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Pfizer’s RSV Vaccine: Rare Neurological Condition An ‘Important Potential Risk’ Of The Jab

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Third COVID-19 Vaccine Dose Protection Only Good For 3 Months?


The first RSV vaccine candidate from Pfizer is under fire from the US Food and Drug Administration (FDA) after a rare neurological syndrome has been identified as a potential risk of getting the jab.

During the clinical trial of Pfizer’s RSV vaccine, two people who received the shot were diagnosed with Guillain-Barre syndrome later. As a result, the FDA has asked Pfizer to conduct a safety study if the vaccine is approved, according to documents released Friday.

The two adults, who suffered from the syndrome, were in their 60s, and belonged to a group of 20,000 volunteers who received the shot in Pfizer’s Phase 3 clinical trial. Interestingly, one person’s illness subsided after three months, while the other one was improving after a period of six months. In contrast, no case of Guillain-Barre was observed in people who didn’t receive the jab, according to CNN.

“Given the temporal association and biological plausibility, FDA agrees with the assessments of the investigators that these events were possibly related to study vaccine. … Therefore, [Guillain-Barre] is being considered an important potential risk,” the FDA said.

Guillain-Barre syndrome is a rare neurological disorder that affects the nerves. In this condition, the immune system damages one’s own nerves. This, in turn, causes muscle weakness and even paralysis in some cases. While most people recover completely, in some, the syndrome can turn fatal or lead to lasting effects.

Guillain-Barre has an incidence rate of 1.5 to 3 cases for 100,000 adults over age 60 in the US, according to the FDA.

“Given the higher than the background rate of GBS observed in the Phase 3 study, FDA will recommend a postmarketing study and enhanced surveillance for further evaluation of GBS and other immune-mediated demyelinating conditions with postmarketing use,” the FDA said.

However, in a briefing document submitted for next week’s meetings, Pfizer makes a case that the two incidents have other possible explanations, and assured its shot was a “well-tolerated and safe vaccine, with a benefit-to-risk ratio that is favorable.”

Furthermore, the pharma company said that it will conduct a safety study on Guillain-Barre syndrome if its vaccine gets the green light.

RSV is a virus that causes flu-like illness in people of all ages. According to the US Centers for Disease Control and Prevention, RSV is associated with 177,000 hospitalizations and 14,000 deaths per year among adults 65 or older.

Currently, no vaccine is approved for immunization against RSV.

As per the FDA documents, the Pfizer vaccine was 66.7% effective at preventing moderate lower respiratory tract illness with two or more symptoms and 85.7% effective at preventing severe illness.

Another RSV vaccine candidate, GSK’s jab for older adults, was found to be 83.5% effective at preventing severe lower respiratory tract disease. Here also, the company reported a potential case of Guillain-Barre syndrome among vaccine recipients, but added there was insufficient evidence to confirm a diagnosis. 

However, the FDA posits, the case is related to the vaccine, and a review of GSK’s safety plan will be conducted by the agency.





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Feeling Tired All The Time? Possible Causes And Solutions

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Long days of work, lack of sleep, and stress at the office can be the most common factors that make you feel tired. However, feeling “tired all the time” (TATT) without known reasons can be an indication of an underlying health issue that needs immediate attention.

Finding the exact cause of the lingering tiredness can be the first step toward solving the symptom.

Health conditions that cause fatigue:

1. Anemia – Anemia is one of the most common causes of fatigue. A person who has anemia does not have enough red blood cells in the body, causing symptoms such as tiredness, dizziness, feeling cold and crankiness.

Most often, anemia is caused by iron deficiency. Hence, the condition can be best resolved by including iron-rich foods in the diet and use of iron supplements.

2. Sleep Apnea – It causes the body to stop breathing momentarily during sleep. The condition can affect the quality of sleep and hence make you feel fatigued.

For milder cases of sleep apnea, lifestyle changes such as losing weight or quitting smoking can help solve the sleep disorder. In more severe cases where there is an obstruction in breathing, surgeries and therapies can help.

3. Diabetes – A person who has diabetes has changes in blood sugar level, which can cause fatigue. A patient who is already on diabetic medication can also experience tiredness as a side effect of the medication.

Early identification and taking the correct treatment is the key to managing diabetes. Losing extra weight and having a healthy diet also help in the treatment.

4. Thyroid – Thyroid diseases can be due to an overactive or an underactive thyroid gland. In people who have an underactive thyroid (hypothyroidism), the metabolism slows down leading to symptoms such as lethargy and fatigue. In people with an overactive thyroid (hyperthyroidism), the metabolism speeds up leading to fatigue and difficulty sleeping.

Right diet and lifestyle choices, along with medications, can help in thyroid management.

5. Infections – A person can show symptoms of fatigue when the body is fighting a viral or bacterial infection. Infections ranging from the flu to HIV can cause tiredness.

Along with fatigue, other symptoms such as fever, headache, body aches, shortness of breath and appetite loss can also accompany the infection. Treating the symptoms and taking adequate rest helps in faster recovery.

6. Food allergies – Fatigue may be an early warning sign of hidden food allergies and autoimmune disorders such as celiac disease. Identifying the allergen using a food allergy test or through an elimination diet can help in allergy treatment.

7. Heart disease – If you feel exhausted from an activity that used to be easy, then it is good to check your heart health, as fatigue can be an indication of underlying heart disease.

