FDA RECOMMENDS EMERGENCY APPROVAL OF PFIZER VACCINE IN US - The Daily Guardian
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FDA RECOMMENDS EMERGENCY APPROVAL OF PFIZER VACCINE IN US

Shalini Bhardwaj

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A Food and Drug Administration (FDA) panel has given the nod for the emergency use of the Covid-19 vaccine developed by Pfizer-BioNTech in the USA.

According to the US media, the FDA is likely to provide an EUA for the vaccine on Saturday. This approval is a mechanism to facilitate the easy access and availability for the use of vaccines during emergency situations such as the Covid-19 pandemic.

The authorisation has been given for people aged 16 years or older. The agency is expected to authorise the vaccine within days, prioritising healthcare workers and nursing home residents for receiving the first shots of the vaccine.

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Learning second language boosts cognitive function

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A new study that was jointly conducted by Baycrest and York University has reported that learning a second language is an effective and enjoyable way to improve brain health.

Researchers found that older adults who studied Spanish showed similar improvements in certain critical cognitive skills as did those who engaged in brain training activities that targeted those skills. The findings were published in the journal Aging Neuropsychology and Cognition.

“These results are exciting because they indicate that older adults can reap cognitive benefits from an enjoyable activity in which they might want to participate, regardless of these benefits,” says Dr. Jed Meltzer, Baycrest’s Canada Research Chair in Interventional Cognitive Neuroscience, a neurorehabilitation scientist at Baycrest’s Rotman Research Institute (RRI) and the lead author on this study.

In the study, the researchers recruited 76 older adults aged 65-75. All participants spoke only one language, were cognitively healthy, had never formally studied Spanish before and had not studied any other language in the past 10 years.

Participants were randomly assigned to one of three groups: language learning, brain training or a waitlist (with no language learning or brain training), which served as the control group. For 1

6 weeks, those in the language learning group spent 30 minutes a day, five days a week learning Spanish using Duolingo, an online language learning app. Those in the brain training group spent the same amount of time but used BrainHQ by Posit Science.

The researchers assessed participants’ performance on specific cognitive tasks before and after the 16 weeks. These tasks were similar to the exercises in BrainHQ. At the end of the intervention, they also measured participants’ adherence to the learning schedule and their enjoyment of the program they followed (language learning or brain training).

They found that participants in the language learning group showed similar improvements as the brain training group in two areas of cognition: working memory and executive function – that is, the ability to manage conflicting information, stay focused and avoid distractions.

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Older adults’ stimulant usage associated with higher risk of cardiovascular events

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Use of prescription stimulant medications in older adults increases the risk of cardiovascular events by 40 per cent within the first thirty days of medication use, suggests new research led by Mina Tadrous, Assistant Professor, Leslie Dan Faculty of Pharmacy, University of Toronto.

The study was published today in JAMA Network Open and is one of the first studies to explore the connection between cardiovascular (CV) events among older patients despite their increased baseline risk and the increasing use of stimulants to treat multiple conditions in this group including depression, poststroke recovery, motor function, and fatigue.

“Use of prescription stimulants in older adults has been increasing dramatically in recent years and so we need to explore any associated risk with these medications at a broad level to help improve patient awareness and safe medication use,” said Mina Tadrous, a pharmacist and lead investigator of the study. “We found an increased risk in cardiovascular events like ventricular arrhythmia among patients using these medications within the first thirty days of starting the medication.”

To determine the relative risk of CV events associated with stimulant use, researchers studied Ontario residents age 66 years or older using data from population-based health care databases from January 1, 2002, to December 31, 2016. They compared 6,457 older adults who initiated stimulant use and 24,853 matched older adults who did not initiate such use. Results indicated a 40 per cent increased risk among the group using the stimulant medications.

Researchers also found that the risk of CV events was highest in the first month of use but then started to trend downward at the 180-day mark and also at one year after use. This decreasing risk can be explained by a number of potential factors including that those patients who experienced cardiovascular issues stopped using the medications, most likely in coordination with advice from health providers, said Tadrous. “We think these are important findings because they provide mevidence to continue to inform prescribing choices by health providers and so that patients and caregivers are aware of risks associated with these medications and know what to watch out for when using them for the first time,” he said.

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GLENMARK LAUNCHES FIXED-DRUG COMBINATION TO MANAGE TYPE 2 DIABETES

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Glenmark Pharmaceuticals Limited (Glenmark), a research-led global pharmaceutical company has launched a fixed drug combination for the management of type 2 diabetes.

