Brazil Starts Its Covid-19 Vaccine Rollout

 Brazil began its Covid-19 vaccine rollout Sunday with the shot developed by China's Sinovac, minutes after its approval by regulators, promising to bring relief to a country that is struggling to cope with a surge in infections.

The country's health regulator, Anvisa, approved emergency use of the Chinese vaccine, known as CoronaVac, as well as the shot developed by AstraZeneca PLC and Oxford University.

The ruling follows a bitter tug of war between President Jair Bolsonaro and São Paulo's powerful state governor, João Doria, to secure the first vaccines for the country of more than 210 million people.

Gov. Doria, who is expected to run for president next year, has led a partnership with Chinese company Sinovac Biotech Ltd. to test and produce CoronaVac in São Paulo, criticizing what he has called a "genocidal" lack of action by Mr. Bolsonaro.

The dispute comes as the country's average daily death toll approaches 1,000 people, with scientists warning that a new variant that likely emerged in the Amazon could be partly responsible for a recent surge in infections. For the past week, Brazil has registered an average of more than 50,000 new cases of the disease each day -- the highest since the pandemic began.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-Brazil-Starts-Its-Covid-19-Vaccine-Rollout-3rd-Update-32215080/

High Cognitive Performance at Age 100

 Cognitively healthy centenarians appeared to have resilience mechanisms that helped them maintain high levels of cognitive performance despite risk factors for decline, a Dutch cohort study showed.

Of 330 people 100 years old or older, no decline was seen in most cognitive domains over a mean follow-up of 1.6 years except a slight drop in memory function (β −0.10 SD per year, 95% CI −0.14 to −0.05 SD, P<0.001), reported Henne Holstege, PhD, of Amsterdam University Medical College in the Netherlands, and co-authors in JAMA Network Open.

Cognitive reserve and physical health factors were tied to levels of cognitive performance, but not to decline in function. Postmortem findings in 44 participants showed varying loads of amyloid beta, neurofibrillary tangles, and neuritic plaques, none of which were linked to cognitive performance or decline.

Dementia risk increases exponentially with age and reaches approximately 40% per year for people 100 years old, Holstege and colleagues said: "This exponential increase implies that a person who lives between 70 and 95 years is exposed to the same dementia risk as a person who lives between age 100 and 102: an estimated 60%."

"Thus, 25 years of dementia risk in the younger population is compressed into 2 years in centenarians," the researchers added. "This indicates that prolonged stability of cognitive functioning in centenarians may be considered more extraordinary than in nonagenarians."

"While a mean follow-up of 1.6 years might at first blush seem short, for a segment of the population where annual mortality is approximately 30%, this is a relatively long time and an important positive feature of the work," noted Thomas Perls, MD, MPH, of Boston University School of Medicine, in an accompanying editorial.

People who enroll in centenarian studies often are better off than centenarians in general because of volunteer bias, but "this is acceptable because the authors explicitly state that they studied a population of cognitively healthy centenarians," Perls wrote. "As extreme outliers, these centenarians are likely an informative cohort for discovering behavioral, environmental, and/or biological mechanisms of resistance and resilience to Alzheimer's disease and related dementias."

The research included neuropsychology test data and postmortem neuropathology reports about Dutch centenarians who participated in the 100-plus Study between January 2013 and April 2019. Participants self-reported being cognitively healthy, which was confirmed by a proxy.

Median age was 100.5 and most participants (72%) were women. Mini-Mental State Examination scores were a median of 25.2, suggesting normal cognition. Most people in the study could walk independently (79%), and had good vision (66%) and good hearing (56%). Nearly one in three (30%) had a prior stroke or transient ischemic attack, and 63% had hypertension.

Follow-up was up to 4 years. Higher global cognition was linked to higher scores on the Barthel index, a measure of independence in activities of daily living (β 0.37 SD per year, 95% CI 0.24-0.49, P<0.001). Higher global cognition also was tied to higher education, a factor associated with cognitive reserve (β 0.41 SD per year, 95% CI 0.29-0.53, P<0.001).

Carrying an APOE4 or APOE2 allele was not significantly associated with performance in any cognitive domain or with rate of decline. "This may suggest that the effects of APOE alleles are exerted before the age of 100 years," Holstege and co-authors noted, and is in line with populations studies that show the fraction of APOE4 carriers decreases progressively in 80- and 90-year-olds.

