the FDA's decision, significantly limiting the potential problems caused by refusing to cover the drug.

There is some evidence that private insurance companies are already doing this. A month after the FDA's approval, several private health insurers announced they would not cover the drug, and sales of Aduhelm have been well short of expectations. This early response from private insurance companies is causing financial problems for Biogen, whose stock price has plummeted in the months since FDA approval of the drug. A recent report indicated that Biogen plans to cut expenses by at least $500 million and will lay off more than 1,000 employees, largely due to the disappointing sales of Aduhelm.

But perhaps even more important than the initial response from the private sector is Medicare's decision about whether to cover Aduhelm. Although it almost always does, Medicare is not required to cover a drug just because it has been approved by the FDA. Currently, coverage determinations for aducanumab are being made at the local level by Medicare Administrative Contractors who represent 12 jurisdictions across the country. But on July 12, 2021, CMS opened a National Coverage Determination (NCD) analysis to determine whether Medicare will establish a national Medicare coverage policy for Aduhelm.

The NCD process, which takes 6 months for an initial determination and 9 months for a final decision, is designed to help CMS decide whether the drug meets the Medicare law's "reasonable and necessary" standard for coverage. The process, which was established by statute, involves an intensive review of the clinical evidence in published clinical studies and/or professional society guidelines, along with public comments, to determine coverage. The result of the NCD process could lead to a few possible outcomes: a decision to cover the drug nationally; to limit coverage to a subset of the Medicare population; to leave the decision in the hands of Medicare Administrative Contractors; or to refuse to cover the drug at all.

Until the results of the NCD are available next April, Medicare coverage will continue to depend on the decisions of Medicare Administrative Contractors in each of 12 jurisdictions across the U.S. This has already led to an increase in costs for Medicare beneficiaries. Based on the assumption that Medicare would cover the drug, Medicare's "Part B" outpatient premium increased by $21.60 a month for 2022. CMS indicated that about half of this increase reflects the expected costs of administering Aduhelm because it is delivered intravenously in a physician's office, a service that would be covered by Medicare Part B.

In addition, in September 2021, CMS advised state Medicaid programs that they must cover Aduhelm as an outpatient drug. States may limit the use of the drug by developing stringent medical necessity criteria, but they are required to cover the drug because it has been approved by the FDA. A survey conducted for the National Association of Medicaid Directors in October estimated that Aduhelm could cost the Medicaid program an additional $1.9 billion in 2022. Another study, published by the Kaiser Family Foundation, argued that, even with Medicaid drug rebates, covering Aduhelm could lead to "substantial" increases in Medicaid spending. This decision has alarmed Medicaid directors who view this as an inappropriate cost-shift from the Medicare program to the Medicaid program.

Regardless of the outcome of the NCD process, there is a concern that the reliance on the NCD mechanism lets the FDA off the hook for lowering the bar for approval, and lets Biogen off the hook for not conducting adequate clinical trials in the first place. This also means that CMS has to use even more tax dollars to pay for the additional data collection and analysis. While it is prudent for CMS to take this step, it is important to acknowledge that taxpayers are now subsidizing industry-led research and paying for the FDA's questionable approval decision.

Some proponents of using the NCD process in this case have argued, quite sensibly, that the review should involve the "minimum set of essential data elements" to speed up the process and make it less costly. Nevertheless, relying on Medicare and other payers to limit the damage of the FDA decision may be useful in this situation -- but it is an imperfect solution. It does not address the potential cost shift to Medicaid (although states may be able to address this by severely limiting the drug's use), and even more concerning, this approach may set a dangerous precedent, particularly given the historic reluctance of CMS to use the NCD process for drugs.

Will the NCD approach create an incentive for industry to get fast FDA approval for interventions, based on questionable data, hoping that it can still get public and private payers to foot the bill?

Michael K. Gusmano, PhD, MA, is a research scholar at The Hastings Center, and a professor of health policy and associate dean for academic programs in the College of Health at Lehigh University.

https://www.medpagetoday.com/opinion/second-opinions/96411

Zepp Health Updates Guidance

 Zepp Health Corp. (NYSE: ZEPP) announced today an update to its guidance for the fourth quarter 2021, as well as an update to the progress of its share repurchase program.

