May 11, 2021

New research: Transplant recipients remain vulnerable to Covid-19 even after two vaccine doses


The new study evaluated this immunogenic response following the second dose of either the Moderna or Pfizer-BioNTech vaccine for 658 transplant recipients, none of whom had a prior diagnosis of Covid-19.

 

In a study published in JAMA, Johns Hopkins Medicine researchers have concluded that although two doses of a coronavirus vaccine confers some protection for people who have received solid organ transplants, it’s still not enough to enable them to dispense with masks, physical distancing and other safety measures.

 

This is a follow-up study to an earlier one published in March in JAMA, in which the researchers reported that only 17% of the participating transplant recipients produced sufficient antibodies after just one dose of a two-dose Covid-19 vaccine regimen.

 

“While there was an increase in those with detectable antibodies — 54% overall — after the second shot, the number of transplant recipients in our second study whose antibody levels reached high enough levels to ward off a SARS-CoV-2 infection was still well below what’s typically seen in people with healthy immune systems. Based on our findings, we recommend that transplant recipients and other immunocompromised patients continue to practice strict COVID-19 safety precautions, even after vaccination,” lead author Brian Boyarsky is quoted as saying on the Johns Hopkins website.

 

People who receive solid organ transplants (such as heart, lungs and kidneys) often must take drugs to suppress their immune systems and prevent rejection. Such regimens may interfere with a transplant recipient’s ability to make antibodies to foreign substances, including the protective ones produced in response to vaccines.

 

The new study evaluated this immunogenic response following the second dose of either the Moderna or Pfizer-BioNTech vaccine for 658 transplant recipients, none of whom had a prior diagnosis of Covid-19. The participants completed their two-dose regimen between December 16, 2020, and March 13, 2021.

 

In the most recent study, the researchers found that only 98 of the 658 study participants — 15% — had detectable antibodies to SARS-CoV-2 at 21 days after the first vaccine dose. This was comparable to the 17% reported in the March study.

 

At 29 days following the second dose, the number of participants with detectable antibodies rose to 357 out of 658 — 54%. After both vaccine doses were administered, 301 out of 658 participants — 46% — had no detectable antibody at all while 259 — 39% — only produced antibodies after the second shot.

 

The researchers also found that among the participants, the most likely to develop an antibody response were younger, did not take immunosuppressive regimens including anti-metabolite drugs and received the Moderna vaccine. These were similar to the associations seen in the single-dose study.— Source: Johns Hopkins Medicine.


https://indianexpress.com/article/explained/transplant-recipients-remain-vulnerable-to-covid-19-even-after-two-vaccine-doses-7308730/

New research: 1/3rd patients hospitalised with severe Covid-19 still show lung effects after a year


People are most commonly hospitalised for Covid-19 infection when it affects the lungs — termed Covid-19 pneumonia.

 

A new study has shown that most patients discharged from hospital after experiencing severe Covid-19 infection appear to return to full health, although up to a third do still have evidence of effects upon the lungs one year on.


People are most commonly hospitalised for Covid-19 infection when it affects the lungs — termed Covid-19 pneumonia. While significant progress has been made in understanding and treating acute Covid-19 pneumonia, very little is understood about how long it takes for patients to fully recover and whether changes within the lungs persist.

 

In this new study, published in The Lancet Respiratory Medicine, researchers from the University of Southampton worked with collaborators in Wuhan, China, to investigate the natural history of recovery from severe Covid-19 pneumonia up to one year after hospitalisation.

Eighty-three patients were recruited after they were discharged from hospital following severe Covid-19 pneumonia and were followed up after three, six, nine and twelve months. At each time point they underwent clinical assessment as well as measures of how well the lungs function, a CT scan of their chest to take a picture of the lungs, and a walking test.

 

Over 12 months in most patients, there was an improvement in symptoms, exercise capacity, and Covid-related CT changes. By 12 months the majority of patients appeared to have fully recovered although about 5% of patients still reported breathlessness. A third of patients’ measures of lung function were still reduced — in particular how efficiently oxygen is transferred in the lungs into the blood — and this was more frequently found in women than in men. In around a quarter of patients CT scans showed there were still small areas of change in the lungs, and this was more common in patients with more severe lung changes at time of hospitalisation.

 

The researchers acknowledged that this study only involved a small number of patients and the findings will require confirmation in additional studies. However they have identified a number of important implications.


https://indianexpress.com/article/explained/1-3rd-of-patients-hospitalised-with-severe-covid-19-still-show-lung-effects-after-a-year-7310035/


1 in 7 hospital staff infected with Covid-19 after vaccination: small study

People who get infected with Covid-19 even after getting a vaccine shot are known as “breakthrough cases”, implying that the infection has broken through the protection provided by the vaccine.

Of the 113 participants, 28 had been administered Covaxin while 85 were inoculated with Covishield.

A small-scale study in healthcare workers at a private hospital in Delhi found that “breakthrough” infections occurred in 13.3% of them (about 1 in 7), with one requiring hospitalisation. The study was conducted on healthcare workers from Fortis Centre of Excellence for Diabetes, Metabolic Diseases and Endocrinology and has been published in the journal Diabetes & Metabolic Syndrome: Clinical Research & Reviews.

What are breakthrough cases?
People who get infected with Covid-19 even after getting a vaccine shot are known as “breakthrough cases”, implying that the infection has broken through the protection provided by the vaccine. According to the Union Ministry of Health and Family Welfare, the incidence of such cases in both vaccines in use in India — Covaxin and Covishield — has remained low.
 
How was the study conducted?
The hospital has 123 employees out of whom 113 had been vaccinated by the time the study took place. The workers included doctors, nutritionists, nurses, paramedical workers, and maintenance staff. The healthcare facility caters to patients of diabetes with or without complications, related metabolic disorders & those requiring non-emergency surgeries.

A detailed database was maintained by the hospital regarding vaccinations and Covid-19 infections of all the employees from January till date. All infections after any dose of vaccinations were recorded. The study was conducted between January 16 till date. Of the 113 participants, 28 had been administered Covaxin while 85 were inoculated with Covishield.
 
