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Shalini Bhardwaj



New Delhi: The drug-maker company Pfizer said it decided to withdraw its application for Emergency Use Authorisation (EUA) of Covid-19 vaccine in India and will be re-submitting its data with additional information to Drug Regulatory Authority of India.

“In pursuance of the Emergency Use Authorisation of its Covid-19 vaccine, Pfizer participated in the Subject Expert Committee meeting of the Drug Regulatory Authority of India on 3 February. Based on the deliberations at the meeting and our understanding of additional information that the regulator may need, the company has decided to withdraw its application at this time. Pfizer will continue to engage with the authority and resubmit its approval request with additional information as it becomes available in the near future. Pfizer remains committed to making its vaccine available for use by the Government in India and to pursuing the requisite pathway for emergency use authorisation that enables the availability of this vaccine for any future deployment,” said a Pfizer spokesperson.

Pfizer was the first pharmaceutical company to apply for a EUA licensure from the Drugs Controller General of India (DCGI) for its Covid-19 vaccine in India after getting clearance in the UK and Bahrain.

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Medically Speaking




A recent study by an international team of researchers show that weight-loss medications and surgical procedures show promise for reducing the long-term effects of high blood pressure (also called hypertension) in people who are overweight or have obesity.

This finding was suggested by a new American Heart Association scientific statement published in the Association’s journal Hypertension. A scientific statement is an expert analysis of current research and may inform future guidelines. “Weight loss achieved through dietary changes and increased physical activity are the cornerstones of treatment for high blood pressure that’s related to being overweight.

However, these lifestyle behaviours are often not sustained over the long term. Subsequently, reductions in blood pressure aren’t maintained over time,” said Chair of the statement writing group Michael E. Hall, M.D., M.S., FAHA, associate division director for cardiovascular diseases at the University of Mississippi Medical Center in Jackson, Mississippi.

He added, “The new scientific statement suggests medical and surgical strategies may help with long-term weight and blood pressure improvement, in addition to a heart-healthy diet and physical activity.”

Previous scientific statements from the American Heart Association have addressed the impact of diet, physical activity and weight control related to blood pressure. The new statement is focused on obesity-related high blood pressure. Overweight or obesity is a weight that is higher than what is considered healthy for an individual’s height.

Specifically, a body mass index (BMI) of 30 or greater is considered obese, and a BMI of 25 to 29 is classified as overweight. The writing group for the scientific statement included experts in the fields of obesity and high blood pressure, and they reviewed existing research to provide the latest guidance on weight-loss strategies to reduce high blood pressure.

The impact of diet and physical activity National guidelines recommend a heart-healthy diet to help manage weight and control blood pressure. These guidelines emphasize dietary patterns rather than individual foods and nutrients. The most well-established healthy eating patterns are the Mediterranean diet and Dietary Approaches to Stop Hypertension (DASH).

The diets are similar in emphasizing eating more fruits, vegetables, legumes, nuts and seeds with moderate amounts of fish, seafood, poultry and dairy, and low quantities of red and processed meats, and sweets.

“There’s no doubt that eating healthy foods has beneficial effects on both weight and blood pressure,” said Hall. “Numerous weight-loss diets are often successful in the short term; however, eating healthy foods consistently and long term, and maintaining weight loss are challenging.”

Intermittent fasting, an approach that alters the timing of eating and fasting during the day or each week, produced some weight reduction and modest reductions in blood pressure in a few studies involving people with metabolic syndrome – a group of five conditions that can lead to heart disease, including high blood sugar, low levels of HDL cholesterol, high triglyceride levels, large waist circumference and high blood pressure.

Metabolic syndrome is diagnosed when someone has three or more of these conditions. However, analyses of several studies found that intermittent fasting had a weak impact on blood pressure and was no more effective than other diets in reducing weight.

Increasing physical activity as well as improving cardiovascular fitness and reducing the amount of sedentary time can help lower body weight and reduce blood pressure. The statement suggests exercise is critical to reduce weight and lower blood pressure, as supported by the Association’s June 2021 statement on first-line treatment for elevated blood pressure and cholesterol.

