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Challenges ahead for India in getting Pfizer and Moderna vaccines

Top experts from the fields of medicine and science weigh in on the hurdles that lie for India on the road to getting its hands on the coronavirus vaccines.

Shalini Bhardwaj

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In an interview with The Daily Guardian, scientific and medical bigwigs Dr Randeep Guleria, Director, AIIMS, Pawanexh Kohli, founding CEO of India’s National Centre for Cold-Chain Development (NCCD), Dr Lalit Kant, former HoD, Epidemiology and Communicable Diseases, and Dr Satyajit Rath, Scientist at IISER, Pune, spoke about the vaccines developed by Pfizer and Moderna and whether India is ready to receive them.

Dr Randeep Guleria.
Dr Lalit Kant.
Pawanexh Kohli.
Dr Satyajit Rath.

Q. WHY WOULD THE PFIZER AND MODERNA VACCINES PROVE TO BE DIFFICULT FOR INDIA?

“It is not any more difficult in India than everywhere else,” said Pawanexh Kohli. According to the experts, the vaccines produced by both Moderna and Pfizer are mRNA vaccines. If approved, these would be the first mRNA vaccines approved for use in humans. Although it is easy to maintain the temperature of these vaccines, if or when they are exposed to higher temperatures, they will lose their potency. “The long haul will be done with dry ice and insulated boxes,” Kohli added. It should be noted that the vaccine, at -70° Celsius, will require thousands of specialised insulated boxes designed for dry ice capability.

Dr Lalit Kant elaborated, “There are three issues that countries like India would need to tackle. The first is its availability, as most of the doses to be produced in 2020 have already been purchased by some countries, notably the US and the UK. Second, its shipping and storage require ultralow temperatures (Pfizer’s requires -80°C), and putting in place an appropriate cold chain would be a major challenge. And, third, we are still unsure about the long-term safety of the vaccines and the duration of protection. The Pfizer vaccine does not use a preservative and there are chances of contamination of unused vaccines.”

DO WE HAVE ENOUGH PREPARATIONS TO ACCEPT THE CHALLENGE OF THE DELIVERY OF THESE VACCINES?

Dr Randeep Guleria of AIIMS pointed out, “The -70° Celsius storage requirement will be a challenge for India, especially maintaining a cold chain in rural areas.”

However, Dr Kant said, “I do not think India needs to go for vaccines that have such complex cold chain requirements. There would be other vaccines available which would not have such stringent cold chain requirements. The cost is another issue. It has been learnt the US has agreed to buy 100 million doses of Pfizer’s vaccine for up to $1.95 billion.”

“I think the BioNTech (Pfizer) and the Moderna Covid-19 vaccine candidates will be almost impossible to implement on any substantial scale in India in their current state since they require storage at -70°, which is impractical in Indian vaccination situations,” said Dr Satyajit Rath too, adding, “There are efforts being made to test if these vaccine candidates can work at higher storage temperatures, and there are also efforts being made to develop cheap low-maintenance ultra-cold storage methods. However, the outcomes remain uncertain. At the moment, as matters stand, I do not see any realistic actual modalities in place to implement this category of Covid-19 vaccines in India.”

WHAT CAN BE DONE IN THIS CASE?

Pawanexh Kohli said, “For -70°C, no dispersed facilities are available for cryogenic storage and these must be managed by the regular replenishment of dry ice at key nodal locations. Their subsequent movement would be at 2-8°C and done like all others. Otherwise, the option of flying or railroading them in insulated boxes with dry-ice can also happen. However, the vaccine supply is not to be planned for long-term storage but for regular evacuation and distribution. Using existing assets for this emergent need will be the most timely and efficient deployment for the purpose now.”

