Healthcare workers are at the top of the priority list of groups to receive the Covid-19 vaccine. Vaccines have been rolled out in some countries, while others like India are giving final touches to their plans. Vaccines that are or would be rolled out are being done after receiving Emergency Use Authorisation (EUA) from each country’s regulatory agency. According to the WHO, about 70% of healthcare workers, who are the beating hearts of every healthcare system, are women. A large proportion of them is in the reproductive age group. It is estimated that in the US over three lakh health workers will be pregnant or breastfeeding as initial doses of vaccine(s) are being rolled out. In India, we have roughly 13 lakh Anganwadi workers, nine lakh ASHAs, and two lakh Auxiliary Nurse Midwives—all women; about 90% of over 30 lakh nurses are women. There are about one million MBBS doctors of which 13-15% may be women. A significant number are likely to be pregnant or breastfeeding when the vaccine(s) would start being distributed. Will they get an emergency use authorised vaccine?
Vaccine(s) that have received EUA (like the Pfizer-BioNtech) or are in the pipeline (like the Moderna, AstraZeneca) have not been tested for safety and efficacy in pregnant and lactating women. The traditional sequential approach in a typical clinical trial is to conduct the efficacy trials in non-pregnant women. Once a vaccine has been found to be effective and safe, a bridging study is usually performed enrolling pregnant women as volunteers. The major advantage is that they are protected from the potential risk of the candidate vaccine under trial. The downside is that it delays the approval of the vaccine. This means that a large number of frontline healthcare workers may remain unvaccinated.
Let’s take a step back and see if SARS-CoV-2 affects pregnant women differently than non-pregnant women. Results of surveillance being carried out by the US CDC provide information on over 23,400 pregnant women between 15 and 44 years with laboratory-confirmed infection with SARS-CoV-2 virus. Even after taking into consideration age, ethnicity, and underlying health conditions, pregnant women were at about three times higher risk of requiring admission in ICU, ventilator support or heart-lung by-pass machine compared to those who are not. Deaths are also more likely among pregnant women. The study did not include pregnant women who tested positive but were asymptomatic. A report from Sweden shows that the risk of being admitted to ICU may be higher in lab-confirmed pregnant women than others. In the UK, information about the outcome of over 400 pregnant women indicates that one in ten required intensive care. According to the WHO, pregnant women or recently pregnant women who are older, overweight, and have pre-existing medical conditions seem to have an increased risk of developing severe Covid-19.
Given that pregnant women are at a higher risk of developing severe Covid-19 as compared to others, how have regulatory agencies addressed this issue while giving EUA for the vaccines?
The first vaccine to receive the EMU was Pfizer-BioNTech vaccine known as BNT162b2.Pfizer-BioNTech vaccine is an mRNA vaccine. The active ingredient is messenger RNA, synthetic in nature, that carries instructions for making the virus’ spike protein. mRNA is delivered in a tiny sphere of inert fatty material called a lipid nanoparticle.
The UK government was the first to accord EUA to the Pfizer-BioNTech vaccine but has not recommended the vaccine for pregnant and lactating women. Its Medicines and Healthcare products Regulatory Agency (MHRA) has advised pregnant women should not have the vaccine until more information is available.
In the US, the FDA and the CDC have left the door open for the healthcare workers to decide. The FDA notes that while there have been no specific studies in these groups, there is no contraindication to receipt of the vaccine for pregnant or breastfeeding women. They are advised to discuss potential benefits and risks of vaccination with their healthcare provider. The Canadian government has toed the line of its neighbour – the US.
It is learnt that Pfizer-BioNtech has applied for emergency use authorisation in India. Would the DCGI go the UK way or join the US and Canada group. Without the appropriate data, the regulatory agency in India is likely to lean towards the UK’s decision.
It is not difficult to appreciate the dilemma of the regulators. They are dealing with a new virus and a vaccine developed using new technology without much data specific to pregnancy and lactation. The Pfizer-BioNTech is not a live virus vaccine, and therefore there’s no reason to believe that it would put an expectant mother or her unborn child at risk, nor that it would cause any harm to breastfed babies but still evidence is needed.
