VA-SenaSeptember 9, 2020
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2min2322

Astrazeneca Pharma India Share: The parent company AstraZeneca “voluntarily paused” a randomized clinical trial of its coronavirus vaccine asa volunteer developed an unexplained illness.

 

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AstraZeneca Pharma India shares dived nearly 7 per cent on Wednesday, after its parent company, AstraZeneca, “voluntarily paused” a randomised clinical trial of its coronavirus vaccine, citing unexplained illness of a volunteer. The AstraZeneca Pharma stock declined by as much as 13.40 per cent – or ₹ 64.80 – to ₹ 3,650 apiece at the weakest level recorded on the BSE during the session, having started the day weaker at ₹ 3,800 compared to its previous close of ₹ 4,214.80. (Track AstraZeneca Pharma India Shares Here)

“As part of the ongoing randomized, controlled global trials of the Oxford coronavirus vaccine, our standard review process was triggered and we voluntarily paused vaccination to allow review of safety data by an independent committee,” a company spokesperson said on Tuesday.

The nature and severity of the illness is not yet known. In large trials, illnesses occur by chance and trials do get paused for an independent review. But this is the first instance of a pause in COVID-19 vaccine trials.

AstraZeneca is one of nine companies in late-stage Phase 3 trials for COVID-19 vaccine candidates. It has collaborated with the University of Oxford to develop the vaccine.


VA-SenaSeptember 9, 2020
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2min2279

The top medical research has made these revelations to investigate the effectiveness of plasma therapy for the treatment of COVID-19 after conducting a study in 39 hospitals across India.

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The Convalescent Plasma (CP) therapy didn’t help in reducing death due to the coronavirus, the India Council of Medical Research (ICMR) revealed in a study.

The top medical research has made these revelations to investigate the effectiveness of plasma therapy for the treatment of COVID-19 after conducting a study in 39 hospitals across India.

For this, the ICMR researchers did an open-label, parallel-arm, phase II, multicentre, and randomized controlled trial from April 22 to July 14 this year. The trial was registered with the Clinical Trial Registry of India (CTRI) for the purpose, it said.

1,210 patients (moderately ill, confirmed COVID-19 cases) admitted across 39 trial sites were screened. Of these, 29 were teaching public hospitals and 10 were private hospitals spread across 14 states and Union Territories representing 25 cities.

The study was conducted on 464 randomly enrolled participants who were hospitalized and were moderately ill, confirmed COVID-19 patients. 235 participants were put in the intervention arm while 229 subjects were in the control arm.

According to the study, participants were randomised to either the control or the intervention arm. Two doses of 200 ml CP was transfused 24 hours apart in the intervention arm.


VA-SenaSeptember 8, 2020
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2min2241

First Batch Of Russia’s Covid Vaccine Sputnik V Released Into Public

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The Russian health ministry registered the first vaccine against COVID-19, named Sputnik V, on August 11.

Moscow: The first batch of Sputnik V vaccine against coronavirus, developed by Russia’s Gamaleya National Research Center of Epidemiology and Microbiology and the Russian Direct Investment Fund (RDIF) has been released into civil circulation, regional deliveries are planned in the nearest future, the Russian Health Ministry informs.

“The first batch of the ‘Gam-COVID-Vac’ (Sputnik V) vaccine for the prevention of the new coronavirus infection, developed by the Gamaleya National Research Center of Epidemiology and Microbiology of the Ministry of Health of Russia, has passed the necessary quality tests in the laboratories of Roszdravnadzor (medical device regulator) and has been released into civil circulation,” the ministry said in a statement.

The Russian health ministry registered the first vaccine against COVID-19, named Sputnik V, on August 11.

Moscow Mayor Sergey Sobyanin expressed hope on Sunday that the majority of the Russian capital’s residents will be vaccinated against the coronavirus within several months

According to the health ministry, the delivery of the first batch of the Russian vaccine to the country’s regions is planned in the nearest future.

 


VA-SenaJuly 20, 2020
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7min27610

 

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A group of Indian-origin doctors has warned that inherent racial bias in medical research and practice could be exacerbating the disproportionately severe impact of COVID-19 among ethnic minorities in the UK and globally, as they call for a wider study into lifestyle-related risks among them.