While postmortem levels of amyloid beta, neurofibrillary tangles, and neuritic plaques varied widely, it's "intriguing that the highest stages of amyloid beta pathology were present in the brains of high performing centenarians, while the highest tau (i.e., neurofibrillary tangles) and neuritic plaque levels were not," the researchers observed. "This indicates that maintained cognitive health may be explained by resilience to the effects of even the highest levels of amyloid beta pathology, and a combination of resilience and resistance against neurofibrillary tangles and neuritic plaques."

The study had several limitations, Holstege and colleagues noted: the sample is not representative of all centenarians, and unmeasured confounders may have influenced results.

Disclosures

The study was supported by Stichting Alzheimer Nederland, StichtingDioraphte, and Stichting VUMC Fonds.

The researchers reported relationships with AC Immune SA, Alkermes, Alnylam Pharmaceuticals, Alzheon, Anavex Life Sciences, Biogen, Brainstorm Cell, Cortexyme, Denali Therapeutics, EIP Pharma, ImmunoBrain Checkpoint, GemVax, Genentech, Green Valley, Novartis, Novo Noridisk, PeopleBio Co, Renew LLC, Roche Holding AG, Cognition Therapeutics, Inc., FUJIFILM Toyama Chemical Co Ltd, IONIS Pharmaceuticals Inc., UCB, Vivoryon Therapeutics AG, Brain Research Center, Boehringer Ingelheim, Lundbeck, and Janssen Pharmaceuticals.

The editorialist reported no conflicts of interest.

Primary Source

JAMA Network Open

Source Reference: Beker N, et al "Association of Cognitive Function Trajectories in Centenarians With Postmortem Neuropathology, Physical Health, and Other Risk Factors for Cognitive Decline" JAMA Netw Open 2021; DOI: 10.1001/jamanetworkopen.2020.31654.

Secondary Source

JAMA Network Open

Source Reference: Perls T "Cognitive Trajectories and Resilience in Centenarians -- Findings From the 100-Plus Study" JAMA Netw Open 2021; DOI: 10.1001/jamanetworkopen.2020.32538.

https://www.medpagetoday.com/neurology/dementia/90720

Don't Allow a Marijuana Free-for-All

 As the new year is upon us, and vaccines have finally given us a glimmer of light at the end of the long COVID tunnel that still lies ahead, we would be wise to consider the public health implications of another health policy issue that has become increasingly salient. This past November, voters in several states including New Jersey and Arizona moved to legalize recreational marijuana use, reflective of a national trend toward decriminalization in recent years.

As there is growing consensus that the "war on drugs" has been costly and ineffective, with enforcement patterns that have disproportionately penalized people of color, decriminalizing marijuana is a logical and ethical course of action. However, changes to marijuana policy should be based on science and enacted thoughtfully and judiciously in order to minimize potential harm while protecting individual liberty.

While the concept of marijuana as a "gateway drug" that escalates to more dangerous substance use has been largely debunked, it would be an error to infer it is therefore harmless. Inhaling any burning substance causes lung damage and a cascade of inflammation that significantly increases the risks of cancer and cardiovascular disease. Smoking marijuana in particular has been associated with a nearly five-fold increased risk of heart attack in the hour immediately following.

While vaping marijuana eliminates some of these concerns, this method of delivery has been associated with severe lung injury as well.

As a cardiologist, I have seen firsthand how little the public is aware of the potential cardiovascular risk from smoking marijuana. Accordingly, when counseling patients I urge them to avoid inhalation of any substances and to opt for oral formulations if they express a strong intent to continue using marijuana.

Still, as I emphasize to patients, this is a measure of harm reduction rather than harm elimination, and more research is needed to better understand the chronic effects of marijuana itself. We already know, for example, that heavy chronic marijuana consumption in young people under the age of 25 has been associated with decreased cognitive and executive function.

In addition to risks of self-harm, marijuana may pose a risk of harm to others through inhalation of secondhand smoke or through motor vehicle accidents due to impaired judgment and motor skills.

On the other hand, marijuana derivatives may provide some therapeutic benefit for certain individuals. In patients with advanced malignancy or AIDS, tetrahydrocannabinol can help to regulate mood, suppress nausea, and improve appetite.

