DELHI HC SEEKS AFFIDAVITS FROM BHARAT BIOTECH AND SII ON CAPACITY - The Daily Guardian
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DELHI HC SEEKS AFFIDAVITS FROM BHARAT BIOTECH AND SII ON CAPACITY

Shalini Bhardwaj

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Delhi HC

The Delhi High Court has asked Serum Institute of India and Bharat Biotech to disclose the capacity they have to manufacture Covaxin and Covishield vaccines, respectively. A bench of the Delhi High Court comprising Justice Vipin Sanghi and Rekha Palli directed the Centre to explain in its affidavit the reasons behind keeping the vaccination drive strictly under the government’s control. The court directed the oganisations to file the affidavit to clarify the capacities to produce Covisiled and Covaxin per day/week/month. The court said, “We are either donating or selling off the vaccines to other countries without looking at our own needs. There has to be a sense of urgency about this.”

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Research finds breastfeeding is being overtly discouraged by infant formula websites

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Despite public health efforts to support breastfeeding and informed choice, during a news study, an analysis of websites for baby formula manufacturers found that their messages and images discourage breastfeeding while touting the benefits of the formula.

The study, led by researchers at the NYU School of Global Public Health and published in the journal Public Health Nutrition, is the first to compare information and portrayals of breastfeeding with infant formula feeding on manufacturer websites directed at U.S. consumers. “Many factors influence parents’ decision to breastfeed or use formula, including breastfeeding support and work schedules. But we also know that marketing and advertising play a critical role,” said Jennifer Pomeranz, assistant professor of public health policy and management at NYU School of Global Public Health and the study’s lead author. “It is important to understand the messages caregivers are receiving directly from formula companies, whose websites are targeting pregnant women and new parents with marketing claims disguised as feeding advice and support.”

Breastfeeding has many well-documented benefits for infants and mothers. Because breast milk is a complete source of nutrition for babies and can protect them from infections and certain diseases later in life, the U.S. and global health authorities recommend breast milk as the sole source of nutrition during a child’s first six months and encourage continued breastfeeding.

Previous research shows that marketing from formula companies can influence norms and attitudes around infant feeding and may use unsubstantiated health claims to promote formula and diminish confidence in breast milk. To prevent this, the World Health Organization urges countries to ban the marketing of formula to consumers; while the U.S. still allows it, the Surgeon General recommended that infant formula be marketed in a way that does not discourage breastfeeding.

Pomeranz and her colleagues analyzed the websites of three major formula brands that make up 98 per cent of the U.S. market, as well as two organic brands, to compare messages and images about breastfeeding and breast milk with those about infant formula feeding.

The researchers found that substantial messaging on the five formula manufacturers’ websites focused on discouraging breastfeeding. The websites actually contained more messages about breastfeeding or breast milk than formula, but much of the breastfeeding content (40 per cent) focused on challenges, such as having a low supply of breast milk or difficulty latching.

The websites were significantly more likely to mention the benefits of formula (44 per cent)–for instance, statements that formula provides brain and gastrointestinal benefits–than benefits of breastfeeding or breast milk (26 per cent).

Moreover, manufacturers compared formula feeding to breastfeeding, rather than comparing their brands positively to other brands.

Images on the websites also illustrated the benefits of formula–including the ease of feeding, with babies holding their own bottles–while making breastfeeding look difficult and labour intensive.

“Infant formula manufacturers’ repeated communication about breastfeeding problems such as reduced breast milk supply or sore nipples, coupled with images of women holding their breasts to breastfeed, implies that breastfeeding is hard, painful work. These recurring messages may ultimately discourage breastfeeding,” said Pomeranz.

“Even if websites frame their ‘advice’ as providing solutions to the problems identified, it is completely inappropriate for a formula company to disseminate information–let alone negative information–about breastfeeding to new parents and mothers in particular,” added Pomeranz.

The researchers identified other marketing tactics on formula websites, including the use of discounts or coupons, contact information for sales representatives, and claims of health and nutritional benefits of infant formula over breast milk.

“These marketing practices directed towards U.S. consumers would be legally suspect in other countries, many of which follow W.H.O. recommendations and prohibit direct-to-consumer marketing of infant formula,” added Pomeranz.

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NEW INSIGHTS INTO FUNDAMENTAL WORKINGS OF IMMUNE SYSTEM IN RESPONSE TO SKIN CANCER THERAPY

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New research led by the University of Birmingham suggests that skin cancer patients could have a better prognosis if their T cells send messages from five specific genes in their immune response to drugs given to treat the disease.

