Bio-Technology : news and updates

What is the News?

The University of Cambridge has found out new genes emerging in the genome of living organisms. They have called them novel Open Reading Frames or as nORFs.

Human Genome Project:

• Human Genome Project(HGP) was an international, collaborative research program conducted from 1990 to 2003. The main goal was to completely map and understand all the genes of human beings.
• Apart from that it also strengthened the study of human diseases and aided new drug discovery.
• But even after the research, the number of ‘known’ genes has remained constant for two decades.
• Hence, a team from the University of Cambridge has set out to find whether new genes emerge in the genome of living organisms and if they do, how they do so.

About the research:

Novel Regions:

• These novel regions were explored and cannot be defined by our current ‘definition’ of a gene. Hence, these novel regions are called novel Open Reading Frames or as nORFs.
• These regions are also broadly involved in diseases. They were seen as dysregulated (poor ability to manage) in 22 cancer types.
  • Dysregulated means that they could either be mutated, upregulated, or downregulated or could be uniquely present.
• Further, these regions can form structures. They can undergo biochemical regulation like known proteins. They can also be targeted by drugs in case they are disrupted in diseases.

Significance of the research:

• This research shows that there is an urgent need to redesign our existing drugs. Because they currently target only the known proteins and not target the novel regions.

Source: The Hindu

What is the News?
Scientists have unveiled the detailed genome of the Asian malaria vector mosquito Anopheles stephensi.

Click Here to Read about Malaria

Who conducted the research?

• The research was conducted by the Tata Institute for Genetics and Society (TIGS) and Institute of Bioinformatics and Applied Biotechnology both in Bengaluru.

What was the need for the research?

• There is a need for intricate knowledge of the genomes of vector mosquitoes. It will be helpful in order to find an advanced form of defence against malaria transmission including targeted CRISPR and gene drive-based strategies.
  • CRISPR technology: It is a gene-editing tool. It allows researchers to easily alter DNA sequences and modify gene function.

Key Finding of the research:

• It unearthed more than 3,000 genes of the Anopheles stephensi genome that previously evaded scrutiny.
• These newly discovered genes play key roles in the metabolism of ingested blood meal, reproduction, and immunity against microbial parasites.

Significance of this research:

• This detailed genome of the malaria mosquito vector is vital for the development of genetic control strategies of disease transmission, It would help malaria biologists in India and the rest of the world towards the goal of malaria elimination.
• The newly discovered genes can also help address the issue of growing insecticide-resistant mutations in Asian and African An. stephensi populations.

National Framework for Malaria Elimination(NFME) 2016-2030

• The framework has been developed with a vision to eliminate malaria from the country. It will contribute to improved health and quality of life and alleviation of poverty by 2030.
• Goals:
  • Eliminate malaria (zero indigenous cases) throughout the entire country by 2030; and
  • Maintain malaria–free status in areas where malaria transmission has been interrupted and prevent re-introduction of malaria.

Source: The Hindu

What is the News?

Indian drug regulator approved Serum Institute to conduct a phase-2/3 trial of CovoVax COVID-19 vaccine that was originally developed by Novavax Inc. In this case, the regulator allowed the vaccine manufacturer to use a placebo in the control group.

What is a Placebo?

• It is a substance or treatment which is designed to have no therapeutic value. All placebos have one common feature, that they do not contain an active substance meant to affect health.
• Common placebos include inert tablets (like sugar pills), inert injections (like saline), sham surgery, and other procedures.

How Are Placebos Used?

• Researchers use placebos during research. It helps them understand the effect, a new drug or some other treatment might have on a person with a particular condition.
• For instance, some people in a study might be given a new drug to lower cholesterol. Others would get a placebo. None of the people in the study will know if they got the real treatment or the placebo.
• Researchers then compare the effects of the drug and the placebo on the people under the study. That way, they can determine the effectiveness of the new drug and check for its side effects.

What is the Placebo effect?

• Sometimes a person can respond to a placebo. The response can be positive or negative. For instance, the person’s symptoms may improve. Or the person may have what appears to be side effects from the treatment. These responses are known as the “placebo effect”.

Source: The Hindu

What is the News?

A study by NIMHANS, Bengaluru has rejected the assumption that if one stops drinking, the damage to health from excessive consumption of alcohol can be reversed.

About the study:

• The study has been published online in the American Journal of Medical Genetics.
• It tracked patients at NIMHANS Centre for Addiction Medicine outpatient clinic from March 2015 to April 2016.
• It analysed the DNA chemistry of the individuals who had been drinking on an average of 10 drinks/day.

Key Findings of the study:

• Excessive alcohol consumption can cause irreversible changes to the DNA. It will continue even when alcohol is no longer consumed.
• The effects of alcohol are more noticeable in those who had started drinking at an early age. This suggests that starting to drink early may physically alter many genes including those of the brain.

Source: The Hindu

What is the News?

The Government of India has decided to waive off some GST amount against the import of gene therapy — Zolgensma. This therapy is required to treat a child who is suffering from Spinal Muscular Atrophy.

Spinal Muscular Atrophy

• Spinal muscular atrophy is a rare genetic disease. The person suffering from this disease cannot control the movement of their muscles.
• Caused By: It is caused by the loss of nerve cells that carry electrical signals from the brain to the muscles. The protein needed for this signaling is coded by a gene. Everyone has two copies of this gene- one from the mother and the other from the father. A child develops this disorder only if both the copies are faulty.
• Vulnerable Group: The disease most often affects babies and children. With time, it progresses and makes it extremely difficult for the babies to carry out basic activities like sitting up, lifting their head, or swallowing milk.

Zolgensma Gene therapy

• Gene Therapy Treatment: There is also a gene therapy treatment named Zolgensma which replaces the faulty gene. US regulators approved this therapy in May 2019.
• Zolgensma works by supplying a healthy copy of the faulty gene. It allows nerve cells to then start producing the needed protein. This halts the deterioration of the nerve cells and allows the baby to grow more normally.

Source: The Hindu

What is the News?
The Food Safety and Standards Authority of India(FSSAI) has amended its rules. Under new rules, it put a cap on trans fatty acids(TFAs) in food products. Previously, it tightened the norms for oils and fats in the food.

What are the new rules?

• According to FSSAI, Food products contain edible oils and fats. The use of industrial trans fatty acids in these products shall not be more than 2% by mass of the total oils/fats. These rules are effective from 1st January 2022.
• The allowed limit of TFA was at 5%. In December 2020, the FSSAI had capped TFAs in oils and fats to 3% by 2021, and 2% by 2022.
• The present amendment has been introduced to achieve the 2022 target.
• It is in line with the WHO’s call for the elimination of industrially-produced trans-fatty acids from the global food supply by 2023.
• Achievement of the 2% limit is equal to elimination of TFAs.

About Trans Fatty Acids:

• They are created in an industrial process.  It adds hydrogen to liquid vegetable oils to make them more solid. It increases the shelf life of food items and can be used as an adulterant as they are cheap.
• Present in: They are present in baked, fried, and processed foods as well as adulterated ghee. They become solid at room temperature.
• Harmful Effects: They are the most harmful form of fats. They clog arteries and cause hypertension, heart attacks, and other cardiovascular diseases.
• As per the WHO, intake of industrially-produced trans-fatty acids results in approx. 5.4 lakh deaths each year globally.

Initiatives against Trans Fats:

• Heart Attack Rewind Campaign: It is a mass media campaign launched by FSSAI. It calls for the elimination of industrially-produced trans fat in the food supply by 2022.
• REPLACE campaign: REPLACE stands for Review, Promote, Legislate, Assess, Create awareness and Enforce. It is a WHO campaign to eliminate industrially-produced artificial trans-fats from the global food supply by 2023.
• Eat Right India Movement: It was launched by FSSAI in 2018. It is a preventive healthcare measure to trigger social and behavioural change among people. The movement aims to improve public health in India and combat negative nutritional trends to fight lifestyle diseases.

Click Here for Further Reading on Trans Fats

 Source: The Hindu

What is the News?

The Prime Minister mentioned the garbage to power Plant (Waste to power) plant in his speech. The plant is being commissioned inside the Dr. B.R. Ambedkar Agriculture Market.

About the Garbage-to-power plant:

• Developed by:  CSIR-Indian Institute of Chemical Technology(IICT)
• Technology: It is based on a biomethanation technology-based Anaerobic Gas lift Reactor(AGR). CSIR-Indian Institute of Chemical Technology (IICT) has patented the reactor.
  • Biomethanation: It is a process by which organic material is microbiologically converted to biogas, under anaerobic conditions.
• How does the plant work?
  • To initiate the process of biomethanation, conveyor belts carry tonnes of vegetable waste to shredders.
  • The shredded waste is then converted into a semi-liquid mixture. It is then put into large containers or pits to start the process of anaerobic digestion. Organic waste is eventually converted into biofuel which has two major components, methane and carbon dioxide.
  • The fuel is then put into ‘100 percent biogas generators’ that converts the fuel into electricity and reaches the market’s electricity bulbs.

Source: The Hindu

Why in News?
Verbio AG, a German company is setting up compressed biogas(CBG) plant in  Bhutal Kalan village in Punjab. Increasing CBG production is much more beneficial compared to the Production of CNG.

