Vitamin D Insufficiency 'May Account for Almost 9 of 10 COVID-19 Deaths'

 by 

Hermann Brenner

 ^1,2,* and

Ben Schöttker

 ^1,2

¹

Division of Clinical Epidemiology and Aging Research, German Cancer Research Center, 69120 Heidelberg, Germany

²

Network Aging Research, University of Heidelberg, 69120 Heidelberg, Germany

^*

Author to whom correspondence should be addressed.

Nutrients 2020, 12(12), 3642; https://doi.org/10.3390/nu12123642

PDF: https://www.mdpi.com/2072-6643/12/12/3642/pdf

Excerpt

Note: In lieu of an abstract, this is an excerpt from the first page.

Evidence from observational studies is accumulating, suggesting that the majority of deaths due to SARS-CoV-2 infections are statistically attributable to vitamin D insufficiency and could potentially be prevented by vitamin D supplementation [...] View Full-Text

This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited

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https://www.mdpi.com/2072-6643/12/12/3642#stats_id

Judge tosses Bayer's $650M PCB pollution settlement

 

• Bayer (OTCPK:BAYRY -2.2%) heads lower after a U.S. federal judge faults provisions of the settlement Bayer reached in July with ~2,500 U.S. cities, counties and ports over PCB pollution that was blamed on Monsanto, which Bayer acquired in 2018.
• The judge says provisions for release of liability for future claims are too broad, particularly in light of the "modest" settlement fund.
• The PCB litigation was part of Bayer's agreement to pay as much as $10.9B to settle U.S. lawsuits related to Roundup, including $1.25B to support a separate class agreement to address potential future litigation.
• https://seekingalpha.com/news/3640062-judge-tosses-bayers-650m-pcb-pollution-settlement

Autolus AUTO6 shows encouraging anti-tumor activity in neuroblastoma study

 

• Autolus Therapeutics (AUTL +8.5%) announces publication of data from Phase 1 study evaluating AUTO6 (1RG-CAR T) in childhood neuroblastoma, in Science Translational Medicine. The trial was sponsored and run by Cancer Research UK’s Centre for Drug Development.
• New results highlight that AUTO6 can induce rapid regression of bulky disease in a solid tumor setting without inducing on-target off-tumor toxicity, despite dose dependent CAR T expansion that was observed in all six patients treated at the higher cell dose cohorts in this study.
• Three of these six patients demonstrated evidence of transient CAR T cell activity. Despite the presence of clear CAR T cell activity, no neurotoxicity was observed.
• AUTO6 is a second generation GD2-targeting CAR T candidate, developed in collaboration with UCL.
• These data support Autolus’ development of AUTO6NG, which builds on same approach utilizing the GD2 CAR with additional programming modules for enhanced efficacy and persistence. Currently, AUTO6NG in preclinical studies and is expected to clinical studies next year.
• https://seekingalpha.com/news/3640076-autolus-therapeutics-auto6-shows-encouraging-anti-tumor-activity-in-neuroblastoma-study

Pfizer marks 1st 'mass air shipment' of COVID-19 shot amid cold-chain scrutiny

 Pfizer, alone among its peers, has faced fever-pitch scrutiny over the stringent cold storage requirements for its COVID-19 vaccine—and the logistical challenges that could pose. Looking to ease the doubters' concerns, Pfizer has now shipped its first doses by air to the U.S., and distributors are watching closely. 

Late last week, United Airlines started ferrying Pfizer’s COVID-19 vaccine hopeful from the Brussels International Airport in Belgium to Chicago O'Hare, The Wall Street Journal reported, marking the first “mass air shipment” of a coronavirus vaccine. 

Pfizer’s BioNTech-partnered vaccine hopeful BNT162b2 has yet to receive the FDA authorization needed to ship straight to administration sites and doctors, but the shot can be pre-positioned at distribution sites, the Journal said, potentially easing the deployment process should the shot pass muster with regulators.

On Sunday, the Department of Health and Human Services confirmed that early doses of Pfizer's shot were en route from Belgium but declined to reveal exactly where the shots would end up in the U.S. "in an effort to minimize the potential risk to delivery and distribution, we are unable to provide specific details regarding where vaccines are produced and stored."

Getting a jump start on a U.S. rollout could be a big help for Pfizer, which is facing heightened scrutiny for its vaccine's cold-chain requirements—the most stringent of any of the COVID-19 vaccine leaders.