What were the findings?
Out of the 113 who had been vaccinated, a second dose was administered to 107. Breakthrough symptomatic Covid-19 infections (more than 14 days after the second dose)  was seen in 15 persons (13.3% of 113). All were symptomatic with fever and half of them had sore throat and cough. “A few had loose motion and loss of smell and taste. Symptoms lasted from 3-14 days. Except one who required hospitalisation, all 14 persons with breakthrough infections had mild Covid- 19 disease,” said Dr Anoop Misra, Chairman of the healthcare facility.
 
What are the implications?
The researchers concluded that high prevalence of “breakthrough” infection is seen in the healthcare facility. Dr Misra said: “Covid-19 infections after complete doses of vaccination will be important morbidity post pandemic, and may become a source of further infections. We need more research and data especially in community dwelling people. ‘Breakthrough’ infection in India after complete vaccination should be a prime area of research. This is an important area and clearly needs more research. It is reassuring that the majority of breakthrough infections seen in our facility are mild. But a significant area of concern is that asymptomatic infections were missed since RT-PCR test was selectively done in symptomatic patients. These asymptomatic patients are likely to promote viral spread.”

An Expert Explains: Challenge ahead in vaccinating India

 

Covid-19 vaccines are being developed at a pace faster than for any other disease, yet there are shortages. India will look forward to procuring more vaccines and a proposed IP waiver from global manufacturers.

 

Covid-19 vaccines were developed at an astonishing pace. No other disease has seen so many vaccines developed so fast. Out of 250 candidate vaccines that were being developed, at least 10 have already been approved for emergency use in different parts of the world. Most of the first flush of approved vaccines were based on two technologies never used in humans earlier. These include mRNA-based vaccines of Pfizer-BioNTech, Moderna, and the viral vector-based vaccines of Astra Zeneca/Oxford University, Sputnik V, and Coronavac of CanSino Biologics from China.

 

Vaccines based on the time-tested technology of using an inactivated virus include Covaxin of Bharat Biotech-ICMR, Janssen of Johnson and Johnson, and vaccines from Sinovac and Sinopharm from China. All these are safe and efficacious in protecting from severe disease and death but not necessarily from infection. These are given as two jabs, with the exception of Janssen, a single-shot vaccine, possibly a trendsetter for future vaccines.

 

At least 50 more vaccines are in the pipeline with three or four close to approvals in different parts of the world. Several, including a DNA-based vaccine from Zydus Cadila in India, are in the final stages of development.

 

So many and yet shortage

With so many vaccines being developed, it may create the impression that it is not very difficult to make efficacious vaccines against a virus like SARS-CoV-2. Far from it! Vaccine development is a highly complex and a specialised enterprise. Under normal circumstances, it takes 10-15 years to develop any vaccine after the scientific rationale has been worked out. The world over, and now very much in India, the question being raised is that even after so many vaccines having been approved, why is there a huge shortage of supply, and unjustifiable and inequitable access to these vaccines?

 

First, with about seven billion people to be vaccinated worldwide, with mostly two jabs each, the demand is obviously very high. Second, the rich nations have behaved as they always do. More than 80% of available vaccines have been ordered and/or already stocked by a few countries representing only about 20% of the world population. Even with a WHO-led effort like COVAX, only about 1% of the African population has received vaccines so far.

 

There are other complexities as well. For example, as of now, only three vaccines — Pfizer, Moderna, and recently Janssen — have been approved by the US FDA. The most affordable AstraZeneca vaccine still awaits approval. With recent reports of Pfizer getting approval for immunising the age group 12-16, and Moderna and Janssen close to completing safety and efficacy trials in this age group, it is clear that western countries, which have already immunised a significant portion of their adult populations, will proceed to vaccinate young children and, perhaps, even babies. It will therefore become even more difficult to access these vaccines in the free market.

 

On the other hand, approval for Sputnik V was recently denied in Brazil. Vaccines of China’s Sinovac and Sinopharm are not yet approved in western countries. Efficacious and safe vaccines, regardless of their origin, need to be critically but quickly examined and added to the pool.

 

Shortage in India

India is in the grip of the most ferocious second wave of the pandemic seen anywhere in the world. With more than 4 lakh cases reported per day, there is a serious concern that the virus could mutate into more dangerous variants and if the chain of viral multiplication is not controlled soon, it will become a global problem. New waves the world over are driven by mutants and although current vaccines seem effective against these, the chances of emergence of immune-escape mutants will only increase if the pandemic is not brought under control.

India, with its inherently fragile healthcare system, has come under immense pressure as never before. There is an acute shortage of medical oxygen, and there is a big gap in the supply chain of the ambitious programme to vaccinate all its adult population. Although India ranks number three after the US and China in the absolute number of vaccines administered, only about 13% of its population has received a single jab and about 2% fully vaccinated. Many countries have already vaccinated more than half their adult population.

 

With India being known as the hub of vaccine manufacturing, everybody is asking why it is so, and why is it difficult to ramp up production of the two available vaccines. Vaccines are complex formulations of many components and depend on a seamless supply of raw materials that are mostly imported. From production of the bulk material to filling of the formulation in vials is a highly complex and time-consuming process that cannot be hastened. Ramping up of existing production, even after adequate funds are available, will inevitably take a minimum 2-3 months.

Even if the licence is granted to vaccine manufacturers, actual production will take several months of preparation to kick off. The vaccination drive to cover India’s adult population will therefore face a supply chain crunch at least for the next few months, unless a large number of vaccines are imported. This option should be carefully but quickly considered.

 

With at least three or four more vaccines, including Sputnik V, Janssen, and Novavax, already slated to be produced in India and several more being indigenously developed, India would certainly be producing vaccines to vaccinate major parts of the world, hopefully by the end of 2021. There is a joint proposal of India and South Africa that will be taken up once again at the World Trade Organization, and as per the latest update, the US has already responded positively in support of the proposal when it comes up for consideration sometime soon. Under this proposal, companies already producing Covid vaccines will be expected to share their IPR for at least a given period with enough safeguards of their own interests. That will greatly help in producing high quality and affordable vaccines for the whole world and, hopefully, all this will happen before the virus is able to develop immune escape mutants. The race is on and humanity has no option but to defeat the virus and stay ahead in this race.


https://indianexpress.com/article/explained/covid-19-india-second-wave-challenge-ahead-in-vaccinating-india-7310011/

May 10, 2021

COVID-19: When can you get second vaccine shot if infected after first dose?

