Following the breakthroughs in the race to deliver a coronavirus vaccine reported by Pfizer-BioNTech and then Moderna, the University of Oxford expects to release data on the efficacy of its own candidate in the coming weeks, with the latest trial results published in The Lancet suggesting it produces a strong immune response in older adults.
Developed jointly with global pharma giant AstraZeneca, who have enlisted manufacturing partners in different parts of the world, the ChAdOx1 nCov-2019 vaccine – it's a working title - is the one most likely to play a large role in any large or medium-scale vaccination effort in Bangladesh.
Phase 2 data published in The Lancet on Wednesday suggests one of the groups most vulnerable to serious illness and death from Covid-19 could “build immunity” on the ‘Oxford vaccine’, as it is more fondly known.
The vaccine has been shown to trigger a robust immune response in healthy adults aged 56-69 and over 70.
According to the researchers, the trial demonstrated similar immune responses across all three age groups – 18-55, 56-69, and 70 and over.
Upon closer scrutiny, the study of 560 healthy adults, including 240 over the age of 70, found, interestingly, that the vaccine is better tolerated in older people than in younger adults.
Volunteers received two doses of the vaccine candidate or a placebo meningitis vaccine. No serious adverse health events related to the vaccine were seen in the participants.
In an interview Thursday with the BBC, Prof Andrew Pollard, one of the leaders of the Oxford Vaccine Group, said research was slowed by low infection rates over the summer, but the Phase III trials are now accumulating the data needed to report results as a renewed surge of the pandemic hits countries around the world.
“I think we’re getting close, and it’s definitely going to be before Christmas based on the progress,” he said.
Three vaccine candidates – from Pfizer-BioNTech, Moderna and Russia’s Sputnik- have already reported good preliminary data from phase three trials, each topping 90% in early efficacy readings. Public health experts have been willing to accept efficacy as low as 50%.
The Oxford data is from an earlier stage, which tests the safety of the vaccine and the body's response to it, but in the long run it's likely this vaccine could be easier to roll out because it doesn't need to be stored at very cold temperatures – as has been reported about the Pfizer and Moderna shots.
Maintaining the cold chain for coronavirus vaccines won’t be easy even in the richest of countries, especially when it comes to those that require ultracold temperatures of around minus 70 degrees Celsius (minus 94 F).
Earlier this month, Bangladesh entered into a deal with the Serum Institute of India (SII) to acquire 30 million doses of the potential vaccine being developed by AstraZeneca for Covid-19.
SII and Bangladesh’s own pharmaceutical giant, Beximco Pharma, signed a Memorandum of Understanding (MoU) for “priority delivery of the vaccine doses”.
Once the deal is activated following final approval of the vaccine, Beximco will purchase five million doses of the vaccine per month to distribute in Bangladesh – although under what type of scheme is still unclear.
SII will supply the vaccine at a price of around $4 to $5 per dose, a rate similar to what India pays. It partnered with AstraZeneca, the Gates Foundation and the Gavi vaccine alliance to produce over a billion doses of Covid-19 vaccine(s) for supply worldwide.
The latest data
As reported by the UK’s state news agency, the Press Association, Dr Maheshi Ramasamy, an investigator in the Oxford Vaccine Group and a consultant physician, said: “Older adults are a priority group for Covid-19 vaccination, because they are at increased risk of severe disease, but we know that they tend to have poorer vaccine responses.
“We were pleased to see that our vaccine was not only well tolerated in older adults, but also stimulated similar immune responses to those seen in younger volunteers. The next step will be to see if this translates into protection from the disease itself.”
Researchers say their findings are promising as they show that older people are having a similar immune response to younger adults.
Ramasamy added: “The robust antibody and T-cell responses seen in older people in our study are encouraging. The populations at greatest risk of serious Covid-19 disease include people with existing health conditions and older adults. We hope that this means our vaccine will help to protect some of the most vulnerable people in society, but further research will be needed before we can be sure.”
The study also found that the vaccine, being developed with AstraZeneca, was less likely to cause local reactions at the injection site and symptoms on the day of vaccination in older adults than in the younger group.
Adverse reactions were mild – injection-site pain and tenderness, fatigue, headache, feverishness and muscle pain – but more common than seen with the control vaccine.
Thirteen serious adverse events occurred in the six months after the first dose was given, none of which were related to either study vaccine.