Facts:

• Compressed Biogas(CBG): It is a purified form of biogas. It can be produced from waste including municipal solid waste, sludge from wastewater treatment plants, market residues, agricultural residues, cattle dung, sugarcane press mud among others.

Process of Producing CBG: CBG from biomass involves a two-pronged approach.

1. First Step: Biogas is produced through the anaerobic decomposition of biomass.
   • Anaerobic Process: In this process, microorganisms break down biodegradable material in the absence of oxygen. The process is used for industrial or domestic purposes to manage waste or to produce fuels.
2. Second Step: Biogas contains 55 to 60% methane, 40 to 45% carbon dioxide (CO2) and trace amounts of hydrogen sulphide. The second process involves purifying the gas to remove carbon dioxide and hydrogen sulphide gases to prepare CBG.

How is CBG different from Compressed Natural Gas(CNG)?

1. Chemically, CBG is the same as CNG — both are compressed methane — and have the same calorific value.
2. But, CNG is a by-product of petroleum, and CBG can be produced from any biomass, be it crop residue, cattle dung, sugarcane press mud, municipal wet waste, or effluents from a sewage treatment plant.
3. Hence, this makes CBG a commercially viable option as it can be directly used to replace CNG in transportation fuel. Just like CNG, CBG too can be transported through cylinders or pipelines to retail outlets.

Other advantages of CBG:

1. Compressed biogas has the potential to minimize India’s need to import fuel.
2. The solid by-products of CBG can be used as bio-manure. According to experts, bio-manure produced using paddy straw can result in a 20% increase in crop yield.
3. The other by-product from CBG is CO2. It is used to produce a liquid or solid CO2. It has a high demand for food preservation or to be used in fire extinguishers.

Government Initiative to promote CBG:

1. Sustainable Alternative to Affordable Transport(SATAT) Initiative: It was launched in October 2018 to promote the Compressed Biogas (CBG)
2. The scheme targeted the production of 15 million metric tonnes (MMT) of CBG by 2023.
3. Public sector undertakings oil marketing companies(OMCs) including IOCL partnered with potential entrepreneurs under this initiative to set up plants and supply CBG to them for sale as automotive and industrial fuels.

Source: Down To Earth

Source: click here

Syllabus: GS 3

Synopsis: Mutation of the coronavirus has become a new threat for the world. India must take precautionary measures to deal with it.

Introduction 

New SARS-CoV-2 variants have emerged independently in several countries and the virus is changing very quickly.  If it continues to change, currently available vaccines will become ineffective.

Why do viruses mutate?

All the viruses carry a genetic code in the form of RNA or DNA. The DNA is replicated as the cells multiply and this process may cause random errors in the new DNA.

Errors in DNA can be corrected by the enzymes present in the cell. However, RNA doesn’t contain enzymes, thus errors caused in RNA cannot be corrected. It causes more genetic changes (mutations)in RNA than DNA viruses.

How are vaccines tested for efficiency against emerging variants?

• Indirect tests are conducted in labs. It will find if variant virus escapes antibodies developed after natural infection or vaccination.
• Antibodies that neutralize the original virus are tested on the variant viruses. 

Are the emerging variants vulnerable to vaccines?

• The emerging variants from South Africa could pose a challenge to current vaccines. Not enough information is available yet for the Brazil variant.
• However, the studies have only tested antibody responses. Vaccines also increase cellular immunity to eliminate infection which has not been tested.

The evidence currently does not suggest that vaccines are failing. 

• However, Moderna and Pfizer/BioNTech have agreed that their vaccines have had reduced protection against the South African variant. Both the companies are now working on developing new vaccines to fight these variants.

What steps should India take in this situation?

There is no local transmission of the new variants in India until now. Only the UK variant viruses have been found in travellers coming to India. 

1. Firstly, India should strictly implement masks and limit crowds. It should also do the contact tracing of people infected with the new UK variant. 
2. Secondly, India should also put a ban on travel from South Africa and Brazil just like the US did. India must also be cautious of people with a history of travel to South Africa since October 2020, and Brazil since December 2020.
3. Thirdly, the most efficient way to catch emerging variants is increased genomic surveillance. So far, there are only about 5,000 SARS-CoV-2 sequences from India in public databases, which accounts for only 0.05 percent of confirmed cases. 

The setting up of an inter-ministerial group -Indian SARS-CoV-2 Genomics Consortium (INSACOG) to increase genomic surveillance is a step in the right direction. India should take more such steps. 

What is the news?
An expert body is looking into Bharat Biotech’s application for testing its  Covid-19 vaccine, BBV154. This is an Intranasal Vaccine.

What is Intranasal Vaccine?

• Vaccines are administered as injectable shots into the muscles(intramuscular). Or the tissue just between the skin and the muscles(subcutaneous).
• However, with intranasal vaccines, the solution is sprayed into the nostrils and inhaled instead of injecting it.

Benefits of Intranasal Vaccine:

• The nasal route has excellent potential for vaccination due to the organized immune systems of the nasal mucosa.
  • It is non-invasive, Needle-free.
  • Ease of administration – does not require trained health care workers.
  • Elimination of needle-associated risks (injuries and infections).
  • High compliance (Ideally suits for children and adults).
  • Reduces the overall cost of a vaccination drive as for example BBV154 requires a single-dose regimen.

Potential Setbacks of Intranasal Vaccine:

• Past attempts to develop intranasal vaccines, including for measles flu, have not been very successful.
• These vaccines use live, weakened viruses, but have never cleared clinical trials.
• Only a live attenuated influenza flu vaccine has been licensed through this route of delivery.

Source: Indian Express

What is the News?
Indian Council of Medical Research (ICMR) and the National Institute of Virology(NIV) study found Covaxin effective against the new UK variant of Covid-19.

About the Study:

• The study has found that Covaxin has a good neutralization capacity against the U.K variant of the COVID-19 virus. This capacity was the same against the strain used for making the vaccine.

How were the neutralization studies carried out?

• Under this study, the virus isolated from people is grown in the lab using cell lines. When viruses successfully grow in them, the pathogenic effects of the viruses are observed in the cells.
• The sera (the protein-rich liquid separated from blood after it is clotted) taken from vaccinated people are then added to the cell line culture system and its ability to prevent the virus from causing pathogenic effects is observed.
• In this case, the sera taken from vaccinated people were able to neutralize the virus and hence prevent pathogenic effects being produced in the cell lines containing the virus.

Further Reading on Vaccines

Source: The Hindu

Why in News? 

WHO, UNICEF, IFRC and MSF announced the establishment of a Global Ebola Vaccine Stockpile to ensure response to outbreak.  

 Facts: 

• • Global Ebola Vaccine Stockpile: The stockpile is led by International Coordinating Group(ICG) on Vaccine Provision which includes the WHO, UNICEF, the International Federation of Red Cross and Red Crescent Societies(IFRC), and Médecins Sans Frontieres (MSF) with financial support from Gavi, the Vaccine Alliance.  
  • Purpose: The stockpile will ensure timely access to vaccines for countries at risk during outbreaks. 
  • Ebola Vaccine: The injectable single-dose Ebola vaccine rVSV-ZEBOV is manufactured by Merck, Sharp & Dohme(MSD) Corp and developed with financial support from the government of the United States of America (USA). 
  • Based in: The stockpile will be based in Switzerland. 

 To Read About Ebola: http://bit.ly/3bWL96g

News: Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) has entered into Technology Transfer Agreements with Pune based Biorad Medisys for flow Diverter Stents.

The cost of the Chitra Flow Diverter stent is expected to be priced significantly lower than the currently imported ones.

Facts:

What are Flow Diverter Stents?

• It is a endovascular technique used for diverting blood flow away from an intracranial aneurysm or localized ballooning of arteries in the brain, helping reduce chances of its rupture and related stroke. Currently, India does not manufacture flow diverters stents,
• Flow diverters have the advantages of being flexible and adaptable to the shape and course of the vessel. Also, flow diverters promote healing of the vessel wall by removing the constant stress of blood flow on it.

What are Technology Transfer Agreements?

• Technology transfer is the process by which a technology, expertise, know-how or facilities developed by one individual, enterprise or organization is transferred to another individual, enterprise or organization.
• It may happen from country to country, from industry to industry or from research laboratory to an existing or new business.

Article source

Synopsis: Government has released a Vaccine Fact sheet that contains guidelines for administering both vaccines (Covaxin and Covishield). 

Background 

• Union Health Ministry has sent a comprehensive fact sheet for both vaccines (Covaxin and Covishield) to all states and immunisation officer.  
• The Centre has also asked the states and immunisation officers to disseminate the fact sheet to all programme managers, cold chain handlers, and vaccinators before the rollout. 

What is this fact sheet? 

The fact sheet contains the general guidelines that should be followed during the initial phase of the Covid-19 vaccination drive, while vaccinating the priority group (3 crore people). 

The fact sheet contains the guidelines on the following aspects,  

• • Physical specifications such as dosage, cold chain storage requirements. 
  • Specific guidelines on contraindications (a factor due to which the vaccine is to be withheld to certain categories of people)  
  • Guidelines on adverse events   
  • Details on special precautions. 

Now we will examine in detail, the exceptions, precautions, and possible adverse events that are mentioned in the fact sheet. 

