Monthly Archives: January 2021
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that NVX-CoV2373, its protein-based COVID-19 vaccine candidate, met the primary endpoint, with a vaccine efficacy of 89.3%, in its Phase 3 clinical trial conducted in the United Kingdom (UK). The study assessed efficacy during a period with high transmission and with a new UK variant strain of the virus emerging and circulating widely. It was conducted in partnership with the UK Government’s Vaccines Taskforce. Novavax also announced successful results of its Phase 2b study conducted in South Africa.
“With today’s results from our UK Phase 3 and South Africa Phase 2b clinical trials, we have now reported data on our COVID-19 vaccine from Phase 1, 2 and 3 trials involving over 20,000 participants. In addition, our PREVENT-19 US and Mexico clinical trial has randomized over 16,000 participants toward our enrollment goal of 30,000. NVX-CoV2373 is the first vaccine to demonstrate not only high clinical efficacy against COVID-19 but also significant clinical efficacy against both the rapidly emerging UK and South Africa variants,” said Stanley C. Erck, President and Chief Executive Officer,Novavax. “NVX-CoV2373 has the potential to play an important role in solving this global public health crisis. We look forward to continuing to work with our partners, collaborators, investigators and regulators around the world to make the vaccine available as quickly as possible.”
For its part, Johnson & Johnson announces Single-Shot Janssen COVID-19 Vaccine Candidate that met primary endpoints in interim analysis of its Phase 3 ENSEMBLE Trial. The vaccine is ‘85% Effective Overall in Preventing Severe Disease and Demonstrated Complete Protection Against COVID-19 related Hospitalization and Death as of Day 28′ reports Johnson & Johnson.
U.S. regulators have approved the first long-acting drug combo for HIV, monthly shots that can replace the daily pills now used to control infection with the AIDS virus. The approval of the two-shot combo called Cabenuva is expected to make it easier for people to stay on track with their HIV medicines and to do so with more privacy. It’s a huge change from not long ago, when patients had to take multiple pills several times a day, carefully timed around meals.
“That will enhance quality of life” to need treatment just once a month, said Dr. Steven Deeks, an HIV specialist at the University of California, San Francisco, who has no ties to the drug’s makers. “People don’t want those daily reminders that they’re HIV infected.”
Cabenuva combines rilpivirine, sold as Edurant by Johnson & Johnson’s Janssen unit, and a new drug — cabotegravir, from ViiV Healthcare. They’re packaged together and given as separate shots once a month. Dosing every two months also is being tested.
The U.S. Food and Drug Administration approved Cabenuva for use in adults who have had their disease well controlled by conventional HIV medicines and who have not shown signs of viral resistance to the two drugs in Cabenuva. The agency also approved a pill version of cabotegravir to be taken with rilpivarine for a month before switching to the shots to be sure the drugs are well tolerated. ViiV said the shot combo would cost $5,940 for an initial, higher dose and $3,960 per month afterward. The company said that is “within the range” of what one-a-day pill combos cost now. How much a patient pays depends on insurance, income and other things. Studies found that patients greatly preferred the shots.
“Even people who are taking one pill once a day just reported improvement in their quality of life to switch to an injection,” said Dr. Judith Currier, an HIV specialist at the University of California, Los Angeles. She consults for ViiV and wrote a commentary accompanying one study of the drug in the New England Journal of Medicine. Deeks said long-acting shots also give hope of reaching groups that have a hard time sticking to treatment, including people with mental illness or substance abuse problems. “There’s a great unmet need” that the shots may fill, he said.
Taking a regular afternoon nap may be linked to better mental agility, suggests research published in the online journal General Psychiatry. It seems to be associated with better locational awareness, verbal fluency, and working memory, the findings indicate. Longer life expectancy and the associated neurodegenerative changes that accompany it, raise the prospect of dementia, with around 1 in 10 people over the age of 65 affected in the developed world.
As people age, their sleep patterns change, with afternoon naps becoming more frequent. But research published to date hasn’t reached any consensus on whether afternoon naps might help to stave off cognitive decline and dementia in older people or whether they might be a symptom of dementia.
The researchers explored this further in 2214 ostensibly healthy people aged at least 60 and resident in several large cities around China, including Beijing, Shanghai, and Xian. In all, 1534 took a regular afternoon nap, while 680 didn’t. All participants underwent a series of health checks and cognitive assessments, including the Mini Mental State Exam (MMSE) to check for dementia. The average length of night time sleep was around 6.5 hours in both groups. Afternoon naps were defined as periods of at least five consecutive minutes of sleep, but no more than 2 hours, and taken after lunch. Participants were asked how often they napped during the week; this ranged from once a week to every day.
The dementia screening tests included 30 items that measured several aspects of cognitive ability, and higher function, including visuo-spatial skills, working memory, attention span, problem solving, locational awareness and verbal fluency. The MMSE cognitive performance scores were significantly higher among the nappers than they were among those who didn’t nap. And there were significant differences in locational awareness, verbal fluency, and memory.