The authors note some limitations to their study, including that the participants in the oldest age group had an average age of 73-74 and few underlying health conditions, so they may not be representative of the general older population, including those living in residential care settings or aged over 80.
To fight the ever-growing threat from antibiotic-resistant bacteria, Australian researchers developed a therapy containing a repurposed experimental Alzheimer's drug, successfully killing some of the most difficult to treat superbugs.
Released on Thursday, the study, conducted by researchers from The University of Queensland (UQ), the University of Melbourne, and the Griffith University in Australia, used a metal transporting property of the drug called PBT2 to disrupt the antibiotic resistance mechanisms of those bacteria.
"Led by UQ's Dr. David De Oliveira, our team hypothesized that, by using this experimental Alzheimer's treatment to disrupt the metals inside these bacteria, we would also disrupt their mechanisms of antibiotic resistance," Professor Mark Walker from UQ said.
"This was shown to be the case, with the Alzheimer's drug - combined with the antibiotic polymyxin - successfully tackling antibiotic-resistant superbugs like klebsiella pneumoniae, acinetobacter baumannii, pseudomonas aeruginosa and escherichia coli."
The newly discovered use of PBT2 has also raised hope to revive some old antibiotics previously regarded as ineffective to treat infections caused by superbugs.
"Given that we've been able to combine it with the antibiotic polymyxin to treat polymyxin-resistant bacteria, we may be able to make other now-ineffective antibiotics become effective again for treating infectious disease," Professor Mark von Itzstein from the Institute for Glycomics in the Griffith University said.
"This could resharpen, so to speak, some of the weapons we thought we'd lost in our fight against antibiotic-resistant bacteria."
Researchers said the treatment of combining polymyxin with PBT2 had also been proved effective on animal models and they hope the clinical trial would be started in a not-too-distant future as PBT2 had already been found safe to use on humans.
Only four percent of the Covid-19 patients showed signs of a ‘cytokine storm’, with extremely high levels of immune molecules, says a study.
A study of Washington University School of Medicine in St. Louis and St. Jude Children's Research Hospital in Memphis, Tennessee, suggests that only 4 percent of Covid-19 patients had the sky-high levels of immune molecules that signify a so-called "cytokine storm,” reports Xinhua.
The researchers analyzed immune cells and molecules in blood samples from 168 Covid-19 patients, 26 influenza patients and 16 healthy people.
The samples were drawn from influenza patients in 2019 or 2020, and from Covid-19 patients and healthy controls this year. They also collected information about how each patient fared - whether a patient ended up needing intensive care or mechanical ventilation - and whether he or she survived.
The numbers of inflammatory cells in the blood of Covid-19 and influenza patients were about the same. Seven or 4 percent of the Covid-19 patients showed signs of a cytokine storm, with extremely high levels of cytokines even when compared to other severely ill patients.
The majority of the Covid-19 patients with acute respiratory failure not only did not have a cytokine storm, they had less inflammation than influenza patients who were equally ill.
A few clinical trials have shown that some severely ill Covid-19 patients improve on steroid drugs such as dexamethasone that suppress inflammation. The key will be to find a way to identify the people at high risk for a cytokine storm when they first arrive at the hospital.
"The subjects in the cohort with the 'true' cytokine storm phenotype are such outliers immunologically compared to the others, it seems likely that there are significant differences in multiple immune pathways driving this phenotype," said co-senior author Paul Thomas. "If we can identify features of those pathways that can be assessed quickly in a clinical setting, it could be useful for patient stratification."
With cytokine storms largely ruled out, the cause of most cases of respiratory failure in Covid-19 patients remains unknown.
"In the population we studied, 24 percent died but only 4 percent had a cytokine storm," said co-senior author Philip Mudd, an assistant professor of emergency medicine who sees patients at Barnes-Jewish Hospital. "Most people who died of Covid-19 died without a cytokine storm. Severe flu is more inflammatory than severe Covid-19. So, what's causing their lungs to fail? We still don't know. We're trying to find out."
The findings were published Friday in Science Advances.
A study of the University of Michigan (UM) suggested that human-caused noise and light pollution can harm individual species of bird populations.
The researchers looked at a huge collection of data sets to assess how artificial light and human-caused noise affected the reproductive success of 58,506 nests from 142 bird species across North America. They considered several factors for each nest, including the time of year breeding occurred and whether at least one chick fledged from the nest.