First, the general guidelines in the fact sheet contain the following directives to ensure that proper care is taken while administering the vaccine. 

• • Only people over the age of 18 years are eligible for vaccination. 
  • Since 2 doses of vaccines are required per person, every Person should be administered the same vaccine in both the dosage. It is to deal with the issue of possible interchangeability. 
  • While administering the vaccine to a person with a history of any bleeding or coagulation disorder, platelet disorder, clotting factor deficiency, or coagulopathy, it should be done with caution. 
  • Both Vaccines have to be stored at +2°C to +8°C and needed to be protected from light. If it is found frozen it has to be discarded. 

Second, the specific guidelines on contraindications. The three categories of people for whom the vaccine should not be administered. They are, 

• • Persons who have shown a history of an allergic reaction. 
  • People who show an immediate or delayed onset of an allergic reaction to vaccines or injectable therapies, pharmaceutical products, and food items. 
  • Pregnant and lactating women.  

Third, guidelines on temporary contraindications. 3 categories of persons for whom vaccination is to be deferred for four-eight weeks. They are, 

• • Persons showing active symptoms of SARS-CoV-2 infection. 
  • Covid-19 patients who have been treated with anti-SARS-Cov-2 monoclonal antibodies or convalescent plasma. 
  • Acutely unwell and hospitalised patients (with or without intensive care) due to any illness. 

Fourth, the fact sheet under not contraindicated, specifically mentions that persons suffering from following health conditions can get vaccinated. However, the response to the Covid-19 vaccine may be less in these individuals. They are; 

• • Persons with a past history of Covid-19 infection. 
  • Persons with a history of chronic diseases and comorbidities (cardiac, neurological, pulmonary, metabolic, and malignancies). 
  • Persons with immunodeficiency or HIV, and patients on immune suppression due to “any condition” can be administered with the Covid-19 vaccine.  

Fifth, the fact sheet has also separately mentioned the Possible Adverse Reactions for both the vaccines along with the required precautions to be taken during the adverse reaction. 

Guidelines provide the list of mild adverse events and rare adverse events that may follow the vaccination from both Covishield and Covaxin. It also provides for the precautions and medication that will be required in the above cases.  

For example; In case of Mild adverse events for Covishield like myalgia (deep muscle pain), malaise (a feeling of overall discomfort), common painkiller paracetamol may be used. 

How Covid-19 vaccines administered in other countries have performed till now? 

Though the overall performance is found to be safe so far, there were few adverse events recorded in a small section of the population. For example, in the case of the US,  

• The US Centers for Disease Control (CDC), monitoring by the Vaccine Adverse Event Reporting System detected 21 cases of anaphylaxis (a severe, life-threatening allergic reaction that occurs rarely after vaccination) out of a reported 1,893,360 first doses of the Pfizer-BioNTech vaccine. 
• Whereas in the case of Modern’s mRNA vaccine, which was authorized for emergency use in the US, the CDC said data is still limited.

Synopsis: Government has issued strategic guidelines for the effective rollout of COVID vaccine program. There are challenges in the way of the Vaccine program that should be tackled as soon possible. 

Strategic guidelines for COVID vaccine programme 

With limitations of Vaccine related to efficiency and efficacy in mind, government has framed strategic guidelines for COVID vaccine programme 

• Guidelines were framed using the knowledge acquired over three decades of implementing the Universal Immunisation Programme. It aims to aims to cover 30 crore people by July 2021. 
• It has specified involvement of 19 departments, donor organisations and NGOs at the national, state, district and block level in the roll out of COVID vaccine programme. 
• The guidelines have also clearly mentioned the priority criteria. Citizens eligible for the first round of COVID vaccine programme includes the following, 

• • • The caregivers and front-line workers working under the department of health, defense, municipalities, and transportation. 
    • Persons above the age of 50.  
    • And persons below the age of 50 who suffers from comorbidities such as diabetes, hypertension, cancers, and lung diseases are all included. 

• The strategic guidelines have also clearly stated in detail, 
  • • The skills, roles, and responsibilities of the required human resources. 
    • The quantum of logistics required for delivering vaccines at point of use.  
    • The requirement of physical infrastructure, monitoring systems based on digital platforms, and feedback systems for reporting adverse events. 

However, it has been criticised that the guidelines are ideal and have failed to provide solutions for real-time issues of our health system.  

What are the challenges involved in effective rollout of COVID vaccine programme? 

There are many challenges to roll out COVID vaccine programme. They are, 

• First, unequal distribution of cold storage facilities among states. For example, out of the 28,932 cold chain points, half are in the five southern states, Maharashtra and Gujarat. 

• • Whereas the eight states in the North and Odisha that account for over 40 per cent of the country’s population have only 28 per cent of the cold chain points.  

• Second, pertaining issues in our health care sector such as poor human resources, a weak private sector, poor safety and hygiene standards, frequent power outages, poor infrastructure will reduce the capacity to implement the vaccine programme with speed, quality, and accuracy. 
• Third, a massive immunization programme for 30 crore people can distort the routine health service delivery and affect other immunisation drives, and can lead to exhaustion of health care workers. 
• Fourth, acquiring the data for under the 50s with comorbidities will be challenging though we have data for the above-50-year-olds in the electoral rolls. 

• Fifth, there are also challenge of tackling Fudging, false certification, and siphoning off vaccines to private facilities in the event of vast price differences between private hospitals and public hospitals. 
• Sixth, the non-availability of efficacy data could result in huge wastage and gives scope for errors and duplication during the procurement and supply of vaccines. 
• Seventh, the trust among the people on COVID vaccines are decreasing leading to suspicions and fears due to various reasons such as  

• • • Non-transparency of data on either of the two vaccines proposed for use in the program. 
    • Opacity with which the licenses were given etc. For example, have not completed the Phase 3 trials that confirm the safety and efficacy of the vaccine.  
    • Above all, India hasn’t signed the advance purchase agreements for vaccines that have completed Phase 3 trials from other countries. 

What is the way forward? 

• First, avoid the complexity of listing the priority groups throughout our country. It should be replaced by covering the complete area in one go, instead of sequencing them into different groups.  

• • • The areas could be ranked on the basis of a vulnerability index based on disease burden, caseload of COVID infections, demographic profile, health-seeking behavior and availability of infrastructure, etc. 

• Second, to create confidence in the community we need to establish an independent team of experts under the aegis of the WHO to ensure adherence to recruitment standards, consent conditions, adverse event record management, compensation standards. 
• Third, to build trust about vaccination programme we need to plan for large–scale public education and information programme through State- and local-level networks where people are informed, sensitised and their feedback was taken.  
• Fourth, People should be involved in decision-making. For this Local leader from public figures, religious leaders, self-help groups, the media, and even educational institutions need to participate to help citizens understand its importance and build trust 
• Fifth, Science, evidence, and data analytics need to be extensively used for effective policymaking. 
• Finally, vaccination is not a complete solution to end the epidemic. We need to adopt safe behavior through a communication strategy. For this, the government can use its experience of controlling the HIV/AIDS epidemic.  

The need of the hour is a winning strategy against epidemic that has drained us economically, socially and psychologically.  Government needs to understand that the effective way of improving uptake of the vaccine while reducing costs is by creating participatory frameworks of engaging experts and communities and building effective and reliable public information, and transparency.

Synopsis: Many issues have been highlighted in the Phase-3 trial of Bharat Biotech’s COVID-19 vaccines. Those issues could have been avoided after HPV vaccine trial controversy. 

Introduction 

In a previous case, Human papilloma virus (HPV) vaccine trial was carried out on nearly 23,500 girls in the 10-14 age group in Vadodara, Gujarat and Khammam without proper consent. Almost eight years later the Supreme Court of India criticized the government for its inability to take action on illegal clinical trials carried out in India by multinational countries. 

Present situation of the approval process in India suggests nothing much has changed. 

• The phase-3 clinical trial of Bharat Biotech’s COVID-19 vaccine resembles the HPV vaccine because it seems that the trial is suffering from serious violations. 
• The ICMR which has assigned the task of promulgating research ethics guidelines is also the cosponsor of the Covaxin trial. 

What are the problems in the Covaxin phase 3 trial? 

After the 2013 SC order, The Indian regulator made audio-video recording of the informed consent of each individual participant mandatory in 2019. Written consent from the participant had to certainly be taken before the audio-video recording. 

However, the process was not followed properly; 

• Firstly, no efforts were made to explain and inform the participants about the pros and cons of taking part in the trial instead; they were deceived by the trial site to think they were getting a COVID-19 vaccine for free. 
• Secondly, many participants didn’t know about their rights to get free medical care in case of any adverse events. 

• • Many aware participants sought medical help from private practitioners whereas some of the participants don’t possess mobile phones, thus medical follow-up was not possible.  

• Thirdly, not enough time was given to discuss with the family before signing the consent form. At least in a few instances, the consent was taken after vaccination, which is a serious violation.  

• • Participants were not given a copy of the consent form and other documents to prove their participation. 

• Fourthly, 700 participants in the trial were illiterate and there is no evidence that an impartial witness was present during the entire informed consent process to attach his/her signatures to the consent form.   
• Fifthly, communities living close to the hospital have told the media that they were offered ₹750, and luring people in trial for money is unethical.  

