DeSantis calls for states to be allowed to buy monoclonal antibody treatments

 Florida Gov. Ron DeSantis (R) called on the federal government to allow states to purchase monoclonal antibody treatments on Monday as his state and the country are slammed with COVID-19 cases.

The governor said during a press conference in Fort Lauderdale that the state is waiting to obtain enough doses to open five to 10 more monoclonal antibody treatment sites. But with the federal government in “control” of the supply, that plan is “all contingent on the federal government sending the doses we need,” he said.

Under the federal government’s “exclusive arrangement,” DeSantis said he does not think Florida is able to purchase its own monoclonal antibodies, although the state has set aside money in case the option becomes available.  

“We’re past the point now where we’re able to get it directly from any of these companies,” DeSantis said. “The federal government has cornered the entire market.”

“We do not believe that the federal government should be holding back any more medications,” he added. “We have to offer this particularly for our elderly population.”

The Department of Health and Human Services (HHS) paused the distribution of some monoclonal antibody treatments, including from Regeneron, in recent weeks after preliminary data showed a reduced effectiveness against the omicron variant. 

But the governor said HHS “decided to reverse course,” and the state expects to receive between 30,000 and 40,000 additional antibody doses. 

While DeSantis said officials believe cases are “overwhelmingly” attributable to the omicron variant in the state, especially in South Florida, he noted that “delta is still there.”

“It may not be as good as it was against delta, but we obviously want to have that here for patients to be able to do it,” he said.

Florida has seen its COVID-19 cases climb more than eight times higher in two weeks, according to data from The New York Times. The state’s hospitalizations have tripled in that time, but deaths are still declining. 

Texas Gov. Greg Abbott (R) also requested federal assistance, including for more monoclonal antibody treatments, last week as the state faces climbing case counts.

https://thehill.com/policy/healthcare/588020-desantis-calls-for-states-to-be-allowed-to-buy-monoclonal-antibody

Emergence in Southern France of a new SARS-CoV-2 variant of probably Cameroonian origin

 Philippe Colson, Jérémy Delerce, Emilie Burel, Jordan Dahan, Agnès Jouffret, Florence Fenollar, Nouara Yahi, Jacques Fantini, Bernard La Scola, Didier Raoult

doi: https://doi.org/10.1101/2021.12.24.21268174

This article is a preprint and has not been peer-reviewed [what does this mean?]. It reports new medical research that has yet to be evaluated and so should not be used to guide clinical practice.

PDF: https://www.medrxiv.org/content/10.1101/2021.12.24.21268174v1.full.pdf

ABSTRACT

SARS-CoV-2 variants have become a major virological, epidemiological and clinical concern, particularly with regard to the risk of escape from vaccine-induced immunity. Here we describe the emergence of a new variant. For twelve SARS-CoV-positive patients living in the same geographical area of southeastern France, qPCR testing that screen for variant-associated mutations showed an atypical combination. The index case returned from a travel in Cameroon. The genomes were obtained by next-generation sequencing with Oxford Nanopore Technologies on GridION instruments within ≈8 h. Their analysis revealed 46 mutations and 37 deletions resulting in 30 amino acid substitutions and 12 deletions. Fourteen amino acid substitutions, including N501Y and E484K, and 9 deletions are located in the spike protein. This genotype pattern led to create a new Pangolin lineage named B.1.640.2, which is a phylogenetic sister group to the old B.1.640 lineage renamed B.1.640.1. Both lineages differ by 25 nucleotide substitutions and 33 deletions. The mutation set and phylogenetic position of the genomes obtained here indicate based on our previous definition a new variant we named “IHU”. These data are another example of the unpredictability of the emergence of SARS-CoV-2 variants, and of their introduction in a given geographical area from abroad.

Competing Interest Statement

DR has a conflict of interest being a consultant for Hitachi High-Technologies Corporation, Tokyo, Japan from 2018 to 2020. All other authors have no conflicts of interest to declare. Funding sources had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript.

Funding Statement

This work was supported by the French Government under the Investments for the Future program managed by the National Agency for Research (ANR), no. Mediterranee-Infection 10-IAHU-03 Region Provence Alpes Cote d Azur and European funding FEDER PRIMMI (Fonds Europeen de Developpement Regional-Plateformes de Recherche et d Innovation Mutualisees Mediterranee Infection), no. FEDER PA 0000320 PRIMMI Hitachi High-Technologies Corporation, Tokyo, Japan.

https://www.medrxiv.org/content/10.1101/2021.12.24.21268174v1

New COVID-19 Variant With 46 Mutations Discovered In Southern France

 Since its arrival in late November, the unquestionably mild Omicron strain of Covid-19 has sent daily new infections to record highs, while hospital admissions - and particularly deaths - have remained relatively low compared to the giant new denominator.

But it was only a matter of time before a new variant hit the scene. Like omicron, it appears this new variant originated in an African country  - Cameroon - after being isolated by scientists in southern France.