In addition, cannabidiol has shown promise as a potential anti-epileptic agent to manage debilitating seizures in children. It has been suggested that broader populations might benefit from cannabis-related effects on mood disorders and chronic pain, but further research is needed in this area to establish whether the benefits outweigh the risks.

Decriminalization of marijuana will create significant opportunities to conduct this research, but common-sense regulation based on science must be implemented simultaneously to create an ethical policy framework. This should aim to promote public health through comprehensive education programs and protection of vulnerable populations such as adolescents, while recognizing the right of autonomous adults to make decisions about their own health but not to act in a way that might compromise the health of others.

Mental health and addiction experts should lead the development of guidelines, such as those published by the American Society of Addiction Medicine, including an age limit of at least 21 to minimize risk of potential harm to young developing brains. Smoking or vaping any substances in public places should be prohibited so as not to impinge upon the liberty of others who do not wish to inhale secondhand smoke, just as there should be strict legal consequences for driving under the influence of substances that may lead to impaired function and increased risk of harm to others though motor vehicle collisions.

On the contrary, possession and use of marijuana by adults that does not directly affect others should not carry significant criminal penalties, particularly as enforcement patterns in practice have only served to entrench systemic racism.

There is substantial need for more research to guide specific policy development going forward, and in the meantime, recreational use (though not medicinal use) should be generously taxed to fund research efforts as well as addiction treatment in order to enhance benefits to society.

As with so many current issues, the rhetoric regarding marijuana use has too often been subservient to political agendas, with some conservatives condemning it as dangerous and criminal, while some liberals – and aspiring marijuana entrepreneurs – want to exonerate it as completely benign.

Instead, a nuanced and fact-based approach is necessary to promote the dual moral imperatives of personal liberty and harm reduction.

Sarah C. Hull, MD, MBE, is a cardiologist at Yale School of Medicine and associate director of its Program for Biomedical Ethics.

https://www.medpagetoday.com/publichealthpolicy/healthpolicy/90709

Covid Vax 'More Effective If Longer Gap Between Doses': Serum Institute

 The efficacy of the Covishield vaccine goes up if the gap between two doses is more than 28 days, a top scientist at Adar Poonawalla's Serum Institute of India (SII) said Friday, a day before the launch of India's Covid vaccination drive.

Both the vaccines being used in India - Serum's Covishield and Bharat Biotech's Covaxin - are two dose shots with a prescribed gap of 28 days between the jabs.

Suresh Jadhav, executive director, SII, said results were much better when this gap was increased by a few weeks.

"Even if the difference is of four weeks, it gives good protection, but around 70-80 per cent. If the gap is increased further up to six weeks or eight weeks or 10 weeks, the results are much higher," Dr Jadhav told NDTV.

He explained that the clinical trial was conducted in phase 3 with a 28-day gap, so that became the standard.

But if the second dose was taken faster, it would certainly guarantee 70 per cent protection to the receiver, Dr Jadhav said.

"But if you want protection for a longer period and a higher level, it is better to take it after six to eight weeks," he added.

https://www.ndtv.com/india-news/covishield-efficacy-higher-if-gap-over-28-days-serum-institute-to-ndtv-2353191

99.99% of coronavirus killed in 30 seconds with Japan firm's UV LED

 A deep ultraviolet (UV) LED with the ability to inactivate 99.99% of coronavirus particles when shined on surfaces for 30 seconds under certain conditions has been developed by a Japanese firm.

Nichia Corp., based in the city of Anan, Tokushima Prefecture, is ready to mass-produce the LED, and apparently hopes to use it in air purifiers, air conditioning systems and other equipment.

According to the company, the LED emits deep UV light with a wavelength of 280 nanometers, and has an optical output of 70 milliwatts. The inactivation of virus particles is said to be most effective at a wavelength of 260 nm, but the optical output drops at shorter wavelengths, which would reduce the deep UV LED's lifespan. The company says that at 265 nm, the LED has an estimated lifespan of about 2,000 hours. At 280 nm, that can be expanded by about 10 times, to some 20,000 hours.