The research, carried out in mice, cells in the laboratory, and using publicly available data from patients with advanced melanoma before and after treatment with Nivolumab therapy, was published in the journal Immunity. T cells are white blood cells that protect the body from harm from viruses, bacteria, and cancer cells and explore their environments by using their T cell receptor (TCR) to recognise fragments – called antigens – of microbes or damaged cancer cells.

The TCR controls the behaviour of the T cell and can send messages to the T cells’ command centre to kick-start an immune response. This process is important for vaccine research and treatment of autoimmune conditions but is particularly of interest for cancer treatments to improve the anti-tumour function of T cells.

The researchers carried out the study to better understand how the amount of antigen controls how the TCR sends messages to the T cells’ command centre, and how this affects the type of immune response. They wanted to explore how antigen amounts control the expression of so-called ‘immune checkpoints’ that act as brakes on immune responses. It is these immune brakes, such as one called PD1, that are the target of drugs that seek to increase the immune response in cancer immunotherapy.

Lead author Dr David Bending, of the University of Birmingham’s Institute of Immunology and Immunotherapy, explained: “Through our research, we discovered that the amount of antigen determined how many immune checkpoints or immune brakes a T cell had on its cell surface.

“When we exposed T cells to the highest amounts of antigen, they stopped sending signals to their command centre, and this was because they had increased the number of immune brakes, which shut down the messengers. This made these T cells unable to respond to antigens for a period.”

By blocking one of the immune brakes, called PD1, the researchers were able to re-awaken some of these ‘unresponsive’ T cells. They found that these re-awakened T cells not only started sending messages to their command centres, but the messages they sent were louder and clearer.

“The response from the command centre was that the T cells started to increase the number of messages from five specific genes,” added Dr Bending. “By looking for the messages from these five genes, we were able to show that these stronger and louder messages were increased in melanoma patients who survived for longer on drugs that block the immune brake PD1. We think that this means that those cancer patients whose immune cells can send messages from these five genes in response to drugs that target PD1, a good outcome is far more likely.”

The researchers said their finding shows that the immune system likely requires an optimal level of stimulation to mount the most effective immune response in skin cancer patients. Dr Bending added: “Our research gives us an interesting insight into fundamental workings of the immune system. It suggests that both the amount of antigen around a T cell and also the number of immune brakes the T cells have at their surface are very important in controlling immune responses. Furthermore, we have shown that we can alter the balance of the immune response through stopping some of these immune brakes, which results in a stronger T cell response.”

The study has generated a new potential readout to monitor patients on drugs targeting PD1 in cancer. It also may be useful for exploring the potential of combinations of drugs that target multiple immune checkpoints to try to further re-awaken T cells in cancer patients.

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Witnessing abuse of sibling can lead to mental health issues

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A new study from the University of New Hampshire showed that children who witness the abuse of a brother or sister by a parent can be just as traumatised as those witnessing violence by a parent against another parent.

According to the study, such exposure is associated with mental health issues like depression, anxiety and anger. The findings of the study were published in the journal ‘Child Abuse and Neglect’.

“When we hear about exposure to family violence, we usually think about someone being the victim of direct physical abuse or witnessing spousal assault,” said Corinna Tucker, professor of human development and family studies.

“But many children witness abuse of a sibling without being a direct victim and it turns out we should be thinking more about these dynamics when we tally the effects of family violence exposure,” added Tucker.

In their study, the researchers used the combined data from three national surveys to look more closely at the experiences of over 7000 children between the ages of one month to 17 years old.

This included any incident in which a child saw a parent hit, beat, kick or physically hurt (not including spanking) a sibling in their household over the course of their lifetime. Of the 263 (3.7 per cent) youth who had been exposed to parental abuse against a sibling (EPAS), more witnessed abuse by fathers (70 per cent) than mothers.

Exposure was greatest for boys and adolescents and for those whose parents had some, but not completed, college education. It was lowest in families with two biological or adoptive parents. Rates did not differ by race or ethnicity. Youth exposed to EPAS showed higher levels of mental distress like anger, anxiety and depression.

“In some families, EPAS may be part of a larger family climate of violence,” said Tucker. Tucker added, “As more family members are exposed to violence in the household, there can be less emotional security among family members and less opportunities for children to observe, learn and practice healthy responses to stress.”