“The Moderna vaccine is at -20°C, which is the same as ice cream. That can be done easily and will still be at 2-8 °C at the last mile in regular reefer trucks. Keeping other vaccines at 2 to 8 °C is the same as we do with fresh produce, with last-mile storage the same as the other, in regular reefer trucks. At the delivery centre, they will need small fridges with active cooling—grid or solar-powered or backed with small DG sets. Also, temperature monitors with data loggers, and the syringes, which we may run short of! Vaccine givers are also required—people have to be organised if the plan is to do it at a mass scale and quickly,” he added.

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OXFORD-ASTRAZENECA VACCINE IS SAFE, SAYS SERUM INSTITUTE

Shalini Bhardwaj

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OXFORD

In a statement released by AstraZeneca, the company has admitted to its dosing error and said that the Oxford-AstraZeneca vaccine is safe and effective. Partnered company Serum Institute of India (SII), which is holding trials for the vaccine in India, also said that the vaccine candidates are safe and trials are running smoothly with strict adherence to all the necessary protocols in India and that there is no need to panic.

“The AstraZeneca-Oxford vaccine is safe and effective. Even the lowest efficacy results are at 60-70%, making it a viable vaccine against the virus. That said, varied age groups with different dosage forms will result in slight variations and efficacy. We must be patient and not panic. The Indian trials are running smoothly with strict adherence to all the necessary processes and protocols. So far, there are no concerns. However, we are going through the data that is available and will make a further statement, if needed,” the Pune-based SII said in a statement.

DCI FACES IRREGULARITIES AND CORRUPTION CHARGES

DCI FACES IRREGULARITIES AND CORRUPTION CHARGES

After the removal of Dr Majumdar as president of the Dental Council of India (DCI), the appointment of the council’s secretary has come under the spotlight. Due to procedural lapses and non-transparency in the appointment of DCI’s secretary, Dr Sabyasachi Saha may be disallowed to exercise his powers as the post-holder.

“The appointment of Dr Saha was made with the approval of the central body of DCI. Till the time the governing body reconsiders its earlier decision to appoint Dr Sabyasachi Saha as secretary, Dr Saha may be disallowed to exercise his powers as secretary, DCI, and M L Meena, Joint Secretary (Legal & Admin) may be asked to officiate as secretary, DCI in the interregnum,” said a letter issued to the Acting President by Nipun Vinayak, Joint Secretary, Department of Health & Family Welfare.

MEDICAL COLLEGES TO OPEN DOORS FOR STUDENTS

MEDICAL COLLEGES TO OPEN DOORS FOR STUDENTS

Maulana Azad Medical College (MAMC) has issued a notice to reopen the institute by December 1. The notice has been issued after receiving recommendations from apex medical regulator, the National Medical Commission (NMC), which recently issued directions to reopen medical colleges on or before December 1, 2020.

All institutions will have to adhere to Covid-related SOPs. The circular said, “All medical colleges/institutions shall ensure strict compliance of guidelines issued by the Ministry of Health Ministry Welfare State/UT Government about Covid-19 preventive measures including social distancing, use of mask and sanitisation measure of hostels, class, laboratories, lecture theatres, etc.”

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ANTIBIOTIC RESISTANCE: SILENT KILLER IN THE SHADOWS OF COVID-19

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ANTIBIOTIC RESISTANCE: SILENT KILLER IN THE SHADOWS OF COVID-19

Covid-19 has led to loss of many lives and crippling of economies of several countries. However, beyond the most obvious fallouts of this deadly disease caused by an insidious virus, the shadow of upsurge of antibiotic resistance is looming over the entire mankind which will be realised in the time to come. A medical revolution of colossal proportions happened on 28 September 1928, when the first antibiotic was discovered by Sir Alexander Fleming, a Scottish bacteriologist. This discovery was heralded as a path-breaking moment in the history of medicine as it seemed that the human race had finally found a new direction to combat deadly bacterial infections. What followed that event was the discovery, mass production, and prescriptions of several antibiotics over the next few years.