While metabolic syndrome (MetS) that increases a person’s wider health risk is known to be behind the severity of the deadly virus among some ethnic groups, UK-based cardiologist Aseem Malhotra and British Association of Physicians of Indian Origin (BAPIO) chairman JS Bamrah and US-based infectious disease and obesity physician Ravi Kamepalii highlight that the genetic factors behind MetS are not being properly factored in.

They warn that genetic predisposition may be a key factor behind South Asians developing conditions linked to obesity, such as Type 2 diabetes, at much lower levels of body fat.

But these are not being identified as high risk and managed appropriately because of the general focus on Body Mass Index (BMI) as a proxy for “healthy weight”.

“Using Body Mass Index (BMI) as a proxy for ‘healthy weight” may provide the illusion of protection and will miss a substantial proportion of those from black and South Asian ethnic minority groups with MetS risk,” they write in the peer-reviewed academic journal ‘The Physician’.

BMI is determined by a person’s weight relative to their height and a BMI above 30 is taken as the standard measure for unhealthiness in the UK.

According to Public Health England (PHE), those from black, Asian and minority ethnic (BAME) backgrounds are at increased risk of poor outcomes from COVID-19.

Last month, an official UK government review found that historic racism is among the factors behind this higher risk of ethnic minorities contracting and dying from COVID-19.

In their paper titled ‘Poor metabolic health is the major issue for increased COVID-19 mortality in BAME groups’, the doctors note: “Just as racism is endemic in the NHS [National Health Service], racial bias exists in the identification and management of patients from BAME backgrounds at high risk.

“Normal BMI metabolically unhealthy have a threefold increased all-cause mortality and or cardiovascular event risk compared to metabolically healthy normal weight over a 10-year period. Unfortunately, the current NHS risk assessment tool doesn’t directly measure metabolic health which is a more sensitive method to identify and subsequently manage BAME individuals at high risk.”

Poor diet, lack of activity and severe Vitamin D deficiency are highlighted as the common factors leading to poor metabolic health and increased infection severity risk among BAME backgrounds, particularly South Asians.

The doctors have called for an immediate update of the risk assessment tool to take into account five factors that will help identify those from ethnic minority backgrounds at the highest risk from not just Covid-19 complications, but longer-term risk of death and heart attack.

These five factors are: blood pressure above 120/80mmHg, (pre-hypertension or hypertension); HbA1c > 5.7 (pre-diabetes/Type 2 diabetes); high blood triglycerides; low HDL-Cholesterol; and increased waist circumference.

MetS, which has been identified as having up to several-fold increased risk of mortality from COVID-19, is defined as having at least three of the above risk factors but this is not being assessed in the current NHS risk assessment tools, the doctors note.

They also draw on a “concerning picture” of lifestyle factors not being addressed behind those risk factors, which include a diet low in whole fruit and vegetables, and one that’s high in sugar and refined carbohydrates especially in those from South Asian backgrounds.

Indians are consuming at least twice the amount of sugar as recommended as a maximum limit by the World Health Organisation (WHO), their paper notes.

Also, given a genetic tendency to lower genetic cardiorespiratory fitness, people from South Asian backgrounds may require 233 minutes of moderate activity per week to get the same cardiometabolic risk benefits as a white European doing 150 minutes per week.

The paper adds: “Vitamin D plays an essential role in innate and adaptive immunity. Severe Vitamin D deficiency, which has been strongly correlated with adverse outcomes from Covid-19, also has a high prevalence amongst BAME groups in the UK. The majority of those from South Asian or black backgrounds are either deficient or severely deficient.

“It’s imperative that those from BAME backgrounds know their Vitamin D status but it’s not currently routinely measured in primary care. In those who are deficient measures should be taken to correct it. More sun exposure is required to generate adequate levels compared to those of lighter skin colour.”

The most important food sources of Vitamin D are fatty fish, cod liver oil, eggs and mushrooms but as a back-up supplements may also be used to top up a deficiency.