• Although the company maintained that the amount was the reimbursement for the transportation and loss of wages, an open announcement of remuneration was unethical.   

• Lastly, it is not yet confirmed that institutional ethics committee approved the advertisement for inviting people to the trial, in lieu of money.   

Way forward 

• India has already approved 2 vaccines for restricted use and the virus spread slowing down, so enrolling participants will be more challenging. Therefore, a thorough and impartial inquiry will bring back confidence in clinical trials. 

Introduction  

The permission of two COVID-19 vaccinats for emergency use is nearing. There is now hope of an end to the pandemic. But for the administration of vaccination and treatment properly and skillfully, a trained and effective workforce is required. 

Present strength of healthcare workers in India 

• In India, over 4,00,000 frontline workers have been trained to respond to COVID-19. 
• However, this includes people with no prior experience also. Thousands have been trained for (1) contact tracing, (2) quarantine strategies, (3) ventilator management, (4) personal protective equipment, and (5) psychological issues. 

In this context, Project Echo provides a cost effective way if ncreasing our workforce – both number wise and qualitywise.

What is project ECHO? 

India was a recipient of an effective global innovation called Project ECHO.  

• ECHO is a low-cost way out for growing the size of health workers in underserved communities to offer patients with the best possible care and facilities.  
• ECHO was utilised as a strategy for treating Hepatitis C in the beginning but now is being used for newly trained experts in HIV, malaria, tuberculosis, addiction, mental health, and many other conditions. 
• Under this project, health workers, nurses and doctors are trained through video conferencing technology. They learn speciality care from subject matter experts and from each other’s community informed knowledge.  
• ECHO provides the ability to spread healthcare workers in the most remote areas of the country and give them training similar to what a healthcare worker in one of our largest cities would receive. 

What needs to be done before the vaccine arrives? 

India is led by the Serum Institute of India which has the largest manufacturing capacity in the world. However, certain aspects need to be figured out and planned before the COVID-19 vaccine becomes widely available: 

• Firstly, real skills need to be cultivated for planning out the following: 

• • Delivery system of these vaccines needs to be figured out. 
  • Storage and handling of the vaccines. 
  • India needs to overcome cultural and religious obstacles for those who are unwilling to accept a vaccine. 
  • People need to be counselled about the side-effects of the vaccine. 

• Secondly, more trained health experts are required to support vaccine treatment. 
• Thirdly, further preparation of the ECHO model can be done to identify new healthcare workers who can be trained to be COVID-19 experts.

News: A command and control centre has been set up at Airports Authority of India Cargo Logistics and Allied Services Company Limited(AAICLAS) to monitor the movement of COVID-19 vaccines.

Facts:

Source: The Hindu

• What will AAICLAS do? It will be the nodal body for coordinating air transportation of the vaccines across a network of 41 airports with Pune — where vaccine manufacturer Serum Institute of India is located — as the hub.
• Process of Vaccine Transportation:
  • • The 41 airports or cities where transportation efforts will be focused include Karnal, Mumbai, Chennai and Kolkata, each of which has a Government Medical Stores Depot (GMSD) of the Central government’s Ministry of Health and Family Welfare.
    • Once vaccines dispatched by the manufacturers arrive at these four big depots, they will be further distributed across 37 State depots.
    • Thereafter, they will be sent to district depots and finally to the primary health care centres.
    • Each of these centres has a temperature tracker which will upload temperature data on a central server for real time monitoring.

Article Source

News: Scientists at the CSIR-National Institute for Interdisciplinary Science and Technology(NIIST) in Kerala have come up with a new product called banana grit or granules.

Facts:

• Banana Grit or Granules: It has been developed from raw Nendran bananas. The product resembles ‘rava’ and broken wheat.
• Purpose: The product has been labelled as an ideal ingredient for a healthy diet as it utilises the presence of resistant starch in bananas which is reported to improve gut health. Hence, the dishes prepared with banana grit and its byproduct improves gut health.
• Significance: Developing new uses for Nendran Banana comes as a boon to farmers who have often been struggling against falling prices.

Additional Facts:

• Nendran Banana or famously known as Chengalikodan is a banana variety originated and cultivated in Chengazhikodu village of Thrissur District in Kerala
• Where is it cultivated? It is now cultivated on the banks of the Bharathapuzha river.It has got the Geographical indication registration from the Geographical Indications Registry, Chennai.
• Uses: Generally consumed ripe, it also finds use in typical Kerala dishes such as avial and thoran.

Article source

News: Government of India has launched the Indian SARS-CoV-2 Genomic Consortia Group(INSACOG).

Facts:

• INSACOG: It has been established to monitor the genomic variations in the SARS-CoV-2 on a regular basis through a multi-laboratory network.
• Composition: It comprises 10 labs (NIBMG Kolkata, ILS Bhubaneswar, NIV Pune, CCS Pune, CCMB Hyderabad, CDFD Hyderabad, InSTEM Bengaluru, NIMHANS Bengaluru, IGIB Delhi and NCDC Delhi).
• Coordinated by: The group is coordinated by the Department of Biotechnology (DBT) along with the Ministry of Health and Family Welfare(MoH&FW), ICMR and CSIR.
• Nodal Unit for Maintaining Database: National Centre for Disease Control(NCDC) will be the nodal unit for maintaining a database of all samples of the new variants of public health significance. The data will be epidemiologically analysed, interpreted, and shared with states for investigation, contact tracing and planning response strategies.
• Other key Functions of the INSACOG:
  • It will establish sentinel surveillance for early detection of genomic variants with public health implications and to determine genomic variants in unusual events or trends such as super-spreader events.
  • Knowledge generated through this vital research consortium will also assist in developing diagnostics and potential therapeutics and vaccines in the future.
  • The group will also closely work with NCDC on activities like SOPs, data annotation, data analysis, data release among others.

Synopsis- There is need for more genome sequencing from samples from all over the world in order to come up with effective approaches to control and prevent COVID-19 infections.  

Background- 

• A new variant of the pandemic SARS-CoV-2 coronavirus is spreading rapidly in Britain and prompting high levels of concern. 
• Six samples of the recent U.K. returnees have been found to be positive with a variant of SARS- CoV-2 virus.
• From 25 Nov-23 Dec, about 33,000 passengers landed at various Indian airports from the U.K. So far, only 114 have been found positive and samples have been sent to 10 INSACOG (Indian SARS-CoV-2 Genomics Consortium) labs for genome sequencing.

Thus, only through detailed epidemiological studies combined with genome sequencing data can we confirm the presence and spread of the variant in India.  

What are the findings related to new stain of coronavirus and will it cause concern in India? 

The genomic analysis undertaken by the COVID-19 Genomics U.K. Consortium found that- 

• First. The new variant of coronavirus is named “VUI 202012/01” and is defined by a set of 23 changes or mutations. Among the 23 mutations, the two of which are particularly worrisome and specifically N501Y makes is more transmissible. 
  • • It includes a genetic mutation in the “spike” protein that can lead to an easy and immediate spread of the virus, making it deadlier. This new variant has 17 mutations that affect the shape of the virus.
• Second, It is about 70% more transmissible- The variant has the potential to increase the number of people a person can infect by over 0.4 

However, it might not be able to spread wildly in India as a sizeable percentage of people are already infected.  

Read more – Mutation in Coronavirus 

Why it is important to undertake more genome sequencing of the virus? 

The genome sequencing study would determine if the COVID patients are carrying the existing strain of SARS-CoV-2 or the mutant strain.  

• First, to understand the evolving nature of the virus–So far, we are doing very less frequent genomic sequencing compared to western nations. For instance, in England, around 10 percent of the infected virus samples are sequenced to study the nature of the virus. 
• Second, to find an immune escape variant of the SARS-CoV-2, [which means a mutation in the virus that allows it to evade the immune system]  
  • • One of the immune escape variants found in genomes from India, known as N440K variant — was found to be in 2.1 percent of the gene sequences in India.
• Third, The N501Y mutation can arise independently here in India. Hence more genome sequencing and genomic epidemiology is needed. 

Steps were taken by the Indian Government regarding this-  

• The genomic surveillance consortium (INSACOG) has been recommended for laboratory and epidemiological surveillance of circulating strains of the SARS-CoV-2 in India. 
• Under this initiative, 5 percent of the positive cases will be tested for Whole Genome Sequencing, from all the States and UT. 

Read Also : Current affairs for upsc

What is the way forward? 

Genome sequencing is very much important of the higher percentage of the samples to understand the evolving nature of the virus. 

Source: PIB

News: Union Health Minister of India has been nominated by the Global Alliance for Vaccines and Immunisation(GAVI) as a member of the GAVI Board.

Facts:

• Union Health Minister will be representing the South East Area Regional Office(SEARO)/ Western Pacific Regional Office (WPRO) constituency on the GAVI Board from 1st January,2021 until 31st,December 2023.

What is GAVI?

• Gavi is an international organisation – a global Vaccine Alliance created in 2000.
• It brings together public and private sectors with the shared goal of creating equal access to new and underused vaccines for children living in the world’s poorest countries.
• GAVI has observer status at the World Health Assembly.
• As part of its mission to save lives, reduce poverty and protect the world against the threat of epidemics, GAVI has helped vaccinate more than 822 million children in the world’s poorest countries preventing more than 14 million future deaths.