A mass optimism swept the world towards the dawn of a new period termed as the antibiotic era. A race to produce new antibiotics led to hundreds of antibiotics being churned out and consumed by the masses for bacterial infections. Even in his acceptance speech of Nobel Prize conferred to him, Sir Fleming had warned mankind against indiscriminate use of antibiotics, since that would lead to the bacteria developing resistance against the antibiotics which had been designed to kill them. Unmindful of this warning, overuse of antibiotics all over the world finally led to a global phenomenon, known as Antibiotic Resistance. This was a blanket term to describe the emergence of novel bacterial strains which are resistant to several antibiotics, known as multi-drug resistant bacteria (MDR) and all antibiotics, 2 known as all drug resistant bacteria (ADR).

The battle between the humans and these bacteria, also known as ‘Super bugs’ has set the ball rolling once again, for the sharp descent into the ‘Pre-antibiotic’ era in the future.

The new drug pipeline for drug-resistant bacteria is drying out, causing alarm and concern about the impending doom of mankind. While sometimes resistance occurs naturally, in most cases, it happens due to clinical misuse and self-medication. The other causes for antibiotic resistance are irresponsible disposal of untreated chemicals from manufacturing units and healthcare systems in the environment, indiscriminate feeding of antibiotics to livestock, and overuse of pesticides on crops, which are consumed unknowingly by humans. The multipronged solution to the worldwide predicament of antibiotic resistance includes creating awareness among the common man about the phenomenon of antibiotic resistance in order to prevent self-medication, careful monitoring of specific bacterial responses to various antibiotics, limiting the prescriptions of antibiotics by clinicians, and prevention of environmental pollution.

There is also a need to discover and design new drug molecules which could be used in lieu of the commonly prescribed antibiotics. In recent times, the outbreak of the pandemic of Covid-19 has only led to escalate the imminent threat of antibiotic resistance. Though Covid-19 is caused by a coronavirus, its health complications are often compounded by serious secondary bacterial infections. In the ensuing chaos of this pandemic, two diverse phenomena are occurring which are causing overuse of antibiotics. One, several patients are not being able to access the healthcare workers due to lockdowns and are indulging in self-medication. Second, since Covid-19 has caught the world at the wrong foot unexpectedly, many antibiotics are being widely used to combat bacterial infections in the Covid-19 patients in hospitals all over the world.

The sudden emergence of this deadly virus has not given enough time to the healthcare workers to prudently balance the treatment of the patients against the future danger of the antibiotic resistance, which will be felt for centuries to come. The bright side of the problem is that the emergence of this pandemic has brought the spotlight on the infectious diseases caused by superbugs, which is making the governments and policymakers of all the countries in the world take these phenomena seriously. This event has indicated that despite the cutting-edge technologies and sophisticated medical care, pandemics of gigantic magnitudes caused by superbugs may happen in future as well. Despite the doomsday prophecies, it is hoped that this global crisis will help the world to educate itself better about the constant and impending threat of superbugs and antibiotic resistance, and recognise the critical tip of the iceberg that we are collectively sitting on.

The mankind has valiantly fought and emerged victorious after the onslaught of past pandemics. Hence, careful monitoring of antibiotic use and aggressive repurposing of drugs to enhance the drug pipeline for new antibiotics while limiting environmental pollution will give a new direction for mankind to overcome the global threat of antibiotic resistance.

Prof Sujata Sharma is associated with the Department of Biophysics, AIIMS, New Delhi.

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SOCIAL VACCINATION IS STILL THE WAY FORWARD

Dr Neeraj Nischal

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SOCIAL VACCINATION IS STILL THE WAY FORWARD

The festive season is here, and so is winter. With all of us stranded at home for most of the year, the desire for celebration and social gathering is climbing. We are all eagerly waiting for the distribution of Covid-19 vaccines, so we may gain immunity and go about our lives as it was the case in the pre-coronavirus era. Vaccine development and immunisation are, however, time-consuming. Thus, while the scientific community works on a biologic solution, we must continue to take part in the practice of the ‘social vaccine’.

