Study: Pfizer Covid pill showed no benefit in younger adults

Study: Pfizer Covid pill showed no benefit in younger adults


Pfizer’s Covid-19 pill appears to provide little or no benefit for younger adults, while still reducing the risk of hospitalization and death for high-risk seniors, according to a large study published Wednesday.

The results from a 109,000-patient Israeli study are likely to renew questions about the U.S. government’s use of Paxlovid, which has become the go-to treatment for Covid-19 due to its at-home convenience. The Biden administration has spent more than $10 billion purchasing the drug and making it available at thousands of pharmacies through its test-and-treat initiative.

The researchers found that Paxlovid reduced hospitalizations among people 65 and older by roughly 75 per cent when given shortly after infection. That’s consistent with earlier results used to authorize the drug in the U.S. and other nations.

But people between the ages of 40 and 65 saw no measurable benefit, according to the analysis of medical records.

Changing nature

The study has limitations due to its design, which compiled data from a large Israeli health system rather than enrolling patients in a randomized study with a control group — the gold-standard for medical research.

The findings reflect the changing nature of the pandemic, in which the vast majority of people already have some protection against the virus due to vaccination or prior infection. For younger adults, in particular, that greatly reduces their risks of severe Covid-19 complications. The Centers for Disease Control and Prevention recently estimated that 95 per cent of Americans 16 and older have acquired some level of immunity against the virus.

“Paxlovid will remain important for people at the highest risk of severe Covid-19, such as seniors and those with compromised immune systems,” said Dr. David Boulware, a University of Minnesota researcher and physician, who was not involved in the study. “But for the vast majority of Americans who are now eligible, this really doesn’t have a lot of benefit.” A spokesman for Pfizer declined to comment on the results, which were published in the New England Journal of Medicine.

Authorisation

The U.S. Food and Drug Administration authorised Paxlovid late last year for adults and children 12 and older who are considered high risk due to conditions like obesity, diabetes and heart disease. More than 42 per cent of U.S. adults are considered obese, representing 138 million Americans, according to the CDC.

At the time of the FDA decision, there were no options for treating Covid-19 at home, and Paxlovid was considered critical to curbing hospitalizations and deaths during the pandemic’s second winter surge. The drug’s results were also far stronger than a competing pill from Merck.

The FDA made its decision based on a Pfizer study in high-risk patients who hadn’t been vaccinated or treated for prior Covid-19 infection.

“Those people do exist but they’re relatively rare because most people now have either gotten vaccinated or they’ve gotten infected,” Boulware said.

Yet to be published

Pfizer reported earlier this summer that a separate study of Paxlovid in healthy adults — vaccinated and unvaccinated — failed to show a significant benefit. Those results have not yet been published in a medical journal.

More than 3.9 million prescriptions for Paxlovid have been filled since the drug was authorized, according to federal records. A treatment course is three pills twice a day for five days.

A White House spokesman on Wednesday pointed to several recent papers suggesting Paxlovid helps reduce hospitalizations among people 50 and older. The studies have not been published in peer-reviewed journals.

“Risk for severe outcomes from Covid is along a gradient, and the growing body of evidence is showing that individuals between the ages of 50 and 64 can also benefit from Paxlovid,” Kevin Munoz said in an emailed statement.

Administration officials have been working for months to increase use of Paxlovid, opening thousands of sites where patients who test positive can fill a prescription. Last month, U.S. officials further expanded access by allowing pharmacists to prescribe the drug.

The White House recently signaled that it may soon stop purchasing Covid-19 vaccines, drugs and tests, shifting responsibility to the private insurance market. Under that scenario, insurers could set new criteria for when they would pay for patients to receive Paxlovid.

Published on

August 25, 2022



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BioAsia 2023 to be held in February 24-26

BioAsia 2023 to be held in February 24-26


Hyderabad, August 24

The 20 th edition of BioAsia, the marquee life sciences and health tech event, hosted by the Government of Telangana, will be conducted from February 24-26, 2023.

Minister for Industries and Commerce, KT Rama Rao, has launched the logo and the theme “Advancing for ONE: Shaping the next generation of humanized healthcare” of BioAsia 2023.

A major hub

Over the past couple of decades, Hyderabad has established itself as not only the healthcare and life sciences hub for India but has also emerged as a major hub for the world. The city further burnished its credentials during the Covid-19 pandemic by playing a key role in helping immunize the world through supply of vaccines.

“As the world has begun to come back to normalcy, we are geared to host the next year’s grand event in-person and host a galaxy of world leaders in Hyderabad. The event has truly evolved over the years as a pre-eminent global meeting for researchers, academia, industry, healthcare providers and policy makers to discuss collaborative opportunities,’‘ the Minister said.

About the event

According to Shakthi Nagappan, CEO, BioAsia and Director (Life Sciences), Government of Telangana, Bio Asia 2023 will bring together life sciences and healthcare leaders, academia, start-ups, regulators and investors, on one stage to deliberate on the cross-cutting themes of One Health, disruptive technologies in health, and accessibility and affordability in healthcare for all. 