A similar situation is likely to emerge when AstraZeneca and Serum Institute of India or Bharat Biotech submit their application for emergency use authorisation. Pregnant healthcare personnel will continue to wait till safety and efficacy data emerges. We need far-sighted and ethical actions, especially when it comes to diseases like Covid-19, the precaution should be weighed vis-a-vis the benefits the vaccine would offer.
Generating evidence for Covid-19 in pregnancy and lactation should become a priority. Since the immune responses to vaccination in pregnant women cannot be assumed from that of non-pregnant women and because the assessment of safety of vaccination in pregnancy is unique, pregnant women should be included in appropriately designed vaccine trials. The vaccine developers/ manufacturers should ensure that at least some of the candidate vaccines prioritised for development should use platforms and adjuvants that have been found safe and effective in vaccines developed earlier for other infections.
At the global level, the public health and medical establishments must move forward with responsible and informed inclusion of pregnant women in the design, clinical trials, and implementation of vaccine programmes both now and in the future. This will ensure that pregnant and lactating healthcare workers receive the same protection as their non-pregnant colleagues.
The writer is an infectious disease epidemiologist and an independent consultant.
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FERTILITY INDUSTRY: HOW DIGITAL HEALTH IS REINVENTING THE PATH TO PARENTHOOD
Being a parent is indeed challenging. However, the path of parenthood comes with its fair share of struggles and is often not spoken about. Infertility is one of the major hindrances that couples have to face. The fertility clinical practitioners are, however, making concerted efforts to ensure couples can experience the journey and become parents. As per the last estimate, more than 9 million IVF babies have been born globally since the first in 1978. This statistic depicts that the fertility clinics and IVF centres are putting in their best foot forward to deal with the challenge of infertility.
PRESENT LANDSCAPE OF INDIAN FERTILITY INDUSTRY
Infertility is becoming the new epidemic in our country. According to the research released by the fifth round of the National Family Health Survey, India’s Total fertility rate has decreased from 2.2 to 2.0. This implies the total fertility rate is 2 children per woman which has declined from 2.2 children in 2015-16. It is below the current replacement level of 2.1 children per woman.
What is indeed ironic is that India despite being one of the populous country suffers from infertility as a major issue. Clinical, racial and ethnicity factors are considered to be the major reasons causing infertility in India. Along with these, longer median age for family planning coupled with unhealthy lifestyle are the biggest the surge in infertility.
However, there is a bright light at the end of the tunnel. The digital medical advancements are now driving the unprecedented growth of the fertility segment in India. Digital health is paving the way for operational efficiency, implementation of Covid-safe protocols, telehealth adoption as well as a surge in egg freezing. It is expected these advancements will transform the scenario of the fertility industry in India in the times ahead.
DIGITAL MEDICAL ADVANCEMENTS DRIVING THE GROWTH OF THE INDIAN FERTILITY MARKET
Medical science has evolved over the period of time. The fertility science particularly is advancing in the wake of the growing domain of medical science and breakthroughs in research.
THE EMERGENCE OF DIGITAL INTERACTIONS
During the pandemic, clinics cross trained staff so that they can take over multitude of responsibilities. The non-medical interactions were also replaced with digital interactions. The discontinued cycles could be resumed all due to technology. It is anticipated that once clinics will understand the true potential of digital health and leverage it optimally; they will be able to turn all the more efficient and focus on key areas such as patient experience.
TELEHEALTH: THE NEW NORM
Just like the healthcare sector, even the fertility practice is adopting telehealth as a practice. In the earlier times, the industry survived on physical appointments and check-ups. Digital consults were unheard of. However, digital adoption during the pandemic led to the virtual consultations and remote monitoring emerging at the forefront. These have now become the new norm and it is expected will be the future of the industry as well.
Hence, it would be appropriate to say that the fertility industry is now going digital. This is helping to reduce the friction for new patients and they can now get consultations without physically visiting the clinics.