The authors stress that many of the risk factors they have highlighted can be improved, and even reversed, very quickly through diet and lifestyle changes but more research and publicity on diet and lifestyle interventions in metabolically unhealthy BAME groups, including those with a normal BMI who are at highest risk, is urgently required.

“The evidence is clear, time for action on metabolic health is long overdue. Otherwise there will be even more misery and devastation when the next pandemic comes round,” they warn.


VA-SenaJuly 14, 2020
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5min26460

Glenmark Pharmaceuticals on Monday announced a price reduction of its generic version of favipiravir, FabiFlu, by 27 per cent in India.

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Glenmark Pharmaceuticals, a research-led, integrated global pharmaceutical company, on Monday announced a price reduction of its generic version of favipiravir, FabiFlu, by 27 per cent in India. This means the new MRP would be INR 75 per tablet from the earlier INR 103 per tablet. The pharmaceutical firm also announced that it has commenced post-marketing surveillance (PMS) study on FabiFlu to closely monitor the efficacy and safety of the drug in 1000 patients that are prescribed with the oral antiviral, as part of an open-label, multicenter, single-arm study.

The price reduction has been made possible through benefits gained from higher yields and better scale, as both the API and formulations are made at Glenmark’s facilities in India, the benefits of which are being passed on to patients in the country, the company said in a release on Monday. Glenmark has successfully developed the active pharmaceutical ingredient (API) and the formulation for FabiFlu through its own in-house R&D team within the country, ensuring self-reliance with regard to long-term production and manufacturing. The API is manufactured at the Gujarat production facility which is USFDA & MHRA-UK approved. The formulation product is manufactured at the facility in Himachal Pradesh, which is also USFDA and MHRA-UK approved.

“We expect this post-marketing surveillance study to shed more light on the drug’s clinical effectiveness and safety in a large cohort of patients prescribed FabiFlu. Our priority from the start of this pandemic has been to offer patients in India an effective treatment for COVID-19, while also ensuring accessibility to the masses. Our internal research shows us that we launched FabiFlu in India at the lowest market cost as compared to the cost of Favipiravir in other countries where it is approved. And now we hope that this further price reduction will make it even more accessible for patients across the country,” said Mr Alok Malik, Senior Vice President & Head – India business, Glenmark Pharmaceuticals Ltd., commenting on these developments.

Despite investing significantly in R&D, clinical trials and the manufacturing of FabiFlu (API and formulations), Glenmark has managed to keep the pricing of FabiFlu® lower as compared to its price in other countries. FabiFlu in India was originally launched at INR 103/tab, while, its price as INR is higher in the remaining countries. (INR 600/tab in Russia, INR 378/tab in Japan, INR 350/tab in Bangladesh and INR 215/tab in China). Based on trade data available for 200mg/tab from the respective countries and currency rates in respective countries equivalent to INR recorded.

On June 20th, Glenmark announced that it received manufacturing and marketing approval from India’s drug regulator for FabiFlu, making it the first oral Favipiravir-approved medication in India for the treatment of mild to moderate COVID-19. The manufacturing and marketing approval was granted as part of the accelerated approval process, considering the emergency situation of the COVID-19 outbreak in India. The approval’s restricted use entails responsible medication use where every patient must have signed informed consent before treatment initiation.

Most patients exhibiting mild to moderate symptoms can benefit from FabiFlu use. The company has also completed the phase 3 clinical trial with Favipiravir (FabiFlu) in mild to moderate COVID-19 patients in India. The trial results will be available shortly.

Glenmark is also conducting another Phase 3 clinical trial to evaluate the efficacy of two antivirals drugs Favipiravir and Umifenovir as a combination therapy in moderate hospitalized adult COVID-19 patients in India. The combination study which is called the FAITH trial is looking to enroll 158 hospitalised patients of moderate COVID-19 in India. Early treatment with combination therapy will be evaluated for safety and efficacy as it is emerging as an effective approach in shortening the duration of virus shedding, facilitating early clinical cure and discharge of patients.


VA-SenaJuly 14, 2020
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4min28290

 

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Russian scientists claimed on Monday that they hope to launch the world’s first coronavirus as soon as next month, as per report. On Sunday, Russia’s Sechenov University said that it had successfully completed clinical trials of a COVID-19 vaccine developed by the state-run Gamalei Institute of Epidemiology and Microbiology.