The event will also have a start-up showcase where over 100 select health-tech entrepreneurs from across the world can pitch their innovative solutions to pressing health issues, he added. 

BioAsia 2022 was extremely successful with virtual participation of about 37,500 delegates from about 70 countries. 

Published on

August 24, 2022



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Surreal gardens of glowing plants

Surreal gardens of glowing plants


Wouldn’t you like to have your own fairyland in your backyard — a garden in which the leaves and flowers glow in darkness? If you do, help is at hand.

Engineering plants with auto-luminescence — glow in darkness — has been the quest of scientists for some time. In the recent past, notable success has been achieved.

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But how is it possible to make plants emit light? One simple way, with which scientists experimented initially, is to take the genes responsible for the glow in fireflies and inject them into plants. But there seem to be other methods too.

Scientists from the Institute of Bioorganic Chemistry, Russian Academy of Sciences, Moscow, produced through biosynthesis a fungal luciferin, a compound that produces a glow in luminescent fungi. These fungi use a compound called caffeic acid (not to be confused with caffeine) to achieve bioluminescence. Four enzymes act on caffeic acid to produce luciferin.

Now, caffeic acid is present in plants. The scientists genetically engineered plants to relocate some of the caffeic acid to the fungi, and allowed the fungi to do the job.

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More recently, researchers at MIT, USA, have developed plants that glow in the dark and produce light all night, by embedding them with nanoparticles that absorb light during the day and release it when it gets dark. They took a compound called strontium aluminate, gave it a protective coat of silica, and embedded it into the stomata or pores on the surface of leaves. Strontium aluminate is a ‘phosphor’ — a material that can absorb light or ultraviolet radiation and release it during the night. The scientists say that it is possible to bring in glowing plants that provide not just a fun-glowbut also actual lighting.





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A toothy solution for stem cell harvesting

A toothy solution for stem cell harvesting


The bone marrow has till now been the single most common source of stem cells. However, other sources such as the umbilical cord or adipose tissue are being tapped too. Dr Geetanjali Tomar, scientist at Savitribai Phule Pune University, has been interested in the use of gingival cells (cells from oral gum tissue) in regenerative, or stem cell therapy since her PhD student days. In 2010, she co-authored a paper that, for the first time, highlighted the possibility of using gingival stem cells.

Her most recent paper appeared this year in June in  Science Advances, the journal published by the American Association for Advancement of Science, in which she and her co-authors show that, irrespective of the age of the donor, stem cells from gingival tissue help regenerate neuronal cells [or nerve cells]. This finding, she says, could eventually help in the treatment of nerve-related disorders such as Parkinson’s and Alzheimer’s.

Why gingiva? Dr Tomar says, “It is very difficult to extract cells from the bone marrow. These would come from the knee cap of a donor who may not be healthy and is likely afflicted with arthritis or some such condition related to the bone.”

Plus, the recovery time after extraction of bone marrow tissue is more compared with that for gingival tissue.

“Extracting bone tissue is a highly invasive procedure. Gingiva offers no such complication. Anyone can donate gingival tissue and the healing time is about 7-10 days.”

Age no bar

Dr Tomar and her research team collaborated with Deenanath Mangeshkar Hospital and Research Centre in Pune to collect gum tissue from otherwise healthy patients undergoing root canal treatment, teeth extraction or crown implants. In lab conditions, the team discovered that the growth of the stem cell culture was uniform, irrespective of the donor’s age. Samples from even an 80-year-old showed normal growth. Typically, with age, stem cells tend to develop tumours over time. This was not observed in the lab growth derived from gingival tissue.

However, when the stem cells were induced to develop osteoblasts or bone cells, or adipose tissue, the ability declined with the increasing age of the donor. Only in the regeneration of neuronal cells, stem cells derived from gingival tissue were uniformly effective, despite age differences.

Use of stem cells in regenerative therapy

Stem cells are the basic building blocks that help generate other cells — which could either be stem cells or other specialised cells for specific functions, such as blood cells, nerve cells, bone cells or heart muscle cells.

In the treatment of cancer, an infusion of stem cells from a donor or from oneself has shown promise.

Cancer is a disease that kills numerous cells in a short period of time. To negate the effect of cancer, stem cells perform the critical function of regenerating healthy cells to replace the damaged ones.

Stem cell therapy was first tried in 1958 by French oncologist Georges Mathé, who performed the first bone marrow graft to help save six Yugoslavian nuclear researchers who had been accidentally irradiated.

Stem cells are useful not just in cancer treatment but also in understanding how diseases occur and affect the body, and in testing new drugs, according to the Mayo Clinic website.

Stem cells can be derived from embryos, bone marrow, fat tissue or perinatal fluids such as umbilical cord blood.