The Indian Council of Medical Research (ICMR) has said that the incidence rate of "breakthrough cases" in India is less than 0.05 per cent.

There have been some reports of people getting infected with COVID-19 even after a vaccine shot, which experts have termed as “breakthrough cases”. The Indian Council of Medical Research (ICMR), however, said that the incidence rate of such cases in India is less than 0.05 per cent.

 

Even if you get infected after the first vaccine dose, it does not mean you cannot take the second shot. However, the second dose of the vaccine must be deferred for at least four to eight weeks after recovery, according to the Health Ministry.

The four-eight week deferred period of the second dose is applicable for:

*People who have active symptoms of COVID-19 infection
*Patients who have been anti-COVID-19 monoclonal antibodies or convalescent plasma
*Acutely unwell and hospitalised patients (with or without intensive care) who suffer from any other illness

 

According to Centres for Disease Control and Prevention (CDC), asymptomatic COVID-19 patients can receive the second vaccine dose once they have met the criteria to discontinue home isolation.

 

CDC has also said there are multiple factors that affect how a vaccine works in “real-world conditions” including the host, mutants variants, and programmatic factors such as following dosing schedules or storing and handling vaccines properly.


https://indianexpress.com/article/lifestyle/health/when-can-you-get-second-vaccine-shot-if-infected-after-first-dose-7307002/

New research: Non-steroidal inflammatory drugs are safe for patients with Covid-19

Early in the pandemic, there was debate on whether the use of such drugs increased the severity of Covid-19, which led to urgent calls for investigations.

The use of non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, does not lead to higher rates of death or severe disease in patients who are hospitalised with Covid-19, according to a new observational study of more than 72,000 people in the UK published in The Lancet Rheumatology journal.

 

NSAIDs are common treatments for acute pain and rheumatological diseases such as rheumatoid arthritis and osteoarthrosis. Early in the pandemic, there was debate on whether the use of such drugs increased the severity of Covid-19, which led to urgent calls for investigations.

 

The ISARIC CCP-UK (International Severe Acute Respiratory and emerging Infection Consortium Clinical Characterisation Protocol United Kingdom) study found evidence that the continued use of NSAIDs in patients with Covid-19 is safe.

In the study, around a third of patients (30.4%. 1,279 out of 4,211) who had taken NSAIDs prior to hospital admission for COVID-19 died, a rate which was similar (31.3%. 21,256 out of 67,968) in patients who had not taken NSAIDs. In patients with rheumatological disease, the use of NSAIDs did not increase mortality.

 

In a press release from the journal publishers, Prof Ewen Harrison of the University of Edinburgh, lead author of the study, was quoted as saying: “NSAIDs are commonly used to treat people all over the world for a range of conditions, from minor aches and pains to chronic conditions such as arthritis and cardiovascular disease. Many people rely on them to be able to carry out their day-to-day activities. When the pandemic began over a year ago, we needed to be sure that these common medications would not lead to worse outcomes in people with COVID-19. We now have clear evidence that NSAIDs are safe to use in patients with COVID-19, which should provide reassurance to both clinicians and patients that they can continue to be used in the same way as before the pandemic began.”

 

The study collected data on the medication patients had been prescribed, were currently taking, or had taken within 14 days prior to being admitted to hospital, as well as demographic information, and medical history. The study cohort included patients with confirmed or highly suspected Covid-19 infection admitted to 255 healthcare facilities in England, Scotland, and Wales, between January and August 2020.


https://indianexpress.com/article/explained/explained-non-steroidal-inflammatory-drugs-are-safe-for-patients-with-covid-19-study-finds-7306402/

Explained: Variants and the Covid-19 surge

The reasons for the second surge are not yet fully clear. Faster-spreading virus variants could be just one reason, and cannot explain the trends in every state. Yet scientists are keeping an eye on some variants.

There are several things about the coronavirus epidemic that are not very well understood, or explained by the facts at hand. For example, the unexpected five-month long decline in cases in India starting in mid-September last year. An even bigger surprise has been the ferocity of the second wave that has seen the daily count of cases in India soaring to more than four lakh.

Lack of ‘Covid-appropriate behaviour’ has been cited as one of the main reasons for the rapid rise in infections from March. But that is only part of the explanation. Even during the five-month lull, the adoption of masks wasn’t universal, nor was physical distancing being strictly followed. Election rallies have also been blamed, but these do not explain the phenomenal rise in cases in states such as Maharashtra, Delhi, Punjab or Karnataka that had no elections. In any case, the second wave had started much before the large political rallies began to take place.
 
The newer variants
Scientists have also been examining whether biological changes in the virus had anything to do with the unprecedented surge in infections in the last two months. Viruses mutate, and mutations that help it survive and circulate better are selected. In the last few months, several new variants of the virus have been found to be circulating in the Indian population.
 
A few of these have greater transmissibility, meaning they have a better ability to infect human beings. One particular variant, called B.1.617, first found in Vidarbha region of Maharashtra, has received a lot of attention because of its ability to transmit at a faster rate and, possibly, also to evade the immune response. Other fast-transmitting variants, such as the one that first emerged in the United Kingdom, called B 1.1.7, that has been found to be present in large numbers in northern India, could also be the reasons for the rapid rise in cases.
 
Steep rise in new cases since March

While scientists acknowledge that these new variants could have contributed to the surge in cases, they have reluctant to say that these are the main cause for the ferocity of the second wave. They have been maintaining that the epidemiological evidence is still not clinching enough. On Wednesday, the government, for the first time, linked the B.1.617 variant with the surge seen in some states. But it reiterated that the clinical and epidemiological correlation was still not fully established.
 
Not the same everywhere
Anurag Agrawal, director of Delhi-based Institute of Genomics and Integrative Biology (IGIB), said while the new variants had been found to be circulating in many parts of the country, not every surge in cases could be attributed to these. Even within a state, the spread of the virus in some areas could be directly because of these faster-transmitting variants, while in others some other factor could be responsible.
 
“In Maharashtra, for example, the rise in cases in the Vidarbha region can possibly be explained by the emergence of the B.1.617 variant. But this variant does not explain the surge in Mumbai. That is because this variant has not been found in adequate numbers in the Mumbai population. There, the main reason for the rise could be something else… reopening of the local trains, possibly, in the month of February,” he said.
 