The head and chief researcher at Sechenov University Center for Clinical Research on Medications Elena Smolyarchuk told Russian news agency TASS that clinical trials of the vaccine on volunteers have been completed and study data showed the candidate’s effectiveness.

“The research has been completed and it proved that the vaccine is safe,” Smolyarchuk was quoted as saying by TASS of its trial.

The Gamalei center’s director Alexander Gintsburg told TASS that he hopes the vaccine will ‘enter civil circulation’ on August 12-14, adding that private companies may begin mass production by September, The Moscow Times reported.

Meanwhile, the World Health Organization’s protocols said that a vaccine has to go through three phases of studies before being approved for large-scale production. Also, WHO’s draft landscape of coronavirus vaccines lists the Russian candidate vaccine study as a phase 1 trial. Perhaps, till date, no vaccine has been approved for large-scale use without undergoing the third phase of testing, which is the largest in terms of the number of participants. A candidate vaccine usually undergoes industrial production if the last phase shows clear and definitive evidence of its safety and efficacy.

According to The Moscow Times report, Smolyarchuk had said earlier in July that some participants developed typical responses to injections like headaches, elevated body temperatures. However, these symptoms were resolved within 24 hours.

In a July 3 press release, the university stated that the Russian Health Ministry will take a decision on the effectiveness of the substance based on the results of biochemical tests.

The Sechenov First Moscow State Medical University will discharge the two groups of volunteers on July 15 and July 20 after spending 28 days in isolation to protect them from exposure to other infections. The trial participants, aged 18-65, will be monitored for six months after their release, added Smolyarchuk.

It may be noted that the first stage of the vaccine trial at the university was launched on June 18 in a group of 18 volunteers who were vaccinated against the virus. The second group involving 20 participants were administered the vaccine on June 23.

Russia is one of the several nations racing against time to develop a safe vaccine against COVID-19, which has so far claimed at least 569,879 lives and infected about 12,992,640 people worldwide.


VA-SenaJuly 1, 2020
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3min26510

National Doctor’s Day 2020: Salute The Frontline Warriors; Know The Theme And Significance

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While almost every one of us has always known the importance of doctors in our lives, this pandemic has shown has made us realize how immense is the contribution of doctors and medical professionals in our society.

While we are fear the coronavirus sitting at homes, and home isolating ourselves, the doctors risk their lives every day to cure us, help us and save us. We feel good that the recovery rate of India in this pandemic is better than others, but who made this possible. Doctors are those who ensure we recover from every ailment and remain healthy. A salute to all medical professionals, the frontline warriors who get out of their homes everyday and provide round the clock services to save our lives.

Doctors are truly the greatest heroes, of not just the present but of all time.

Why do we celebrate Doctor’s day? India celebrates National Doctor’s Day on July 1 each year, in honour of the birth and death anniversary of the great physician and the second Chief Minister of West Bengal, Dr. Bidhan Chandra Roy. Since then India has grown by leaps and bounds in the medical field, not just to further Dr. B.C. Roy’s work but also with new and innovative techniques. This day serves to show gratitude to all those who have selflessly aided us in our time of need and tirelessly worked for the health of their patients by commemorating the greatest representative of these ideals.

Doctor’s Day Theme The theme of this year’s Doctors Day is “Lessen the mortality of COVID 19”. This includes awareness about asymptomatic hypoxia and early aggressive therapy.

In India, this day is organized by the Indian Medical Association (IMA). According to IMA, Doctor’s Day of 2020 is of special importance. Every member of IMA and the local branch take a lead in the local area and bring about a change in the current situation (Covid-19 pandemic). Doctors Day of 2020 is dedicated to the innumerable doctors who are serving during this epidemic in the primary and secondary care setups as well as the dedicated COVID care hospitals.

PM and other leaders express gratitude and Salute the Covid Warriors Prime Minister Narendra Modi took to twitter and posted a video to thank the Covid warriors who have been taking care of each one of us and serving the country without thinking about their lives.