This is an observational study, and so can’t establish cause. And there was no information on the duration or timing of the naps taken, which may be important.
Rows of huge tanks full of chemical solutions storing energy generated from massive solar and wind farms and powering whole cities: It’s a landscape that millennials might very well equate with the new normal. Batteries will power this new paradigm, and they won’t necessarily all be lithium-ion batteries. The flow battery is staking a claim in the renewable energy world of the future. Flow batteries are definiively the future of energy storage, or at least an important part of it.
What are flow batteries? They are systems of two connected tanks, both containing electrolyte liquids: one with a positively charged cathode and the other with the negatively charged anode, just like a lithium-ion battery. Electricity passes from one electrolyte liquid to the other via a membrane between the tanks.
Rechargeable like lithium-ion batteries, flow batteries have longer lives because the electric current flowing from tank to tank does not degrade the membrane. True flow batteries are also called redox flow batteries, after the two reactions they utilize: reduction, or a gain of electrons, and oxidation, or loss of electrons from electrolyte liquid to electrolyte liquid.
Now researchers in WMG at the University of Warwick, in collaboration with Imperial College London, have found a way to enhance hybrid flow batteries and their commercial use. The new approach can store electricity in these batteries for very long durations for about a fifth the price of current technologies, with minimal location restraints and zero emissions.
The scientists enhanced three hybrid flow cells using nitrogen doped graphene (exposed to nitrogen plasma) in a binder-free electrophoresis technique (EPD). Wind and solar power are increasingly popular sources for renewable energy. Unfortunately, intermittency issues keep them from connecting widely to the National grid. One potential solution to this problem involves in the deployment of long-duration battery technology, such as the redox flow battery. Despite its great promise the current costs of this system are a key determining factor to real-world adoption. An affordable grid battery should cost £75/kWh, according to the US Department of Energy. Lithium-ion batteries, which lead the charge for grid storage, cost about £130/kWh. The hybrid flow battery’s total chemical cost is about 1/30th the cost of competing batteries, such as lithium-ion systems. Scaled-up technologies may be used to store electricity from wind or solar power, for multiple days to entire seasons, for about £15 to £20 per kilowatt hour.
A team of researchers from the Montreal Heart Institute believe they have found an effective weapon against COVID-19: colchicine, an oral tablet already known and used for other diseases. For Dr. Jean-Claude Tardif, who led the study, this is a “major scientific discovery,” he said. Colchicine is the first “effective oral drug to treat out-of-hospital patients.” As colchicine is a well-understood drug, it could be used very quickly to treat people with COVID-19, the researcher says.
“Colchicine is old as it is — we’ve been treating gout with it for hundreds of years — so it’s available in pharmacies,” Tardif said, speaking in French. “So any doctor, tomorrow, who reads this can definitely decide to prescribe if he wants.”
Analysis of the study found that colchicine resulted in reductions in hospitalizations by 25 per cent, the need for mechanical ventilation by 50 per cent, and deaths by 44 per cent.
Evidence increasingly indicates that male sex is a risk factor for more severe disease and death from COVID-19. Male bias in COVID-19 mortality is observed in nearly all countries with available sex-disaggregated data, and the risk of death in males is ∼1.7 times higher than in females. Aging is strongly associated with higher risk of death in both sexes, but at all ages above 30 years, males have a significantly higher mortality risk, rendering older males the most vulnerable group. Sex differences are intertwined with differences in gender roles socially and with behavioral factors, which also influence COVID-19 incidence and outcomes. However, there are also possible biological mechanisms of male sex bias that affect the severity of COVID-19, particularly with respect to immune responses.
Sex differences beyond sex organs are present across species and extend to physiological systems, including the immune system. Infection by different pathogens results in differential immune responses and disease outcomes by sex, and although the pattern depends on age and other host factors, male sex is more often associated with lower immune responses and higher susceptibility and/or vulnerability to infections in animals. This is generally also the case in humans: Male patients have higher viral loads for hepatitis B virus (HBV) and HIV. Conversely, females generally mount a more robust immune response to vaccines, such as influenza vaccines. However, the heightened immune responses in females can also lead to detrimental immunopathology in infections.
The physiological response to virus infection is initiated when virus replication is detected by pattern recognition receptors. This leads to two antiviral programs by the infected cells.
Israel‘s Health Minister Edelstein provided ministry data showing that 2,272,000 people have so far had the first of the two-shot Pfizer-BioNTech vaccine, including 550,000 who have also had their second dose. The number represents close to a quarter of Israel’s 9.3 million citizens and maintains its position as the country with the highest per capita vaccination rate in the world, according to monitoring groups.
Edelstein on Wednesday presented figures showing that over 210,000 vaccination shots were administered the day before, a new record for the country’s mass inoculation program.