Due to greater than anticipated effects of Covid, including a more persistent worldwide chip shortage and newly increased Covid restrictions and lockdowns in key European markets as a result of the Delta and the new Omicron variants, the company now expects its net revenues for the fourth quarter of 2021 to be between RMB1.6 billion and RMB1.75 billion, compared to the guidance of between RMB1.75 billion and RMB2.0 billion provided on November 16, 2021. Expectations remain for the company to maintain profitability. This outlook is based on the current market conditions and reflects the company management's current and preliminary estimates of market and operating conditions and customer demand, which are all subject to change.

Also, on the company's November 16 quarterly results call, management announced an authorization of up to US$20 million to repurchase shares, in part to fund the company's employee stock plan. Since that announcement, the company has bought back approximately US$3.6 million of stock. The company intends to continue the repurchase program.

About Zepp Health Corporation (NYSE: ZEPP)

Zepp Health is a leading global developer of smart health technology, whose mission is to connect health with technology. Since its inception in 2013, Zepp Health has developed a platform of proprietary technology including AI chips, biometric sensors, data algorithms and operating systems, which drive a broadening line of smart health devices for consumers, data analytics services for population health, and industrial medical technology for diagnostics and care delivery. Zepp Health is one of the largest global developers of smart wearable health and consumer fitness devices, shipping 46 million units in 2020. Zepp Health Corp. is based in Hefei, China, with U.S. operations, Zepp Health USA, based in Cupertino, Calif.

https://finance.yahoo.com/news/zepp-health-provides-updates-guidance-120000337.html

Britain approves Pfizer's antiviral COVID-19 pill

 Britain has approved Pfizer's COVID-19 pill for patients over the age of 18 years who have mild to moderate infection and are at high risk of their illness worsening.

The approval comes as the country scrambles to build its defences amid a record hit a daily record of new COVID-19 cases on Thursday, government data showed surge in COVID-19 cases.

Based on data, the pill, Paxlovid, is most effective when taken during the early stages of COVID-19, Britain's Medicines and Healthcare products Regulatory Agency (MHRA) said on Friday, recommending that the drug be used within five days of the onset of symptoms.

Pfizer this month said Paxlovid showed near 90% efficacy in preventing hospitalisations and deaths in high-risk patients, and recent lab data suggests the drug retains its effectiveness against the fast spreading Omicron variant of the coronavirus.

"We now have a further antiviral medicine for the treatment of COVID-19 that can be taken by mouth rather than administered intravenously. This means it can be administered outside a hospital setting," MHRA chief June Raine said in a statement.

https://finance.yahoo.com/news/1-britain-approves-pfizers-antiviral-115804729.html

Are We Testing for Omicron Wrong?

 If confirmed in follow-up research and if the diagnostics industry can pivot quickly enough, findings from a South African study could make COVID-19 testing a lot easier for patients and healthcare workers, as the SARS-CoV-2 Omicron variant becomes the dominant source of infection.

In a manuscript posted to the medRxiv preprint server on Friday, researchers from the University of Cape Town reported that saliva samples yielded more accurate results in PCR analyses when Omicron was involved compared with those collected via nasal swabs.

When patients carried the Delta variant, on the other hand, nasal swabs were more accurate, according to the group, led by Diana Hardie, MBChB, MMedPath, who also heads the diagnostic virology laboratory at Groote Schuur Hospital.

The findings came from an analysis of 382 patients tested at Groote Schuur from August through this month, with viral whole-genome sequencing performed on isolates from those with positive results. Just over 300 were tested prior to Omicron's emergence, with 31 testing positive for the Delta variant. Another 74 arrived at the hospital after Omicron became common, of whom 36 were positive for that variant.

All patients had both saliva and mid-turbinate nasal samples taken for RT-PCR analysis. The "gold standard" for positivity in the study was detection of SARS-CoV-2 RNA with either swab.