VA-SenaJuly 1, 2020
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4min25880

COVID-19 Duty: Haryana Deploys Final-Year MBBS Students Amid Rise In Coronavirus Cases

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The director general of medical education and research in Haryana said in an order that 1,106 final-year MBBS students of 11 government and private medical colleges in the state have been assigned COVID-19 duties and they shall report to civil surgeons of the districts concerned.

Amid rising number of COVID-19 cases, the Haryana Government has said final-year MBBS students studying in government and private medical colleges will be deployed for effective management of the pandemic. The death toll due to COVID-19 in Haryana on Sunday rose to 160 with 11 fresh fatalities, while the infection tally climbed to 10,635 as 412 more people tested positive for the disease, a health department bulletin said.

The director general of medical education and research in Haryana said in an order that 1,106 final-year MBBS students of 11 government and private medical colleges in the state have been assigned COVID-19 duties and they shall report to civil surgeons of the districts concerned.

There has been a surge in the number of COVID-19 positive cases in Haryana. The government is in the process of creating additional healthcare facilities to effectively manage the COVID-19 cases which required additional manpower, the order dated June 19 said.

The government has decided that all final-year MBBS students of all government and private medical colleges in the state shall be deputed with the health department with immediate effect, it said. The directors of medical colleges and civil surgeons shall ensure that the students are provided all necessary training, it added.

According to the order, the students have been asked to report to the civil surgeons concerned by June 22. If needed, the civil surgeons shall also ensure boarding and lodging arrangements for the students, the order stated.

Coronavirus cases in Haryana have risen sharply during the past three weeks, with Gurgaon and Faridabad accounting for majority of the cases as well as fatalities. Of 11 fresh fatalities on Sunday, Gurgaon and Faridabad, among Haryana’s worst-hit districts, accounted for nine fresh fatalities. The death toll in Gurgaon and Faridabad, which fall in the National Capital Region (NCR), has now climbed to 64 and 56, respectively.

The state health department bulletin said with 11 more COVID-19 deaths the total number of fatalities in the state has risen to 160. Of the total fatalities in Haryana, 109 are males and 51 females. With 412 fresh infections, the total number of COVID-19 cases in Haryana rose to 10,635 on Sunday, the bulletin said. Gurgaon alone accounts for 4,427 cases in Haryana, while Faridabad has 2,237 cases.

 


VA-SenaJuly 1, 2020
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2min27310

Maharashtra Medical Education Department Asks DMER To Publish Timetable 45 Days Before Exams

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The Maharashtra Medical Education and Drugs Department (MED) on Wednesday asked the Directorate of Medical Education Research (DMER) and the Maharashtra University of Health Sciences (MUHS) to publish the timetable 45 days before exams for AYUSH and other courses.

The MED also directed that one day’s gap between each paper must be given.

“The MED GoM decides to hold exams for medical, AYUSH and other MUHS Courses. Direct Directorate of Medical Education Research and MUHS to publish timetable 45 days before the date of exams and a day’s gap between each of the papers,” said the MED in a tweet.

Maharashtra Education Minister Amit Deshmukh said that the state government has taken steps to conduct these examinations as per the guidelines of the National Medical Commission. He further said that the safety of students in times of COVID-19 is a “top priority”.

“Under the leadership of CM Uddhav Thackeray Ji, GoM (Government of Maharashtra) has taken steps to conduct medical exams of all branches of health sciences as per the guidelines of the National Medical Commission. We are watchful of the COVID-19 pandemic, student safety and interest is our top priority,” he tweeted.

Maharashtra, the worst-hit state by the COVID-19 pandemic, on Wednesday reported 3,890 new cases, taking the total count to 1,42,900.

The state health department said in a bulletin that 208 deaths were reported in the last 24 hours, taking the toll to 6,739.

A total of 4,161 patients were discharged on Wednesday and the number of discharged patients is presently at 73,792. The recovery rate in the state is 51.64 per cent.


VA-SenaMay 21, 2020
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7min24240

A recent large-scale study concludes that both type 1 and type 2 diabetes are associated with an increased risk of COVID-19-related in-hospital death. It finds that one-third of coronavirus-related deaths in hospitals in England are individuals with diabetes.

