Shortcuts for vaccine can risk large number of people: AIIMS Director - The Daily Guardian
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Shortcuts for vaccine can risk large number of people: AIIMS Director

All India Institute of Medical Sciences Director Dr Randeep Guleria talks to The Daily Guardian about the status of ongoing vaccine trials at AIIMS, how important it is to follow proper guidelines during trials, and his concerns about Russia’s new vaccine claims.

Shalini Bhardwaj

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All India Institute of Medical Sciences Director Dr Randeep Guleria talks about the status of ongoing vaccine trials at AIIMS, how important it is to follow proper guidelines during trials, and his concerns about Russia’s new vaccine claims.

Q. Why is India experiencing a spike in Covid-19 cases?

A. Our numbers are high because the population is also large. But if you look at cases per million of the population, then the numbers are not that high. Right now, in smaller towns and states like Bihar, Uttar Pradesh and Karnataka, there is an increase in cases, but this will flatten gradually and show a downward trend.

Q. When do you think the graph will start declining?

A. It depends on how the virus behaves. If everyone maintains physical distancing, hand-washing, wearing masks and getting themselves tested as soon as they have symptoms, then this will happen much earlier. But since the lockdown lifted, people have started moving around, not wearing masks, not physically distancing — if this continues, then the cases will continuously increase because then people are allowing the virus to spread.

Q. Many scientists and doctors are uneasy with Russia’s vaccine and have questioned it. Do you think it may put people at risk?

A. Whenever you have a vaccine, there are two very important things: One is safety and the other is efficacy. If we look at safety, then it is quite short-term. This means any immediate reaction can occur early, within 24 to 48 hours, while some can occur later on. We also know vaccines which lead to neuro-related problems, while there are some reactions which occur with the infection. So, it has been shown that sometimes you get the vaccine-dependent enhancements that you have been vaccinated for but when you get Covid-19, immunity isn’t that high and it actually leads to a more severe infection. So, whenever you talk of a vaccine, you have to be sure that there won’t be long-term or short-term side effects and that there are no vaccine-related side effects with the infection. Because you are going to administer it to a large number of healthy people, it will be very unethical if you cause all those people to get a severe disease or the side effects of the vaccine, rather than safety from the disease. Safety is very important and one should also have good safety data. People are worried now because there is no data published by Russia or reviewed by WHO or any other international agency, which can say that there is good safety data as far as the vaccine is concerned. Secondly, how effective is the vaccine? Is it creating immunity which is longlasting or short-lasting, is it just for a few weeks or a month or a few years? That data is also not there. They should share this data with the world. If they have data on safety and efficacy, then it is a good thing. But without the data, people will obviously get worried, especially because in other vaccines, the data has been shared globally and is available in the public domain. This should also be made available in the public domain so that people can see, analyze and feel comfortable about the vaccine.

Q. What results have been seen in the vaccine trials at AIIMS? What stage have the ongoing trails reached?

A. The Bharat Biotech vaccine is already in the second phase. Initial signals are good and safe, but we have to wait for 28 days to see the safety and immunogenicity of people undergoing the trials. But a number of patients have received their second dose and they are being followed up. This has been done in multiple sites. So far, ten groups of people have been followed up but then the numbers will increase when we see the results after 28 days. So, you will get some data within the next few weeks.

Q. What kind of reactions have been noticed in people during the trials?

A. Some people had a reaction where the injections had been given. Other than that I don’t think that there are any serious reactions, which is why it is being continued now with the second dose and the follow-up.

Q. What about the Mycobacterium W (Mw) drug trials which were started in AIIMS before Covaxin trials?

A. Mw is also for immunity. There is some data which suggests that it may be helpful in treating Covid-19 or for improving immunity in severe Covid-19 infections. That study has also been conducted on different groups of patients, one for mild cases and another on serious patients. This is the drug which is being marketed by Cadila, whose trials are being conducted together with CSIR.

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Difficult conversation about death with children: The dos and don’ts

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‘A child asked her grandmother when her mother would return. The grieving grandmother told her that her mother had gone to heaven and became a star. She will watch her from there.’ All of us at some point in our childhood would have been told a story such as this. The intention of the grandmother is none else than to comfort the child. Won’t it be easier to look up at the sky and remember her mother? or believe she is safe with God.

But what really happens when you use euphemisms like ‘gone to a better place’ or ‘gone to heaven’. Usage of such terms can be very confusing for children and sometimes scary too! They may struggle to understand how heaven might be better than being with them, why did their loved one leave, how do you become a star?

