Canada sees urgent need to get more young vaccinated against Covid

 As Canada faces a fourth wave of COVID-19 infections caused by the Delta strain, new modeling shows an “urgent need” to get more young individuals vaccinated, the public health department said on Friday (Sept 3).

According to the Public Health Agency of Canada (PHAC), given the present rate of immunization, new COVID-19 cases might exceed hospital capacity within months, surpassing the peak of Canada’s third wave.

In a presentation, PHAC stated that the modeling revealed a need to increase the total rate of immunizations, particularly for the 18-39 age range, to limit the impact of the Delta resurgence.

“The basic fact is that millions of individuals across Canada are still unvaccinated, putting them at risk of COVID-19 infections and serious illness,” said Theresa Tam, Canada’s chief public health officer.

Alberta’s western province has announced that unvaccinated Albertans will be given C $100 (US $79.96) gift cards as an incentive to get vaccinated. It is the first jurisdiction in Canada to give financial incentives to encourage people to get vaccinated.

Alberta has the lowest vaccination rate in the country and is the state with the most new COVID-19 cases, with 1,339 new cases reported on Thursday.

At a press conference on Friday, Alberta Premier Jason Kenney said, “This is a crisis of the unvaccinated.” “You are endangering yourself and our healthcare system.”

As hospitals struggle to cope with an influx of coronavirus patients, the province is postponing non-essential procedures and restoring an indoor mask mandate to try to contain the virus.

https://dabigcnews.org/2021/09/04/canada-sees-urgent-need-to-get-more-young-people-vaccinated-against-covid-19/

Israel to present COVID-19 booster shot data to FDA

 Israel this month will present data from an extensive rollout of COVID-19 vaccine booster shots to the U.S. Food and Drug Administration, which is weighing White House plans to begin a booster drive in the United States.

Sharon Alroy-Preis, head of public health at Israel’s Health Ministry, said the ministry had been asked by the U.S. Food and Drug Administration (FDA) to brief its advisors at a Sept. 17 meeting.

The virtual session will consider a third booster shot of the Pfizer Inc/BioNTech SE vaccine, and may discuss others.

“We have been asked to come and present Israel’s experience and our data so that we can truly help the whole world to learn,” Alroy-Preis told Israeli Channel 12 TV news.

A week ago Israel began offering a Pfizer COVID-19 booster to people as young as 12 in a campaign that began in July among seniors. Israeli health officials said the drive has slowed a rise in severe illness caused by the Delta variant.

Officials have said the effectiveness of the second dose of the Pfizer vaccine waned five months after administration, making a booster necessary. A third dose, they said, restored the level of protection of the second shot.

So far 2.6 million people out of a population of 9.3 million have received three doses of the Pfizer vaccine in Israel.

U.S. President Joe Biden had been expected to launch a campaign to administer 100 million booster shots on Sept. 20. But U.S. vaccine makers other than Pfizer have lagged in seeking authorisation for an additional dose.

https://wtvbam.com/2021/09/05/israel-to-present-covid-19-booster-shot-data-to-fda-experts/

Biotech week ahead, Sept. 7

Biotech stocks extended their gains in the week ending Sept. 3, partly aided by the broader market strength. The news flow was fairly light ahead of the Labor Day holiday weekend.

Clinical readouts swung stocks wildly during the week. Forte Biosciences, Inc. FBRX 82.3% plunged over 80% in reaction to its announcement that the Phase 2 clinical study of its investigational asset FB-401 for the treatment of atopic dermatitis failed to meet its primary endpoint with statistical significance.

On the regulatory front, Impel NeuroPharma, Inc. 

IMPL 19.33% received the Food and Drug Administration's approval for Trudhesa, its lead candidate, for the treatment of acute migraine. On a not-so-positive note, a Wall Street Journal report suggested that the FDA is in no hurry to approve Pfizer, Inc. PFE 0.04%-BioNTech SE BNTX 1.76%'s COVID-19 vaccine booster shot.

Here are the key catalytic events for the unfolding week:

Conferences

• International Liver Conference Association, or ILCA, Annual Conference (virtual): Sept. 2-5
• European Respiratory Society, or ERS, International Conference 2021 (virtual): Sept. 5-8
• Goldman Sachs Eleventh Annual Biotech Symposium: Sept. 7-10
• Citi's 16th Annual BioPharma Conference (virtual): Sept. 8-10
• 2021 Wells Fargo Virtual Healthcare Conference (virtual): Sept. 9-10
• Morgan Stanley 19th Annual Global Healthcare Conference (virtual): Sept. 9-15
• American Urological Association, AUA, Conference (virtual): Sept. 10-13
• Heart Failure Society of America, or HFSA, Annual Scientific Meeting (both virtual and in-person, hybrid format): Sept. 10-13
• International Association of the Study of Lung Cancer, or IASLC, 2021 World Conference on Lung Cancer (virtual): Sept. 11-14

Clinical Readouts/Presentations

Pliant Therapeutics, Inc. PLRX 0.77% will release Tuesday, Sept. 7, interim clinical data from an ongoing Phase 2a positron emission tomography imaging trial of PLN-74809 in patients with idiopathic pulmonary fibrosis.