The Covid-19 social vaccine includes social distancing, hand hygiene, face masks, and isolation. Since the discovery of the mode of spread of the SARS-CoV-2 virus, these measures have been widely popularised. Over the last nine months, Covid fatigue has set in all of us, and there has been laxity in the practice of the laid down Covid appropriate behaviour. Without reinforcement, this will only worsen.

We are currently in the unlock process after a long lockdown phase. At this time, the number of cases in certain parts of India is again on the rise. The disease is just as, if not more rampant in its spread, and has not heeded to our efforts of lockdown. Social vaccination is still the only way to safeguard ourselves. The virus will enter our homes if we falter and permit it. It is up to us to keep ourselves and those around us safe and healthy.

To elaborate the measures yet again, social distancing includes physical distancing of individuals by at least six feet. We do not have to be socially or emotionally distant in these times, just physically distant. We have been blessed with technology to bring the world closer. The utilisation of these online platforms will help us socialise when we have to practice social distancing. Washing your hands with soap and water (or alcohol hand rubs) for at least 20 seconds, frequently, will keep you from spreading the virus by touch. Let us strengthen the Indian tradition of ‘Namaste’, and say no to handshakes. Face masks will not only protect you from Covid-19 but other winter viruses like the common cold, and influenza. Most importantly, remember to be socially vigilant, and isolate yourself if you are symptomatic.

A vaccine is not a magic bullet to end the pandemic. The introduction, logistics, and effects of vaccination is a drawn-out process. Even with a sound biological vaccine, social vaccination is still the most crucial aspect of disease prevention. The two should go hand-in-hand to control the disease and are not mutually exclusive. Both of these would need staggering community participation, with the social vaccine requiring the full and conscious effort of the entire population without which it is bound to fail. The fate of the pandemic rests in the hands of each and every one of us. Here’s to celebrating the festive season the way it was meant to be, with lights and goodwill.

Dr Neeraj Nischal is Associate Professor, Medicine Department, All India Institute of Medical Sciences, New Delhi. He wrote this article with the help of Dr Sujay Halkur Shankar, Resident Doctor at AIIMS.

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We have to watch out for mutations of the virus: Dr Shahid Jameel

Virologist Dr Shahid Jameel discusses the parameters for an effective vaccine against the coronavirus pandemic and how to prepare for a large-scale vaccination drive.

Shalini Bhardwaj

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Dr Shahid Jameel

In an exclusive Interview with The Daily Guardian, Dr Shahid Jameel, Virologist and Director of Trivedi School of Biosciences at Ashoka University, talks about how to judge the efficacy of a Covid-19 vaccine, how India needs to plan for the vaccination drive and whether the novel coronavirus is likely to mutate in the near future. Excerpts:

Q. What would you say about the companies claiming the efficacy of their vaccines only through press releases?

A. Press releases are quick ways for companies to make their achievements public, but they are geared more towards shareholders and financial markets. A factual position can only be judged when the scientific details of a trial are published in a peer-reviewed publication. We should wait for those. At this time, the percentage of efficacy is not important and should not be used to compare different vaccines. All this means is that vaccines based on the viral spike protein will work to protect against disease, and sometimes against infection as well.

Q. What kind of a vaccine should be given to the people?

A. A vaccine that has been proven to be safe and has good efficacy. This is the reason why human clinical trials are done in stages – Phase 1 for safety in small numbers of volunteers; Phase 2 for safety and immunogenicity in larger numbers of volunteers; and Phase 3 for safety and efficacy in very large numbers of volunteers with gender, racial and age diversity.

Q. How much efficacy should that vaccine have before being approved for people?

A. It depends upon how infectious a virus is. In this case, the WHO and US FDA have set a benchmark of 70% efficacy before a vaccine candidate will be considered for approval.