As such children may experience intense feelings of anxiety, sadness, guilt, anger etc. on losing a loved one. They themselves may be struggling with their feelings and more often than not they look to the other caregivers for guidance and support. In these moments, not openly sharing about the loss or telling them how they should be strong and try to move on can prove to be very damaging for the child. Unaddressed feelings of grief can lead to development of anxiety, depression and even cause post-traumatic disorder in children.

How we talk about death and conversations around it, can therefore go a long way in determining how our children cope with their grief. The words you choose will have to depend on the emotional maturity and development of your child. But there are some basic guidelines that medical experts outline which should be applied when having a conversation with a child about loss.

To begin with, there is no right time to inform a child about the loss. Children should be informed sooner than later lest they find out on their own which can throw them into an emotional spiral. The person who talks to the child about the loss should be someone who they are close to, like the primary caregiver or if the person is grieving and not in a position to talk, then the next person the child is attached to. Talking about loss can be a difficult conversation and requires all the love and attention of the person breaking the news.

When talking about loss, first assess their understanding of loss. Different age groups perceive death and loss, differently. For a toddler it may be a temporary loss with the expectation of seeing the caregiver after sometime. For a younger child, death may mean something more permanent and can therefore generate a strong sense of loss and sadness.

Avoid using euphemisims like ‘passed away’ or ‘gone to sleep’ when talking about loss. Children tend to focus on words literally and using unreal words and telling stories about what happened to their loved one, can leave them wondering, confused and anxious. They might also feel that death is not permanent and their loved one may come back. It is therefore important to use real words like ‘death’, and ‘dying’ and state exactly what happened in order to prepare them for real life situation and help them cope better with their feelings.

Talk to your child in age-appropriate language while talking about the loss. As per medical experts, younger children within the age range of 2-5 years, can be explained about death in simple words. For instance, you can let them know that when a person dies, their body stops working- that means the heart does not beat and they do not breathe. For older children in the age range of 6-9 years, a caregiver can add more information and explain with what they might relate. For instance ‘every organism has a life cycle. Humans also have a life cycle. You are born, you die and in between you live.’

Children may get curious and ask questions repeatedly. Respond to the questions honestly, openly and with patience. Share with them, what you think is relevant for their age and do not overwhelm the child with facts and description. It can make the loss scary, and result in feelings of anxiety.

Children may struggle with their emotions as you talk about the loss. Encourage them to express their feelings and let them know it’s ok for them to cry. Avoid telling them how they should or should not feel. There are no rules to grieving. Acknowledging their feelings and letting them express is the first step to healing.

Some children may also carry the guilt, if they believed they were in any way responsible for the death of their loved one. For instance, if they said something hurtful to their grandmother after which she died. Let them know it’s not their fault.

More importantly, as you have this most difficult conversation, mindfully listen to your child’s responses and reactions and be available to support them. Be open about your feelings and reassure the child that you are taking care of yourself and that you are going to be with them and keep them safe.

As adults, when we lose a loved one, we struggle with our emotions. For a child it’s even harder as they are still in the process of developing their emotional and cognitive skills and are therefore not as equipped to navigate through the torrent of emotions they may experience on losing a loved one. Having an open conversation about the loss can support your child to cope better with the loss and prevent it from turning into a traumatic experience.

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PROMISING OVARIAN CANCER TREATMENT PROVES BOTH EFFECTIVE, EFFICIENT

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Preclinical trials of a new radiopharmaceutical to treat ovarian cancer have produced successful results, dramatically limiting tumour growth and decreasing tumour mass. Designed specifically for ovarian cancers that are resistant to traditional therapies, the new radiopharmaceutical can be produced in 25 minutes at a low cost, which leads to better efficiency compared with alternative methods.

This research was presented at the Society of Nuclear Medicine and Molecular Imaging 2021 Annual Meeting. According to the American Cancer Society, more than 20,000 women are diagnosed with ovarian cancer each year and nearly 14,000 will die from the disease. Ovarian cancer patients have a five-year survival rate of 49.1 per cent. It is the fifth leading cause of cancer-related death among women.

In the study, researchers utilized a new generator system to develop the targeted alpha-therapy Pb-214-TCMC-trastuzumab to treat HER2-positive ovarian cancer. Ovarian cancer cells and mice bearing ovarian cancer tumours were split into three groups: those treated with Pb-214-TCMC-trastuzumab, those treated with Pb-214-TCMC-IgG and an untreated control group. All groups were imaged over time to determine the effectiveness of the treatment. Compared to the Pb-214-TCMC-IgG and control groups, the tumour signal for mice and cells treated with Pb-214-TCMC-trastuzumab decreased dramatically over the course of the study, signalling the efficacy of the therapy. There were no adverse side effects from the treatment as determined by the weight loss of all animals surviving.