Medications for weight loss

If lifestyle modifications have not been successful in achieving weight reduction and blood pressure control, the statement suggests prescription medications may be considered for people who have obesity or who are overweight and have a weight-related health issue such as high blood pressure.

“Currently, only a fraction of eligible individuals are prescribed medicine or referred for metabolic surgery,” said Hall. “We often don’t consider medications or metabolic surgery until after there has been target organ damage, such as heart injury or having a stroke. However, we may be able to prevent these complications. When combined with lifestyle changes, anti-obesity medicines and surgical procedures can be effective long-term solutions for weight loss and blood pressure control in select individuals who are overweight or have obesity.” A newer class of medications called GLP-1 receptor agonists have been shown to help with sustained weight loss and significantly reducing blood pressure, according to the statement. GLP-1 agonists, such as liraglutide and semaglutide, are synthetic hormones, self-administered in a daily or weekly injection, that reduce appetite and help people to feel full.

Both medications were initially approved to treat type 2 diabetes because they lower blood sugar by stimulating the release of insulin. The U.S. Food and Drug Administration recently approved both medications for weight management and weight loss in individuals classified as overweight or obese.

Surgery for weight loss

Metabolic surgery (also called bariatric surgery or gastric bypass surgery) can aid weight loss in people with severe obesity, defined as people who have a BMI of 40 or higher, or if they have a BMI of 35 or higher along with an obesity-related health condition including hypertension. The statement includes a research review on metabolic surgery. High blood pressure was resolved in 63 per cent of people who had metabolic surgery, and several studies showed less use of blood pressure-lowering medicines after surgery.

“Metabolic surgery techniques are continuing to evolve, and they are getting less invasive and less risky,” said Hall. “For select individuals, medications or metabolic surgery or both may be considered in addition to healthy diet and increased physical activity.”

The statement highlights questions and gaps in research data on the use of medications and surgery to prevent and treat obesity-related hypertension. These issues include whether these strategies will have the intended outcome of preventing organ damage, how effective they are for individuals who already have kidney disease or heart failure.

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Covid-19 vaccinated pregnant women pass protection to newborns



A new study has found that women who receive the mRNA Covid-19 vaccine during pregnancy pass high levels of antibodies to their babies. The findings of the study were published in the ‘American Journal of Obstetrics and Gynecology MFM’. The effectiveness of the Pfizer-BioNTech and Moderna mRNA Covid-19 vaccines, the researchers say, lies in their ability to trigger the production of the right antibodies, blood proteins capable of protecting individuals from infection.

Whether this protection could pass from mothers to their infants before birth had remained a question. The new study of 36 newborns whose mothers received either the Pfizer-BioNTech or Moderna Covid-19 vaccine during pregnancy found that 100 per cent of the infants had protective antibodies at birth.

Antibodies can either be produced as part of the natural response to infection or triggered by vaccines. With that in mind, the research team was able to tell apart antibodies in the neonatal blood that were created in response to natural infection from those made in response to the vaccines.

The result is relevant because natural antibody responses against the SARS-CoV-2 virus are not sufficiently protective for many people. Recent data from the Centers for Disease Control and Prevention (CDC) suggests that just 23 per cent of pregnant women have been vaccinated, despite growing evidence of prenatal vaccine safety.

Led by researchers at NYU Grossman School of Medicine, the study authors observed the highest levels of antibodies in cord blood of mothers who were fully vaccinated during the second half of their pregnancies. This insight provides evidence of transferred immunity to neonates, which correlates to protection against infection for infants during the first months of life.

“Studies continue to reinforce the importance of vaccines during pregnancy and their power to protect two lives at once by preventing severe illness in both mothers and babies,” said Ashley S. Roman, MD, director of the Division of Maternal-Fetal Medicine and the Silverman Professor of Obstetrics and Gynecology in the Department of Obstetrics and Gynecology at NYU Langone Health, and one of the study’s principal investigators.

“If babies could be born with antibodies, it could protect them in the first several months of their lives, when they are most vulnerable,” added Roman.

As the Covid-19 vaccines received authorisation from the US Food and Drug Administration, the CDC consistently asserted that they should not be withheld from people who are pregnant and want the vaccine.