The first official case is reported to be a traveler from Cameroon, and it's now spreading in Southern France where at least 12 people have been infected with it, according to research published on medrvix.

To be clear - we know virtually nothing about this new strain aside from the fact that it exists. Nothing on severity, transmissibility, 'long covid', etc. We do know it's highly mutated from the original strain, much like Omicron. It's also too soon to tell if it will be classified as a 'variant of concern.'

In the medrvix preprint, which has yet to be peer-reviewed, experts from a French government-backed program said they had identified 46 mutations in the variant.

"SARS-CoV-2 variants have become a major virological, epidemiological and clinical concern, particularly with regard to the risk of escape from vaccine-induced immunity," the paper's authors wrote.

The scientists also postulated that the new variant was probably of "Cameroonian" origin. Readers can find the complete report below. The variant has been given the name B.1.640.2, and was first detected by experts at the IHU Mediterranee Infection Foundation in Marseille.

According to the paper, the scientists' analysis of the variant's genome revealed 46 mutations and "37 deletions resulting in 30 amino acid substitutions and 12 deletions. Fourteen 43 amino acid substitutions, including N501Y and E484K, and 9 deletions are located in the 44 spike protein."

Read the full report below:

2021.12.24.21268174v1.full on Scribd

New variants are discovered frequently, but most don't go on to become "variants of concern", like omicron, delta and beta. The WHO has assigned each variant of concern with a name from the Greek alphabet (the first was "alpha", the second "beta", while letters "Xi" and "Nu" have been skipped because they are "confusing", per the WHO).

https://www.zerohedge.com/medical/new-variant-46-mutations-discovered-southern-france

Medicaid Implements Waivers for Some Clinical Trial Coverage

 Federal officials will allow some flexibility in meeting new requirements on covering the costs of clinical trials for people enrolled in Medicaid, seeking to accommodate states where legislatures will not meet in time to make needed changes in rules.

Congress in 2020 ordered US states to have their Medicaid programs cover expenses related to participation in certain clinical trials, a move that was hailed by the American Society of Clinical Oncology (ASCO) and other groups as a boost to trials as well as to patients with serious illness who have lower income.

The mandate went into effect on January 1, but the Centers for Medicare & Medicaid Services (CMS) will allow accommodations in terms of implementation time for states that have not yet been able to make needed legislative changes, wrote Dan Tsai, the director of Medicaid, in a December 7 letter. Tsai's letter doesn't mention specific states. CMS didn't immediately respond to a request seeking information on the states expected to apply for waivers.

Medicaid has in recent years been a rare large US insurance program that does not cover the costs of clinical trials. The Affordable Care Act of 2010 mandated this coverage for people in private insurance plans. The federal government in 2000 decided that Medicare would do so.

"A Hidden Opportunity"

A perspective article last May in the New England Journal of Medicine referred to the new Medicaid mandate on clinical trials as a "hidden opportunity," referring to its genesis as an add-on in a massive federal spending package enacted in December 2020.

In the article, Samuel Takvorian, MD, MSHP, of the University of Pennsylvania, Philadelphia, and co-authors noted that rates of participation in clinical trials remain low for racial and ethnic minority groups, due in part to the lack of Medicaid coverage.

"For example, non-Hispanic White patients are nearly twice as likely as Black patients and three times as likely as Hispanic patients to enroll in cancer clinical trials — a gap that has widened over time," Takvorian and co-authors write. "Inequities in enrollment have also manifested during the COVID-19 pandemic, which has disproportionately affected non-White patients, without their commensurate representation in trials of COVID-19 therapeutics."

In October, researchers from the Arthur G. James Cancer Hospital and Ohio State University, Columbus, published results of a retrospective study of patients with stage I-IV pancreatic cancer that also found inequities in enrollment. Writing in the Annals of Surgical Oncology, Mariam F. Eskander, MD, MPH, and co-authors reported what they found by examining records for 1127 patients (0.4%) enrolled in clinical trials and 301,340 (99.6%) who did not enroll. They found that enrollment in trials increased over the study period, but not for Black patients or patients on Medicaid.

Eskander told Medscape Medical News the new Medicaid policy will remove a major obstacle to participation in clinical trials. An oncologist, Eskander said she is looking forward to being able to help more of her patients get access to experimental medicines and treatments.

But that may not be enough to draw more people with low incomes into these studies, said Eskander, who is now at Rutgers University. She urges greater use of patient navigators to help people on Medicaid understand the resources available to them, as well as broad use of Medicaid's nonemergency medical transportation (NEMT) benefit.

"Some patients will be offered clinical trial enrollment and some will accept, but I really worry about the challenges low-income people face with things like transportation and getting time off work," she said.

https://www.medscape.com/viewarticle/965866

Storm prompts Va. Health Dept. to close community vaccination centers

 The Virginia Department of Health says it’s closing all of its community vaccination centers because of bad weather.

The department said in a news release that the centers will be closed Monday. Some areas of Virginia are expected to see several inches of snow.