“The short 27-minute half-life of Pb-214 is ideal for fractioned alpha particle therapeutic applications,” stated Mike Zamiara, study author and president of Niowave Inc. in East Lansing, Michigan. “The generator system can provide Pb-214 every hour, potentially providing a new source of alpha-particle therapy to patients at a lower cost. In the future, the generator system will be available for many therapeutic products in a turn-key system under development, providing reliable doses for improved patient care.”

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Study examines the effects of corona on human kidney cells

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Researchers have studied human kidney cells in the lab to examine the effects of COVID-19 on kidney health. The findings appear in an upcoming issue of the Journal of the American Society of Nephrology (JASN). Many individuals who develop COVID-19 also experience kidney damage, but it’s unclear if this is a direct result of viral infection or a consequence of another condition or the body’s response to the infection. To investigate, a team led by Benjamin Dekel, MD, PhD (Sheba Medical Center, in Israel) cultivated human kidney cells in lab dishes and infected them with the virus that causes COVID-19. The researchers found that although the virus that causes COVID-19 could enter, infect, and replicate in human adult kidney cells, this did not typically lead to cell death.

Prior to infection, the cells contained high levels of interferon signalling molecules, and the infection stimulated an inflammatory response that increased these molecules. In contrast, infection of kidney cells deficient in such molecules resulted in cell death, suggesting a protective effect. The cells in these experiments were grown as a three-dimensional spheroid that imitates the healthy kidney or as a two-dimensional layer that mimics the cells of an acutely injured kidney. Cells that mimicked an acutely injured kidney were more prone to infection and additional injury but not cell death.

“The data indicate that it is unlikely that the virus is a primary cause of acute kidney injury seen in COVID-19 patients. It implies that if such injury takes place in the kidney by any cause, the virus might jump on the wagon to intensify it. Therefore, if we’re able to limit the common scenario of acute kidney injury in the first place, then there might be the possibility to minimize the potential damage caused by the virus,” Dr Dekel explained.

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Radiotracer effective for detection and assessment of lung fibrosis

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Positron emission tomography (PET) using a 68Ga-labeled fibroblast activation protein inhibitor (FAPI) can noninvasively identify and monitor pulmonary fibrosis, according to research presented at the Society of Nuclear Medicine and Molecular Imaging 2021 Annual Meeting.

By binding to activated fibroblasts present in affected lungs, FAPI-PET allows for direct imaging of the disease process. Idiopathic pulmonary fibrosis (IPF) causes substantial scarring to the lungs, making it difficult for those impacted to breathe. It is a significant cause of morbidity and mortality in the United States, with more than 40,000 deaths annually.A major challenge in the diagnosis and treatment of IPF is the lack of a specific diagnostic tool that can noninvasively diagnose and assess disease activity, which is crucial for the management of pulmonary fibrosis patients.“CT scans can provide physicians with information on anatomic features and other effects of IPF but not its current state of activity. We sought to identify and image a direct noninvasive biomarker for early detection, disease monitoring and accurate assessment of treatment response,” said Carolina de Aguiar Ferreira, PhD, a research associate at the University of Wisconsin-Madison in Madison, Wisconsin.

In the study, researchers targeted the fibroblast activation protein (FAP) that is overexpressed in IPF as a potential biomarker. Two groups of mice–one group with induced pulmonary fibrosis and one control group–were scanned with the FAPI-based PET/CT radiotracer 68Ga-FAPI-46 at multiple time points. Compared to the control group, the mice with induced pulmonary fibrosis had much higher uptake of the radiotracer, allowing researchers to successfully identify and evaluate areas of IPF. “Further validation of 68Ga-FAPI-46 for the detection and monitoring of pulmonary fibrosis would make this molecular imaging tool the first technique for early, direct, and noninvasive detection of disease. It would also provide an opportunity for molecular imaging to reduce the frequency of lung biopsies, which carry their own inherent risks,” noted Ferreira. “This development will demonstrate that functional imaging can play an invaluable role in the evaluation of the disease process.”Abstract 10.

“Targeting Activated Fibroblasts for Non-invasive Detection of Lung Fibrosis,” Carolina Ferreira, Zachary Rosenkrans, Ksenija Bernau, Jeanine Batterton, Christopher Massey, Alan McMillan, Nathan Sandbo, Ali Pirasteh and Reinier Hernandez, University of Wisconsin – Madison, Madison, Wisconsin; and Melissa Moore, Frank Valla and Christopher Drake, Sofie Biosciences, Dulles, Virginia.

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COVID-19 LINKED TO ALZHEIMER’S DISEASE-LIKE COGNITIVE IMPAIRMENT

Reports of neurological complications in Covid-19 patients and ‘long haulier’ patients whose symptoms persist after the infection clears are becoming more common, suggesting that SARS-CoV-2 may have lasting effects on brain function.