Dr Roman and colleagues confirm the strong evidence that the mRNA vaccines are safe during pregnancy in a study published on August 16 in the ‘American Journal of Obstetrics and Gynecology–Maternal-Fetal Medicine’, titled ‘Covid-19 Vaccination in Pregnancy: Early Experience from a Single Institution’.

The study found no increased risks during pregnancy, birth complications, or identifiable risks to the fetus among those who received the vaccine.

In the current study, though the sample size is small, “it is encouraging that neonatal antibody levels are high if women are vaccinated,” said Jennifer L. Lighter, MD, associate professor in the Department of Pediatrics, hospital epidemiologist at Hassenfeld Children’s Hospital at NYU Langone, and the study’s senior author.

Existing studies analyse antibodies to the spike protein (anti-S IgG) alone, which may be present after natural infection or vaccination, and do not include antibodies to the nucleocapsid protein (anti-N IgG), which is only present following natural infection.

Among the 36 samples collected, all had high levels of anti-S IgG. Of those samples, 31 were tested for anti-N IgG and were negative. “High levels of transplacental antibody transfer are not surprising. It is consistent with what we see with other immunisations,” said Dr Lighter.

“Our findings add to a growing list of important reasons why women should be advised to receive the Covid-19 vaccine during pregnancy for the added benefit of their newborn receiving crucial protection,” added Dr Lighter.

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New experiments by indoor air researchers at Lawrence Berkeley National Laboratory (Berkeley Lab) have shown that certain circumstances will result in poor mixing of room air, meaning airborne contaminants may not be effectively dispersed and removed by building level ventilation.

The findings of the study were published in the journal ‘Indoor Air’. Using CO2 as a tracer to track small respiratory aerosols that travel by air currents in a room, the Berkeley Lab team found that when overhead vents (or diffusers) are supplying heated air, it created thermally stratified conditions that block the flow of clean air down to the “breathing zone” in the middle height of the room.

As a result, even when people are sitting more than 6 feet from each other, some occupants may be exposed to respiratory aerosols from others at a rate 5 to 6 times higher than if the same room were well mixed. “When everything’s well mixed, everybody’s exposed to the same conditions,” said Berkeley Lab indoor air researcher Woody Delp.

“When it’s not well mixed, you can have, from a Covid perspective, potential hot spots. So, if there’s one infected individual in the room, instead of having their expelled breath fully dispersed and then properly diluted and removed by the HVAC system, another person sitting next to them or even across the room could get a high concentration of that infected person’s emitted viral aerosol,” Delp added.

Delp noted that this situation would occur only in the case of heated air being supplied from the overhead diffusers. When cold or neutral air is being supplied, the researchers did not see the thermal stratification occur; instead, the room was found to be well mixed in those circumstances. While the basic risk from overhead heating has been known for years, it had not previously been quantified under controlled but realistic conditions of a meeting or classroom.

The results are important for understanding how large the risk can be when occupants are intentionally spaced for safety. “Ventilation is essential to maintaining good air quality,” said Brett Singer, the lead author of the study and head of Berkeley Lab’s Indoor Environment Group.

“But if you’re heating overhead without intentionally mixing the air in the room, you will not get the full benefit of ventilation,” added Singer.

Fortunately, there is a simple solution, the study found: using portable air cleaners that pull air in from below and push it out through the top.

“They take care of the mixing and then they also filter the air, so they have a double benefit,” Singer said.

The researchers positioned eight thermal manikins (which are like retail display mannequins but used for scientific research instead) and had a researcher present to operate an aerosol emissions device in a 20-by-30-foot room set up first like a conference room, with participants seated in a circular pattern, then reconfigured like a classroom, with one standing at the front of the room and eight participants facing forward.

Singer noted that most previous studies of the effects of imperfect mixing on contaminant dispersal used only one or two simulated occupants. In this study, the manikins released plumes of heat, much as a person would. CO2 was released at mouth level to simulate small respiratory aerosols. The temperature of the CO2, as well as the velocity of its release, were adjusted to simulate a person talking.