8. Depression/ anxiety – Fatigue can also be an indicator of a mental health disorder such as depression or anxiety. A combination of medication and psychotherapy can help relieve symptoms.

Lifestyle causes

Apart from serious health conditions, certain lifestyle habits such as dehydration, poor diet, stress and insufficient sleep can cause exhaustion. Having a well-balanced diet, regular exercise and routine sleep can help solve fatigue caused by lifestyle habits.

Published by Medicaldaily.com



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How To Overcome Your Sleep Debt And Reclaim Energy

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Picture this: you’re burning the midnight oil, studying or binge-watching your favorite shows, all at the expense of a good night’s sleep. Have you ever stopped to think about the toll it takes on your body and mind? The consequences can be more serious than you might realize.

Not getting enough sleep can translate into a multitude of issues, including weight gain, lack of focus, tiredness, a haze of confusion, and even depression. If you too are encountering similar issues lately then chances are you have a sleep debt.

Wondering what is sleep debt?

People from 13-18 years of age need 8 hours of sleep, whilst adults beyond that age will require at least 7 hours of snooze.

Sleep debt is a collection of the total hours you haven’t slept or traded your sleep for something else. Sleep debt keeps piling up as a person falls short of the total hours of sleep recommended for an adult, according to the Centers for Disease Control and Prevention.

And when you keep letting go of your sleep for other activities, the body adapts to the new normal and effects start to reflect on the energy levels, which deplete.

“However, like every other debt out there, this too has a repayment option,” Dr. Kunal Kumar, medical director of the Sleep Center at Einstein Medical Center in Philadelphia, told Livestrong.

Below are some expert-vetted ways you can pay back the sleep debt. (Courtesy: Livestrong and Sleepfoundation)

Just like financial debt, imagine sleep debt as a debt you owe to your body. It needs to be repaid. The good news is that catching up on sleep is indeed possible.

  • Maintain a set sleep schedule: Overhauling the sleep schedule is a pretty difficult task to achieve, and it’s best to do that gradually. Create a set sleep schedule by making some small changes to your routine. Instead of making abrupt shifts in your bedtime or wake-up time, adjust them gradually by 15 to 30-minute increments.
  • Minimize your gadget usage: Wind down activities and minimize electronic usage before bed to promote better sleep. Relax and prepare for quality sleep by dimming the lights and setting an alarm for 30 minutes to an hour before bed.
  • Reshuffle your sleeping arrangements: Are you finding it hard to get a good night’s sleep due to excessive sweating? Well, here’s a handy solution: consider upgrading to a cooling mattress or opting for cooling sheets. These innovative sleep essentials can help regulate your body temperature, and keep you comfortably cool throughout the night, ensuring a more blissful slumber. Memory foam pillows can work wonders in relieving neck and back discomfort in case you are struggling with backache.
  • Improve the bedroom environment: Create a sleep-friendly bedroom environment by adjusting the temperature for comfort, and blocking out disruptive lights, or noises that might disturb your restful slumber. And if your mattress, pillow, or sheets are worn out or no longer providing the support you need, consider treating yourself to new ones.

Published by Medicaldaily.com



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Omega-3 Fatty Acids Slow The Progression Of Amyotrophic Lateral Sclerosis: Study

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Omega-3 fatty acids are known for a range of health benefits, from promoting brain and heart health to reducing inflammation and protection against several chronic conditions.

In a new study, researchers found that omega-3 acids, especially the type found in foods like flaxseeds, walnuts, chia seeds, canola oil and soybean oil, can slow down the progression of amyotrophic lateral sclerosis (ALS).

It is a debilitating nervous system disease that gradually worsens over time and can be fatal. The condition results in a loss of muscle control and affects the nerve cells in the brain and spinal cord. It is also known as Lou Gehrig’s disease after the baseball player who was diagnosed with it.

The initial symptoms of the disease include muscle weakness, difficulty in walking and hand movements. The symptoms can slowly progress to difficulties with chewing, swallowing, speaking and breathing.

The exact cause of ALS is not known. However, around 10% of people get it from a risk gene passed down from a family member. It is estimated that more than 32,000 people in the U.S. live with the condition.

In the latest study, researchers from Harvard T.H. Chan School of Public Health in Massachusetts evaluated 449 people living with ALS in a clinical trial. The team assessed the severity of their symptoms, the progression of their disease, along with the levels of omega-3 fatty acids in their blood, for 18 months.

The study suggested that alpha-linolenic acid (ALA), a type of omega-3 found in plants, is particularly beneficial in slowing the progression of ALS. The participants with the highest levels of ALA had a 50% reduced risk of death during the study period compared to those with the lowest levels of ALA.

Researchers also found a reduction in death risk in participants who had eicosapentaenoic acid, the type of omega-3 fatty acid found in fatty fish and fish oil, and linoleic acid found in vegetable oils, nuts and seeds.

A previous study conducted by the same team suggested that a diet high in ALA and higher blood levels of the nutrient could reduce the risk of developing the condition.

“In this study, we found that among people living with ALS, higher blood levels of ALA were also associated with a slower disease progression and a lower risk of death within the study period. These findings, along with our previous research suggest that this fatty acid may have neuroprotective effects that could benefit people with ALS,” said Kjetil Bjornevik, the lead author of the study.

Published by Medicaldaily.com



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