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A new Cleveland clinic-led study has identified mechanisms by which COVID-19 can lead to Alzheimer’s disease-like dementia.The findings, published in Alzheimer’s Research and Therapy, indicate an overlap between COVID-19 and brain changes common in Alzheimer’s and may help inform risk management and therapeutic strategies for COVID-19-associated cognitive impairment. Reports of neurological complications in COVID-19 patients and ‘long haulier’ patients whose symptoms persist after the infection clears are becoming more common, suggesting that SARS-CoV-2 (the virus that causes COVID-19) may have lasting effects on brain function.

However, it is not yet well understood how the virus leads to neurological issues. “While some studies suggest that SARS-CoV-2 infects brain cells directly, others found no evidence of the virus in the brain,” says Feixiong Cheng, PhD, assistant staff in Cleveland Clinic’s Genomic Medicine Institute and lead author on the study. “Identifying how COVID-19 and neurological problems are linked will be critical for developing effective preventive and therapeutic strategies to address the surge in neurocognitive impairments that we expect to see in the near future.” In the study, the researchers harnessed artificial intelligence using existing datasets of patients with Alzheimer’s and COVID-19. They measured the proximity between SARS-CoV-2 host genes/proteins and those associated with several neurological diseases where closer proximity suggests related or shared disease pathways. The researchers also analyzed the genetic factors that enabled SARS-COV-2 to infect brain tissues and cells.

While researchers found little evidence that the virus targets the brain directly, they discovered close network relationships between the virus and genes/proteins associated with several neurological diseases, most notably Alzheimer’s, pointing to pathways by which COVID-19 could lead to Alzheimer’s disease-like dementia. To explore this further, they investigated potential associations between COVID-19 and neuroinflammation and brain microvascular injury, which are both hallmarks of Alzheimer’s.“We discovered that SARS-CoV-2 infection significantly altered Alzheimer’s markers implicated in brain inflammation and that certain viral entry factors are highly expressed in cells in the blood-brain barrier,” explained Dr Cheng. “These findings indicate that the virus may impact several genes or pathways involved in neuroinflammation and brain microvascular injury, which could lead to Alzheimer’s disease-like cognitive impairment.”

The researchers also found that individuals with the allele APOE E4/E4, the greatest genetic risk factor for Alzheimer’s, had decreased expression of antiviral defence genes, which could make these patients more susceptible to COVID-19. “Ultimately, we hope to have paved the way for research that leads to testable and measurable biomarkers that can identify patients at the highest risk for neurological complications with COVID-19,” said Dr Cheng. Dr Cheng and his team are now working to identify actionable biomarkers and new therapeutic targets for COVID-19-associated neurological issues in COVID long-hauliers using cutting-edge network medicine and artificial intelligence technologies.

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No health worries for children born to mothers given seasonal flu vaccine in pregnancy

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Correspondent,Ottawa

A population-based study, published in the Journal of the American Medical Association (JAMA), has found flu vaccination during pregnancy does not lead to an increased risk of adverse early childhood health outcomes.

Although pregnant people are not more susceptible to acquiring influenza infection, they are at an increased risk of severe illness and complications if they get the flu during pregnancy. For this reason, all pregnant people are advised to receive a flu shot each year, yet only 36% received it according to a study monitoring four flu seasons in Nova Scotia. Safety concerns are reportedly a leading reason women may not receive influenza vaccination in pregnancy.

Dr Deshayne Fell, an Associate Professor of Epidemiology in the Faculty of Medicine at the University of Ottawa and a Scientist at the CHEO Research Institute, a pediatric healthcare and research centre, led the study along with researchers in Ontario and at Dalhousie University in Nova Scotia. The study followed over 28,000 children from birth up to an average age of 3.5 years, with the results suggesting that maternal influenza vaccination during pregnancy was not associated with:

– Immune-related health conditions, such as asthma, ear infections or other types of infection.

– Non-immune-related health problems like neoplasms, sensory impairment.

– Nonspecific health needs such as Emergency Department visits and hospitalisations did not increase.

“This study adds to what we know from other recent studies showing no harmful effects of flu vaccination during pregnancy on the long-term health of children,” says Dr Fell, whose other recent work includes studying the effectiveness and safety of Covid-19 vaccines during pregnancy.

She added, “This is important because we know that getting the flu shot during pregnancy not only protects the pregnant person but has the added bonus of protecting newborn babies from getting the flu during their first few months of life, which is when they are most susceptible to respiratory infections but still too young to get the flu shot themselves.”

The study, Association of Maternal Influenza Vaccination During Pregnancy with Early Childhood Health Outcomes, is published in JAMA.

With ANI inputs

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