Pfizer, BioNTech experimental COVID-19 vaccine shows promise in early trial: Study

Agencies
July 2, 2020

The American pharmaceutical giant Pfizer Inc. and the European biotechnology company BioNTech SE have conducted an experimental trial of a COVID-19 vaccine candidate and found it to be safe, well-tolerated, and capable of generating antibodies in the patients.

The study, which is yet to be peer-reviewed, describes the preliminary clinical data for the candidate vaccine -- nucleoside-modified messenger RNA (modRNA), BNT162b1.

It said the amount of antibodies produced in participants after they received two shots of the vaccine candidate was greater than that reported in patients receiving convalescent plasma from recovered COVID-19 patients.

"I was glad to see Pfizer put up their phase 1 trial data today. Virus neutralizing antibody titers achieved after two doses are greater than convalescent antibody titers," tweeted Peter Hotez, a vaccine scientist from Baylor College of Medicine in the US, who was unrelated to the study.

Researchers, including those from New York University in the US, who were involved in the study, said the candidate vaccine enables human cells to produce an optimised version of the receptor binding domain (RBD) antigen -- a part of the spike (S) protein of SARS-CoV-2 which it uses to gain entry into human cells.

"Robust immunogenicity was observed after vaccination with BNT162b1," the scientists noted in the study.

They said the program is evaluating at least four experimental vaccines, each of which represents a unique combination of mRNA format and target component of the novel coronavirus, SARS-CoV-2.

Based on the study's findings, they said BNT162b1 could be administered in a quantity that was well tolerated, potentially generating a dose dependent production of immune system molecules in the patients.

The research noted that patients treated with the vaccine candidate produced nearly 1.8 to 2.8 fold greater levels of RBD-binding antibodies that could neutralise SARS-CoV-2.

"We are encouraged by the clinical data of BNT162b1, one of four mRNA constructs we are evaluating clinically, and for which we have positive, preliminary, topline findings," said Kathrin U. Jansen, study co-author and Senior Vice President and Head of Vaccine Research & Development, Pfizer.

"We look forward to publishing our clinical data in a peer-reviewed journal as quickly as possible," Jansen said.

According to Ugur Sahin, CEO and Co-founder of BioNTech, and another co-author of the study, the preliminary data are encouraging as they provide an initial signal that BNT162b1 is able to produce neutralising antibody responses in humans.

He said the immune response observed in the patients treated with the experimental vaccine are at, or above, the levels observed from convalescent sera, adding that it does so at "relatively low dose levels."

"We look forward to providing further data updates on BNT162b1," Sahin said.

According to a statement from Pfizer, the initial part of the study included 45 healthy adults 18 to 55 years of age.

It said the priliminary data for BNT162b1 was evaluated in 24 subjects who received two injections of 10 microgrammes ( g) and 30 g -- 12 subjects who received a single injection of 100 g, and 9 subjects who received two doses of a dummy vaccine.

The study noted that participants received two doses, 21 days apart, of placebo, 10 g or 30 g of BNT162b1, or received a single dose of 100 g of the vaccine candidate.

According to the scientists, the highest neutralising concentrations of antibodies were observed seven days after the second dose of 10 g, or 30 g on day 28 after vaccination.

They said the neutralising concentrations were 1.8- and 2.8-times that observed in a panel of 38 blood samples from people who had contracted the virus.

In all 24 subjects who received two vaccinations at 10 g and 30 g dose levels, elevation of RBD-binding antibody concentrations was observed after the second injection, the study noted.

It said these concentrations are 8- and 46.3-times the concentration seen in a panel of 38 blood samples from those infected with the novel coronavirus.

At the 10 g or 30 g dose levels, the scientists said adverse reactions, including low grade fever, were more common after the second dose than the first dose.

According to Pfizer, local reactions and systemic events after injection with 10 g and 30 g of BNT162b1 were "dose-dependent, generally mild to moderate, and transient."