Pfizer's shot must be kept at a frigid -94 degrees Fahrenheit long term with a very limited shelf life at normal refrigerated temps. The drugmaker, for its part, has developed specialized, GPS-monitored coolers that can keep the vaccine at required temperatures for up to 10 days. Meanwhile, the company has developed real-time GPS capability to report potential temperature variations, reducing the odds that the shot will lose its potency before it reaches patients. 

Looking to cope with Pfizer's frigid requirements, the Federal Aviation Administration (FAA) gave United Airlines the go-ahead to move 15,000 pounds of dry ice per flight, more than five times what’s normally permitted, the Journal reported. Dry ice, which the FAA classifies as a hazardous material, can only be moved in limited quantities, as it can lower the amount of oxygen in the air as it converts back into carbon dioxide gas.

Pfizer, meanwhile, has positioned refrigerated storage sites at its final-assembly centers in Kalamazoo, Michigan, and Puurs, Belgium, and is working to boost capacity at distribution sites in Pleasant Prairie, Wisconsin, and Karlsruhe, Germany.

The drugmaker has also been running “dry rehearsals” of its rollout scheme at more than 50 distribution sites across the U.S. The dry runs include taking the sites through the process of receiving the vaccines, opening them and administering them; plus, Pfizer has even created YouTube videos for staffers to consult during the process.

The process is “very, very doable,” Operation Warp Speed's Gen. Gustave Perna said last week. Perna added that the rehearsals had boosted confidence among administration sites.

Pfizer and BioNTech recently filed their shot for emergency use authorization in the U.S. after late-phase data showed the vaccine was 95% effective in phase 3. The mRNA-based vaccine is set to go before the FDA's independent vaccines advisory committee and the Centers for Disease Control's Advisory Committee on Immunization Practices (ACIP) on Dec. 10, Warp Speed chief Moncef Slaoui said last week. Those reviews will take place "in parallel" so that the CDC can almost immediately defer to ACIP on how to distribute and allocate authorized doses, Slaoui said. 

Meanwhile, the government aims to start shipping doses to distributors within 24 hours of a positive decision, with vaccinations slated to take place as quickly as 48 hours after an authorization, Slaoui said.

United isn't the only one steeling itself for a global rollout of Pfizer's shot: American Airlines has been running trial flights from Miami to South America to test thermal packaging and shot distribution logistics, the Journal said.

FedEx and DHL have also rolled out temperature-monitoring systems to keep tabs on future vaccine shipments, while United Parcel Service and Lufthansa are building so-called "freezer farms" comprised of multiple freezers at airport hubs to store vaccines during their journey to distributors. 

Elsewhere, the U.K. is also taking steps to ready itself for distribution. The country’s Medicines and Healthcare Products Regulatory Authority (MHRA) could approve Pfizer and BioNTech’s shot by Dec. 7, the Financial Times reports, and recently appointed Nadhim Zahawi as vaccine rollout minister.

Zahawi will temporarily halt most of his responsibilities at the U.K.’s Department for Business, Energy and Industrial Strategy (BEIS) as he works as a joint minister between the BEIS and the Department for Health and Social care to oversee distribution arrangements for Pfizer’s vaccine, Pharmaphorum said. The U.K. has secured 40 million doses of Pfizer’s product.

https://www.fiercepharma.com/manufacturing/first-pfizer-doses-from-belgium-touch-down-at-o-hare-international-report

McKinsey consultants proposed Purdue offer rebates for opioid overdoses

 Purdue Pharma has faced years of intense scrutiny over its opioid painkiller marketing, culminating with last month’s Department of Justice settlement worth more than $8 billion. Behind the scenes, global consulting leader McKinsey & Company helped guide marketing strategy for years and pitched the idea of rebates to distributors for overdoses, according to The New York Times. 

After last month's settlement, new documents released through Purdue’s bankruptcy process show that McKinsey advised the company on ways to boost sales, according to the newspaper. In 2017, McKinsey advisors said that one way Purdue could improve OxyContin's performance was to offer distributors rebates for opioid overdoses that were attributable to its drug. 

For instance, the advisors predicted in 2019 that around 2,500 CVS customers might overdose. Under a proposed rebate of $14,810 per overdose, that’d mean a payment to CVS of $36.8 million that year. CVS and Anthem never received such rebates, representatives told the Times. 