GAVI Board:

• The GAVI Board normally meets twice a year in June and November/ December and holds an annual retreat, normally in March or April.
• The board is responsible for strategic direction and policy-making, oversees the operations of the Vaccine Alliance and monitors programme implementation.
• With membership drawn from a range of partner organisations, as well as experts from the private sector, the Board provides a forum for balanced strategic decision making, innovation and partner collaboration.

Synopsis: Indian is one of the world’s leading vaccine manufacturer, thus will have better access to vaccines, but the distribution of manufactured vaccine will prove to be a formidable task.

Dry run to test preparedness for the nationwide roll-out of a COVID-19 vaccine kicked off in four States — Assam, Andhra Pradesh, Gujarat and Punjab.

What is dry run of Vaccines?

• A dry run is aimed at testing the planned operations and the laid out mechanisms for Covid-19 vaccination in the state. It will provide insights into any gaps or bottlenecks so that those could be addressed before the commencement of the actual drive.
• Intended beneficiaries of each State, registered on Co-WIN’ app, have been sent text messages, containing info about the time and place of their “COVID-19 vaccination”.

Read – About Co-Win app and platform

• All the beneficiaries will have to register themselves compulsorily on Co-Win platform and provide a photo ID proof upon asking.
• Authorities will prepare a report for the STF, after conducting this dry run. STF will review the report and provide feedback and guidance to the authorities on further actions.
• The report will also be submitted to the Union Ministry of health and Family Welfare.

India’s vaccine distribution infrastructure

India has created a network of Cold Chain Infrastructure for vaccines at various levels. Presently, Vaccine distribution takes place through following process and infrastructures;

1. Vaccines are produced by Manufacturers or procured by suppliers through agreements and arrangements.
2. These vaccines are then delivered to 4 Government Medical Store Depots (GMSDs) in Karnal, Mumbai, Chennai and Kolkata.
3. From these GMSDs vaccines are delivered to state, divisional and regional vaccine stores.
4. They further distribute these vaccines to District Vaccine stores (DVCs). DVCs then deliver vaccines to PHCs, CHCs and Private facilities.
5. From these centers beneficiaries can get themselves vaccinated.

All these distributions take place through insulated Vans and Vaccine carriers.

Some of the important facts and figures

• In Phase-1, Government is aiming at vaccinating 300 million most vulnerable people by August 2021 i.e.  600 million doses till August.
• At present India is having About 27000 cold chain points across the country.
• India’s present distribution capacity is 360 million doses in 8 months for both government and private facilities. It includes the Capacity of Private Cold Chain infrastructure at 200 million and government capacity at 160 million.
• The above capacity includes the infrastructure of the current immunization program, if leveraged for the covid vaccination.
• Due to the electronic vaccine intelligence network (eVIN) system, a real-time supply chain management system, India’s vaccine management has improved

What are the challenges in vaccine distribution in India?

1. Firstly, to complete the aims of the first phase of the covid vaccination drive, the public sector distribution capacity will need to be expanded 2-3 times.
2. Secondly, there are gaps in the vaccine distribution system. As per the Audit of health ministry in 2017-18, 26% of eVIN cold chain points reported instances of stock out during the period of assessment. More than a fifth of facilities reported wastage of vaccines.
3. Third, Interstate disparity in the distribution of cold chain infrastructure across the country. For instance, roughly 4 cold chain points serve 100,000 population in Gujarat, whereas there is just one cold chain for the same number of people in Jharkhand. 
4. Fourth, unique requirements of the COVID-19 Pandemic such as Identifying beneficiaries, ensuring they show up on the day of vaccination, and administering a second dose after a month, provide vaccine across age groups instead of current programmes focus on particularly vulnerable sections, etc. All these require micro-level planning with a proper collaboration from the top.
5. Fifth, Post-vaccination challenges such as documentation of vaccination and the tracking and investigation of vaccine safety events, all are equally important to create positive public opinion about vaccination.
6. Sixth, India has performed poorly on the analysis by WHO-UNICEF in 2018, it ranked among 89 countries in 51-75 percentile range on effective vaccine management.
7. Seventh, If the present infrastructure of universal immunization programme is used as planned, what will happen to the regular immunization drive, is also a big challenge in front of government.

India is one of the biggest producers of vaccines in the world. Serum Institute of India (SII) alone is a producer of more than 1.5 billion vaccine doses every year and is expected to produce 1 billion doses of the Novavax vaccine by 2021.

As now, the vaccine is being authorized by Emergency Use Authorisation method, Need is to augment the capacity of vaccine distribution on an urgent basis.

Source: The Indian Express

News: A team of scientists from IIT Delhi won an innovation contest (Innovate 4 SDG) organised by the United Nation Development Programme (UNDP) Accelerator Lab India for their innovation of a “plant based mock egg”.

Facts:

• Mock Egg: It has been developed from very simple farm based crop proteins, which not only looks and tastes like an egg but is also very close in nutritional profile to poultry eggs.
• Significance: The development of the mock egg meets the protein needs of the diet-specific, health conscious, vegan and vegetarian people and will also help in addressing the longstanding battle for malnutrition and clean protein food for people.

Additional Facts:

• UNDP’s Accelerator Lab: It is an innovative initiative by UNDP, State of Qatar and the Federal Republic of Germany to find 21st century solutions to today’s complex new challenges.
• UNDP Accelerator Lab India: It is a part of a network of 60 global labs covering 78 nations that tests and scales new solutions to global challenges like climate change and inequality.
  • Objective: It seeks to address some of the most pressing issues facing India, such as air pollution, sustainable water management and client-resilient livelihoods through innovation.

Source: The Indian Express

News: Union Minister for Health and Family Welfare has inaugurated India’s first pneumococcal conjugate vaccine(PCV) named “Pneumosil”.

Facts:

• Pneumosil: It has been developed by the Serum Institute of India Private Limited (SIIPL) in collaboration with partners like the Bill and Melinda Gates Foundation.
• Pneumosil was licensed by the Drugs Controller General (India) in July 2020.

What is Pneumococcal conjugate vaccine(PCV)?

• It is a pneumococcal and a conjugate vaccine used to protect infants, young children and adults against disease caused by the bacterium Streptococcus pneumoniae (pneumococcus).
  • Conjugate: It is a type of vaccine that joins a protein to an antigen in order to improve the protection the vaccine provides.
• It contains purified capsular polysaccharide of pneumococcal serotypes conjugated to a carrier protein to improve antibody response.
• The unique feature of the PCV is its composition which is specially tailored to the prevailing serotype prevalence of S Pneumoniae in India and other regions of the world.

What is Pneumococcal disease?

• Pneumococcal disease is the name given to a group of diseases caused by a bacterium called Streptococcus pneumoniae, (also known as pneumococcus).
• Diseases caused by pneumococcus include 1) severe diseases such as pneumonia, meningitis and bacteraemia (presence of bacteria in the blood) and 2) milder diseases such as middle ear infection (otitis media), sinusitis and bronchitis.
• Cases: Pneumococcal disease is a significant contributor to the under-five mortality rate worldwide.Annually India witnesses an estimated 71% of pneumonia deaths and 57% of severe pneumonia cases.Every year, nearly 67,800 children under five years of age die from pneumococcal diseases.
• Vaccine: Hence, recognising its widespread fatality, WHO recommended the inclusion of PCV in routine childhood immunisation programmes in all countries.

Source: The Hindu

News: Researchers at the Indian Institute of Science Education and Research (IISER) have identified a gene called “BBX11”.

Facts:

• BBX11: It is a gene that facilitates in the greening of plants by playing a crucial role in regulating the levels of protochlorophyllide — an intermediate in the biosynthesis of the green pigment chlorophyll.

What is Chlorophyll? It is a pigment that gives plants their green color and it helps plants create their own food through photosynthesis ( a process by which light energy is converted to chemical energy through the synthesis of organic compounds).

Role of BBX11 in the Synthesis of Chlorophyll: The synthesis of chlorophyll in plants is a lengthy, multi-step process:

• When a seedling emerges from under the soil it must quickly synthesize chlorophyll to start supporting its own growth.
• In order to facilitate quick synthesis of chlorophyll, plants make a precursor of chlorophyll called ‘protochlorophyllide’ in the dark which glows red when blue light is shone on the plant.
• As soon as the plant comes out into the light from under the soil, light-dependent enzymes convert protochlorophyllide to chlorophyll.
• However, if there is excess of free protochlorophyllide, then exposure to light converts it into molecules that cause ‘photobleaching’.
• Thus, it is very important to regulate the amount of protochlorophyllide synthesized by the plant and here comes the vital plant played by the ‘BBX11’
• If it is less, plants are unable to efficiently ‘green’ in order to harvest sunlight. If the amount of protochlorophyllide is more, then plants bleach under the light.

Significance of the study: This study could have tremendous implications in the agriculture sector in tropical countries like India and can help provide leads to optimise plant growth under stressful and rapidly changing climatic conditions.

Source: The Indian Express

News: US Food and Drug Administration(FDA) has approved a first-of-its-kind intentional genomic alteration(IGA) in a line of domestic pigs referred to as GalSafe pigs.These pigs may be used for food and human therapeutics.