Researchers said that this study highlights the unique contribution of EPAS to feelings of fear and mental health distress in youth. They hope it will broaden the thinking around domestic violence to recognize EPAS as a form of indirect exposure and calls for practical and clinical applications like intervening by asking siblings about their exposure to the violence, increased education and encouragement for parents, especially fathers and offering ways for exposed children to help by supporting siblings and feeling safe telling another adult.

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CHRONIC CO-MORBIDITIES LINKED TO MORE SEVERE COVID-19 INFECTION IN CHILDREN: STUDY

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While risk factors for hospitalisation and poor outcomes are well documented in adults, less is known about the clinical factors associated with Covid-19 disease severity in children.

A new study attempted to determine the factors associated with severe coronavirus infection in children. The findings of the study were published in the ‘Journal of Hospital Medicine’. In an effort to aid mitigation strategies for children who are at high risk of developing severe Covid disease, a group of physicians at Monroe Carell Jr. Children’s Hospital at Vanderbilt studied data from 45 children’s hospitals around the country — 20,000 patients were included.

“This is one of the largest multicenter studies of children with Covid-19 in the United States,” said James Antoon, MD, PhD, FAAP, assistant professor of Pediatrics at Children’s Hospital and lead author of the study. “And given the recent, concerning increases in COVID cases nationwide and the fact that the vast majority of children remain unvaccinated and susceptible, these findings should be taken into account when considering preventive strategies in schools and planning vaccinations when available for children less than 12 years of age,” he said.

The study determined the factors associated with severe disease and poor health outcomes among children presenting to the hospital with Covid-19. These included older age and chronic co-morbidities such as obesity, diabetes and neurologic conditions, among others.

“These factors help identify vulnerable children who are most likely to require hospitalization or develop severe Covid-19 disease,” said Antoon.

“Our findings also highlight children who should be prioritized for Covid-19 vaccines when approved by the FDA,” added Antoon.

The retrospective cohort study noted that approximately 1 out of every 4 children admitted to the hospital with Covid developed severe disease and required ICU care during April and September 2020.

“Across the country there is a raging debate on how best to protect children and schools from Covid-19,” said Antoon. “Some children are at increased risk for more severe disease and many of them are not yet eligible for vaccination against Covid,” added Antoon.

Antoon further said, “With schools opening and some already in session, these children need to be protected by vaccinating as many people as possible while also using practical strategies to limit spread, such as masking, distancing and ventilation.”

Study investigators hope that the findings will buoy mitigation efforts that proved most beneficial for children and adolescents during the pandemic, including remote learning, social distancing, hand-washing and mask-wearing both for students and teachers.

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Will be able to inoculate entire population by the end of the year: NTAGI Chief NK Arora

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On Friday, India established a new milestone by administering more than 2 crore Covid-19 vaccinations in a single day. The country is the first in the world to reach such a large-scale vaccination target in one day.

Dr NK Arora, Chief of National Immunization Technical Advisory Group (NTAGI), praised the achievement saying, “I would like to congratulate India as a whole, as well as the citizens’ enthusiasm for immunisation. We know of nations like the United States and the United Kingdom that had large inventories of vaccines but individuals who were not ready to accept them. It’s happening at such a rapid speed that 1.37 lakh individuals may have already been vaccinated as we speak. This has been in the works since March 2020, and it will not be completed overnight.”

Taking into consideration the speed of vaccination, do you believe we are on the right track to vaccinate entire country by year end as previous government claims?

Dr NK Arora: People thought that it would take us 3 to 5 years to immunize the entire nation, but we achieved it. The reason behind this is that there are 4 to 5 sectors. Right from the beginning, there has been a philosophy of vaccine Atmanirbharta. Each and every vaccine administered in this country is Made In India and that is why we are not begging anyone else. Secondly, the preparation for rollout started in July when Corona vaccine centre planning was being done. Thirdly, we have a very expensive child immunization framework and infrastructure and this vaccination had been put on that. Fourthly, adults were being immunized for the first time and nobody was sure whether they will come up for vaccine or not. There was vaccine hesitancy even among the medical professionals for the first 6 to 8 weeks and there was a very proactive program to take care of that. Fifth, a major program for managing and keeping a record of this supply system was present.

Co-Win is a phenomenal platform and I believe country is very proud to have such digital platform for the management. Finally, we have a genomic surveillance program which is Cutting edge Technology, which is monitoring and picking up virus samples from all over the country to check how effective our vaccine is. I must recall here that we immunize 17 crore children every week under the Polio Immunisation Program, that is 2.5 crore children being immunized each day. If we can do that, we can do this also.

When can we expect children’s vaccination?