BOOSTING OPERATIONAL EFFICIENCY
The IVF Clinics are becoming digitally native. In fact, digital transformation has become imperative where demand is surpassing the supply and hence it needs to scale quickly as well as boost efficiency. The implementation of technologies in workflow management will help streamline the operations and this can contribute in increasing the success rate of the couples undergoing IVF.
INTRODUCING INNOVATIVE TECHNIQUES
Social freezing (freezing of eggs, sperms and embryos that are stored for future use and can be retrieved), PGT (Preimplantation Genetic Testing to detect any chromosomal changes in the embryo), and ERA (Endometrial Receptive Array technique that helps in analyzing the optimal time for embryo implantation), are the recent innovations that have been introduced in the fertility sector recently due to digital revolution of the segment.
TECH DEPLOYMENT: THE NEED FOR THE INDIAN FERTILITY SEGMENT
Technological advancements happening at a rapid pace will lead to the collaboration of medical professionals as well as tech experts that will help produce effective outcomes in the reproductive segment. For the IVF centres, undergoing digitization has become imperative to deal with unforeseen situations and enjoy a competitive edge in the market. It will also help them provide evidence based service delivery to the couples seeking solutions for infertility. The clinics are now emerging to be all the more robust, efficient and tech-savvy. It is expected that these trends that will lead to the sector reaching great heights in the times to come.
The author is CEO, Milann Fertility & Birthing Hospitals.
Ask a Birth Injury Lawyer: 8 Frequently Asked Questions
Medical malpractice can devastatingly affect a patient’s health, especially for pregnant women. If you were a victim of birth injuries, a lawyer must review your case and help you understand a strategy to move forward. A birth injury lawyer understands the nuances of the law regarding medical malpractice and is the most qualified to help you get fair compensation.
Ask a Birth Injury Lawyer: 8 Frequently Asked Questions1. How Long Can I Wait Before Filing a Lawsuit?The statute of limitations for medical malpractice resulting in birth injuries in Maryland is five years from the moment of the injury or five years from when the injury is discovered. If a child who suffered injuries at birth wants to file a claim, they have three years after reaching 18 years of age. Parents can file a lawsuit on behalf of their infant son. It’s important to understand that the longer you wait before filing a claim, the more challenging it becomes to prove. 2. Who Can Be Held Liable for Birth Injuries?All medical staff related to birth can be liable for birth injuries. This includes nurses, obstetricians,anesthesiologists, and other healthcare professionals present at birth. Sometimes, you can also sue the hospital where the baby was delivered. Consult a birth injury lawyer in Baltimore who can help you determine who you need to sue. 3. What Evidence Will I Need to Provide?To prove a medical malpractice case (including birth injuries), you will need all medical records concerning the case, from the first appointment during your pregnancy. Other valuable evidence may include:
- Testimonies from a witness present during the delivery (for example, your partner or doula)
- Testimonies from other healthcare professionals who review your case
Your attorney will conduct a “discovery” phase, in which they will help you gather all the evidence required to prove your case in court. 4. Do I Need Expert Certification for a Birth Injury Claim?Before you file a lawsuit for any medical negligence (including birth injury) in Maryland, you need a “Certificate of a Qualified Expert.” The law defines qualified experts as board-certified medical professionals in the field of the claim (in this case, obstetricians or gynecologists) or a medical professional who teaches the relevant medical specialty and has done it for at least five years. This certificate must certify that:
- You received substandard medical attention
- Your injuries (or your child’s injuries) directly result from the inappropriate standard of care
- Failure to perform a necessary cesarean section
- Failure to properly monitor a newborn
- Failure to prevent tearing or hemorrhaging in the mother
- Failure to properly use birthing tools
- Failure to diagnose conditions such as preeclampsia or high blood pressure