Israelis recieve a Covid-19 vaccine, at a vaccination center operated by the Tel Aviv Municipality
Urging continued adherence to Health Ministry lockdown guidelines, which on Tuesday were extended until January 31, Edelstein wrote “a little more and this will be behind us.”
His figures were more optimistic than numbers released by the ministry during the morning, which showed that 56,008 people had their first dose on Tuesday and another 114,769 had the second shot for a total of 170,777. It was not clear why there was a discrepancy in the numbers.
The ministry said 8,511 new cases were confirmed Tuesday, a drop of some 1,500 from the record-shattering 10,058 cases detected on Monday. The figure for Tuesday was the lowest weekday daily caseload in over a week. The positive test rate also dropped to 9.2%, having reached 10.2% on Monday.
Picture the familiar double helix of human DNA — a long, twisted ladder with 3 billion rungs on it, each made of a pair of genetic bases (A, T, C, and G). A mistake in just one base along that ladder — an A where there should be a G — can be enough to cause a disease. In fact, researchers have linked over 31,000 different mistakes, known as “point mutations,” to human diseases. Now, an advanced form of gene therapy — called base editing — could make it possible to safely correct them.
Base editing is a type of gene editing technology, just like CRISPR. However, while CRISPR cuts through both strands of the DNA ladder to swap in different genes, a base editor makes precise changes to individual letters along the genome — a much less invasive kind of DNA surgery.
“It’s like your spell-checker,” neuroscientist Jeffrey Holt said. “If you type the wrong letter, spell checker fixes it for you.” Base editing was first developed by Broad Institute researcher David Liu in 2016, and it’s not perfect — the best base editors still make off-target edits and aren’t 100% efficient. However, the technique is more efficient than CRISPR and causes fewer errors, which has made it the focus of considerable research into correcting disease-causing point mutations.
“Base editing is like your spell-checker. If you type the wrong letter, it fixes it for you,” explained Jeffrey Holt. Holt was part of a team that used base editing to partially restore the hearing of mice with a point mutation that causes deafness in people. Earlier in 2020, University of Illinois researchers used base editing to slow the progression of ALS in mice. More recently, Liu was part of a group that used base editing to correct the point mutation that causes progeria, a premature-aging syndrome, in mice. By changing a T to a C in a single gene, they were able to more than double the lifespan of mice with the disease.
There’s no guarantee that a therapy that works in mice will translate to humans (although gene editing is conceptually much simpler than drugs that rely on complex chemistry). To find out whether base editing can live up to its promise as a disease-curing technology, we need human studies — and now, one is just on the horizon.
On January 12, Massachusetts-based biotech company Verve Therapeutics announced the promising results of a study testing a base editing treatment for heterozygous familial hypercholesterolemia (HeFH), a genetic heart disease. HeFH is fairly common, affecting about one in 500 people, and it causes consistently high levels of “bad” cholesterol (LDL-C) — that makes people with the disease susceptible to heart attacks or strokes at a relatively young age. In primates with HeFH, Verve used base editing to change an A to a G in a single gene. Within two weeks, the animals’ blood LDL-C levels had dropped by 59%. Six months later, they were still just as low.The treatment, dubbed “VERVE-101,” was well-tolerated, with no adverse effects reported.
“When we started, we had no idea this would work,” Verve CEO Sekar Kathiresan said in a press release, adding, “It works, and we expect this to be durable for the lifetime of the animals.” Now, Verve wants to find out if VERVE-101 works in humans.
Norway expressed increasing concern about the safety of the Pfizer Inc. vaccine on elderly people with serious underlying health conditions after raising an estimate of the number who died after receiving inoculations to 29. The latest figure adds six to the number of known fatalities in Norway, and lowers the age group thought to be affected to 75 from 80. While it’s unclear exactly when the deaths occurred, Norway has given at least one dose to about 42,000 people and focused on those considered most at risk if they contract the virus, including the elderly.
“There are 13 deaths that have been assessed, and we are aware of another 16 deaths that are currently being assessed,” the agency said. All the reported deaths related to “elderly people with serious basic disorders,” it said. “Most people have experienced the expected side effects of the vaccine, such as nausea and vomiting, fever, local reactions at the injection site, and worsening of their underlying condition.”
Official reports of allergic reactions have been rare as governments rush to roll out vaccines to try to contain the global pandemic. U.S. authorities reported 21 cases of severe allergic reactions from Dec. 14-23 after administration of about 1.9 million initial doses of the Pfizer vaccine. The first Europe-wide safety report on the Pfizer-BioNTech vaccine is due to be published at the end of January. Until Friday, the vaccine produced by Pfizer and BioNTech SE was the only one available in Norway, and “all deaths are thus linked to this vaccine,” the Norwegian Medicines Agency said in a written response to Bloomberg on Saturday.