INmune Bio, Inc. INMB 10.03% is due to present additional Phase 1b data on XPro, its selective DN-TNF inhibitor candidate for the treatment of Alzheimer's disease, treatment resistant depression, and other neurological diseases where neuroinflammation is implicated. The presentation is scheduled for Tuesday, Sept. 7, at 4:30 pm.

Valneva SE VALN 0.42% said, at the Goldman Sachs Biotech Symposium, it will present an update on its late stage vaccine candidate VLA-15 against Lyme disease. The company is partnering with Pfizer for this program. Valneva will also present updates on its two more late-stage vaccine candidates - VLA2001 against COVID-19 and VLA 1553 against chikungunya. VLA2001 is being evaluated in combination with Dynavax Technologies Corporation DVAX 0.06%'s vaccine adjuvant and alum. The presentations are scheduled for Tuesday, Sept. 7.

Cardiff Oncology, Inc. CRDF 1.61% will present new data from its Phase 1b/2 clinical trial evaluating onvansertib in combination with standard-of-care FOLFIRI/Bristol-Mysrs Squibb Company BMY 0.76%'s Avastin in KRAS-mutated metastatic colorectal cancer. The presentation is organized as a virtual KOL event for analysts, investors, and the scientific community on Wednesday, Sept. 8, between 4 pm and 5 pm.

ImmunityBio, Inc. IBRX 5.44% will present at the AUA conference Phase 2/3 clinical results of IL-15 Superagonist N-803 with BCG in BCG-unresponsive bladder cancer. The presentation is scheduled for Friday, Sept. 10.

Mersana Therapeutics, Inc. MRSN 2.9% will host a webcast to discuss progress of its clinical development strategy for upifitamab rilsodotin and report updated interim data from the ovarian cancer expansion cohort of the UpRi Phase 1 study. The webcast is scheduled for Friday, Sept. 10, at 8 am.

Earnings

• Centogene N.V. CNTG 0.96% (Tuesday, before the market open)
• Affimed N.V. AFMD 5.51% (Wednesday, before the market open)
• Trinity Biotech plc TRIB 6.05% (Thursday, before the market open)

IPOs

IPO Quiet Period Expiry

Dermata Therapeutics, Inc. DRMA 1.61%

https://www.benzinga.com/general/biotech/21/09/22811453/the-week-ahead-in-biotech-sept-5-11-focus-on-conferences-and-clinical-readouts-in-another-quiet-w

Actuaries suggest individual insurance premiums won't see large swings in 2022

 

• Next year's insurance premiums in the individual and small group market will not see wild swings given the underlying trends in the market even in light of the coronavirus pandemic, according to the annual report from the American Academy of Actuaries.
• There is more information available now about how COVID-19 continues to affect healthcare spending and utilization, unlike the 2021 rate-setting season, and "those impacts are not expected to be material," per the report released Thursday.
• However, it does caution that experiences may differ regionally and drive premiums as the impact of the pandemic is uneven across the country.

How insurance carriers set rates is largely dependent on the experience of years prior, which is why rate-setting amid the pandemic posed difficulty for many of them.

There was a great deal of uncertainty in setting rates for 2021 due to the anomaly of 2020 and the upheaval the pandemic caused to normal healthcare utilization.

The actuaries said that even though the pandemic continues, and even in the current wave of the highly contagious delta variant, carriers know more than they did when trying to set rates for 2021.

Carriers have likely considered a few key drivers to premium changes, including whether new waves of cases will emerge later in 2021 or in 2022, and whether those will be regional or nationwide. Plans have also likely considered the effects of deferred care and whether that has led to health deteriorating for members. And they've likely factored in the cost of additional vaccines.

A report from researchers at Georgetown University's Center on Health Insurance Reforms also finds premiums, at least in some states, remained relatively stable in spite of the lingering pandemic.

"For the most part, insurers in the five states assessed are proposing modest premium increases compared to past years. In some cases, they even propose premium decreases," Sabrina Corlette wrote in July after examining early rate filings insurers submitted in D.C., Maine, Oregon, Vermont and Washington.