According to an official statement, the company launched a fixed-dose combination (FDC) of its novel, patent-protected, globally researched Sodium-Glucose Co-Transporter Inhibitor (SGLT2i) – Remogliflozin Etabonate and another widely used DPP4 inhibitor (Dipeptidyl Peptidase 4 inhibitor) – Vildagliptin, with Metformin (first-line medication for the treatment of type 2 diabetes).

“The combination contains Remogliflozin (100 mg) + Vildagliptin (50 mg) + Metformin (500/1000 mg) in a fixed-dose and must be taken twice daily to improve glycemic control in patients. Glenmark has launched the same under two brand names Remo MV and Remozen MV,” the company said in a statement.

With the launch of Remogliflozin-Vildagliptin-Metformin fixed-dose combination (FDC), Glenmark has become the first company in the world to do so and India becomes the first country to gain access to this FDC drug.

“Glenmark received approval from the DCGI (the drug approval authority in India) for manufacturing and marketing this fixed-dose combination in late September 2021,” said the statement. It’s FDC of Remogliflozin-Vildagliptin-Metformin tackles most of the pathophysiology in type 2 diabetes that makes it an appealing fixed-dose combination in managing uncontrolled type 2 diabetes.

The company said that the cost of the drug will be Rs 16.50 per tablet, to be taken twice daily as against Rs 75 as an average cost of existing brands.

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‘LONG COVID’ CAN NEGATIVELY IMPACT COGNITIVE FUNCTION, QUALITY OF LIFE

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Patients experiencing post-acute COVID syndrome (PACS, also known as “long COVID”) may have symptoms for at least 12 months after initial COVID-19 infection, significantly and negatively impacting their cognition, ability to work, participation in physical activity, interaction with others, and overall quality of life, according to a new Mount Sinai study.

The findings of the study were published in the ‘American Journal of Physical and Rehabilitation Medicine’. The study is one of the first to measure the actual impairment and impact of PACS on patients and detail factors that may exacerbate their symptoms. This work will help guide lawmakers and national and international health agencies to develop strategies and policies to support these patients during their lengthy recovery.

“With millions of Americans at risk of developing PACS by the end of the pandemic, a second, longer-term public health emergency has emerged. It is imperative to understand the burden of this novel condition and develop targeted interventions to help patients participate in daily activities, as well as policies that will assist them with their disability and employment status,” said senior author David Putrino, PhD, Director of Rehabilitation Innovation for the Mount Sinai Health System.

“This study is a concerning reminder of how severely debilitating PACS symptoms are, the toll they take on health and wellness, and the fact that, without active treatment, these symptoms appear to persist indefinitely,” Putrino added.

A team of researchers did a retrospective, observational study of 156 patients treated at Mount Sinai’s Center for Post-COVID Care between March 2020 and March 2021. The patients had previously had COVID-19 and had not yet been vaccinated at the time of the study.

Patients filled out surveys on persistent symptoms and triggers of symptom exacerbation a median of 351 days from their first day of infection – patients received surveys after scheduling their first appointment and timestamped once submitted.

They were asked detailed questions about fatigue, breathlessness, ability to complete the moderate and vigorous-intensity physical activity, cognitive function, health-related quality of life, anxiety, depression, disability, and their pre-and post-COVID-19 employment status.

The most common reported symptoms were fatigue (82 per cent of patients), followed by brain fog (67 per cent), headache (60 per cent), sleep disturbance (59 per cent), and dizziness (54 per cent).

They performed a more detailed evaluation of the severity of self-reported cognitive impairment and discovered that more than 60 per cent of PACS patients had some level of cognitive impairment (either mild, moderate or severe), with symptoms including diminished short-term memory, difficulty remembering names, and issues with decision-making and daily planning.

In total, 135 patients answered questions about their employment pre- and post-COVID-19, and the number of patients in full-time work (102) went down to 55.

Going further, the study noted factors that the patients said made their PACS symptoms worse. The biggest trigger was physical exertion (reported by 86 per cent of patients), followed by stress (69 per cent), dehydration (49 per cent), and weather changes (37 per cent).

“Many of the symptoms reported in this study have been measured, but for many, this is the first time they have been objectively documented using well-validated patient-reported outcomes, and linked to changes in activities of daily living and quality of life,” explained Dr Putrino and concluded that “we need to aggressively pursue policies that will better support and protect these patients in the long-term.”

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HERE’S WHY VACCINATING KIDS WILL HELP US IN OUR WAR AGAINST COVID-19 PANDEMIC

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Vaccine

We can now say that India will soon be able to ebb the Covid-19 pandemic as kids between 2-18yrs will now get vaccinated, and we will hopefully cover the maximum population of our nation. In good news, the Subject Expert Committee on Covid-19 has granted emergency use approval to Covaxin for children in the aforesaid age group. Although kids in the age of 12-18yrs had recently been authorized to receive the COVID vaccine shots, children below that age remained vulnerable.