And how did the team track this? Dr Tomar says that in bone cells the level of calcium and phosphate keeps rising with the creation of new cells, while in adipose tissue the stem cells become filled with fat globules, which were monitored.

In the paper published this year, the team suggested that these stem cells likely retained their neuronal differentiation ability [to turn into nerve cells of different types). They also said that an autologous stem cell therapy (treatment using one’s own stem cell) for age-related neurodegenerative diseases such as Parkinson’s and Alzheimer’s would be ideal.

Allogeneic therapy involves the use of donated stem cells. “In autologous therapy, chances of rejection of cells or other complications associated with allogeneic transplantation can be avoided,” she says.

Covid-19 treatment

Interestingly, the team expanded the experiment to see if stem cell-induced regeneration can help reverse lung damage due to Covid-19 infection. Some studies in Japan as well as Korea used samples from stem cell banks to show that regenerative therapy worked in Covid-19 patients. “Those studies were preliminary, so we expanded our study to review results with stem cells derived from gingiva in autologous therapy for Covid-19 patients.”

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The team injected mice with lipopolysaccharides (LPS), which are bacterial cell wall components that replicate bacterial infection. Once LPS populated the lungs of the mice, immune system cells went into overdrive to get rid of them.

Though the team did not inject mice with the Covid-19 virus, the approach helped replicate the inflammation caused in lungs.

(The team separated the mice into two groups and treated one with gingival stem cells.)

The mice that were not injected with stem cells showed up to 60 per cent lung damage within 5-6 days. “There was bleeding and clotting inside the lung tissues” says Dr Tomar. “Though the inflammatory response did not go down significantly for the group that was administered stem cells, the degeneration in the lungs was less by 50-60 per cent.”

Significantly, the age of the donor — be they young, middle-aged, or old — did not matter. “Tissues from all age groups of donors were able to reduce the damage.”

The team measured improvement in lung condition across eight parameters including presence of blood clots and fibroids, and the infiltration of immune cells into the lungs.

Though the team studied the results for four days, it suggests 2-3 rounds of stem cell administration for significant improvement in Covid-19 patients.

Published on

August 21, 2022



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Solar cell with 24.8% efficiency?

Solar cell with 24.8% efficiency?


In the world of solar photovoltaic cells, even a single point change to the right of the decimal is big. With conventional solar cells, you’d be lucky if you convert 20 per cent of the light energy that falls on them into electric energy. The number is said to be better with perovskite solar cells, which are made with materials in which atoms are arranged in a particular manner. But perovskite cells are not stable, so they don’t last long. Research is afoot globally to produce a stable perovskite solar cell that is economically viable.

Now a group of Chinese researchers have claimed they have produced a perovskite solar cell with an efficiency of 24.8 per cent. In a paper published in the  Joule magazine, Hao Huang et al credit it to “ligand-engineered deposition strategy”. They claim to have achieved “an impressive power conversion efficiency of 24.8 per cent with a fill factor (a measure of the quality of the module) of 0.83”. But what of stability? They “can maintain 95 per cent of initial efficiency on exposure to ambient air for 2,000 hours”.

Gallium from fly ash

Fly ash from coal-fired power plants is a nuisance and disposing of it safely is a challenge. Some fly ash goes into manufacturing bricks, but that is very little.

Now, the Indira Gandhi Centre for Atomic Research and the Bhabha Atomic Research Centre claim they could determine the concentration of gallium — a metal with wide applications in strategic fields such as communications and satellite broadcast — in fly ash.

In a paper published in  Applied Radiation and Isotopes, Manish Chant et al say the gallium content in the fly ash samples of the bituminous coal collected from south-central and eastern India was found to be 17.2-47.9 mg/kg while it was 6.3–33.3 mg/kg for samples of lignite coal collected from south-central and western India. The researchers used a technique called ‘neutron activation analysis’ (bombarding a material with neutrons to convert some atoms into radioactive materials). The samples of coal ash “proved to be a potential source of gallium,” the paper says.

Stronger, lighter concrete

Scientists at the Department of Civil Engineering, Visvesvaraya National Institute of Technology (VNIT), Nagpur, have developed a modular toilet unit cast with geopolymer concrete (GPC), incorporating industrial wastes. In a paper published in  Case Studies in Construction Materials, Sandeep Tembhurkar et al say the toilets are easy to install, scalable and durable.

The density of GPC is 92.9 per cent of the density of conventional concrete, which makes it lighter and easier to install. The compressive strength is 32MPa, which is 148.6 per cent higher than conventional units. Flexural strength is 209 per cent higher with the use of crushed sand in wall panels, slab, and foundation, and steel fibres in wall panels. Water absorption is 86.6 per cent of that in conventional units.

The central and state governments provide assistance of about ₹14,000 per toilet unit under the Swachh Bharat Abhiyan programme. With GPC there is savings of about ₹1,600 per toilet, the paper says.

Published on

August 21, 2022



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