Facts:

• What is intentional genomic alteration in animals? It means making specific changes to the genome of the organism using modern molecular technologies that are popularly referred to as “genome editing” or “genetic engineering”.
• Purpose: Such changes in the DNA sequence of an animal may be carried out for research purposes to produce healthier meat for human consumption and to study disease resistance in animals among other reasons.
• Difference: The FDA maintains that the only difference between an animal with an IGA and one that does not have an IGA is that the IGA gives them a new trait or characteristic such as faster growth or resistance to certain diseases.

Additional Facts:

• Genome editing: It is a type of genetic engineering in which DNA is inserted, deleted, modified or replaced in the genome of a living organism.Editing DNA can lead to changes in physical traits like eye color and disease risk.

News: India’s first indigenous mRNA vaccine candidate HGCO19 has received approval from Indian Drug regulators to initiate Phase I/II human clinical trial.

Facts:

• HGCO19: It is a novel mRNA vaccine candidate developed by Gennova, Pune and supported with seed grant under the Ind-CEPI mission of Department of Biotechnology of Ministry of Science & Technology.

Additional Facts:

• mRNA vaccines: It is a new type of vaccine to protect against infectious diseases.It does not use the conventional model to produce immune response.mRNA vaccine carries the molecular instructions to make the protein in the body through a synthetic RNA of the virus.The host body uses this to produce the viral protein that is recognized and thereby making the body mount an immune response against the disease.
  • Advantages: mRNA-based vaccines are scientifically the ideal choice to address a pandemic because of their rapid developmental timeline.The mRNA vaccine is considered safe as is non-infectious, non-integrating in nature and degraded by standard cellular mechanisms.
• Ind-CEPI mission: It is a Department of Biotechnology mission that aims to strengthen the development of vaccines for the diseases of epidemic potential in India as well as build coordinated preparedness in the Indian public health system and vaccine industry to address existing and emerging infectious threats in India.The mission is implemented by Biotechnology Industry Research Assistance Council(BIRAC).

Source : Click here

News: A new drug called Molnupiravir has been shown to stop the transmission of SARS-CoV-2 (COVID-19) in 24 hours.

Facts:

• Molnupiravir: It is an experimental antiviral drug which is orally active (can be taken orally) and was developed for the treatment of influenza.
• Developed by: The drug is being developed by the biotechnology firm Ridgeback Biotherapeutics in collaboration with pharmaceutical firm Merck.
• Significance: This is the first demonstration of an orally available drug to rapidly block SARS-CoV-2 transmission and it can be a game-changer

Emergency Use Authorisation (EUA)

This article explains the process of Emergency Use authorization, based on The Indian Express Article “Three Covid-19 vaccine developers seek emergency use approval in India” 

Central Drug Standard Control Organisation (CDSCO) has received applications from 3 vaccine developers seeking Emergency Use Authorisation/Approval (EUA) for their candidate Covid-19 vaccines which are still under trial. These Vaccines are COVISHIELD, COVAXIN, and BNT162b2.

None of the Vaccine developers has yet generated data about the effectiveness of their vaccine from phase-III trials conducted in India.

What is the normal process of Vaccine Development?

In normal circumstances, a Vaccines has to go through several phases, with each phase taking many months to get completed, but in the case of COVID, it is expected that vaccines would be in the market within a year from its start, after seeking Emergency Use Approval (EUA) from their respective governments.

After Pre-clinical testing of Vaccines, it is tested on the human under clinical trials before its mass production.

Clinical trials: It involves testing on humans. There are 3 phases of clinical trials;

1. Phase I of a clinical trial is conducted on a small group of healthy individuals. It only indicates what is the ideal dose required to administer in the next stage, it provides evidence of the vaccine’s ability to generate an immune response and its safety.
   1. The vaccine is not considered safe if it develops any major complication, however little headache and fevers are expected.
2. In phase II, the range of participants is expanded to a few hundred healthy participants to check the immune response system in the body and it also assesses the time period for which antibodies last to provide immunity against the virus.
3. Phase-III involves a very large group of people (Thousands of individuals) to investigate its efficiency among large population groups. Half of the population is administered the actual Vaccine and the other half are administered dummy vaccines.
   1. Individuals administered Vaccines are checked on fixed intervals which can be months in normal conditions to see whether their immune system is responding to the virus or not.

After the Vaccine is successfully tested, it would require regulatory approval before it can be produced in bulk quantity.

Emergency Use Authorisation (EUA)

The term “Emergency Use Authorisation (EUA)” has been used mainly by the regulatory agencies like FDA in the US and some other countries with the following guidelines;

FDA has specified that it would consider an application for EUA only if phase 3 data showed

• it was at least 50% effective in preventing the disease.
• This data needed to be generated from “well over” 3,000 trial participants, “representing a high proportion of participants” enrolled.
• These participants needed to be followed up for any serious adverse effects for at least one month after all dosages had been given.
• EUA can be granted only in a declared public health emergency.

Accelerated Approval Process in India

In India, New Drugs and Clinical Trials Rules, 2019 governs Clinical trials of new drugs and vaccines and their approvals.

But the term Emergency Use Authorisation (EUA) has not been used anywhere in rules in India. However, 2019 rules provide for an “Accelerated Approval Process” for granting approval to a drug that is still in clinical trials. The definition of a new drug in the 2019 Rules includes a vaccine.

Conditions for Accelerated Approval Process

• There should be a prima facia case that the drug is of Therapeutic benefits.
• “Accelerated approval may also be granted to a new drug if it is intended for the treatment of a serious, or life-threatening condition, or disease of special relevance to the country, and addresses unmet medical needs,”.
• Approval can be granted even if “remarkable” effectiveness is reported even from phase-II trials.

Approval granted to drugs or vaccines that are still in clinical trials is temporary, and valid only for one year. 

Examples of granting EUA

• FDA granted its first EUA for use of Tamiflu drug for infants and young children for the treatment of H1N1 infection for the civilian population in 2009.
• Remdesivir or faviparir, are existing drugs approved for other ailments received EUA for treatment of Covid-19, including in India.

Issues in EUA of Vaccines

• Due to tolls or public sentiments, Governments are putting pressure on regulatory bodies to fast-track the entire process of Vaccine development. 
• Lack of transparency about vaccine safety and efficacy may negatively impact people’s confidence and willingness to get vaccinated.
• Some surveys have shown that there is vaccine hesitancy among a certain section of people due to the hastening of the vaccine development process.
• Whereas FDA has formulated its guidelines 50% effectiveness and no. of participants, the Indian regulator has not formulated any such guidelines.
• Another issue with EUA-approved drugs and treatments is that they can reflect and exacerbate already existing inequities in the health system if the vaccine administered is found out to be ineffective. It might create a huge burden on the pocket of poor people.
• There are examples of granting EUA to certain drugs like hydroxychloroquine, a malaria drug in haste, which later proved to be ineffective treatment, and the risks of taking it outweighed any benefits.
• If a drug proved to be ineffective later on, after its administration to a huge population, it would be very harmful to the people’s confidence, economy, and health system of the country.

Way forward

Concerns regarding use of Vaccines can be addressed when all stakeholders are transparent at every stage of development and not by merely sharing guidelines regarding vaccine safety with the States. It is important that those seeking emergency-use authorisation share the safety and efficacy data with the authorities and public immediately.

Context: Safety and efficacy data for the new vaccine must be known before emergency-use authorisation for vaccines.

Why in news?

• The Pune-based Serum Institute of India has approached the regulator for nod for its vaccine, Covishield, developed by Oxford University.
• AstraZeneca, which is carrying out the phase-3 trials of the Oxford vaccine in four countries, is yet to secure a nod from any of the regulatory agencies.
• AstraZeneca recently gave details of the interim safety and efficacy data involving 131 COVID-19 cases in the phase-3 trials in the U.K. and Brazil. But details of the trials in India are not out yet.

Why fast tracking of vaccine authorization is needed?

• The unprecedented speed in taking the vaccine from the development stage to approval process in less than a year is remarkable but also necessitated by the toll the virus has taken on lives and livelihoods.
• To reduce mortality and morbidity.

What are the concerns associated with authorization of vaccines?

• Regulatory bodies under pressure: to fast-track the entire process.
• Lack of transparency: Opaqueness about vaccine safety and efficacy does no good in gaining people’s confidence and willingness to get vaccinated.
  • For example, Moderna, Pfizer and AstraZeneca took the extraordinary step of publicly sharing the trial protocol, the time points at which interim analysis of phase-3 trial in India will be carried out for safety and efficacy is unclear.
• No checks: the U.S. FDA has clearly spelt out at least 50% efficacy and stipulated a median follow-up duration of at least two months after completion of the full vaccination regimen to assess a vaccine’s benefit-risk profile for emergency-use approval. However, no such conditions have been mentioned by the Indian regulatory agency. The phase-3 trial of Covishield began on September 21 and completed the enrolment on November 12.
• Fear of side effects and vaccine hesitancy: ineffective or unsafe vaccine is worse than not having one.A survey by the London-based Vaccine Confidence Project revealed that though the intent to get vaccinated was 87% in India, 34% respondents were worried about side-effects while 16% were concerned about fast-moving trials.

What needs to be done?

• Need to engage all stakeholders in a transparent manner at every stage and not by merely sharing guidelines regarding vaccine safety with the States.
• It is also important that those seeking emergency-use authorisation share the safety and efficacy data immediately.