The experiments took place in the FLEXLAB(R), Berkeley Lab’s building simulator and testbed. “With the FLEXLAB, we were able to control every aspect of the HVAC system, which is how we were able to iterate on so many different conditions for the two types of occupancy configurations,” said Chelsea Preble, a research scientist at Berkeley Lab and UC Berkeley and a co-author on the study.

“We were also able to have temperature and air velocity measurements throughout the room in addition to our measurements of CO2. Those helped us verify and quantify the mixing problem,” added Preble. Previous studies have established that CO2 can act as a proxy for the dispersion behaviour of small respiratory aerosols, or particles less than 5 microns in size. A micron is one-millionth of a meter.

While respiratory aerosols are made up of particles in a vast range of sizes, from sub-micron to millimetres, this paper focuses on the smaller particles, which move mostly with the air currents. Larger particles, which behave differently, will be the subject of a future analysis.

“We released the particles and the CO2 at different manikins and tried to see how these tracers and particles spread around the room,” said Haoran Zhao, a Berkeley Lab postdoctoral fellow and co-author on the study. “We had CO2 sensors in each corner of the room at different heights and also at the breathing zone of each manikin,” added Zhao.

The authors are careful to note that their study addresses only the relative risk of poorly versus well-mixed conditions; it cannot be used directly to predict infection risk. “We know the chain of events that it takes to get a person exposed, and it’s complicated and extraordinarily variable. An infected person talking and breathing expels droplets and aerosols of various sizes. But even when some of those are inhaled by someone else, they may or may not get infected,” Delp said.

“From others’ studies, we know that the quantity of viruses emitted by an individual infected person can vary very widely. One person may expel millions of more viruses than another infected person — and that varies over the course of an infection and also appears to be different for delta compared to the earlier variants,” Delp added.

“And to top it off, the number of viruses that it takes to initiate an infection also likely varies between people and with the sizes of the aerosols that are inhaled. As indoor air quality scientists and engineers, our focus is on what can be done with ventilation, filtration, and air distribution to reduce risks even when all the details of the biology are not known,” Delp explained. The study was funded by the Department of Energy through the National Virtual Biotechnology Laboratory, a consortium of DOE national laboratories focused on the response to Covid-19. Other co-authors of the study were Jovan Pantelic, Michael Sohn, and Thomas Kirchstetter.

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A new study suggests early weight loss protects fertility of obese persons



The reproductive function in obese boys can be improved through weight loss, which in turn could protect their fertility in adulthood, according to new research.

The study presented at the 59th Annual European Society for Paediatric Endocrinology Meeting suggests that even after short-term weight loss, alterations in reproductive function could be partially reversed in young boys with obesity. This indicates that early management of obesity in childhood could help prevent future fertility problems in men. Childhood obesity can have some profound effects on future health in adulthood, including a greater risk of cancer, heart disease and type 2 diabetes. Obesity has also been linked to fertility problems in both men and women. The commonest causes of fertility problems in men are usually sperm abnormalities or a low sperm count.

Leydig cells in the testes become active in puberty to produce the main male hormone, testosterone. Sertoli cells in the testes are critical for the production of healthy sperm and produce several reproductive hormones, essential for sperm maturation.

Previous work has shown early alteration of Sertoli cell function in obese boys from the age of 12, with later alteration in Leydig cell function from the age of 14. However, whether weight loss might reverse the altered function of these cells had not been investigated.

In this study, Dr Solene Rerat and colleagues at Angers University Hospital in France investigated how a 12-week educational weight loss programme in 34 boys, aged 10-18 years, affected markers of Leydig and Sertoli cell function, as well as metabolism.

The boys had a healthy, balanced diet, undertook physical activity for at least one hour per day, according to international recommendations, and had weekly individual sessions with a dietician. Before and after the programme, levels of reproductive hormones, body fat composition and blood glucose were measured for comparison. Over the 12 weeks, the boys significantly lost weight and had improved insulin levels, as well as increased testosterone levels.

No significant changes were found in markers of Sertoli cell function. Since fat cells produce an enzyme that converts testosterone to oestrogen, the actual loss of fat mass may account for some of the increased testosterone levels, in addition to the reversal of Leydig cell altered function.