The researchers found that light pollution causes birds to begin nesting as much as a month earlier than normal in open environments, such as grasslands or wetlands, and 18 days earlier in forested environments.
The consequence could be a mismatch in timing - hungry chicks may hatch before their food is readily available.
As the planet warms, birds' food is available earlier due to warmer weather. Birds that maintain their historical breeding times because their internal clocks are set to changes in day length may have fewer chicks survive because the food source they rely on already came and went.
These findings suggest two conclusions about birds' responses to climate change. First, at least temporarily, birds in artificially lit conditions may be tracking climate change better than those in dark areas. Second, when scientists thought birds were adjusting their reproductive timing to climate change, birds may have actually been responding to light cues instead, because many studies were done in areas exposed to some light pollution.
The researchers then delved into greater detail for 27 bird species. They found that a bird's ability to see in low light and the pitch of its call were related to the species' responses to light and noise pollution, respectively.
The more light a bird's eye is capable of taking in, the more that species moved its breeding time earlier in the year in response to light pollution and the more that species benefited from light pollution with improved nest success.
Having examined the effects of noise pollution, the researchers found that birds living in forested environments tended to be more sensitive to noise than birds in open environments.
Noise pollution delayed nesting for birds whose songs are at a lower frequency and thus more difficult to hear through low-frequency, human-caused noise. Mating decisions are made based on the male's song, and in some cases, females need to hear the male's song to become physically ready to breed.
These trait- and environment-specific results have strong implications for managing wildlands, according to the researchers.
The study is the first step toward a larger goal of developing a sensitivity index for all North American birds. The index would allow managers and conservationists to cross-reference multiple physical traits for one species to assess how factors such as light and noise pollution would affect each species.
The study is published Wednesday online in the journal Nature.
US health officials have allowed emergency use of the first antibody drug to help the immune system fight COVID-19, an experimental approach against the virus that has killed more than 238,000 Americans.
The Food and Drug Administration on Monday cleared the experimental drug from Eli Lilly for people 12 and older with mild or moderate COVID-19 not requiring hospitalisation. It’s a one-time treatment given through an IV.
The therapy is still undergoing additional testing to establish its safety and effectiveness. It is similar to a treatment President Donald Trump received after contracting the virus last month.
Early results suggest the drug, called bamlanivimab, may help clear the coronavirus sooner and possibly cut hospitalisations in people with mild to moderate COVID-19. A study of it in hospitalised patients was stopped when independent monitors saw the drug did not seem to be helping in that situation.
The government previously reached an agreement to buy and supply much of the early production of Lilly’s drug.
Only one drug -- Gilead Sciences’ remdesivir -- has full FDA approval for treating COVID-19. Government treatment guidelines also back using dexamethasone and other steroids for certain severely ill, hospitalized patients.
One other treatment has an emergency use designation now — convalescent plasma, or the blood of COVID-19 survivors. No large studies have shown it to be more effective than usual care alone, however.
The new drug is part of an emerging family of biologic therapies that offer a promising new approach to preventing serious disease and death from COVID-19. Experts say the infused drugs could serve as a therapeutic bridge to help manage the virus until vaccines are widely available.
The drugs are laboratory-made versions of antibodies, blood proteins which the body creates to help target and eliminate foreign infections. The new therapies are concentrated versions of the antibodies that proved most effective against the virus in patient studies.
Regeneron Pharmaceuticals Inc. also has asked for emergency authorization for an antibody drug it is testing, the one Trump received.
FDA regulators authorised the Lilly drug using their emergency powers to quickly speed the availability of experimental drugs and other medical products during public health crises.
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In normal times the FDA requires “substantial evidence” to show that a drug is safe and effective, usually through one or more large, rigorously controlled patient studies. But during public health emergencies the agency can lower those standards and require only that an experimental treatment’s potential benefits outweigh its risks.
The emergency authorization functions like a temporary approval for the duration of the COVID-19 pandemic. To win full approval, Lilly will have to submit additional research to fully define the drug’s safety and benefit for patients.
The government has signed an agreement with Lilly to spend $375 million to buy 300,000 vials of the drug. How many doses that would provide is unclear. Each vial contains 700 milligrams and that dose proved ineffective in the early results. It took four times that amount — 2,800 milligrams — to show any effect.
The Lilly drug is authorized for people 12 and older who weigh at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions.