Posts

Beware of a Vaccine Passport

India is in the middle of its mammoth vaccination endeavour to inoculate all adults in the population, with the number of second doses being administered on the rise. The ‘vaccine certificate’ – a digital proof of successful vaccination – has thus become commonplace. While individuals who have only received the first dose of the vaccine are being issued a provisional certificate, those who have received both doses are being issued a final certificate. We analyse the status of vaccine certificates as mere proofs of immunisation, and caution that they may in effect act as potential vaccine passports. On the face of it, there appears to be a distinction between a vaccine certificate as issued by CoWIN, and a vaccine passport. However, digging deeper reveals some disconcerting conceptual overlaps. With a return to pre-pandemic activities in progress, this is a timely inquiry. A paper in The Lancet has defined a vaccine passport as “a potential tool for recording and sharing the immunity status of an individual”. In other words, these so-called passports would enable access to an individual’s health data, specifically their vaccination status and Covid test results. The function of a vaccine passport is not limited to international travel alone and may be relevant for a range of activities, such as gaining entry to workplaces and restaurants. As a term, ‘vaccine passport’ is loaded with baggage and hence nations across the world have shied away from using it. Nevertheless, on stepping beyond mere terminology, we recognise that the widespread use of vaccine certificates in India could potentially function as a veritable vaccine passport. Evidence for the same may be found in the statements of the Chairman of the Empowered Group on Vaccination, who has recognised universal interoperability and verifiability as key facets of the certification process. Moreover, India’s commitment to global standards on vaccine certificates does not inspire confidence. A scrutiny of the WHO interim guidelines on smart vaccination certificates enable local governments to utilise the certificate for “health, occupational, education and travel purposes”, indicating the potential for indiscriminate use of certificates by municipal governments. Such concerns are exacerbated by instances of informational inaccuracies in vaccine certificates being issued by CoWIN. Regulators need to pay close attention to the role of the ‘vaccine certificate’ as an interoperable digital utility. The principle of interoperability per se does not raise significant ethical or constitutional concerns. It is, however, the use of the digital certificate as a sine qua non for the delivery of certain services that pose inherent challenges. A working paper by the University of Oxford’s Centre on Migration, Policy and Society sheds light on a variety of use cases that could potentially discriminate against individuals based on their vaccination status. Such use cases range from the restriction of freedom of movement (persons without a vaccine certificate may be denied from travelling to certain areas), curbing equitable access to education (improper vaccine certificates may be used to deny students admission to the physical premises of a university) and denial of access to private establishments such as hotels or malls. Reports indicate that vaccine certificates are already being linked to passports for international travel, and are becoming essential for domestic air travel in some states. These concerns also offer a glimpse into a second-order problem, the emergence of ‘mission creeps’ – a situation where the vaccine certificate continues to be leveraged technologically to stand as ‘evidence of fitness’ for participating in ordinary everyday activities. India has previously experienced turbulence with such mission creep – publishing and consequently retracting orders that made Aarogya Setu mandatory for inter-state air travel. It is especially relevant to take note of such mission creep due to the unique circumstances we find ourselves in today. In reviewing digital tools created specifically to respond to the current public health crisis, it is worthwhile to remember that these tools are capable of identifying individuals and tracking user data, even after the pandemic is over. Keeping in mind the impact of the pandemic on parliamentary proceedings and the imminent need for strategic intervention, we recommend that the State consider issuing a specialised protocol that outlines the role and functions of the vaccine certificate. The manner of issuing the protocol may be akin to the issuance of the Aarogya Setu (Data Access and Knowledge Sharing) Protocol, 2020, with the Empowered Committee on COVID-19 ideating on the first principles for issuing dignity-preserving vaccine certificates. This would define the scope of the vaccine certificate, and address prominent concerns around its deployment. Sohini Banerjee and KS Roshan Menon are Research Fellow and Research Scholar at Shardul Amarchand Mangaldas & Co.