For the Delta variant, the positive percent agreement for each sampling method, in comparison with this "gold standard," was 71% for saliva and 100% for the nasal swabs. But this was reversed for Omicron, with 100% agreement between saliva samples and the gold standard, but only 86% for nasal swabs.

Nasal swabs have been the standard for COVID-19 screening and diagnosis ever since the virus was discovered, but that may no longer be appropriate in an Omicron-dominated pandemic landscape, the authors concluded.

"These findings suggest that the pattern of viral shedding during the course of infection is altered for Omicron with higher viral shedding in saliva relative to nasal samples resulting in improved diagnostic performance of saliva swabs," Hardie and colleagues wrote.

They noted, as have others, that Omicron is distinguished by "more than 50 distinct mutations." These seem to have resulted in increased infectivity, but they could also affect other aspects of the virus's behavior, including the tissues it may prefer to infect.

With that in mind, Hardie's group pointed to a recent lab study from Hong Kong (as yet unpublished but highlighted in a press release) indicating that Omicron is less likely to lodge in the lung compared with earlier variants. This not only suggests that Omicron is less lethal, but also that the many mutations confer "altered tissue tropism."

However, while saliva sampling may be easier to perform than nasal swabbing, the researchers noted that it's not as simple as spitting in a cup. At Groote Schuur, patients were instructed to swab the inside of the mouth -- both cheeks, above and below the tongue, the gums, and hard palate -- for a total of at least 30 seconds. They were also told not to eat, drink, smoke, or chew anything for at least 30 minutes beforehand.

Another point to consider is that, in the U.S. and most other countries, testing has been predicated primarily on nasal swabs. Although some saliva-based tests have been authorized and are commercially available, the vast majority of currently accessible kits for healthcare use and for at-home self-testing rely on nasal swabs. It would likely take months to retool the supply chain to prioritize saliva sampling -- by which time Omicron may have been supplanted by another variant with its own unique characteristics.

Disclosures

Study authors declared they had no relevant financial interests.

Note that manuscripts posted to preprint servers such as medRxiv have not undergone peer review and thus the results and interpretations should be taken with caution.

Primary Source

medRxiv

Source Reference: Marais G, et al "Saliva swabs are the preferred sample for Omicron detection" medRxiv 2021; DOI: 10.1101/2021.12.22.21268246.

https://www.medpagetoday.com/infectiousdisease/covid19/96385

Nurses React to New CDC Quarantine Guidelines

 Katie Boston-Leary, PhD, director of nursing programs for the American Nurses Association (ANA), discusses criticisms of the CDC's new policy shortening quarantine periods for positive individuals and shares concerns about its effect on healthcare professionals.

The following is a transcript of her remarks:

The ANA's criticisms of the guidance for healthcare workers and healthcare professionals mainly is regarding the reduced amount of days for quarantining and isolation. We have concerns that there's not enough evidence that supports it, that we're still learning about this new variant. We are also seeing that Delta is still very prevalent in our communities as well. So since we have so many unknowns, we have concerns about the timing of this change. We're not necessarily saying that it's wrong. We just feel that there's a lot more to learn before this change is made, and there has to be full transparency regarding how this change came about, why it came about, and why the timing is now.

The other piece that we're concerned about is the lack of requiring testing for healthcare professionals compared to the general public. In different healthcare institutions, if you're in crisis or contingency status, healthcare professionals are not required to have a negative test before they return to work. In crisis standards, part of the requirements of the guidance is whether you're vaccinated, boosted, or unvaccinated, you can test, and even if you're positive, as long as you're asymptomatic, you can continue to work. And that's really concerning for us because, of course, nurses don't just magically appear at work. They have to interface with the public on their way to work. They have to interface with their families, maybe to drop off a child at daycare, or they use public transportation. And who else may be exposed on the way to work, even if the premise is "While nurses are at work, they're wearing PPE, so they're not exposing anyone"? Yes, the risk of transmission is low in that environment, given the use of PPE, but nurses also need to eat, they need to breathe, they need to use the bathroom, they need to be in break rooms. So what happens in those spaces, right? These are community spaces for other healthcare providers.