It said the most commonly reported local reaction was injection site pain, which was mild to moderate, except in one of 12 subjects who received a 100 g dose, which was severe.

The study noted that there was no serious adverse events reported by the patients.

Citing the limitations of the research, the scientists said the immunity generated in the participants in the form of the T cells and B cells of their immune system, and the level of immunity needed to protect one from COVID-19 are unknown.

With these preliminary data, along with additional data being generated, Pfizer noted in the statement that the two companies will determine a dose level, and select among multiple vaccine candidates to seek to progress to a large, global safety and efficacy trial, which may involve up to 30,000 healthy participants if regulatory approval to proceed is received.

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Agencies
April 25,2020

An uncertain prognosis, severe shortage of resources and the imposition of unfamiliar public health measures that infringe on personal freedoms along with large and growing financial losses are undoubtedly contributing to the widespread psychological and emotional distress associated with COVID-19.

The COVID-19 pandemic has forced millions of people to work from home world-wide. Today, due to constant exposure to increasing numbers, an intense fear of contamination have a massive psychological impact on people who are working from home.

Kuhoo Gupta, Healer and Founder of The K Junction talks about wellness during work from home as the situation is resulting in people being vulnerable to severe mental illnesses. Staying positive and optimistic while working from home during pandemic can be heavily challenging.

Gupta states its critical to maintain your mental well-being and immune system, as people with mental upheavals are prone and susceptible to various flu or inflammations. Your bodies immune system reacts abnormally which diminishes the capability of it's function.

The only key to manifesting a wonderful well-being is to try and calm one's mind and focus on constructive and wellness activities, to find a path towards making ourselves more resilient while working from home. Gupta shares 5 tips you can start doing today to improve and enhance your positive outlook.

Remember! Your workplace should be a sacred space where you are able to find a sense of comfort in your work environment. It should help you feel positive, healthier and happier, more like a protective zone.

Fabricating a Positive Workstation

There should be a separate workstation so that one can concentrate while working from home. It would be great if the work desk is stationed somewhere near a window or a balcony door so that one can welcome sunlight, fresh air and a view of plants & birds during the day. Try to have an ergonomic setting of your table and chair so that you keep your posture right while working the whole day. Keeping one or two indoor plants near your work desk will help to make it interesting.

Keep your laptop charger wires and other stuff neatly on your desk to avoid overwhelming yourself. Motivation quotes around you will help to make you overall positive. Keep your notes diary and pen handy at your desk. It will always helps to keep some colorful artifacts around you to make the atmosphere a little cheerful.

Declutter Your Workstation

Avoid the pilling up files and unnecessary stationery at your workstation. Clutter is responsible for the confusion and problems all around and it leads to distraction; thus, a clean desk reflects power which enhances positivity and creates a tranquil workspace that will help your mind focus on productivity. It is important to declutter your work desk once in a few days because physical clutter translates to mental clutter.

Gratitude Notes in workstation and how to manifest

It is a great morning practice to write at least five things you are grateful for. It helps to shift the focus from negative to positive, from scarcity to abundance. One can write gratitude statements on Post it notes and put them at the work daily. This will raise the vibrations and help you stay grounded and positive. You can also compile affirmations and prayers that you resonate. Whenever you take work breaks, it is a good idea to read these.

Crystals to imbibe positivity at workstation

Selenite is a great crystal to spread light and positivity around. Black tourmaline absorbs negativity and is great to shield you from it during lockdown. Shungite is a great crystal to reduce the effects of electromagnetic radiations around you. You can place it near your wifi router, laptop and other devices to reduce the EMF pollution effects on you and your family. Clear quartz is great for energizing you after a tiring meeting. Just hold it in your left hand with eyes closed for five minutes and visualise beautiful energy entering your body and soul.