In Kerala, the new variant that is predominantly in circulation is N440K. But Agrawal said the surge in Kerala could not be attributed to this. “The locations where we found this variant were not the same where the maximum cases were getting reported from. In fact, the surge was found to be the maximum in areas where the presence of this variant was the least,” he said.
 
In Punjab and Haryana, however, there is little doubt about the cause of the surge. In both the states, the UK variant is predominant. In a recent study, more than 80% of the samples taken from infected people in Punjab were found to be of this variant. Neighbouring Delhi also has a large proportion of the UK variant, but in keeping with the character of the national capital which has people coming in from across the country, nearly every variant circulating in other states has marked a presence in Delhi as well. And there are hundreds of them, most of them having little or no impact on the rise in cases.
 
Scientists say that in most places, a surge or a decline in cases can only be explained by a combination of factors. Almost every state has one variant or the other present, but in many places these have had no role in causing the increase in cases. As one of the scientists explained, epidemics are like complex systems where very small changes in inputs, or initial conditions, can lead to dramatic and unexpected outputs. So, at some places, even a large number of wedding gatherings on a particular day could be the reason for a prolonged surge. The exponential nature of the spread of an epidemic makes this possible.
 
Variants under watch
Yet, the new variants are under close watch right now. The government has already classified the B.1.617 as a ‘variant of concern’ though that tag is still to be attached to it officially by the World Health Organization. As reported by this newspaper, this particular variant has undergone further mutations, and at least three different sub-variants, named B.1.617.1, B.1.617.2 and B.1.617.3, are supposed to have the potential to spread even faster, and cause bigger damage than the parent variant.
 
Agrawal said these three new variants were a cause of concern. “I am worried about the B.1.617, and the three new ones emerging from it. I am worried about the UK variant, and also the South African variant. But I am not too much worried about the Brazilian variant, or the B.1.618, or even the N440K. I am currently worried only about the variants that have the potential to cause explosive rise in cases,” he said.

https://indianexpress.com/article/explained/explained-variants-and-the-covid-surge-7306408/

Explained: Transplant recipients remain vulnerable to Covid-19 even after two vaccine Doses

This is a follow-up study to an earlier one published in March in JAMA, in which the researchers reported that only 17% of the participating transplant recipients produced sufficient antibodies after just one dose of a two-dose Covid-19 vaccine regimen.

Researchers have found that although two doses of a vaccine against SARS-CoV-2 confers some protection for people who have received solid organ transplants, it’s still not enough to enable them to dispense with Covid safety measures.

In a study published in JAMA, Johns Hopkins Medicine researchers have concluded that although two doses of a coronavirus vaccine confers some protection for people who have received solid organ transplants, it’s still not enough to enable them to dispense with masks, physical distancing and other safety measures.
 
This is a follow-up study to an earlier one published in March in JAMA, in which the researchers reported that only 17% of the participating transplant recipients produced sufficient antibodies after just one dose of a two-dose Covid-19 vaccine regimen.
 
 “While there was an increase in those with detectable antibodies — 54% overall — after the second shot, the number of transplant recipients in our second study whose antibody levels reached high enough levels to ward off a SARS-CoV-2 infection was still well below what’s typically seen in people with healthy immune systems. Based on our findings, we recommend that transplant recipients and other immunocompromised patients continue to practice strict COVID-19 safety precautions, even after vaccination,” lead author Brian Boyarsky is quoted as saying on the Johns Hopkins website.
 
People who receive solid organ transplants (such as heart, lungs and kidneys) often must take drugs to suppress their immune systems and prevent rejection. Such regimens may interfere with a transplant recipient’s ability to make antibodies to foreign substances, including the protective ones produced in response to vaccines.
 
The new study evaluated this immunogenic response following the second dose of either the Moderna or Pfizer-BioNTech vaccine for 658 transplant recipients, none of whom had a prior diagnosis of Covid-19. The participants completed their two-dose regimen between December 16, 2020, and March 13, 2021.
 
In the most recent study, the researchers found that only 98 of the 658 study participants — 15% — had detectable antibodies to SARS-CoV-2 at 21 days after the first vaccine dose. This was comparable to the 17% reported in the March study.
 
At 29 days following the second dose, the number of participants with detectable antibodies rose to 357 out of 658 — 54%. After both vaccine doses were administered, 301 out of 658 participants — 46% — had no detectable antibody at all while 259 — 39% — only produced antibodies after the second shot.
 
The researchers also found that among the participants, the most likely to develop an antibody response were younger, did not take immunosuppressive regimens including anti-metabolite drugs and received the Moderna vaccine. These were similar to the associations seen in the single-dose study. Source: Johns Hopkins Medicine

Explained: ‘Black fungus’ in Covid-19 patients

Mucormycosis, a serious fungal infection but otherwise rare, has been observed in a number of Covid-19 patients recently. While there is no major outbreak, the national Covid task force has issued an advisory.

Mucormycosis is caused by mucormycetes that generally attacks a diabetic person with low immunity. For a year, even normally healthy patients are reporting this infection post Covid.

A rare but serious fungal infection, known as mucormycosis and colloquially as “black fungus”, is being detected relatively frequently among Covid-19 patients in some states. The disease often manifests in the skin and also affects the lungs and the brain. With a number of mucormycosis cases detected in Delhi, Maharashtra and Gujarat, experts in the national Covid-19 task force on Sunday issued an evidence-based advisory on the disease.

 

What is the disease?

Although rare, it is a serious infection. It is caused by a group of moulds known as mucormycetes present naturally in the environment. It mainly affects people who are on medication for health problems that reduces their ability to fight environmental pathogens, say experts from the Covid-19 task force task force.

 

Sinuses or lungs of such individuals get affected after they inhale fungal spores from the air. Doctors in some states have noted a rise in cases of mucormycosis among people hospitalized or recovering from Covid 19, with some requiring urgent surgery. Usually, mucormycetes does not pose a major threat to those with a healthy immune system.

 

What happens when one contracts it?