A McKinsey spokesperson told the NYT that the company is “cooperating fully with the opioid-related investigations” and decided last year it wouldn’t “advise any clients worldwide on opioid-specific business.” In a settlement document released last month, the Department of Justice detailed McKinsey’s actions as an unnamed “consulting company.” 

Aside from their advice to Purdue, McKinsey officials themselves began to wonder about potential legal consequences from their opioid work, the Times says. In 2018, after Massachusetts sued Purdue, one consultant wrote to another that it "probably makes sense to have a quick conversation with the risk committee to see if we should be doing anything" except "eliminating all our documents and emails," according to a document seen by the newspaper.

"As things get tougher there someone might turn to us," the consultant wrote.

Purdue’s October settlement came after years of investigations over its role in the U.S. addiction and overdose epidemic. As part of the deal, the feds assessed Purdue a $3.54 billion criminal penalty. The company will forfeit another $2 billion and agreed to pay $2.8 billion on civil claims. Purdue's founding family, the Sacklers, agreed to pay $225 million in civil damages. 

Separate from that deal, Purdue proposed to pay between $10 billion and $12 billion to settle state and local claims from around the country. 

https://www.fiercepharma.com/pharma/mckinsey-consultants-proposed-purdue-offer-rebates-for-opioid-overdoses-nyt

AstraZeneca staffers targeted in suspected hacking scheme

 After China, Iran and Russia, North Korea is the latest to be fingered for attempting to steal Western research into COVID-19. Its target? AstraZeneca.

North Korean hackers used sham recruiting schemes to try to breach AstraZeneca’s systems in recent weeks, Reuters reported, citing two people familiar with the matter.

The alleged cyberattacks, which are not thought to have been successful, came as the British drugmaker was knee-deep in developing a COVID-19 vaccine while working on a coronavirus antibody cocktail.

The hacking targeted a “broad set of people,” including those working on COVID research, according to one Reuters source.

The hackers disguised themselves as recruiters on LinkedIn and WhatsApp. In messages sporting fabricated job offers came e-documents with malicious code designed to gain access to the target employee's computer, the sources told the newswire.

Judging by the hackers’ tools and techniques, the sources said they looked to be part of an ongoing hacking scheme by Pyonyang. The campaign, which previously focused on military and media organizations, has pivoted to COVID-related entities, three people who have investigated the attacks told Reuters.

Biopharma companies have routinely been targeted in cyberattacks, but reported hacking incidents and attempts appear to have surged during the pandemic.

Before North Korea, cybersecurity officials from the U.S., U.K. and Canada accused hackers with Russian intelligence ties of trying to steal information and intellectual property around COVID-19 vaccines by using malware. Russia itself has denied any involvement in the attacks. To combat the accusations, Russia facilitated a licensing deal between local drugmaker R-Pharm and AstraZeneca to produce and distribute doses of the company’s experimental COVID shot AZD1222.

In the suspected North Korean attack on AZ, some of the social media accounts used were registered with email addresses from Russia in a bid to mislead investigators, one of Reuters’ sources said.

In addition, China and Iran have also been named by the U.S. government for launching cyberattacks aimed at stealing COVID-related research from pharma companies and health agencies.

India’s Dr. Reddy’s Laboratories was recently forced to isolate all data centers and shut key plants globally after detecting a cyber breach. That incident came on the heels of the company's clearance to start a phase 2/3 trial of Russia’s COVID vaccine, Sputnik V.

https://www.fiercepharma.com/pharma/astrazeneca-staffers-targeted-suspected-hacking-amid-work-covid-vaccine-report

Prevail's gene therapy Orphan drug in Europe for dementia type

 

• The European Commission has designated orphan designation to Prevail Therapeutics' (PRVL +1.2%) investigational AAV9 gene therapy, PR006 for the treatment of frontotemporal dementia with a GRN mutation (FTD-GRN)
• The Company expects to initiate enrollment in Phase 1/2 PROCLAIM trial of PR006 in next month, and anticipates to provide a biomarker and safety analysis on a subset of patients in the PROCLAIM trial in 2021.
• Earlier, the gene therapy received US Orphan Drug and Fast Track designation for the same indication.
• https://seekingalpha.com/news/3640000-prevails-gene-therapy-orphan-drug-in-europe-for-type-of-dementia