Though, similar to the actuaries report, Corlette notes that there are some outliers requesting larger increases in certain areas.

"In all cases, insurers report that the primary drivers of higher premiums are the ever-rising prices charged by health care providers," Corlette said.

The pandemic spurred an economic calamity causing millions to lose their jobs, risking access to health insurance coverage as many Americans receive coverage through their jobs.

However, the nation did not experience a surge in the uninsured rate, which experts attribute to healthcare reform that routed Americans to some other type of coverage, either on an Affordable Care Act exchange or through government programs like Medicaid.

The Biden administration also extended a special ACA enrollment period, allowing more Americans to enroll in coverage as the pandemic persisted. And Medicaid growth reached record heights as policies put in place during the pandemic bar states from kicking beneficiaries off Medicaid plans so long as the public health emergency is in place.

https://www.healthcaredive.com/news/actuaries-suggest-individual-insurance-premiums-wont-see-large-swings-in-2/606070/

Can Intranasal COVID Vaccines Help Stop the Spread?

 There are currently 20 different vaccines, authorized or approved by various national regulatory agencies, that are achieving their goal in the fight against COVID-19. Countless more are in various stages of development and clinical trials. This goal was (and still is) the prevention of hospitalizations, critical illnesses, and death. But now, the Delta variant is spreading like wildfire, overwhelming our hospitals and intensive care units. And clearly, fully vaccinated individuals who contract the highly contagious Delta variant are still able to transmit live virus. COVID-19 continues to fester and mutate. What might come next, Upsilon? Omega? We have utterly failed to break the train of virus transmission.

The Nasal Mucosa and the Chain of Transmission

We need to find new approaches for reducing viral load at the primary portal of entry: the nasal mucosa. Systemic vaccination does not appear to stimulate local mucosal immunity effectively. In the case of a prior infection, you might expect activated nasal IgA to be functional, since infection with the whole virus elicits a broad immune response compared to the mRNA vaccines, which presents just a fragment of the S spike protein. Natural infection starts in the naso-pharynx while systemic vaccines present antigen into the muscle. So, is there an intervention that can effectively stimulate local mucosal immunity?

Intranasal Vaccines

High on the list for reducing viral load and reducing the chance of people spreading the virus should be intranasal vaccines, which would stimulate nasal tissue immune factors (mucosal immunity) including local mucosal IgA.

Daniel Oran, MA, and Eric Topol, MD, from the Scripps Institute published an opinion piece in Scientific American in March highlighting reasons for pursuing intranasal vaccines and for providing financial incentives. As they discuss, these vaccines offer ease of administration and eliminate the issue of "needle phobia." But these vaccines still need to demonstrate efficacy and safety in clinical trials. For some, there is concern about using an attenuated, live COVID-19 virus and the theoretical risk that the vaccine itself can cause the infection. However, this wouldn't be the first vaccine of its kind. Flu-mist for influenza is the prime example of an FDA-approved nasal spray for influenza, which uses an attenuated live quadrivalent influenza vaccine. It is approved for people ages 2 to 49, but should not be used for individuals with a weakened immune system.

Unfortunately, just a few intranasal vaccines are in necessary clinical trials with one recently being withdrawn (Altimmune's AdCOVID, due to insufficient immune response).

The leading contender among clinical trials is Bharat Biotech in India that has started phase II/III trials using a chimpanzee adenovirus which encodes the COVID-19 spike protein. The NIH has tested the current AstraZeneca/Oxford vaccine, repurposed as an intranasal vaccine in a primate model with a reduction in viral load. China's CanSino just published results of its early clinical trial using its aerosol version of its Ad5-nCoV, already approved as an injectable vaccine. If an existing intramuscular vaccine can work as an intranasal spray, then authorization would be much easier to achieve.

Codagenix, from the lab at Stony Brook University, just started a phase I clinical trial of a single dose inhaled Covi-Vax, which uses an attenuated live virus. They don't use a backbone virus to carry an antigen or virus particles. Instead, they use part of the viral genome with capsid proteins altered by hundreds of nucleotide changes, a much safer approach. Peter Palese, PhD, a virologist at Icahn School of Medicine at Mount Sinai has genetically modified a bird virus that makes a protein found on the COVID-19 surface. Both of these efforts do not rely on traditional live viruses and should be deemed safe after more clinical trials.