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Over the last few months, researchers have rushed to gather information on the effects of a virus that, just last year, was unknown to science. The virus, SARS-CoV-2, causes the disease COVID-19.

Now, with millions of cases globally, scientists are trying to understand which factors have an association with poorer outcomes.

Among these factors is diabetes. As the authors of the recent study explain, early analyses from Italy, China, the United States, and the United Kingdom suggest that individuals with diabetes have an increased risk of developing more severe cases of COVID-19.

Stay informed with live updates on the current COVID-19 outbreak and visit our coronavirus hub for more advice on prevention and treatment.

However, until now, studies have not differentiated between type 1 and type 2 diabetes; the latest investigation addresses this gap in our understanding.

The findings are available from the U.K.’s National Health Service (NHS) website; they have not yet been peer reviewed and are awaiting publication.
Diabetes and COVID-19
According to the authors, their study is “the largest COVID-19 related study, covering almost the entire population of England, and is the first study to investigate the relative and absolute risks of death in hospital with COVID-19 by type of diabetes, adjusting for key confounders.”

To investigate, the researchers used data from the National Diabetes Audit: an estimated 98% of doctor’s offices in England participated in this program, the purpose of which is to help monitor and improve diabetes services.

The scientists extracted information from the COVID Patient Notification System, which registers all hospital deaths related to COVID-19. They used data from March 1–May 11, 2020.

As part of the analysis, the authors adjusted their findings for factors that might influence the results, such as age, sex, deprivation, ethnicity, and existing health conditions.

Of the 61,414,470 people registered at a doctor’s office in the U.K., 263,830 individuals had a type 1 diabetes diagnosis, and 2,864,670 had a type 2 diabetes diagnosis. The authors write:

“There were 23,804 COVID-19 related deaths. One-third occurred in people with diabetes: 7,466 (31.4%) with type 2 and 365 (1.5%) with type 1 diabetes.”

After adjusting for age, sex, deprivation, ethnicity, and geographical region, the researchers found that, compared with individuals without diabetes, people with type 1 diabetes had 3.5 times the odds of dying in the hospital with COVID-19. Similarly, individuals with type 2 diabetes had 2.03 times the odds of dying in the hospital with COVID-19.

When the researchers adjusted the data to account for previous hospital admission with coronary heart disease, cerebrovascular disease, or heart failure, the odds changed to 2.86 and 1.81, respectively.

Overall, the authors conclude that “all types of diabetes are independently associated with a significant increased risk of in-hospital death with COVID-19.”

Other findings
The authors also looked at other characteristics they associated with in-hospital COVID-19 deaths. They found that the average age of death was 78.6 and that 61.5% were males. They also identified an association between previous coronary heart disease and an increased risk of death.

When they split the data into five levels of depravation, they demonstrated that “The highest proportion of deaths were in those from the most deprived [fifth] of the population (23.8%), decreasing to 15.8% from the least deprived [fifth].”

Their analysis also found an increased risk for people of black, Asian, or mixed ethnicity.

In agreement with earlier research, the authors found that advanced age strongly influences the risk of in-hospital death from COVID-19; they write:

“[T]here is a 700-fold difference in risk between those aged under 40 compared to those over 80.”

The authors continue, “Age was the dominant risk factor for in-hospital death with COVID-19 and had a much greater influence on risk than diabetes status, sex, ethnicity, or socioeconomic deprivation.”

“Even with the additional risk associated with type 1 diabetes or type 2 diabetes,” they emphasize, “people under the age of 40 years with either type of diabetes were at very low absolute risk of in-hospital death with COVID-19 during the observation period of this study in England.”

The authors note that the study was limited because they could not account for all previous or existing medical conditions. In particular, they mention hypertension and chronic kidney disease, which they could not include due to a lack of available data.

In their conclusion, the authors “encourage the use of these findings, along with those from other studies investigating associations with serious COVID-19 related outcomes, to provide reassurance for people who are at low absolute risk, despite having diabetes.”

“For those who are at higher risk,” they explain, “the results inform public guidance, including recommendations for shielding.”