The company's "Handy UV emitter" trial product uses 12 deep UV LEDs whose optical outputs were raised to 70 mW after adjusting the wavelength to 280 nm. A test by Tokushima University found that 99.99% of virus particles on surfaces were inactivated when hit with the deep UV waves for 30 seconds at a distance of 5 centimeters. It was also confirmed that the UV light with a wavelength of 280 nm had the same effectiveness as that with a wavelength of 260 nm, due to the higher optical output. The firm said that the extended LED lifespan resulting from the adjustments made the product ready for practical application.

Nichia has donated 20 of the LED trial products to the Tokushima Prefectural Government, as well as 30 to Tokushima University, and has been discussing plans to develop and sell products using the deep UV LED with Japanese manufacturers.

https://mainichi.jp/english/articles/20210109/p2a/00m/0na/024000c

Can hyperbaric oxygen therapy be a novel supportive therapy in COVID-19?

 Kirubanand Senniappan, Salome Jeyabalan, Pradeep Rangappa,1 and Muralidhar Kanchi2

 doi: 10.4103/ija.IJA_613_20

Abstract

The coronavirus disease 2019 (COVID-19) is a pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV2). Although 85% of infected patients remain asymptomatic, 5% show severe symptoms such as hypoxaemic respiratory failure and multiple end organ dysfunction (MODS) requiring intensive care unit (ICU) admission with a mortality rate of about 2.8%. Since a definitive treatment is yet to be identified, preventive and supportive strategies remain the mainstay of management. Supportive measures such as oxygen therapy with nasal cannula, face mask, noninvasive ventilation, mechanical ventilation and even extreme measures such as extracorporeal membrane oxygenation (ECMO) fail to improve oxygenation in some patients. Hence, hyperbaric oxygen therapy (HBOT) has been proposed as a supportive strategy to improve oxygenation in COVID-19 patients. HBOT is known to increase tissue oxygenation by increasing the amount of dissolved oxygen in plasma. HBOT also mitigates tissue inflammation thus reducing the ill effects of cytokine storm in COVID-19 patients. Though there is limited literature available on HBOT in COVID-19 patients, considering the present need for additional supportive therapy to improve oxygenation, HBOT has been proposed as a novel supportive treatment in COVID-19 patients.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7791429/

Association of American Physicians and Surgeons (AAPS) Applauds NIH Revised Stance on Ivermectin for COVID

 The National Institutes (NIH) has issued a new statement on the use of the anti-parasitic drug ivermectin for the treatment of COVID-19. Previously, it recommended against this treatment, but now states that its Panel “has determined that there are insufficient data to recommend either for or against the use of ivermectin for the treatment of COVID-19.”

The Association of American Physicians and Surgeons (AAPS) notes that there are now 49 ivermectin studies summarized on c19study.com, 100 percent of which show favorable results. In contrast, there are very few studies of the antibody cocktails now being used under an Emergency Use Authorization.

NIH concludes from its current analysis that “results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide further guidance on the role of ivermectin in the treatment of COVID-19.”

The NIH may be responding to requests related to the testimony strongly favoring ivermectin in a Dec 8 Senate hearing before the Committee on Homeland Security and Governmental Affairs.

While awaiting further studies, patients are dying, AAPS points out. More than a billion doses of this very safe drug have been administered since 1981. Yet many medical facilities and many physicians refuse to prescribe it for COVID-19, citing NIH guidance.

“Perhaps with this change, patients won’t need a court order to get a lifesaving drug,” stated AAPS executive director Jane Orient, M.D. A patient in Buffalo, who was dying on a ventilator, had a dramatic turnaround when family members persuaded an intensive care doctor to prescribe ivermectin. But doctors refused to allow further doses when her condition declined. State Supreme Court Judge Henry A. Nowak ordered the drug to be re-started, and the patient again improved.

“Once a drug is approved, it may be lawfully used for new indications, and at least 20 percent of prescriptions are for ‘off-label’ uses,” Dr. Orient stated. “To have a doctor withdraw a drug that appears to be saving a patient’s life, because a federal bureaucracy thinks it hasn’t been studied enough for that use, is shocking to those who believe in the traditional ethic of Hippocrates.”

The Association of American Physicians and Surgeons (AAPS) has represented physicians in all specialties nationwide since 1943. It provides information on early home treatment for COVID-19. Its motto is omnia pro aegroto (everything for the patient).

https://www.biospace.com/article/releases/association-of-american-physicians-and-surgeons-aaps-applauds-nih-revised-stance-on-ivermectin-for-covid-19/