Other instances of medical malpractice regarding pregnancy and birth include “wrongful birth,” when a healthcare professional fails to inform about any condition that may have resulted in pregnancy termination. It also includes “wrongful pregnancy,” when a woman’s choice to avoid pregnancy fails because of misinformation, defective medication, or defective birth control devices. 6. What Are The Caps For Damages in a Birth Injury Case?To determine a compensation amount for economic damages, the court must consider the severity of the injuries, especially when they have lifelong consequences. Economic damages are not capped in Maryland and include past and future medical expenses and future loss of income. Non-economic damages, such as pain and suffering, are capped at $895,000, and this amount increases by 15% every year. 7. Are There Special Requirements for a Birth Injury Case?In Maryland, all medical negligence cases must begin by filing with the Maryland Healthcare Alternative Resolution Office, and your case will go through an arbitration process. During this process, a panel composed of a lawyer, a healthcare professional, and a general public member will review your evidence and give a verdict, including a compensation amount. However, you have the right to waive arbitration and or reject the arbitration panel’s decision in court. 8. Will I Need to Pay My Attorney’s Fees Out of Pocket?Most birth injury attorneys will accept to be paid a percentage of your winnings. If you lose the case, they won’t make any money. However, you will have to pay for all associated fees. Once you hire a lawyer, ask for a written contract specifying payment conditions and the attorney’s obligations. The law protects you if you or your child are victims of medical negligence resulting in birth injuries. While no amount of money can repair your losses when it comes to a birth injury, fair compensation may help you cope with the challenges ahead of you. Getting professional legal help increases your chances of a good outcome in court.
WARNING SIGNS OF A BRAIN TUMOUR ONE MUST NOT IGNORE
Brain tumour is an abnormal growth of the brain cells. The extra growth inside the brain can exert pressure on the skull, causing life-threatening complications.
Brain tumour is an abnormal growth of the brain cells. The extra growth inside the brain can exert pressure on the skull, causing life-threatening complications. However, not all brain tumours are malignant. Some can be non-cancerous, benign or harmless masses of cancerous cells that mainly target the structural tissue of the brain. It can start either in the brain, or cancer elsewhere in the body can spread to the brain.
According to WHO guidelines brain tumours are categorized into four grades based on the intensity and abnormality of the cells.
· GRADE 1: Cells look benign and grow slowly; survival of the patient is likely.
· GRADE 2: Cells look slightly abnormal. The tumor grows slowly and may spread to other tissues.
· GRADE 3: Cells look abnormal. The tumor grows aggressively and tends to recur.
· GRADE 4: The cells look abnormal and spread quickly. Tumour could be life-threatening.
WARNING SIGNS AND SYMPTOMS OF BRAIN TUMOUR
Depending on the type, location, and stage of the tumor, it can cause both physical and mental symptoms. Some of the commonly observed signs and symptoms of brain tumors are
Unusual headache: Headache can be a common symptom. If someone is experiencing an unusual headache, especially a new one that feels localized to a specific part of the head it could be an early indication of a brain tumor. The headache tends to be more severe in the morning. A brain tumor increases the pressure inside the skull, which can lead to inflammation and tissue damage. Hence, severe, persistent headaches can occur. If there are changes in the frequency or intensity of the headaches, one must consult a doctor.
Seizures: They are one of the most common symptoms of brain tumors. The seizures occur when the brain’s normal patterns of electrical impulses are disrupted. It is reported that brain tumor-related epilepsy (BTE) is common in low- and high-grade gliomas. The risk of seizures varies between 60% and 100% among low-grade gliomas and between 40% and 60% in glioblastomas.
Memory loss, Speech difficulties and hearing loss: Brain tumors can affect the stages of creating, storing and recalling of memory. Retrograde amnesia, a state where one can’t recall memories that were formed before the event that caused the amnesia and anterograde amnesia, where one can’t form new memories after the event that caused the amnesia can occur in people with brain tumor. A brain tumor can affect the communication capabilities of a person and can cause difficulties in uttering or producing sounds, finding the correct word, and understanding what others are saying. It can also have an impact on reading and writing. Also, the pressure exerted by a tumor on surrounding nerves may cause hearing loss and imbalance.