Warning signs include pain and redness around the eyes or nose, with fever, headache, coughing, shortness of breath, bloody vomits, and altered mental status. According to the advisory, infection with mucormycetes should be suspected when there is:

* Sinusitis — nasal blockade or congestion, nasal discharge (blackish/bloody);
* Local pain on the cheek bone, one-sided facial pain, numbness or swelling;
* Blackish discoloration over bridge of nose/palate;
* Loosening of teeth, jaw involvement;
* Blurred or double vision with pain;
* Thrombosis, necrosis, skin lesion;
* Chest pain, pleural effusion, worsening of respiratory symptoms.

 

Experts advise that one should not count all cases of blocked nose as cases of bacterial sinusitis, particularly in the context of immunosuppression and/or Covid-19 patients on immunomodulators. Do not hesitate to seek aggressive investigations for detecting fungal infection, they advise.

 

What’s the treatment?

While it is treated with antifungals, mucormycosis may eventually require surgery. Doctors have said that it is of utmost importance to control diabetes, reduce steroid use, and discontinue immunomodulating drugs. To maintain adequate systemic hydration, the treatment includes infusion of normal saline (IV) before infusion of amphotericin B and antifungal therapy, for at least 4-6 weeks.

 

Experts in the task force have stressed the need to control hyperglycemia , and monitor blood glucose level after discharge following Covid-19 treatment, and also in diabetics. One should use steroids judiciously — correct timing, correct dose and duration are important.

Management of Covid patients with mucormycosis is a team effort involving microbiologists, internal medicine specialists, intensivist neurologist, ENT specialists, ophthalmologists, dentists, surgeons (maxillofacial/plastic) and others.

 

Life after surgery for mucormycosis

Mucormycosis can lead to loss of the upper jaw and sometimes even the eye. “Patients would need to come to terms with loss of function due to a missing jaw — difficulty with chewing, swallowing, facial aesthetics and loss of self-esteem, doctors say. Be it the eye or upper jaw, these can be replaced with appropriate artificial substitutes or prostheses. While prosthetic replacement of the missing facial structures can commence once the patient stabilises after surgery, doctors it is important to reassure him about the availability of such interventions instead of leaving him to panic with the sudden unforeseen loss, augmenting a post-Covid stress disorder which is already a reality,” said Dr B Srinivasan, a maxillofacial prosthodontist. “Prosthetic reconstruction can be effected after surgery, but interim solutions should be planned even before surgery of the jaws for better long-term outcomes. Prosthetic reconstruction can ensure that the cure is not more dreadful than the disease itself,” he said.

 

How can one prevent it?

One should remember that it is a rare disease. However, some groups of people are more vulnerable than others. What predisposes patients is uncontrolled diabetes mellitus, immunosuppression by steroids, prolonged ICU stay, and comorbidities — post transplant/malignancy, voriconazole therapy.

 

Experts advise that you use masks if you are visiting dusty construction sites. Wear shoes, long trousers, long-sleeved shirts and gloves while handling soil (gardening), moss or manure. Maintain personal hygiene including a thorough scrub bath.

 

How frequently are cases being detected?

While cases are on the rise, there has been no major outbreak. Niti Aayog member (health) Dr V K Paul said at a media briefing that there has been no major outbreak and they were monitoring cases being reported.

 

In Maharashtra, Dr Tatyarao Lahane, head of the Directorate of Medical Education and Research, has said that cases of mucormycosis are on the rise. “Traditionally we see a case every few months, usually in very poorly controlled diabetic and immunocompromised patients,” said Dr Parikshit Gogate, consulting ophthalmologist at Ruby Hall Clinic, Pune. “But in the past 2 to 3 weeks, I have seen almost 25-30 of them, mostly in Ruby Hall, some in D Y Patil Hospital.”

Mucormycosis developing in post Covid-19 setting breaks the back of a patient’s family that is barely recovering from this viral infection, infectious diseases consultant in Pune Dr Rajeev Soman wrote in the Journal of Association of Physicians of India in January this year.

 

Dr Soman is one of the expert members who drafted the advisory as part of the national Covid-19 task force. The also task force includes Dr Arunaloke Chakraborti, Head of the Department of Medical Microbiology, PGIMER, Chandigarh; Dr Atul Patel, infectious diseases specialist, Ahmedabad; and several others.

 

Patients most vulnerable to mucormycosis are those who have been treated with steroids and other drugs for Covid 19 to reduce inflammation. Efforts are underway to collect data for large studies being done by the Fungal Infections Study Forum and Clinical infectious Diseases Society, Dr Soman said.

 

What is mucormycosis?

Mucormycosis, commonly called black fungus, is a rare but serious fungal infection caused by a kind of fungus called mucormycete, which is abundant in the environment. It mainly affects people who have health problems or take medicines that lower the body’s ability to fight germs and sickness.

 

Symptoms

These include pain and redness around eyes and/or nose, fever, headache, coughing, shortness of breath, bloody vomits, and altered mental status. Warning signs can include toothache, loosening of teeth, blurred or double vision with pain.

 

Who is vulnerable?

Vulnerable groups include people who have health problems or take medicines that lower the body’s ability to fight germs and sickness. These include those with diabetes, cancer, or those who have had an organ transplant.

 

Prevention

Use masks if you are visiting dusty construction sites. Wear shoes, long trousers, long-sleeved shirts and gloves while gardening. Maintain personal hygiene including a thorough scrub bath.

 

Diagnosis

It depends on the location of the suspected infection. A sample of fluid from your respiratory system may be collected for testing in the lab; otherwise a tissue biopsy or a CT scan of your lungs, sinuses etc may be conducted.

 

Treatment

Mucormycosis needs to be treated with prescription antifungal medicine. In some cases, it can require surgery; it can lead to eventual loss of the upper jaw and sometimes even an eye.


https://indianexpress.com/article/explained/mucormycosis-in-covid-patients-fungal-infections-7308721/

May 04, 2021

In Covid-19 survivors, single Pfizer dose boosts response against key strains: study

The findings looked at immune responses in UK healthcare workers at Barts and Royal Free hospitals following their first dose of the Pfizer/BioNTech vaccine.

A single dose of vaccine boosts potent responses against SARS-CoV-2 coronavirus variants in those with previous Covid-19, a study has found. In those who have not previously been infected and have so far only received one dose of vaccine, the immune response to variants of concern may be insufficient.