Q. Why have there been errors with the AstraZeneca vaccine?

A. I cannot answer that. All I know is what the company has said. Errors happen, but what is important is how transparently they are addressed. I am sure the regulators in all countries that want to license this vaccine will look at the data very carefully.

Q. How does India need to plan ahead for successful vaccination?

A. India’s plan should include the following. Firstly, who should get the vaccine first? The primary aim should be to use the vaccine to protect frontline workers (healthcare, sanitation, essential services), reduce mortality (elderly and those with comorbidities) and control the pandemic.

Secondly, to work out the storage-transfer-delivery logistics down to the last detail. India has a lot of experience with the polio vaccine but that was an oral vaccine not an injectable one. India also has a lot of experience with childhood and maternal vaccines, but we have never delivered such large amounts of a vaccine during a pandemic.

Thirdly, the current capacity is to deliver 1.5 million doses per month, or 18 million doses per year. The Health Minister stated that 250 million Indians would be vaccinated in 2021. That means 500 million doses. At current staff strength, it would take more than two years. Therefore, we must increase trained staff.

Fourthly, should we vaccinate those in high priority groups (e.g. healthcare workers) who have already been infected? This would make little sense and waste precious doses. If we decide not to, then there should be an inexpensive test to find out those who already have antibodies. Today the test costs as much as one vaccine dose. That cost has to be factored in.

Lastly, make the plan available for public scrutiny and comment. This will increase trust in the vaccination programme.

Q. What are the parameters which need to be considered for emergency approval of vaccines?

A. Emergency Use Approval looks primarily at safety in large and diverse populations and also a reasonable level of efficacy.

Q. For how long will these vaccines work?

A. We don’t know the answer to this simply because vaccine trial follow-ups have not been done for long enough. Extrapolating from natural infection, neutralising antibodies wane off in about six months, but that does not mean loss of protection since there are T cells and memory recall responses. Even natural infection has not been followed long enough after recovery to fully answer this question. But, going by other endemic coronaviruses, protection may last up to a year or more.

Q. Do you think this virus can mutate? If it does, what is likely to happen?

A. Every virus mutates and so does this one. RNA viruses mutate faster than DNA viruses. However, compared to other RNA viruses, coronaviruses have the lowest rate of mutation. With over 224,000 SARS-CoV2 genomes sequenced by now, mutations in the spike protein neutralizing domain have not been seen. So, that’s good from the vaccine perspective. But this region has no selection pressure on it to change. Once vaccines are deployed in a big way, such mutations will arise. We would have to watch out for that.

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Pfizer seeks emergency use of Covid-19 vaccine

Shalini Bhardwaj

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Pfizer has announced that its vaccine is 95% effective on the basis of its Phase-3 trials. On Friday, Pfizer said that it is asking US regulators to allow the emergency use of its Covid-19 vaccine.

The company announced that they will submit a request to the US Food and Drug Administration (FDA) for Emergency Use Authorisation, which will potentially enable the use of the vaccine in high-risk populations in the US by mid to end of December 2020.

“Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of Covid-19 globally. Filing in the US represents a critical milestone in our journey to deliver a Covid-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” said Dr Albert Borla, Pfizer CEO and chairman.

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India to get 400-500 mn vaccine doses by July: Harsh Vardhan

Shalini Bhardwaj

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Harsh Vardhan

Union Health Minister Dr Harsh Vardhan has said that India is set to get 400-500 million vaccines by July 2021. He gave this statement during a virtual programme organised by FICCI FLO.

During the programme, National Treasurer Lalita Nijhawan, in an FAQ session, asked the Health Minister about the method of distribution of the vaccines across the country.

“First of all, priority has been given on the basis of medical grounds because we are a country of 135 crore people. For such large numbers of people, nobody can arrange large quantities of doses of vaccines in a single go. By July to August 2021, we will have 400-500 million dosages available. Now it is under clinical trials in many companies,” said Dr Harsh Vardhan.

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