Two Early Non-Vaccine Intranasal Approaches Merit Attention

The research base for intranasal vaccines can be used to support efforts to develop non-vaccine, intranasal therapeutics. A study published in Scientific Advances in May 2021 identified >8,000 high affinity COVID-19 nanobodies, similar to COVID-19 monoclonal antibody cocktails that have FDA emergency authorization. The most potent of these (the Pittsburgh inhalable Nanobody-21, PiN21), showed reduction in viral particles in a hamster lung model. It is possible that when IV monoclonal antibodies are used early, they may provide therapeutic effect in the nasal mucosa by reducing viral load due to high antibody levels in the nasal vascular bed. Perhaps these monoclonals can be formulated as a nasal spray.

In another approach, COVID-19 spike glycoprotein fuses to cell membranes in the nasal mucosa. Rory de Vries, PhD, devised a stable lipoprotein that inhibits this fusion in a ferret model. In theory, this type of nasal spray could be used daily.

Conclusion

Our new priority should be to develop, approve, and distribute prophylactic COVID-19 nasal vaccines that produce protective, local tissue IgA. There are already plenty of winners with systemic intramuscular vaccines. We've successfully blocked serious and critical infections, but we don't have our lives back together, the economy is faltering, our hospitals are on the verge of burnout and collapse, and people are dying. We need to break the chain of transmission now. We need to invest in something different. Do we need another Operation Warp Speed? Not necessarily. But the NIH, private sector, and philanthropies must invest in intranasal vaccine research and support expansion of adaptive clinical trials.

Reformatting monoclonal antibodies and vaccines that have EUA is not starting from zero, but instead, is giving industry, CDC, and FDA a boost in the fight against COVID-19. We need new players and new approaches.

Daniel Teres, MD, is a critical care physician and clinical instructor in public health and community medicine at Tufts University School of Medicine in Boston. Martin A. Strosberg, PhD, is emeritus professor of political science, healthcare policy, and bioethics at Union College in Schenectady, New York.

https://www.medpagetoday.com/opinion/second-opinions/94366

1/3 of US workforce opts for gig work, forgoing employer benefits

 America has seen record growth in its gig economy — workers who are contracted, on-call, temporary or self-employed — as gig work now accounts for a third of U.S. employment. 

With gig work up 34 percent from its 2020 levels, the shift also means that more employees bear the risks of not having benefits like healthcare coverage and paid vacation, according to Vox.

However, the surge of new independent employees includes workers that also hold a full-time position, with 75 percent of new gig workers looking to supplement their current income. 

Vox reports that while the volatility and uncertainty of gig work — including no minimum wage or employer-sponsored benefits — makes it riskier, it comes with benefits of choice ranging from hours to location. 

"Freelancers don't have the social safety net to rely on to get them through the weeks or months that they’re out of work," said Rafael Espinal, executive director of the Freelancers Union.

Mr. Espinal proposed creating "portable benefits," which would provide gig workers with benefits like healthcare coverage regardless of their employment status. 

States like California have gone back and forth between requiring employers to provide contracted employees with the same benefits as regular employees. However, there seems to be little clarity on if either stance will stick permanently.

https://www.beckershospitalreview.com/payer-issues/a-third-of-us-workforce-opts-for-gig-work-foregoing-employer-benefits.html

Exposé on Organized Retail Crime Features CVS Investigator

 In a page 1 article Thursday, September 2, The Wall Street Journal published a wide-ranging article exploring the impact of organized retail crime (ORC) on retail featuring CVS Health Director of ORC and Corporate Investigations Ben Dugan, CFI, who is also president of the national Coalition of Law Enforcement and Retail (CLEAR).

The article provides an inside look at multiple recent ORC investigations, including the 2020 $50 million case Operation Proof of Purchase that was featured in LPM’s November–December 2020 print magazine.

Other retailers mentioned included Target, Ulta Beauty, TJX, and Home Depot, who told the newspaper that the number of investigations into criminal networks “have grown 86% since 2016.”

Much of the article outlined the ongoing controversy between online platforms—primarily mentioning Amazon and eBay—and retailers and law enforcement who claim the platforms facilitate the sale of stolen goods by not properly vetting sellers. Home Depot CEO Craig Menear was quoted from a 2019 investors call when he said, “The digital world has become an easy way to move this product.”

Sgt. Ian Ranshaw of the Thornton, Colorado, Police Department said in the article that Amazon “may be the largest unregulated pawnshop on the face of the planet. It is super hard to deal with them.”

Amazon spokesperson Alex Haurek disputed that characterization and other criticism from retailers and law enforcement by claiming that the company “spent $700 million last year to combat fraud” and do cooperate with law enforcement when a subpoena is presented. Haurek also expressed the company’s opposition to the pending INFORM Consumers Act introduced in Congress earlier this year saying the legislation “favor large retailers at the expense of small businesses that sell online.”

https://losspreventionmedia.com/wall-street-journal-expose-on-orc/