We are having meetings on prioritizing adults and children separately. We have 44 crore children below 18 years of age and 12 crore adolescents between the age of 12 to 17 years of age. From October onwards, we will prioritize those children who are likely to catch severe disease and possible unfortunate death. Healthy children do get infected just like adults but the possibility of severe infection and death is almost zero. Now schools are also opening, and once the parents, teachers and other adults are immunized, children will remain in a protective ring.

What is the status on the WHO approval on Covaxin?

Dr NK Arora: We should most probably get it by this week or the next week at maximum. Most of the paper work has been going on for quite some time and we have already provided the data for the safety of the vaccine and hope that it should be done as soon as possible and people might commute form October onwards.

Everyone is talking about the booster dose, what is the development on that front?

Dr NK Arora: In a meeting, we were just discussing about the efficacy of the vaccines and the vaccine tracker platform announced by the government last week. I would like to share that one dose is providing 97% protection from the virus, while two doses provide 98% efficacy and chances of hospitalization is reduced by 95%. Several parts of the country are conducting studies to see that it is not just the antibodies that provide protection because their decline is a natural process. We are looking at the ground situation and when the scientific evidence comes, we will start with the booster shots as well and we will also identify the subgroups that require special attention. We are regularly scanning through the scientific evidence of our country, not relying on data provided by USA or any other nation. We will work on this data only.

Indemnity was there regarding Pfizer and Moderna. Is that something that is under consideration or are we going to continue on the path of Atmanirbhar Bharat for the time being?

Dr NK Arora: We have our own DNA vaccine which is world’s first vaccine and we will have our own RNA vaccine by November most likely. Indemnity is a sticking issue but we have our own effective vaccines and the discussions are being carried out on our terms.

What would be your advice to the people this festive season?

Dr NK Arora: With folded hands, I would say that pandemic comes once in a century while festivals come each year. So we must have another year of discipline. Spend the days of festivities among your own family members which is safer. I may have been vaccinated but the virus can spread through me to others and similarly I could get infected too. Covid appropriate behaviour and social distancing does not only mean keeping an arm’s distance away from a person, but keeping away from the crowd. We have witnessed a spike during the festivities last time and hence I would really request that people celebrate festivals with discipline this year.

Would you second the claims on third wave or would you deny?

Dr NK Arora: 70 to 75 per cent of our population has already been infected will now. There will be a spike driven by lack of discipline. Whenever we have let our guards down, we will invite a surge. Fortunately, no new variant has come and it is a redeeming point. It will not be wise on our part to not be disciplined for the coming 6 to 8 weeks.

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Better mental health support needed for pregnant individuals during Covid-19

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A team of researchers suggested that more mental health supports are needed for pregnant women after a survey found nearly three-quarters of individuals who had been pregnant during the pandemic reported moderate to high levels of distress and one in five experienced depressive symptoms. The findings appeared in the journal ‘Canadian Family Physician’. The researchers, led by clinicians at Unity Health Toronto, surveyed nearly 1,500 participants online, 87% of whom were Canadian—who had been pregnant during the pandemic. Nearly 69% of respondents reported moderate to high levels of distress and 20% had depressive symptoms.

“The high levels of distress highlight the importance of considering mental health centrally in support for this population,” said Dr Tali Bogler, study lead author and family physician and chair of family medicine obstetrics at St. Michael’s Hospital of Unity Health Toronto. “The findings also highlight the overall impact the pandemic has had on families and the downstream impact this will have,” she added. A limitation of the study is it didn’t have comparable data on distress levels among pregnant people prior to the pandemic. However, a population-based survey conducted in Japan before the pandemic found 28% to 32% of pregnant people reported distress.

Researchers also sought to learn more about the common sources of concern for pregnant women during the pandemic. Participants were provided with a list of 27 concerns. The top five concerns included hospital policies regarding support persons in labour; not being able to introduce their baby to loved ones; getting sick from Covid-19 while pregnant; not being able to rely on family or friends after labour for support; and conflicting medical information on Covid-19 in pregnancy and newborns, especially early in the pandemic. First-time parents were more concerned about the cancellation of in-person prenatal classes and hospital tours whereas second or third-time parents were more concerned about the transmission of Covid-19 from older children in the home. The authors said that family physicians are well placed to support perinatal mental health and can engage in screening practices and offer appropriate treatment such as counselling, public health nursing, and psychiatric appointments. They also recommend hospitals better utilise technology to help address parents’ concerns by arranging more virtual check-ins and hospital tours and provide more online resources with evidence-based information on Covid-19 relevant to expectant and new parents.

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