Dr Rerat states, “These findings underline the need to consider childhood obesity as a factor in future fertility issues. We strongly recommend that early management of childhood obesity is necessary to reverse these impairments, and to help prevent future reproductive problems, as well as lowering the risks of other debilitating diseases.”

The team now plans to measure the reproductive function of the group more long-term and to expand it to include more participants to gather more data to confirm and extend these findings.

Dr Rerat cautions, “Our study only evaluated the effects in a small number of obese boys after a twelve-week therapeutic educational program. Further studies with longer follow up are needed to help us fully study the effect of weight reduction on reproductive function.”

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Link between diet and mental health



Lifestyle components like eating habits, exercise, sleep, and work patterns etc affect our well-being on a regular basis and many health problems both physical and mental, are associated with disbalance in our routine life.

There is no specific diet which treats psychiatric disorders but certain dietary choices and patterns are helpful in improving overall health as well as promote physical and mental stress tolerance which leads to better psychological health.


Among common diet plans, the Mediterranean diet has the strongest evidence supporting its ability to reduce the symptoms of depression.

Compounds in the Mediterranean diet that have links to lower depression rates include:

• omega-3 fatty acids

• vitamin D

• methylfolate

• s-adenosylmethionine

The Mediterranean diet consists of:

• plenty of fruits and vegetables

• whole grains

• potatoes

• cereals

• beans and pulses

• nuts and seeds

• olive oil

• low-to-moderate amounts of dairy products, fish, and poultry

• very little red meat

• eggs up to four times a week

• low-to-moderate amounts of wine to


A 2010 study showed that women who ate unhealthful Western-style diets had more psychological symptoms. The foods that these participants were eating included:

• processed foods

• fried foods

• refined grains such as white bread

• sugary products

• beer

Similar unhealthful dietary patterns that typically lead to obesity, diabetes, and other physical health problems can also contribute to poor mental health.

The balanced Indian meal plans have necessary components for health and well being.


• Eat a combination of locally grown products like whole grains, fruits and vegetables and limited amounts of unrefined fat like cold pressed mustard oil and desi ghee (clarified butter).

• Fish, nuts and seeds like walnuts, pistachios, almonds, flaxseeds and chia seeds have high amounts of omega3 fatty acids which are good for nerve health.

• Poultry, eggs and dairy products are rich in Vitamin B12 which is associated with nerve health and better stress tolerance.

• Balanced calorie intake with good nutritional components (complex carbohydrates, proteins, vitamins, minerals and healthy fatty acids) is the key to good health and weight management. Over eating and under eating both have negative effect on physical and mental well being.

• Regular eating patterns are helpful in maintaining stable sugar levels and boost energy.

• Water makes 60% of body. Drink plenty of plain water for good health.

• Good gut health is linked to balance of good bacteria in our intestines which are plenty in probiotic foods like curd, chaach, and fermented eatables like idli, dosa, and kimchi.

• Sodium is an essential nutrient that controls blood pressure. It is also needed to make nerves and muscles work properly. For this reason, patients need to consume the right amount. Many medicines reduce sodium levels which can lead to hyponatremia with significant nervous system problems. The AHA recommends no more than 2,300 milligrams a day, but patients should move toward an ideal limit of no more than 1,500 mg per day for most adults. Excessive salt comes from packaged and preserved food which in any case need to be avoided.

• Avoid alcohol and nicotine, they may appear to reduce stress but eventually lead to low stress tolerance and mood instability.

• Drugs like pot/weed/grass/opioids and other designer drugs increase vulnerability to major psychiatric disorders.

For specific metabolic disorders like diabetes, obesity, PCOD or inflammatory condition, please consult a dietitian.

The writer is a Senior Psychiatrist and Founder & Director of Manasthali.

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Doctors at the frontlines of the pandemic are facing extremely challenging working conditions. Long gruelling working hours, constant emergencies, witnessing a high death rate, and a persistent struggle to save lives not just cause physical exhaustion but also result in an emotional and mental turmoil.