Covaxin will continue its research and clinical trial and provide updated prescribing information/ Package Insert (PI), Summary of Product Characteristics (SmPC), and factsheet. Moreover, the firm will have to submit safety data including the data on AEFI and AESI, with due analysis, every 15 days for the first two months and monthly thereafter and as per the requirement of New Drugs & Clinical Trials Rules, 2019.

Covaxin gaining approval in children above two years of age is great and timely news as this will help in stemming the spread of COVID19 and help in making the new normal safer. However, there will be many parents who can get skeptical. Here is what you should know.

It is well known that kids and young adults generally suffer a milder version of COVID19. However, the debilitating symptoms can linger for months after even a mild bout of COVID19. What we also know is that there is almost four times less chances of dying if adults were to get vaccinated and the infection rates have been highest among the unvaccinated groups

Vaccination will help to prevent kids from serious illnesses and in reducing the spread in this age group, just as in adults. Although COVID19 in children is sometimes milder than in adults, some kids infected with the Coronavirus can get severe lung infections, become very sick and require hospitalization. This is especially important to remember considering the Delta Variant, which is more contagious than other Coronavirus variants. The current vaccines are still effective in preventing severe illness

Also, this will allow kids to get back to school safely which is the foundation of a healthy productive adulthood. More importantly, they will be able to do things that they were not doing in view of the pandemic. This will go a long way in their academic, social-emotional and physical development Moreover, with kids getting vaccinated, the entire family can be protected

The National Serological Survey suggests about 60% seropositivity in children and thus some immunity to the infection because of a past infection picked up in the pandemic. However, we know that native immunity may not be as durable, resilient, and strong as compared to vaccine acquired immunity. Thus, undoubtedly, vaccine is the need of the hour in this age group not only as a means of protection, but also to help achieve herd immunity.

The Covaxin trial has shown very similar immunogenicity and safety as that seen in adults. The Subject Expert Committee under India’s drug regulator has given its nod for the vaccine based on the interim data submitted. Besides this, zyCOV-D is the first vaccine brought into the Indian market for children between 12-17 years.

Having your child vaccinated against COVID19 can therefore help restore more normal life. The only challenge will be to assure accessibility and availability for a very large vaccination target. Moreover, we will need more data from the vaccine manufacturers about aspects related to the number of children under trial, allergic reactions if any, level of antibodies developed etc., to get a clear picture. We can be hopefully that by Diwali we will receive concrete data to ward off fears.

Dr Sanjith Saseedharan and Dr Jesal Sheth are Consultant & Head-Critical Care, SL Raheja Hospital, Mahim and, Senior Consultant-Paediatrician respectively at Fortis Hospital, Mulund.

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WHOLE GRAIN MAY REDUCE TYPE 2 DIABETES IMPACT

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According to a recent study, increased consumption of whole-grain foods could significantly reduce the incidence of type 2 diabetes and the costs associated with its treatment in Finland.

The findings of the study were published in the journal ‘Nutrients’. “Our study shows that already one serving of full grains as part of the daily diet reduces the incidence of type 2 diabetes at the population level and, consequently, the direct diabetes-related costs, when compared to people who do not eat whole-grain foods on a daily basis,” said Professor Janne Martikainen from the University of Eastern Finland.

“Over the next ten years, society’s potential to achieve cost savings would be from 300 million (-3.3 per cent) to almost one billion (-12.2 per cent) euros in current value, depending on the presumed proportion of whole-grain foods in the daily diet. On the level of individuals, this means healthier years,” added Professor Martikainen.

Type 2 diabetes is one of the fastest-growing chronic diseases both in Finland and globally. Healthy nutrition that supports weight management is key to preventing type 2 diabetes. The association of daily consumption of whole-grain foods with a lower risk of diabetes has been demonstrated in numerous studies.

“According to nutrition recommendations, at least 3-6 servings of whole-grain foods should be eaten daily, depending on an individual’s energy requirement. One-third of Finns do not eat even one dose of whole grains on a daily basis, and two-thirds have a too low fibre intake,” Research Manager Jaana Lindstrom from the Finnish Institute for Health and Welfare said.

The now published study utilised findings from, eg, national follow-up studies, such as the FinHealth Study, to assess the health and economic effects of increased consumption of whole-grain foods on the prevention of type 2 diabetes.

“By combining population-level data on the incidence of type 2 diabetes and the costs of its treatment, as well as published evidence on the effects of how consumption of whole-grain foods reduces the incidence of type 2 diabetes, we were able to assess the potential health and economic benefits from both social and individual viewpoints,” Martikainen said.

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