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Controversy and confusion as AstraZeneca releases results

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Controversy and confusion as AstraZeneca releases results


This week, AstraZeneca released two sets of phase III safety trial results for its Covid-19 vaccine, each showing slightly different efficacy rates. The inconsistency has kicked up controversy and confusion, but experts so far believe there is little impact on safety.

The results

In AstraZeneca’s first set of data, released March 22nd, its vaccine candidate was shown to be 79% effective overall and 80% effective on adults 65 and older, This report, based on 32,449 trial participants with a 2:1 distribution of vaccine to placebo, had 141 cases of Covid-19. None were severe, despite 20% of subjects being in the 65-and-older age category and 60% overall having comorbidities that increased Covid-19 risk.

Later in the week, another set of data was released. Now, the effectiveness was only 76% overall but had risen to 85% for patients aged 65 and older. 49 more cases were included, bringing the total to 190. Eight of these cases were severe, but they had all received the placebo rather than the vaccine. The new report also mentions 14 more unconfirmed cases that could shift the percentage more as analysis continues.

Bridging the gap

As to what happened between the first and second release of data, AstraZeneca released two sets of data so close together, complicated.

AstraZeneca’s initial results raised the eyebrows of those federal officials involved in reviewing AZ’s trial data. The New York Times reported that the trial’s federal medical oversight board sent a private letter to the pharma giant criticizing its report for using an incomplete set of results. Some recent Covid-19 cases had been excluded even after discussion with the board, improving the quoted efficacy rate. Shortly after, the National Institute of Allergy and Infectious Diseases issued a statement on the controversy:

“Late Monday, the Data and Safety Monitoring Board (DSMB) [sent notification] that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial … [and] may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data.” 

The board requested up-to-date information, which became the second round of phase III trial results.

In the company’s press release, Executive Vice President of BioPharmaceuticals R&D Mene Pangalos explained: “The primary analysis is consistent with our previously released interim analysis, and confirms that our COVID-19 vaccine is highly effective in adults, including those aged 65 years and over. We look forward to filing our regulatory submission for Emergency Use Authorization in the US and preparing for the rollout of millions of doses across America.”

Blood clot concern

The AZ vaccine made headlines earlier in the month for a different problem. In early March, the Austrian Federal Office for Safety in Health Care (BASG) received reports of two cases of death by blood clot in patients that had received doses from the same batch of AZ vaccine. Countries across Europe temporarily suspended use of the vaccine.

The European Medicines Agency conducted an investigation into the reports and concluded that most people had no significant risk of blood clots. Clotting was a “very rare” potential reaction in patients with low levels of blood platelets. 

Still safe and effective?

In the wake of the blood clot warnings, the WHO issued its own comment, saying “it is routine for countries to signal potential adverse events following immunization. This does not necessarily mean that the events are linked to vaccination itself, but it is good practice to investigate them.” The WHO believes that “the benefits of the AstraZeneca vaccine outweigh its risks and recommends that vaccinations continue.”

Health Canada added a warning about the blood clot risk to its guidance, but is still recommending people move forward with using all approved vaccines. No risk of blood clots was listed in the clinical trial results released in the US.

As for the difference in trial results? There may not be cause for concern. Stephen Evans BA, MSc, FRCP, of the vaccine center at London School of Hygiene and Tropical Medicine, told the Associated Press that any vaccine with over 60% effectiveness could be important adding that, “Results fluctuate as data accumulate … what counts will be the FDA assessment and that will be done based on scrutiny of the full data and not press releases.”

According to its press releases, AstraZeneca plans to apply for FDA Emergency Use Authorization “in the coming weeks.”

Sean Marsala is a health writer based in Philadelphia, Pa. Passionate about technology, he can usually be found reading, browsing the internet and exploring virtual worlds.





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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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