Dr Shuchin Bajaj



Long working hours, emergency calls, a never ending stream of patients and prolonged stress are factors that are common in the lives of doctors. In countries with a low doctor-patient ratio like India, doctors often experience overwhelming workload and excessive pressure. Factors such as lack of safety and vulnerability to violence further adds to this stress. Even before the coronavirus outbreak challenges healthcare providers like never before, physicians were experiencing a high rate of burnout. Several studies have pointed this out in recent years. A small but powerful indicative study published in the Indian Journal of Psychiatry in 2018 suggested that a significantly higher proportion of doctors in Indian setting experience stress, depression, and burnout. Out of the 445 responders in the study, 30.1% were found to have depression and 16.7% reported having suicidal thoughts. More than 90% of the participants reported some level of burnout.

The coronavirus outbreak has hugely magnified this problem, exacerbating the burnout rate in doctors and other healthcare staff particularly those involved in treating Covid-19 patients. Burnout is a condition where an individual experiences overwhelming mental and physical exhaustion owing to excessive stress. It not just affects the mental and physical health of the individual but also impacts his/her job related outcomes.


In China, a cross-sectional study published in JAMA Network Open Journal in March 2020 found that the coronavirus outbreak had a devastating impact on the mental health of healthcare workers. Out of the 1257 respondents, 50.4% were found to have symptoms of depression, 34.0% reported insomnia, 44.6% reported symptoms of anxiety, and 71.5% reported distress. The researchers concluded that working in the frontline was an independent risk factor for worse mental health outcomes.

Doctors at the frontlines of the pandemic are facing extremely challenging working conditions. Long grueling working hours, constant emergencies, witnessing a high death rate, and a persistent struggle to save lives not just cause physical exhaustion but also result in an emotional and mental turmoil. In countries where severely ill patients exceeded the healthcare capacity to treat, doctors had to actually choose whom to treat and whom to let die. Absence of a clear treatment route is another major work challenge.

Wearing PPEs for long hours is itself a major challenge. Once your PPE is on your ability to eat, drink water or even go to the washroom is restricted. The grueling heat makes long hours of wearing PPEs worse. However, the most significant challenge is the threat from the disease itself. Being in the midst of patients every day puts doctors at a high risk of catching the infection themselves. By first week of May, over 500 doctors, nurses, and paramedics had already been infected by coronavirus in the country. An AIIMS doctors was applauded for putting himself at significant risk when he removed his goggles and face shield to be able to clearly see and re-intubate a seriously ill patient. This tells us how doctors are putting themselves at risk during this global pandemic. As doctors get infected and result in a further depletion of workforce, the remaining physicians face an even greater workload.

Apart from all the above concerns, one major concern for doctors and healthcare staff is the threat of carrying the infection to their home and families.


As much as it is important to ensure the safety of doctors, it is equally important to help them address the mental and physical outcomes of burnout. Governments, healthcare providers, and hospitals must initiate a series of measures to help address this burnout crisis.


Strict adherence to properly wearing PPEs has been found to be effective in minimising infection rate among doctors and healthcare workers. It is extremely important therefore that governments and hospitals ensure adequate supply and sufficient availability of PPEs for doctors. Adequate supply of PPEs and addressing the shortage concerns also allays the mental stress and fear among doctors. It is also important to ensure that doctors do not have to wear the same protective equipment for more than 8-10 hours.


The World Health Organisation has advised doctors to take extra care of their health by consuming healthy food, taking adequate rest, and staying active. The body has also recommended de-stressing and avoiding smoking or drugs. Hospitals must ensure that doctors have regular access to counseling support to advocate healthy living. They must also have access to mental health experts to give them a proper outlet for their mental and emotional turmoil.


Governments and private healthcare providers must also arrange for alternative accommodation for doctors and other healthcare staff members to allow them stay away from their families during the time they are treating Covid-19 patients. This takes off the extra pressure and concern about carrying the virus home.


With the number of patients rising steeply every day, we need to find innovative ways to have sufficient backup resource of doctors. In this situation, it makes sense to train final year MBBS and PG medical students in critical care and keep them ready to be deployed in case the need arises.

The writer is Founder Director, Ujala Cygnus Group of Hospitals.

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