17th June, 2021

image caption
Many post-COVID patients are experiencing new medical problems in US, study finds

Hundreds of thousands of Americans have sought medical care for post-COVID health problems that they had not been diagnosed with before becoming infected with the coronavirus, according to the largest study to date of long-term symptoms in COVID-19 patients. The study, tracking the health insurance records of nearly 2 million people in the United States who contracted the coronavirus last year, found that one month or more after their infection, almost one-quarter — 23% — of them sought medical treatment for new conditions. Those affected were all ages, including children. Their most common new health problems were pain, including in nerves and muscles; breathing difficulties; high cholesterol; malaise and fatigue; and high blood pressure. Other issues included intestinal symptoms; migraines; skin problems; heart abnormalities; sleep disorders; and mental health conditions like anxiety and depression. Post-COVID health problems were common even among people who had not gotten sick from the virus at all, the study found. While nearly half of patients who were hospitalized for COVID-19 experienced subsequent medical issues, so did 27% of people who had mild or moderate symptoms and 19% of people who said they were asymptomatic. “One thing that was surprising to us was the large percentage of asymptomatic patients that are in that category of long COVID,” said Robin Gelburd, president of FAIR Health, a nonprofit organization that conducted the study based on what it says is the nation’s largest database of private health insurance claims. More than half of the 1,959,982 patients whose records were evaluated reported no symptoms from their COVID infection. Forty percent had symptoms but didn’t require hospitalization, including 1% whose only symptom was loss of taste or smell; only 5% were hospitalized. Gelburd said the fact that asymptomatic people can have post-COVID symptoms is important to emphasize, so that patients and doctors can know to consider the possibility that some health issues may actually be aftereffects of the coronavirus. “There are some people who may not have even known they had COVID,” she said, “but if they continue to present with some of these conditions that are unusual for their health history, it may be worth some further investigation by the medical professional that they’re working with.” The report analyzed records of people diagnosed with COVID-19 between February and December 2020, tracking them until February 2021. It found that 454,477 people consulted health providers for symptoms 30 days or more after their infection. FAIR Health said the analysis was evaluated by an independent academic reviewer but was not formally peer-reviewed. “The strength of this study is really its size and its ability to look across the range of disease severity in a diversity of age groups,” said Dr. Helen Chu, an associate professor of medicine and infectious diseases at the University of Washington School of Medicine, who was not involved in the report. “This is a hard study to do with that much data.” The report “drives home the point that long COVID can affect nearly every organ system,” said Dr. Ziyad Al-Aly, chief of the research and development service at the VA St. Louis Health Care System, who was not involved in the new study. “Some of these manifestations are chronic conditions that will last a lifetime and will forever scar some individuals and families,” added Al-Aly, who was an author of a large study published in April of lingering symptoms in COVID patients in the Department of Veterans Affairs health system. In the new study, the most common issue for which patients sought medical care was pain — including nerve inflammation and aches and pains associated with nerves and muscles — which was reported by more than 5% of patients or nearly 100,000 people, more than a fifth of those who reported post-COVID problems. Breathing difficulties, including shortness of breath, were experienced by 3.5% of post-COVID patients. Nearly 3% of patients sought treatment for symptoms that were labeled with diagnostic codes for malaise and fatigue, a far-reaching category that could include issues like brain fog and exhaustion that gets worse after physical or mental activity — effects that have been reported by many people with long COVID. Other new issues for patients, especially adults in their 40s and 50s, included high cholesterol, diagnosed in 3% of all post-COVID patients, and high blood pressure, diagnosed in 2.4%, the report said. Al-Aly said such health conditions, which have not been commonly considered aftereffects of the virus, make it “increasingly clear that post-COVID or long COVID has a metabolic signature marked by derangements in the metabolic machinery.” Relatively few deaths — 594 — occurred 30 days or more post-COVID, and most were among people who had been hospitalized for their coronavirus infection, the report found. The study, like many involving electronic records, only addressed some aspects of the post-COVID landscape. It did not say when patients’ symptoms arose or how long the problems persisted, and it did not evaluate exactly when after infection patients sought help from doctors, only that it was 30 days or more. The database included only people with private health insurance or Medicare Advantage, not those uninsured or covered by Medicare Parts A, B and D, Medicaid or other government health programs. Chu said people without insurance or with incomes low enough to qualify for Medicaid are often “more likely to have worse outcomes,” so the findings may understate the prevalence of some post-COVID health problems or may not represent the full picture. In addition, diagnostic codes in electronic records are “only as good as what is documented by the provider who saw the patient,” said Chu, a co-author of a smaller study of post-COVID symptoms among patients at the University of Washington. For example, neurological or cognitive issues like brain fog may be underreported because doctors may not find an appropriate diagnostic code or patients may not be seeking medical help for that specific issue, FAIR Health said. It’s also possible that some people classified as having asymptomatic COVID-19 infections developed symptoms after they tested positive. And some people who received their first diagnosis of a medical issue like hypertension or high cholesterol post-COVID might have previously had those issues but never sought or received treatment. Another limitation of the study is that it did not compare people who had COVID-19 with those who did not, making it unclear if rates of post-COVID symptoms were higher than in a more general population. Al-Aly’s study, which made such a comparison, found that between one and six months after becoming infected with the coronavirus, patients who’d had COVID had a 60% greater risk of death and a 20% greater chance of needing outpatient medical care than people who had not been infected. The FAIR Health report excluded patients with certain serious or chronic preexisting conditions like cancer, kidney disease, HIV, liver disease and stroke because researchers said it would be difficult to separate their previous health status from post-COVID symptoms. The report did not explore connections between other preexisting conditions patients had and their likelihood of developing post-COVID symptoms. But it said that people with intellectual disabilities or those with Alzheimer’s disease or dementia had a greater risk of dying 30 days or more after their infection. Overall, experts said, the report’s findings underscore the widespread and varied nature of post-COVID symptoms. “People with long COVID need multidisciplinary care,” said Al-Aly, “and our health systems should adapt to this reality and develop capacity to deal with these patients.”