For further read about Emergency Use Authorisation : Click here

Source: Click here

News: Singapore Food Agency(SFA) has approved the sale of a lab-grown meat product.This is the first time cultured meat has been cleared for sale anywhere in the world.

Facts:

• What is Lab Grown Meat? Lab Grown Meat or Cultured meat is meat produced by in vitro cell culture of animal cells instead of from slaughtered animals.
• How is lab-grown different from plant-based meat?
  • The plant based meat is made from plant sources such as soy or pea protein while cultured meat is grown directly from cells in a laboratory.
  • In terms of cellular structure, cultured or cultivated meat is the same as conventional meat — except that cultured meat does not come directly from animals.
• Advantages of Lab Grown Meat:
  • The lab grown meat could reduce land use by more than 95%, climate change emissions by 74-87% and nutrient pollution by 94%.
  • As meat is created in clean facilities, the risk of contamination by pathogens such as salmonella and E coli is significantly reduced thereby reducing the threat posed to public health by growing antibiotic resistance.

Context:  Antimicrobial resistance (AMR), a silent pandemic, is growing at an alarming rate.

Why is AMR growing at an alarming rate?

• AMR:  Globally, about 35% of common human infections have become resistant to available medicines.
• About 700,000 people die every year because available antimicrobial drugs (antibiotics, antivirals, anti-parasitic and antifungals) have become less effective at combating pathogens.
• Resistance to second- and third-line antibiotics the last lines of defence against some common diseases are projected to almost double between 2005 and 2030.
• According to a study published in The Lancet, an estimated 58,000 new-born children die annually from sepsis in India alone because antibiotics can no longer treat certain bacterial infections.
• Reasons for AMR:
• Microorganisms develop resistance to antimicrobial agents as a natural defence mechanism. Human activity has significantly accelerated the process.
• The misuse and overuse of antimicrobials for humans, livestock and agriculture is probably the biggest reason for this.
• Research points to the role of environment and pollution in AMR.
  • Once consumed, up to 80% of antibiotic drugs are excreted un-metabolised, along with resistant bacteria.
• Release of effluents from households and health and pharmaceutical facilities, and agricultural run-off, is propagating resistant microorganisms. Wastewater treatment facilities are unable to remove all antibiotics and resistant bacteria.

What are the problems faced?

• Issues faced: In India, there is capacity to treat only about 37% of the sewage generated annually. The rest is discharged into natural water bodies without treatment.
• An analysis of single wastewater discharge from a treatment facility in India catering to drug manufacturers found concentrations of antibiotics high enough to treat over 40,000 people daily.
• Mode of spread: Water may be a major mode for the spread of AMR, especially in places with inadequate water supply, sanitation and hygiene.
• Wildlife that comes into contact with discharge containing antimicrobials can also become colonised with drug-resistant organisms.

What are the key initiatives to tackle AMR?

• UNEP: The United Nations Environment Programme (UNEP) identified antimicrobial resistance as one of six emerging issues of environmental concern in its 2017 Frontiers Report.
• The UN Environment Assembly pressed the need to further understand the role of environmental pollution in spreading AMR.
• GAP: UN agencies are working together to develop the One Health AMR Global Action Plan (GAP) that addresses the issue in human, animal, and plant health and food and environment sectors.
• MoEF&CC: The Ministry of Environment, Forest and Climate Change (MoEF&CC) issued draft standards which set limits for residues of 121 antibiotics in treated effluents from drug production units.
• The Ministry of Health and Family Welfare and MoEF&CC constituted the inter-ministerial Steering Committee on Environment and Health, with representation from WHO and UNEP.

Way forward

• The Centre and State governments in India can strengthen the environmental dimensions of their plans to tackle antimicrobial resistance.
• It is particularly important to promote measures that address known hotspots such as hospitals and manufacturing and waste treatment facilities.

Context: Aspects of vaccine distribution.

Background

• The World Health Organisation (WHO) declared the COVID-19 a pandemic in march 2020 and the most optimistic prediction for a vaccine to be available was by the middle of 2021.
• Now, the labs around the world are working faster than anticipated and the first vials of a vaccine are likely to roll out in the next two months.

Why stakes in a vaccine against COVID-19 are unprecedented?

• Though, Economies have gradually opened up after lockdowns, festivals have been celebrated in a subdued manner, and polls have been conducted in several countries.
• But it’s the vaccine that can set us free, can give back the human freedom of association, and most importantly, it can relieve the anxiety and worry that has become the part of life in large parts of the planet.

How early research in Corona virus family is helping now?

• The epidemics caused by pathogens of the coronavirus family in the past 20 years, SARS and MERS, have pushed scientists to study the varied interactions between the human immune system and contagions.
• These studies have illustrated that, unlike other flu viruses, coronaviruses make use of various biological pathways in the human body. For example-opting enzymes of the host’s cells.
• Knowledge of the spike protein has made the scientific community to understand the ways in which the immune system behaves when a person contracts the novel coronavirus.
• The recent approaches targeting the spike protein whether through genetic material as in the case of the vaccines developed by Moderna and Pfizer or through a viral vector from chimpanzees as in the Oxford-AstraZeneca vaccine, have benefitted from earlier research with coronaviruses.

What are the challenges to vaccine distribution?

• India, produces 60 per cent of the world’s vaccines and is home to the largest manufacturer, the Pune-based Serum Institute.
• Yet, the country also has the largest number of unvaccinated children in the world.
• NSO data shows that less than 60 per cent children receive the entire basket of vaccines.
• Delay in acceptance or refusal of vaccines despite availability of vaccination services in more than 90 per cent countries in the world is another hurdle in immunisation programmes.

What is the Way forward?

• Securing 1.3 billion people will require a massive public policy effort at improving the country’s public health infrastructure.
• Partnership with the private sector in immunisation programme.
• Controlling the growth of black markets.
• Checking the diversion of resources from regular immunisation programmes.
• Institute transparent mechanisms at points where science and research meet public policy.

The novel coronavirus forces us to do things differently, it demands a different conception of herd from science and public policy.

Context: India’s COVID-19 control plan of actions can be the basis for building a much-needed public health infrastructure.

How can vaccine help in eradicating a disease?

• Preventive medicines: Vaccines play a major role in human mastery over infectious diseases by inducing immunity in individuals.
• Herd immunity: When a vaccine is rolled out as a national programme and increasing proportions of people are vaccinated, ‘herd immunity’ level increases and disease frequency decreases in the vaccinated population.
• The ‘herd effect’ of vaccination: That decelerates transmission of the microbe in the whole community, resulting in decreasing disease frequency even in the unvaccinated segment of population.
  • Herd immunity plus herd effect reduces the overall disease burden in the community.
• Control: In epidemiology, the common word ‘control’ has a specific meaning: ‘deliberate reduction of disease frequency to a desired level, validated with evidence’.
  • • For evidence, disease frequencies must be documented both at baseline and on an ongoing basis, through systematic surveillance. So, control interventions include vaccination programme and disease surveillance.
• Elimination: The extreme form of control is ‘elimination’ of transmission of the microbe in a whole country.
  • • For example, measles and rubella have been eliminated in Sri Lanka through sustained vaccination achieving high coverage.
• Diseases eradicated using vaccine: Eradication is global elimination of an infectious disease. So far, smallpox and cattle plague have been eradicated using their respective vaccines.
  • • Severe Acute Respiratory Syndrome (SARS) was eradicated in 2003 without a vaccine, using ‘non-pharmacological interventions’, or NPI, systematic case detection, contact tracing and quarantine.

What are the statuses of vaccine candidates in India?

• Protective efficacies: Three COVID-19 vaccines have claims of about 90-95% protective efficacy are BNT162b2 (Pfizer-BioNTech), mRNA-1273 (Moderna) and Sputnik-V (Gamaleya Institute).
• Trial phases: Sputnik-V is under phase 2-phase 3 vaccine trials in India, by Dr. Reddy’s Laboratories. Another vaccine, ChAdOx1 nCoV-19 (OxfordAstraZeneca), manufactured under licence by Serum Institute of India as Covishield, is undergoing phase 2-phase 3 trials in India.
• An indigenous vaccine candidate, Covaxin (Bharat Biotech), found safe and immunogenic in phase 1 and phase 2 trials, is now under phase 3 trial.
• Policy development: In India’s national Universal Immunisation Programme (UIP), vaccines are procured and supplied by the Union government and vaccination is implemented by State governments.
  • • States have the freedom to surpass policy limits if no fund is sought.
    • For example, Delhi used the Measles Mumps-Rubella vaccine when the central government policy was only for Measles vaccine and Sikkim unilaterally used human papillomavirus vaccine to prevent cervical cancer in women.

What can be done to tackle the issues?

• Policy issue: An important policy issue is whether vaccination should be confined to only uninfected individuals or should it be for all people. All test results of infected subjects are available on a computer data base and that is one way to identify those who were already infected.
• Trained staff: The vaccination stations should be staffed with trained personnel and supervised by medical doctors.
• Infrastructure: The site must have a waiting area and a post-vaccination staying area to manage any untoward reaction during the first hour.
• Digital list: A computerised master list with details and mobile numbers of all vaccinated subjects needs to be maintained for the purpose of post-vaccination follow up to document rare side-effects.
• Data management: Data management has to be meticulously planned and executed.