Weakness in the hands and legs: Weakness or numbness in the face, arms or legs is a common occurrence in brain tumors. It is caused by brain tumors located in the frontal lobes or the brainstem. Weakness in one foot/leg or both feet/legs can cause difficulty in walking. Hence, one may experience loss of balance while walking.
Sudden shifts in mood or personality: Mood changes are commonly associated with brain tumors located in the frontal lobe. This part of the brain is highly involved in regulating personality and behaviour and it also helps controls a person’s behavior and emotions. Sudden mood change can be seen in persons whose pituitary gland has been affected by tumors. It can cause the gland to under-or overproduce hormones, leading to a hormonal imbalance. Getting to know about one’s diagnosis of brain tumor can greatly affect the mental and emotional state.
WHEN TO SEE A DOCTOR
The above symptoms are a clear indication that one must immediately seek medical help. Upon diagnosis and conducting a range of neurological tests, your doctor will be able to identify and tell you what’s causing the symptoms.
If diagnosed with a tumor, one can identify the types and follow the doctor’s advice. Always remember that early diagnosis and treatment are important to help prevent the tumour from growing.
The writer is the Lead Consultant Neurosurgery & Program Director – Global Centre of Excellence in Neurosciences, Aster Hospitals Bengaluru.
SHOULD YOU PRACTISE YOGA ON AN EMPTY STOMACH?
If practising yoga on an empty stomach works for you, do that. On the other hand, if you feel like eating something to get a better start to your day, consider something light.
In this fast-paced world, where we are all trying to cope with the hectic lifestyle, Yoga has become a preferred choice of exercise for many, not only to stay fit, active and agile but also to reduce stress and promote relaxation of the body and mind. With physical exercise, it becomes important to focus on the right nutrition and right diet as well.
So can you or should you practice Yoga on an empty stomach?
Well, there are many claims doing the rounds, with some saying it’s necessary to do yoga on an empty stomach and other’s saying it’s not. Some also consider eating the right breakfast is necessary. However, remember you and only you will know and understand your body, so make sure you listen to it, protect it and celebrate it.
While it is believed, working out in the morning on an empty stomach is the best approach, as you can get the best of your breath work and your yoga practice, nourishing your body allows a deeper yoga practice. It is necessary to have something light before you exercise in the morning to help jumpstart your metabolism. However, remember to avoid eating anything heavy for at least 4 hours before performing any asanas.
If you are looking for a great way to lose more weight, try practising Yoga while on intermittent fasting. It is one of the best morning workouts as it allows the body to use the stored fat as energy and is easy on the body. If you first eat something and then workout, your body will focus more on burning the food you just put into your body instead of your stored fat. Also doing high impact or cardio workouts while on fasts, requires you to burn a lot of energy because of the high intensity workouts.
In the end, remember everyone’s body is different and reacts differently. What may work for us, will not work for others. It really comes down to observing and understanding your body, listening to what it likes and what it dislikes and what deems fit for you. If practising yoga on an empty stomach works for you, do that. On the other hand, if you feel like eating something to get a better start to your day, consider something light.
The writer is a fitness expert.
HIGH OPTIMISM LEVELS ARE LINKED WITH LONGER LIFESPAN
A new study led by researchers at Harvard T.H. Chan School of Public Health has found that higher levels of optimism were associated with longer lifespan and living beyond age 90 in women across racial and ethnic groups.
The study was published in the Journal, ‘American Geriatrics Society’. “Although optimism itself may be affected by social structural factors, such as race and ethnicity, our research suggests that the benefits of optimism may hold across diverse groups,” said Hayami Koga, a PhD candidate in the Department of Social and Behavioral Sciences at Harvard Chan School and lead author of the study. “A lot of previous work has focused on deficits or risk factors that increase the risks for diseases and premature death. Our findings suggest that there’s value to focusing on positive psychological factors, like optimism, as possible new ways of promoting longevity and healthy ageing across diverse groups.”