The findings, published in the journal Science and led by researchers at Queen Mary University of London, Imperial College London and University College London, looked at immune responses in UK healthcare workers at Barts and Royal Free hospitals following their first dose of the Pfizer/BioNTech vaccine.

They found that people who had previously had mild or asymptomatic infection had significantly enhanced protection against the UK and South Africa variants, after a single dose of the mRNA vaccine. In those without prior Covid-19, the immune response was less strong after a first dose, potentially leaving them at risk from variants.

Blood samples were analysed for the presence and levels of immunity against the original strain of SARS-CoV-2, as well as the UK (B.1.1.7) and South Africa (B.1.351) variants of concern. Along with antibodies, the researchers also focused on two types of white blood cell: B-cells, which ‘remember’ the virus; and T cells, which help B cell memory and recognise and destroy infected cells.

They found that after a first dose, prior infection was associated with a boosted T cell, B cell and neutralising antibody response, which could provide effective protection against SARS-CoV-2, as well as the UK and South Africa variants.

However, in people without previous SARS-CoV-2 infection, a single vaccine dose resulted in lower levels of neutralising antibodies against SARS-CoV-2 and the variants, potentially leaving them vulnerable to infection and highlighting the importance of the second vaccine dose.

The team looked at two variants of concern; however, they think it possible that the findings will apply to other variants in circulation, such as the Brazil (P.1) and India (B.1.617 and B.1.618) variants. Source: Queen Mary University of London.


https://indianexpress.com/article/explained/in-covid-19-survivors-single-pfizer-dose-boosts-response-against-key-strains-study-7300893/


 

Explained: Why a malaria vaccine candidate has raised new hope, and what went into its making


R21/Matrix M has been developed by scientists at University of Oxford, the same location where the AstraZeneca Covid-19 vaccine was developed. They’ have been working on this version for almost 6-7 years now.

A malaria vaccine candidate has shown promise in phase 2b clinical trials, with high efficacy at 77%. The results of the trial were published recently in preprints with The Lancet.

The previous version

The new vaccine candidate, called R21/Matrix M, is a modified version of RTS, S — another candidate against malaria that has been in development for more than 30 years by Walter Reed Institute of Research, GlaxoSmithKline and Bill and Melinda Gates Foundation with the PATH Malaria Vaccine Initiative.

This vaccine is designed to stop the Plasmodium falciparum malaria parasite from entering the liver and preventing the subsequent deadly blood stages. It targets the liver stage protein of the Plasmodium falciparum life cycle.

Thirty years in the making, RTS,S is the first, and to date the only, vaccine to reduce malaria in children. But it is not highly efficacious, according to Dr V S Chauhan, a Rhodes scholar working in the fields of genetic engineering and biotechnology and who is known for his contribution to the development of a recombinant vaccine for malaria.

“Its efficacy is so low that it is not widely given. Research is going on and the new one is a modified version of the previous vaccine. This is new hope but it has to undergo phase 3 trials yet,” Dr Chauhan said.

The new version

R21/Matrix M has been developed by scientists at University of Oxford, the same location where the AstraZeneca Covid-19 vaccine was developed. They’ have been working on this version for almost 6-7 years now.

Study author Adrian Hill, director of the Jenner Institute and professor of vaccinology at the University of Oxford, said in a statement that he believed the vaccine was the first to reach WHO’s goal of at least 75% efficacy.

This vaccine was produced in the Serum Institute of India. The fact that the Institute was chosen as a location for manufacturing shows its tremendous ability to produce good quality, said Chauhan.

The trial
Researchers from Oxford and partners reported findings on R21 over 12 months of follow-up of participants. The phase 2b trial in 450 children in Burkina Faso found the vaccine safe with an efficacy of 77% over this period. This vaccine went into trial in 2014-15. The two-dose trial was divided into a high dose trial (three shots) and low dose trial, and both showed 77% efficacy.

What next

Researchers working together with SII and US vaccine maker Novavax (which supplied the adjuvant) have now started recruitment for a phase 3 trial to assess large-scale safety and efficacy in 4,800 children aged five to 36 months across four African countries. SII has said it is confident of delivering more than 200 million doses of the vaccine as soon as it is approved by regulators.

Why it matters

In 2019, there were an estimated 229 million cases of malaria and 409 000 malaria-related deaths in 87 countries. Children under the age of 5 in sub-Saharan Africa accounted for approximately two-thirds of global deaths.

Between 2000 and 2020, 24 countries reported zero indigenous cases of malaria for 3 or more years. This is the benchmark for the World Health Organization (WHO) certification of a country as malaria-free. Globally, 39 countries have achieved the milestone.

In 2019, India had an estimated 5.6 million cases of malaria compared to about 20 million cases in 2020 according to WHO. The 2020 cases estimates (global, regional and country level) will be published later this year.

The pandemic challenge

In 2020, COVID-19 emerged as a serious challenge to malaria responses worldwide. The WHO has been urging countries to maintain essential health services, including for malaria, while ensuring that communities and health workers are protected from Covid-19 transmission.

According to the results of a new WHO survey, approximately one-third of countries around the world reported disruptions in malaria prevention, diagnosis and treatment services during the first quarter of 2021. In many countries, lockdowns and restrictions on the movement of people and goods have led to delays in the delivery of insecticide-treated mosquito nets or indoor insecticide spraying campaigns. Malaria diagnosis and treatment services were interrupted as many people were unable – or unwilling – to seek care in health facilities. On World Malaria Day (April 25), WHO called on all people living in malaria-affected countries to “beat the fear”.


https://indianexpress.com/article/explained/why-a-malaria-vaccine-candidate-has-raised-new-hope-and-what-went-into-its-making-7300888/

Steroid use too early may be causing drop in oxygen: AIIMS chief Randeep Guleria


Randeep Guleria, a member of the national task force on Covid-19, said hospitals were seeing mild patients who had consumed steroids, triggering virus replication and causing a drop in oxygen levels.

With many patients in the current Covid-19 wave reporting a drop in oxygen saturation levels, in turn requiring hospitalisation, AIIMS Director Dr Randeep Guleria on Monday warned against indiscriminate prescription of steroids, as well as CT scans and tests, for those with mild symptoms.

Talking about effective clinical management, Guleria, a member of the national task force on Covid-19, said hospitals were seeing mild patients who had consumed steroids, triggering virus replication and causing a drop in oxygen levels.