Way forward

• This is a huge opportunity to eliminate the novel coronavirus from India, setting an example to the rest of the world. With will and wisdom we can, and should, accomplish this.

Context- Problems posed by vaccine nationalism and the possible solutions.

What is vaccine nationalism the problems posed by vaccine nationalism?

Vaccine nationalism occurs when a country manages to secure doses of vaccine for its own citizens or residents before they are made available in other countries.

• This is done through pre-purchase agreements between a government and a vaccine manufacturer.

The problems posed by vaccine nationalism-

• It undermines equitable access to vaccines.
• Issue for countries with fewer resources-The most immediate effect of vaccine nationalism is that it further disadvantages countries with fewer resources and bargaining power.
• Deprives access to public health- It deprives populations from timely access to vital public health goods.

What needs to be done? 

1. Global framework for equitable access– International institutions, including the WHO, should coordinate negotiations to produce a framework for equitable access to vaccines during public health crises.
2. Governments should be the custodian of public goods– Governments must step in to regulate vaccine development, innovation, manufacture, sale, and supply ultimately to the public.
3. Prioritization for high risk groups– The first batch of the vaccines should be made available to all frontline, health and social care workers, police and others who are at high risk of getting the infection.
4. Ensuring equity-Equitable distribution and access should be ensured. Equity entails both affordability of vaccines and access opportunities for populations across the world, irrespective of geography and geopolitics.
5. Pre-purchase agreements and contracts should not trump equitable access to global public health goods
6. It was important for WTO members to work together to ensure that intellectual property rights such as patents, industrial designs, copyright and protection of undisclosed information did not create barriers to timely access to affordable medical products.

Way forward-

• Countries around the world should stop engaging in overly nationalistic behaviors.  Failure to do so will harm patient populations across the globe.
• The WTO has a role in getting pharmaceutical firms and countries to treat vaccines and life-saving medicines as a public good.

Context: The pandemic has given the country an opportunity to evolve from being the pharmacy of the world to being the centre of a revolutionary research.

How has India performed in the field of biotechnology over the years?

• Change overtime: India has seen an immense improvement in the number and quality of its healthcare facilities, reduction in pregnancy-related deaths, improvement in sanitation and immunisation coverage and has successfully averted several preventable disease epidemics.
• Department of biotechnology: The Government of India recognised the enormous potential of biotechnology and established a separate department in 1986.
• Contribution of innovators: The researchers and innovators have shown the way forward by introducing low-cost diagnostics and testing kits, manufacturing PPE kits, masks & therapeutics and now conducting clinical trials for COVID-19 vaccine.
• The clinical trial for the vaccine developed by the Oxford University and produced by the Pune-based Serum Institute of India (SII), Bharat Biotech’s Covaxin and Zydus Cadila’s ZyCoV-D, has entered the final phase.
• Tackling the pandemic: The immediate need was to have our indigenous production of masks, PPE’s, ventilators and most importantly diagnostic kits.
• In less than 60 days from 100 per cent import we attained self-sufficiency with a potential to export.
• A vibrant innovation ecosystem: Prime Minister launched the Startup India, Make in India and similar other programmes which have today established a very strong foundation of an ecosystem that has been enabling policy initiatives.
• The Biotechnology Industry Research Assistance Council (BIRAC): BIRAC brings innovators and funders on to a common table, enabling ideas to become a reality and facilitate technological advances that make human progress possible.
• Achievements in biotechnology: the sector employs the best of minds and contributes to the development of generic and affordable medicare.
• The country accounts for approximately 3 per cent of the global biotech industry.
• Industry enterprise, a highly-skilled research force backed by government support, has led the biotechnology sector to grow from $1.1 billion in 2003 to a mammoth $64 billion sector in 2019.
• India has over 2,700 biotech start-ups and are expected to touch the 10,000-mark by 2024.
• Over 3,500 biotech companies generate employment, contribute to the country’s economy and facilitate a sustainable environment.
• By 2025, we aim to be worth a $150 billion industry.

Way forward

• Atma nirbhar: we must motivate our young scientists to continue this path of research and generate new ideas and solutions. “Atma Nirbhar Bharat” will lead to an entrepreneur-friendly ecosystem in the country wherein our energetic youth and their innovations will thrive.
• The pandemic has provided the country with an opportunity to play the lead role in a global biotech ecosystem. It is time to build on our existing strengths and enter the next stage i.e. from being the pharmacy of the world to being the hub of cutting-edge innovation and research.

Context: India must improve its cold chain infrastructure to avail benefits of new vaccines

Elaborate about the potential covid-19 vaccine by Pfizer?

• Potential covid vaccine: Multinational drug company Pfizer has announced promising results from its ongoing phase-3 trial of a potential COVID-19 vaccine.
• Effectiveness in trials: Pfizer, which is using a vaccine candidate by German firm BioNTech, had disclosed in September that for a vaccine to be judged 60% effective, 164 volunteers would have to contract COVID-19.
• Sample size: The claim of 90% is based on a sample of 94 volunteers but it is not known how many belonged to either group. It is also unclear if those who were eventually infected, manifested mild or moderate severity of disease.
• Awaited result: There is still time to be reliably sure that the results actually hold up in a wider population.
• There are no large phase-3 trials of the ‘Covishield’ by the Serum Institute or ‘Covaxin’ by Bharat Biotech Ltd vaccine in India.
• India’s access to vaccine: While there were early discussions with Pfizer, there is as yet no confirmation on whether India can be assured of early access to even a fraction of the vaccine output in the event it is readied.
• m-RNA technology: The vaccine candidate is based on an m-RNA technology, which avoids the use of an infectious particle, such as a portion of the virus, and uses a piece of RNA that is then made into an antigen by the body’s own machinery.
• Faster production: It also does not need to be cultured in chicken eggs or other mammalian cells, allowing it be made faster and more inexpensively.
• Optimum temperature required: They also reportedly need to be refrigerated to nearly minus 70°C and India, with its limited cold chain infrastructure, lacks efficient vaccine storage capacity.
• Basic strategy: It shows that scientists’ basic strategy of developing a vaccine to target the spike protein of the virus is correct and given that this is an approach most vaccine developers are following, the chances of several encouraging results are high.
• Moderna, also employs an m-RNA based approach, it is likely that the new vaccine platform may prove to be a breakthrough approach in developing future vaccines.

Way forward

• India must keep a close watch on such platform-technology and develop expertise. It must also not lose an opportunity to improve its cold chain infrastructure which currently is developed only for rudimentary vaccines.

What are serological surveys

Context: The Indian Council of Medical Research conducted two serosurveys: May 11 to June 4 and August 17 to September 22.

What is serological survey?

• Serological surveys are used to detect the prevalence of antibodies against COVID-19/any diseases.
• Their purpose is to measure the proportion of a population already infected as evidenced by prevalence of antibody against the disease.

How serological surveys are carried out?

• Statisticians stratify the population and select a random sample from all strata so that the prevalence figure obtained is representative of the whole population.
• Random samples are tested from the entire population then, the data are extrapolated to the whole population.

Why antibody is tested?

• Antibodies are the evidence of the host’s response to virus infection.
• Their presence in the blood-serum confirms past infection.

Why the data derived from serosurveys must be interpreted with caution?

• Issue with Asymptomatic cases: Asymptomatic cases constitute more than 80% of those infected with the virus. In people with asymptomatic infections, these antibody levels decline over time and become undetectable by 60 days after proven infection.
• Swift disappearance of S2 antibodies: In a study on exposure-prone healthcare workers in Tennessee, nearly half the subjects with S2 antibodies became negative in two months.
• Inaccuracy: The latent period between infection and the appearance of a detectable antibody is about four weeks. Those who got infected recently before the survey may not be covered.
• If taken at face value, serosurveys may not reflect the true level of antibodies prevalence.

What is the way forward?

• The predicted herd immunity level needed to end the epidemic was 60%. In India, according to the serological surveys, half of the herd immunity level required to end the epidemic was already reached by mid-September.
• However, during the festival the Governments must enforce strict norms regarding crowding, especially inside buildings.
• This will ensure safety of the individuals, family members particularly senior citizens.

Assisted Reproductive Technology Regulation Bill, 2020

News: Government of India has introduced “The Assisted Reproductive Technology (Regulation) Bill, 2020” in the Lok Sabha.

Facts:

• Aim: To regulate the assisted reproductive technology (ART) clinics and the assisted reproductive technology banks, prevention of misuse, safe and ethical practice of assisted reproductive technology services.
• Key Provisions of the bill:
  • National Board: It shall lay down code of conduct to be observed by persons working at ART clinics, to set the minimum standards of physical infrastructure, laboratory and diagnostic equipment and expert manpower to be employed by clinics and banks.
  • Regulatory Boards at State Level: The States and Union Territories shall constitute the State Boards and State Authorities. It shall have the responsibility to follow the policies and plans laid by the National Board for clinics and Banks in the State.
  • National Registry and Registration Authority: It will maintain a Central database and assist the National Board in its functioning.

• Punishment: The bill also proposes for stringent punishment for those practising sex selections, sale of human embryos or gametes, running agencies/rackets/organisations for such unlawful practices.