You can combine this exercise by holding black tourmaline in your right hand and visualize all the tiredness and unwanted energy draining into the black tourmaline. Tiger eye is very effective in eliminating the scattered brain and it allows us to make confident decisions. Green Aventurine neutralizes stress and anxiety from work, allowing us to keep calm.

Lepidolite is known as the Peace Stone, making it one of the best crystals for peace. It improves our overall mood, calms us, soothes us, and reduces our anxiety with a peaceful sense of happiness.

Sodalite is a great crystal for peace because it turns fear and stress into peaceful feelings. It also helps in better communication and can help while making crucial presentations & meetings.

Fluorite is great for healing and rejuvenating the mind and body. You can close your eyes and sit quietly with Fluorite while imagining your body being filled with an incredible energy that puts you at ease with yourself and the world.

Pyrite, also known as abundance stone, is great to put over your business card to manifest abundance at work.

Don't forget to clean your crystals regularly to harness their maximum energy.

Meditate, Do Pranayam and Stay Hydrated!

It is important to take short breaks to maintain productivity at work. Being summer, it is a good idea to get up for a water break once in 30 minutes at least. Even if you keep a water bottle alongside you, walking to the kitchen for water will help your physical body get some much needed movement.

Few iterations of square breathing once in two hours is a great way to boost your mind and body. Square breathing is basically the sequence of inhalation - holding breath - exhalation - holding breath - all for equal time spans. So you can count mentally 1 to 4 in inhalations, then again counting 1 to 4 as you hold your breath, and so on and so forth.

You can also chant any mantra while taking a work break for 1 or 2 minutes. While attending online meetings, where there is nothing much your hands are doing, you can utilize that time to do Yoga Hast/Hand Mudras and harness their energies. Pran Mudra is one of the best options to practice while attending meetings or reading articles, where your hands are free essentially.

You can Also -

Dress up like you would do while going to office so as to feel good in general

Go out on your terrace/balcony once or twice a day to get some fresh air, sunlight and hear birds chirping

Say yes to distractions rather than getting irritated from them, because you cannot avoid them while working from home, like the kids, TV sounds, kitchen sounds etc.

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Agencies
April 21,2020

The Lockdown is not a cure but a critical strategy to prevent the geographical spread of COVID-19.

While pandemics at this level involves actual life threatening situations for individual's or significant others in one's immediate circle, it envisages a marked disruption in routine life. Even after the pandemic has been contained and will come to pass; it's aftermath will leave a trailblazer which demands planning and implementation of a post pandemic reconstruction of society with potentially traumatic experiences varying in intensity, multiplicity and duration.

Degree of Trauma

It would do well for each one of us to realise that the pandemic is "potentially traumatic", since not everyone will experience COVID -19 as a traumatic event in their lives. Yet, there will be those who may develop post pandemic stress reactions, depression and related dysfunction and pathological reactions while still other exhibit healthy reactions to the same set of circumstances.

"Psychological reactions to the pandemic can be distilled into four distinct prototypical patterns, namely, Resilience, Recovery, Chronic and Delayed patterns which may vary in intensity, multiplicity, and duration. Resilient individual have an ability to bounce back from adversity and experience modest or little disruption in normal functioning and are able to maintain a relatively stable, healthy levels of psychological functioning even after enduring the pandemic. Recovery pattern is characterised by relatively rapid reduction in symptoms and return to normal functioning whereas chronic pattern is characterised by symptoms and dysfunction of a long duration," says Pune-based military psychologist Lt Col Dr Samir Rawat.

Challenges at the Individual and Community Levels

From a psychological perspective, post pandemic reconstruction would entail catering to the problems, concerns and needs of those adversely impacted by the COVID -19 with stress symptoms typically characterised by individual's experiencing an overwhelming trauma of the pandemic (for example, recurring nightmares/ breaking into a cold sweat, flashback of stressful events, increasing irritability, low frustration tolerance or emotional numbing).