And lastly, the issues with testing still remain. There's an impression that just because you work in healthcare, you have access to testing for COVID. This is where we need to make sure everyone knows that that's not necessarily the case. Access and availability are still prevalent issues for this group. And so in some cases, some institutions are requiring nurses to go in the public domain to get tested. In institutions where they do offer testing, a lot of their employee health and occupational programs are overwhelmed. So that's another issue. So testing needs to be in place and more readily available and accessible for this plan to work.

The ANA's preferred quarantine and isolation guidance would look like more of a comprehensive program where it is the CDC locking arms with HHS and working with institutions like ANA, AHA [American Hospital Association], and AMA [American Medical Association] to work on how we can make this a more effective strategy. What is put in place right now is very, very siloed in terms of the approach where you test and can stay, and you now have COVID, what does that mean when I go home?

And you have to think about the emotional toll that has on healthcare professionals. Let us set aside the physical ailments. Because part of this is if you're not symptomatic, you should be fine. You can keep working. But being someone that suffered from a breakthrough infection herself, the emotional toll was heavier for me than the physical toll, which was already pretty overwhelming for me. And you have to think about your family, and what that means not just in your immediate family, but in your community. So we feel that a comprehensive approach to address the staffing issues is important, a plan to address the mental health toll that the pandemic has had on nurses – where PTSD [post-traumatic stress disorder] is real in our nursing population.

Then with all those things, in addition to making sure that there's the science behind the change and making sure the timing is right and making sure there's at least some lead time for a lot of other accommodations we put in place and policies to be put in place, and for there to be more education about this prior to rolling it out.

The climate that nurses have been working under and are working within, it's really at the point of being unbearable. And it's very hard to describe in true terms in capturing what nurses have been dealing with. If you really think about anyone in your personal lives, could you name a crisis that you've endured for close to 2 years nonstop, or when you think it's about over here, it comes again. And this is one of those events that just seems so protracted. And with all the preparation that we've gone through as nurses with emergency preparedness training and disaster planning, this is something that no one ever anticipated, right?

And this is where yes, we've heard the words "burnout" and "frustrated." We have a lot of survey data from nurses and in terms of them feeling stressed and overwhelmed, a lot of the unhealthy behaviors that they've undertaken since this all started, and how this is impacting their ability to practice optimally. Especially in an environment where patients are very sick and care is very complex, you need nurses to be at their best. And right now they're not, because of all the issues that they're facing and all the things that they're struggling with. And right now, which is very concerning, we're seeing that nurses feel that the way to deal with the burnout and a lot of what they're experiencing is to leave the profession or leave where their skills are needed.

This is really concerning because we need our nurses to be there for us for when we need care. And nurses are also healthcare consumers too. And it's not just for COVID, it's for all the other things that we go to healthcare institutions for. So it's unbearable. And it's really the place where we're seeing nurses vote with their feet, which is very concerning, particularly for a profession already struggling with the supply and demand issue: not enough nurses, but high demand for their skill sets and care.

https://www.medpagetoday.com/publichealthpolicy/generalprofessionalissues/96465

India's Serum Institute applies for full approval of Covishield vaccine

 

Serum Institute Of India has applied to the country's drug regulator and the health ministry for full approval of its COVID-19 vaccine Covishield, the company's chief executive said on Friday.

Serum Institute, which produces AstraZeneca's COVID-19 vaccine under the brand name Covishield, has supplied more than 1.25 billion doses of the shot in India.

The Indian government now has enough data to consider a full market authorisation, Serum Institute CEO Adar Poonawalla said on Twitter.

Serum Institute, which is also the world's biggest vaccine maker, was granted approval for emergency use of Covishield in India at the beginning of the year.

The country's inoculation drive so far has been dominated by Covishield and Bharat Biotech's inactivated vaccine Covaxin.

Serum Institute has nearly quadrupled its monthly capacity of AstraZeneca's shots to as many as 240 million doses and is prepared to export "large volumes" from January, Poonawalla told Reuters in October.

https://www.marketscreener.com/news/latest/India-s-Serum-Institute-applies-for-full-approval-of-Covishield-vaccine--37445304/