In a previous study, the research group determined that optimism was linked to a longer lifespan and exceptional longevity, which was defined as living beyond 85 years of age. Because they had looked at mostly white populations in that previous study, Koga and her colleagues broadened the participant pool in the current study to include women from across racial and ethnic groups. According to Koga, including diverse populations in research is important to public health because these groups have higher mortality rates than white populations, and there is limited research about them to help inform health policy decisions.
For this study, the researchers analyzed data and survey responses from 159,255 participants in the Women’s Health Initiative, which included postmenopausal women in the U.S. The women enrolled at ages 50-79 from 1993 to 1998 and were followed for up to 26 years.
Of the participants, the 25 per cent who were the most optimistic were likely to have a 5.4 per cent longer lifespan and a 10 per cent greater likelihood of living beyond 90 years than the 25 per cent who were the least optimistic. The researchers also found no interaction between optimism and any categories of race and ethnicity, and these trends held true after taking into account demographics, chronic conditions, and depression. Lifestyle factors, such as regular exercise and healthy eating, accounted for less than a quarter of the optimism-lifespan association, indicating that other factors may be at play.
Koga said that the study’s results could reframe how people view the decisions that affect their health.
“We tend to focus on the negative risk factors that affect our health,” said Koga. “It is also important to think about the positive resources such as optimism that may be beneficial to our health, especially if we see that these benefits are seen across racial and ethnic groups.”
Social isolation is a key reason for dementia
Scientists have found that a major reason for dementia is social isolation, which causes changes in the brain structures associated with memory, according to a study by the University of Warwick.
Setting out to investigate how social isolation and loneliness were related to later dementia, researchers at the University of Warwick, University of Cambridge and Fudan University used neuroimaging data from more than 30,000 participants in the UK Biobank data set. Socially isolated individuals were found to have lower gray matter volumes of brain regions involved in memory and learning.
The results of the study are published online today (June 8, 2022) in Neurology, the medical journal of the American Academy of Neurology, in a paper entitled “Associations of social isolation and loneliness with later dementia” by Shen, Rolls, Cheng, Kang, Dong, Xie, Zhao, Sahakian and Feng.
Based on data from the UK Biobank, an extremely large longitudinal cohort, the researchers used modelling techniques to investigate the relative associations of social isolation and loneliness with incident all-cause dementia. After adjusting for various risk factors (including socio-economic factors, chronic illness, lifestyle, depression and APOE genotype), socially isolated individuals were shown to have a 26% increased likelihood of developing dementia.
Loneliness was also associated with later dementia, but that association was not significant after adjusting for depression, which explained 75% of the relationship between loneliness and dementia. Therefore, relative to the subjective feeling of loneliness, objective social isolation is an independent risk factor for later dementia. Further subgroup analysis showed that the effect was prominent in those over 60 years old.
Professor Edmund Rolls, the neuroscientist from the University of Warwick Department of Computer Science, said: “There is a difference between social isolation, which is an objective state of low social connections, and loneliness, which is subjectively perceived social isolation.
“Both have risks to health but, using the extensive multi-modal data set from the UK Biocomputational scbank, and working in a multidisciplinary way linking sciences and neuroscience, we have been able to show that it is social isolation, rather than the feeling of loneliness, which is an independent risk factor for later dementia. This means it can be used as a predictor or biomarker for dementia in the UK.
“With the growing prevalence of social isolation and loneliness over the past decades, this has been a serious yet underappreciated public health problem. Now, in the shadow of the COVID-19 pandemic, there are implications for social relationship interventions and care — particularly in the older population.”
Professor Jianfeng Feng, from the University of Warwick Department of Computer Science, said: “We highlight the importance of an environmental method of reducing the risk of dementia in older adults through ensuring that they are not socially isolated. During any future pandemic lockdowns, it is important that individuals, especially older adults, do not experience social isolation.”
Professor Barbara J. Sahakian, of the University of Cambridge Department of Psychiatry, said: “Now that we know the risk to brain health and dementia of social isolation, it is important that the government and communities take action to ensure that older individuals have communication and interactions with others on a regular basis.”
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