It could also manifest in depressive symptoms which may result in lack of interest or diminished pleasure in activities and things which you earlier liked to do, feelings of worthlessness or even survivor guilt in case of a loss of a loved one due to COVID-19, fleeting thoughts of death and suicidal ideation. Physical symptoms, on the other hand could be a decrease in appetite, weight and sleep problems, inability to focus and lack of concentration.

Undoubtedly, the pandemic will cause a financial loss of varying magnitude to many, especially the marginalised and economically disadvantaged strata of daily wage earners; it will also lead to loss of jobs (already beginning to show), homelessness, occupational difficulties and new challenges in interpersonal relations at work and on the home front, besides physical health problems and psychological barriers with new norms of accepted social behaviour (social distancing, handshakes, an obsession for cleanliness to name a few).

Emotional battles

Many factors may influence whether individuals come out stronger and more resilient or surrender to the pandemic. Emotion Regulation is one such long term critical factor that can play an important role in contributing to varying degrees of adaptation with negative or positive outcomes. While we know that primary emotions are fear, anger, disgust, joy, anticipation, acceptance, sadness and surprise, other basic emotions include wonder, love, desire, joy, hatred, sadness, attachment, disgust, rage and even expectancy .

To be able to regulate these emotions and avoid negativity , especially on social media platforms is likely to increase efforts in emotion regulation which involves initiating, increasing or maintaining an emotional response.

This means by regulating or on the other hand by stopping, decreasing or avoiding an emotional response, that is, by down-regulating, depending on the individual's objectives and goals or his /her ability to regulate emotions in the valued and given direction.

"One of the best ways to regulate emotions is through cognitive restructuring wherein we change the way we think; after all it is not the event but the interpretation of the event which is perceived as stressful and finding meaning promotes resilience and reduces risk and vulnerability to stress," advises Dr Rawat.

Adding, "Clearly, we need to have a psychological plan to prevent, mitigate and minimise negative outcomes by post pandemic reconstruction of society at an individual and community level all over the country; this has to be integrated by all leaders across verticals in diverse domains."

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Agencies
March 15,2020

Should you let your babies "cry it out" or rush to their side? Researchers have found that leaving an infant to 'cry it out' from birth up to 18 months does not adversely affect their behaviour development or attachment.

The study, published in the Journal of Child Psychology and Psychiatry, found that an infant's development and attachment to their parents is not affected by being left to "cry it out" and can actually decrease the amount of crying and duration.

"Only two previous studies nearly 50 or 20 years ago had investigated whether letting babies 'cry it out' affects babies' development. Our study documents contemporary parenting in the UK and the different approaches to crying used," said the study's researcher Ayten Bilgin from the University of Warwick in the UK.

For the study, the researchers followed 178 infants and their mums over 18 months and repeatedly assessed whether parents intervened immediately when a baby cried or let the baby let it cry out a few times or often.

They found that it made little difference to the baby’s development by 18 months.

The use of parent’s leaving their baby to ‘cry it out’ was assessed via maternal report at term, 3, 6 and 18 months and cry duration at term, 3 and 18 months.

Duration and frequency of fussing and crying was assessed at the same ages with the Crying Pattern Questionnaire.

According to the researchers, how sensitive the mother is in interaction with their baby was video-recorded and rated at 3 and 18 months of age.

Attachment was assessed at 18 months using a gold standard experimental procedure, the strange situation test, which assesses how securely an infant is attached to the major caregiver during separation and reunion episodes.

Behavioural development was assessed by direct observation in play with the mother and during assessment by a psychologist and a parent-report questionnaire at 18 months.

Researchers found that whether contemporary parents respond immediately or leave their infant to cry it out a few times to often makes no difference on the short - or longer term relationship with the mother or the infants behaviour.

This study shows that 2/3 of mum's parent intuitively and learn from their infant, meaning they intervene when they were just born immediately, but as they get older the mother waits a bit to see whether the baby can calm themselves, so babies learn self-regulation.

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