With a rush in patients seeking medical care, Prime Minister Narendra Modi held a review meeting on Monday to boost resources, including making available services of medical students.

“We have to understand that taking steroids at the early stage can give more stimulus to virus replication. In many cases, mild cases are becoming severe and patients are reporting severe pneumonia. Steroids have no role in the first five days of illness,” Guleria said.

For moderate disease, only three specific treatments are effective, he said. “First is oxygen therapy; second, when the illness is moderate and oxygen saturation is low, then there is a role for steroids; third is anticoagulants, because we know Covid-19 pneumonia is a little different from viral pneumonia and promotes the clotting of blood. There could be blood clots in lungs resulting in a drop in blood saturation. Again, in mild illness, there is no role for anticoagulants,” Guleria said.

The AIIMS Director also advised against CT scans and biomarker tests in case of mild symptoms. “Patients must undertake these tests only when they have moderate illness and on the basis of advice by doctors. There is a possibility of over-treatment due to unnecessary reliance on biomarkers,” Guleria said.

“Many people are getting CT scans done on getting a positive report. We are also seeing people getting scans every three-four days. We are exposing the body to radiation. There is no benefit of CT scan in mild disease, or if you are in home isolation and have normal oxygen levels. Studies have shown that in 30-40% of asymptotic patients, some patches will show in CT reports, however they recover on their own without any treatment,” the doctor said.

Underlining other risks of CT scans, Guleria said, “One CT scan is equal to getting 300-400 chest X-rays. There is data from the International Atomic Energy, which deals with radiation protection and medicine, that conducting CT scan multiple times increases the risk of cancer in later life, especially in the younger age group.”

On biomarkers, the AIIMS Director said, “Those testing positive are undergoing blood tests for C-reactive protein (CRP), complete blood count, D dimer. Again for mild illness and when oxygen saturation is under control, there is no requirement for these blood tests. These only cause a panic reaction. These biomarkers are for acute phase reactants, which means that whenever there is inflammation, these will increase. We don’t come to know if the infection is spreading. People think they should take steroids if CRP is more, this causes more damage.”

Following the review meeting by Modi, the Centre announced that the NEET-PG exam was being postponed for at least four months. “This will make a large number of qualified doctors available for Covid duties,” it said, adding it had also decided to allow deployment of medical interns in Covid duties such as tele-consultation, under the supervision of faculty.

The Centre also talked of “early signs” of a drop in cases in the last 72 hours. “There are early signs of plateauing in one or two states. However, many are still showing increase in daily cases,” it said, noting that 22 states had a positivity rate of more than 15%.

https://indianexpress.com/article/india/steroid-use-too-early-may-be-causing-drop-in-oxygen-aiims-chief-randeep-guleria-7300712/

 

TB care is need of the hour

 

India accounts for over 27 per cent of the world's 10.8 million TB cases. Experts throw light on the ailment and talk about the role of community and survivors

TB has killed more people in history than any other infectious disease. Mycobacterium Tuberculosis continues to ravage communities and societies across the globe since its emergence 9000 years ago. India bears disproportionately large burden of the global TB incidence, accounting for over 27 per cent of the world’s 10.8 million TB cases. This burden is further exacerbated as India also is a leading country for people with multiple drug-resistant forms (MDR-TB) that do not respond to commonly used medicines and aggravate mortality.

Multiple factors contribute to the growing rates of TB: Tuberculosis is a social disease. The under-privileged are disproportionately affected due to poor living conditions, malnutrition and access to healthcare. Stigma leads to underreporting and ostracization within the community and the workplaces.  The long treatment period leads to poor compliance, and the chronic nature of the disease leads to rising mortality.

“The severity of the epidemic has led to a host of TB control initiatives in the country with the Government committed to eradicating TB by 2025. We have made great strides in TB care. The scaling-up of diagnosis and treatment and an efficient system has saved millions of lives. However, while these successes are commendable, there remain gaps, such as the medicalised perception of TB, that need to be addressed. For too long, the focus has been on diagnosis and treatment of disease, with minimal attention to supportive services, making TB redressal a challenge,” Dr Dalbir Singh, President, Global Coalition for TB, says.

TB is a multifaceted issue involving society, gender, and inequalities. Viewing it through a solely medical lens hinders our opportunities for patient care. A TB patient’s first interface with a medical service is often an unfamiliar hospital environment, where a heavy emphasis on technical knowledge and treatment procedures reinforces the patient’s growing anxieties. A large part of making TB services accessible involves demystifying the disease. While counselling services ensure that patients are adequately sensitised regarding their illness, these are still centralised facilities that are inaccessible for many. We need to move towards decentralised patient-centric approaches that serve to reduce the burden on marginalised communities.

“While we work towards making TB care more accessible, we must also consider the experiences of those affected by TB. Often, programmes are designed from a position of expertise that fails to account for the needs of those the programme aims to benefit. There is a glaring absence of the patient’s voice in our TB control initiatives and a subsequent lack of understanding of the patient experience. The voices of those affected by TB matter because they break through pre-existing perceptions and provide real experiences and needs of those that have survived TB. There is a need for a sustained effort focused on benefiting them, easing their experiences, empowering them and making them the voice for change,” Dr Rajeev Gowda, Former Rajya Sabha member, adds.

The fight against TB requires the combined effort of many sectors. The pandemic has shown us that it is possible to tackle such diseases if we work together and that there is much to be learned from the COVID-19 response.

https://www.dailypioneer.com/2021/pioneer-health/tb-care-is-need-of-the-hour.html

April 30, 2021

Explained Ideas: Why the govt must vaccinate every Indian for free


Government's Covid vaccine policy is a maze of confusion that could doom India’s future prospects, write Shashi Tharoor and Salman Anees Soz.

COVID-19 has unleashed a devastating second wave in India. In their opinion piece in The Indian ExpressShashi Tharoor and Salman Anees Soz of the Indian National Congress, state that the government has proven woefully unprepared for this crisis and warn against the government’s recently announced vaccine policy.

“We can blame hubris or incompetence or a combination thereof for India’s unfolding tragedy. However, it should now be everyone’s goal to shorten the duration of the broader crisis, which won’t remain restricted to this second wave,” they write.