The centers offer first and second doses of the COVID-19 vaccines along with booster shots. People who already have appointments at one of the centers will be notified of the cancellation. They can visit the department’s website to reschedule.

VDH said it made the decision out of an abundance of caution. It’s closing centers in Charlottesville, Chesterfield, Fairfax, Fredericksburg, Newport News, Prince William, Richmond and Roanoke. No vaccinations will be offered at Norfolk’s Military Circle Mall. But the site will remain open for COVID-19 testing on Monday afternoon, the health department said.

https://apnews.com/article/coronavirus-pandemic-health-storms-virginia-weather-695b1d39dce187b901b762c4e0772f47

Quebec begins retail store closures amid new COVID-19 wave

 Quebec proceeded with the first of three planned closures of non-essential retail stores Sunday as the provincial government tried to curb a new wave of COVID-19 driven by the highly infectious Omicron variant.

Hospitals and health-care resources in Quebec and Canada’s remote northern communities are also being stretched as case numbers explode.

Quebec Premier Francois Legault announced last week that the bulk of the province’s stores would be closed for the next three Sundays, with the exception of pharmacies, convenience stores and gas stations.

Charles Milliard, president of the Quebec Federation of Chambers of Commerce, urged the government to lift the measures as soon as possible.

“The last thing businesses need during these difficult times is additional restrictions” Milliard said in a statement. “We must leave the choice to businesses to open or close at the time that makes the most sense for them, their employees and their customers.”

The closures came as Quebec reported 15,845 new COVID-19 cases, as well as 13 additional deaths linked to the virus.

The Health Department said the number of hospitalizations linked to the disease rose by 70 to 1,231. It said 162 people are in intensive care, an increase of nine.

Quebec City’s main hospital network says it will postpone half of its surgeries and medical appointments starting Wednesday due to the spike in COVID patients.

Martin Beaumont, President and CEO of the CHU de Québec-Université Laval, told a news conference that as many as 10,000 medical appointments could be delayed, allowing roughly 50 nurses to also be redirected to the pandemic’s ward.

The hospital network says 783 health-care workers are in isolation, in addition to the 600 nurses already missing from the workforce before the pandemic’s fifth wave hit.

The strain caused by the growing number of cases is exacerbated in remote communities where health care is already limited.

Bearskin Lake First Nation, a fly-in only community in northern Ontario, declared a state of emergency on Dec. 30 when 43 residents tested positive for the virus. By Sunday, 169 people had confirmed or suspected cases of COVID-19, more than 40 per cent of the total population.

“That’s a crisis,” Nishnawbe Aski Nation Grand Chief Derek Fox said in an interview.

Bearskin Lake has no hospital and is usually served by a nursing station with two nurses. An emergency evacuation would take more than three hours for a plane to get in and out from Sioux Lookout or Thunder Bay, and that’s only if weather permits it to land.

A federal rapid response team with three primary care nurses, a paramedic and two environmental health officers landed in Bearskin Lake on Dec. 30, bringing more testing capacity with them. Two public health nurses were sent by the Sioux Lookout First Nations Health Authority as well.

Outbreaks in remote communities are also affecting Nunavut, northern Quebec and Labrador.

Nunavut confirmed another 22 cases of COVID-19 Sunday, bringing the total to 196 in just 10 days.

Nunavut is discouraging all non-essential travel within the territory and has banned non-essential travel to and from several communities, including Iqaluit, Rankin Inlet, Arviat, Igloolik and Pangnirtung.

Travel bans are also in place now in Nunavik in northern Quebec until mid-January, with only critical or essential travel allowed into or out of the region’s 14 villages.

https://apnews.com/article/coronavirus-pandemic-health-canada-quebec-04def955a6b5051863121beb8306442b

Peoria schools add week to winter break amid COVID-19 surge

 A central Illinois school district has extended students’ winter break by one week to give administrators more time prepare for in-person learning as the omicron variant fuels a surge in COVID-19 cases.

Peoria Public Schools said Sunday in a Facebook post that students’ winter break would be extended through the week of Jan. 3, but all students would return for classes on Jan. 10, the (Peoria) Journal Star reported.

Those days will be made up at the end of the 2021-2022 school year, said Superintendent Dr. Sharon Desmoulin-Kherat.

“In the two weeks since our winter break began, an unprecedented surge in COVID-19 cases both locally and nationally has occurred due to the emergence of the omicron variant,” she said.

The one-week delay will allow the staff “to prepare for continued in-person learning in the face of this new variant,” Desmoulin-Kherat added.

All scheduled high school athletics events will be held this week and the details of restricted spectator guidelines will be communicated by each high school. But middle school athletics and activities will not be held this week.

The district will offer “peace of mind” COVID-19 testing to staff members from 10 a.m. to noon on Tuesday, Jan. 4 and Thursday, Jan. 6 at the three high schools.

Employees who have tested positive during the break are asked to contact human resources to give the district a sense of what their staffing levels will be.

https://apnews.com/article/coronavirus-pandemic-sports-health-illinois-peoria-62eb144fb6bf073df4c590ab23d2db6b