16th June, 2021

image caption
Mankind Pharma launches drug to treat black fungus

Mankind Pharma on Thursday said it has launched Posaconazole Gastro resistant tablets, used to treat black fungus, in the country. The company has launched the drug under the brand name Posaforce 100. “As the cases of black fungus are increasing day by day, the product has been launched to fight against this infection. The drug firm always strives to launch affordable medicines with an endeavour to achieve the best quality standards in the pharmaceutical industry,” Mankind Pharma said in a statement. Posaconazole has been found to be a safer and effective drug of choice for the management of the disease. The drug has received approval from the Drug Controller General of India (DCGI), the drug maker noted Besides, AIIMS and ICMR have also recommended use of Posaconazole as an effective option for the management of mucormycosis, it added. The antifungal drug with minimal potential for nephrotoxicity and excellent tolerability profile has been cleared by the USFDA. Black fungus commonly occurs in soil, and airborne spores often produce infections. Life threatening conditions like severe COVID-19 infection; prolonged immune suppression or reduced immunity, uncontrolled diabetes mellitus or haematological malignancies and even open wounds contamination with Mucorales can lead to this infection. “As the cases of black fungus are increasing day by day, the product has been launched to fight against this infection. The drug firm always strives to launch affordable medicines with an endeavour to achieve the best quality standards in the pharmaceutical industry,” Mankind Pharma said in a statement.

16th June, 2021

image caption
Suven Pharma inks non-exclusive licencing pact with IICT, NIIST for 2-DG & Molnupiravir process tech

Hyderabad: After licencing the process knowhow for synthesis of Covid-19 wonder drug 2-DG (2-Deoxy-D-Glucose) to Lee Pharma, the Indian Institute of Chemical Technology (IICT) has now inked a similar pact with another Hyderabad-based player Suven Pharmaceuticals for 2-DG and anti-viral drug Molnupiravir. The drug helps treat moderately and severely Covid-19 infected patients by speeding up recovery and reducing their oxygen dependency. The agreements for 2-DG and Molnupiravir involve a total fee of Rs 8 lakh plus taxes for grant of licences on non-exclusive basis, Suven Pharma informed the bourses on Thursday, adding that this is a related party transaction as one of its independent directors, Dr S Chandrasekhar, is the director of CSIR-IICT, Hyderabad. Suven Pharmaceuticals said IICT Hyderabad and National Institute of Interdisciplinary Science & Technology (NIIST), Thiruvananthapuram, both Council of Scientific & Industrial Research (CSIR) institutes, have entered into a non-exclusive agreement with the company for the process technology transfer and manufacturing of anti-influenza drug Molnupiravir, which has been repurposed for Covid-19. While the synthetic process knowhow for Molnupiravir was sourced from CSIR-NIIST, the scale up process was carried out by CSIR-IICT. “The complete technology knowhow for Molnupiravir will be transferred and SPL will manufacture and launch it in the domestic market, subject to regulatory approvals,” Suven said. “Molnupiravir was initially developed for the treatment of influenza and is repurposed to completely suppress the Covid virus transmission within 24 hours according to the study recently published in the journal Nature Microbiology. The drug could be a game changer in mitigation of SARS-CoV-2 virus” Suven Pharma said. As per the agreement, CSIR IICT would also provide the process knowhow for the manufacture of new anti-Covid drug 2-DG.