They say a humanitarian and economic catastrophe looms. In this regard, they call the government’s vaccine policy unconscionable and potentially disastrous.

“It will likely create confusion, limit vaccination coverage, breed inequality, and prolong the duration of the crisis,” they state. “Better alternatives are available, which can help save both lives and livelihoods.”

What should be the goals of a vaccination policy during a global pandemic?

“We believe a good policy will seek to achieve maximum coverage, as close to universalisation as possible and do so as quickly and cost-effectively as possible. We should also account for the institutional capacity to implement such a policy. Given that the pandemic disproportionately impacts poor and low-income families, it is vitally important that the policy also be equitable,” they write. At the current rate, they believe, it may take India two years to vaccinate 75 per cent of the population. The government’s vaccine policy could make things considerably worse as they believe it is “fatally flawed on almost all counts”.

What can be an alternative way to vaccination?

In most major countries, vaccines are being given free to all residents. “In that most capitalist of nations, the United States, even billionaires are getting free vaccines. Not just that, undocumented workers are also part of the free vaccine programme. The easiest way to ensure maximum coverage is to offer vaccines for free to everyone. As such, they propose that all vaccine procurement in India be done by the Union government. Identifying manufacturers, negotiating prices, scheduling deliveries, and executing payments should be handled by the central government. The Centre should also devise a transparent formula for distributing vaccines to individual states, they argue.

Won’t this be costly? No, they say. “The cost of a prolonged crisis will be far more devastating to the economy. In 2020-21, the crisis probably cost us close to Rs 8 trillion in economic output,” they write.in


https://indianexpress.com/article/explained/india-coronavirus-vaccine-shashi-tharoor-salman-anees-soz-7293278/

April 28, 2021

Explained: Why has the EU initiated legal action against AstraZeneca?

AstraZeneca started delivery of vaccines to the EU in February and under its contract with the bloc, it promised to deliver about 300 million doses by the end of June. However, in mid-March, the company announced a shortfall in vaccine shipment meant for the EU.

AstraZeneca noted in its statement that half of the EU's supply in the second quarter and about 10 million doses in the first quarter were due to be sourced from the company’s international supply chain.

On Monday, the European Commission (EC) initiated legal action against AstraZeneca over the shortfall in the company’s supply of vaccines to the European Union (EU), which has been a contentious issue between the two for a few weeks now.


Earlier in March, several European countries had temporarily paused the use of the vaccine after reports of blood clots emerged. However, the European regulatory body said that the known benefits of the vaccine outweigh the potential risks.


So, why has the EC launched legal action against AstraZeneca?

Dispute between the EC and the Anglo-Swedish company have been ongoing for a few weeks now. AstraZeneca started delivery of vaccines to the EU in February and under its contract with the bloc, it promised to deliver about 300 million doses by the end of June. However, in mid-March, the company announced a shortfall in vaccine shipment meant for the EU. It said that it would deliver 100 million doses in the first half of 2021, of which 30 million doses would be delivered in the first quarter.

The company cited a lower-than-expected output from the production process as one of the reasons for the shortfall and said that it would compensate by sourcing vaccines from its international supply network. Significantly, AstraZeneca noted in its statement that half of the EU’s supply in the second quarter and about 10 million doses in the first quarter were due to be sourced from the company’s international supply chain.


According to Euro News, in terms of absolute number of vaccinations, the UK is leading in Europe and is “way ahead of the rest of Europe”, with over 46 million vaccinations. Germany, Turkey and France follow with 25 million, 21 million and 19 million doses, respectively. As per a Reuters report, the delays in delivery of the AstraZeneca vaccine are slowing down the EU’s vaccination drive since the bloc was mainly relying on this vaccine. However, after repeated cuts in the supplies, it is now mainly relying on the vaccine developed by Pfizer-BioNTech.


What has AstraZeneca said in response to the legal action?

In response to the EC’s decision, the company has said that it is about to deliver about 50 million doses to European countries by the end of April. “AstraZeneca has fully complied with the Advance Purchase Agreement with the European Commission and will strongly defend itself in court. We believe any litigation is without merit and we welcome this opportunity to resolve this dispute as soon as possible,” the company said in a statement.


Does the Serum Institute of India have a role to play in this?

The Serum Institute of India (SII), which is the largest vaccine manufacturer in the world, is one of the sites where the Oxford-AstraZeneca vaccine for COVID-19 is being manufactured, which will be used in India and other countries around the world. Earlier in January, when the vaccine received Emergency Use Authorisation (EUA) from India, AstraZeneca said in a statement, “The approval in India is an important milestone as it will enable to supply India but also a large number of countries around the world.” This also includes low and middle-income countries, to which vaccines are being supplied under the COVAX program.


In June 2020, the company reached a licensing agreement with SII to supply one billion doses of the vaccine to low and middle-income countries, with a commitment to provide about 400 million doses “before the end of 2020” under the COVAX program.


The program is led by the vaccine alliance GAVI, the World Health Organisation (WHO) and the Coalition for Epidemic Preparedness Innovations (CEPI) in partnership with UNICEF, vaccine manufacturers and the World Bank, among others. The aim is to ensure equitable distribution of COVID-19 vaccines globally in what is being called the largest vaccine procurement and supply operation in history.


In late February, Ghana became the first country in the world to receive a shipment of coronavirus vaccines under the COVAX program. About 600,000 doses of the Oxford-AstraZeneca vaccine, manufactured by SII, were sent to Accra in Ghana on February 23.


However, deliveries of the vaccine manufactured by SII meant for countries participating in COVAX were delayed from March onwards after India banned the exports to meet domestic demand. Critics of the government said that India’s vaccine diplomacy hurt its own domestic needs. As of March-end, COVAX had been supplied with 28 million doses of Covishield (the variant of the Oxford-AstraZeneca vaccine made by SII).


As of April 27, India has exported doses of both Covishield and Covaxin to over 95 countries, including Bangladesh, Bhutan, Brazil, Sri Lanka, the UK and Syria. These 95 countries do not include the 27-member countries of the EU and it is not clear to what extent India’s ban of exports of vaccines has impacted AstraZeneca’s supply chain to the EU.


https://indianexpress.com/article/explained/explained-why-has-the-eu-initiated-legal-action-against-astrazeneca-7291254/