11th June, 2021

image caption
Govt suggests rational use of CT scan for Covid in kids

New Delhi: The government has come out with comprehensive guidelines for the management of Covid-19 among children in which Remdesivir has not been recommended and rational use of HRCT imaging has been suggested. The guidelines issued by the Directorate General of Health Services (DGHS) under the health ministry also said that steroids are harmful in asymptomatic and mild cases of infection. The DGHS recommended steroids only in hospitalised moderately severe and critically ill Covid-19 cases under strict supervision. “Steroids should be used at the right time, in the right dose and for the right duration. Self-medication of steroids must be avoided,” it said. The guidelines also said Remdesivir (an emergency use authorization drug) is not recommended in children. “There is lack of sufficient safety and efficacy data with respect to Remdesivir in children below 18 years of age,” the guidelines said. The guidelines suggested rational use of High-resolution CT (HRCT) for seeing the extent and nature of lung involvement in patients with Covid-19. “However, any additional information gained from HRCT scan of the chest often has little impact on treatment decisions, which are based almost entirely on clinical severity and physiological impairment. “Therefore, treating physicians should be highly selective in ordering HRCT imaging of the chest in Covid-19 patients,” the guidelines said. For asymptomatic and mild cases, the guidelines said antimicrobials are not recommended for therapy or prophylaxis while for moderate and severe cases, antimicrobials should not be prescribed unless there is clinical suspicion of a superadded infection. PTI

11th June, 2021

image caption
AIIMS Patna confirms efficacy of AlchemLife’s Phytorelief to combat moderate cases of COVID-19

AIIMS Patna has confirmed the efficacy of AlchemLife’s Phytorelief in the management of mild and moderate cases of COVID-19 by acting as a natural anti-viral agent which helps in limiting COVID-19 spread in initial stages of the disease. A statement informed that a recent clinical study was conducted by AIIMS Patna on 100 COVID-19 positive cases with mild and moderate symptoms with Phytorelief. It was noted that after ten days of treatment with Phytorelief ® along with standard management, 83 percent of COVID-19 patients, with mild or moderate symptoms, turned negative. Further added that the clinical study indicated that Phytorelief, developed by AlchemLife, a pharma company, which develops and markets phytomedicines, helps in boosting the immunity to fight viruses and in turn helps in reducing the viral load. All the COVID-19 patients (mild and moderate) who were treated with Phytorelief , recovered well and showed significant improvements in all symptoms of COVID-19 like fever, cough, sore throat, and myalgia. Phytorelief is present in pastille form which dissolves in the buccal cavity; therefore, it results in higher bioavailability and faster onset of action. Speaking as a coordinator of the clinical study, Dr. Yogesh, Deputy Medical Superintendent and Additional Professor in AIIMS Patna, said, “Phytorelief improves immunity, as observed in the study; it helps in the recovery and improvement of the general well-being of COVID-19 patients. The results of the study are quite promising and showed a way for treating early stages of viral infection with more efficacy and devoid of any side effects”. He added that Phytorelief pastille is absorbed in the buccal cavity (mouth, saliva), the site of infection, it helps in limiting the spread of viruses in its early stages. Phytorelief contains Phytoactives (the most powerful active ingredients in medicinal plants) of curcuminoids in turmeric, ellagic acid in pomegranate, and gingerols and shogaols in ginger. The synergistic effect of these Phytoactives results in a strong anti-viral, virucidal and anti-bacterial action and can be effective against various viral strains. According to the release, various studies conducted on Phytorelief have shown that it is effective in increasing immunity by upto four times against viruses that cause cough, cold and flu. Can treat the mild form of COVID-19. It is a cost effective, natural solution which has no side effects and can be used by mild and moderate stage COVID-19 patients which would prevent them from getting seriously ill.

11th June, 2021

image caption