eChapters

The process of vaccine development involves numerous stages from research, discovery, innovation, formulation, testing, mass production, logistics, deployment and administering the vaccine to the target population. The COVID-19 pandemic expedited the endeavour to develop vaccine worldwide that is unparalleled in history. In addition to the steps that were similar during the usual vaccine development process, it called for stronger collaborative teamwork with stricter deadlines during the pandemic due to the emergency situation that built up everywhere (in its spread as well as severity). Research was expedited, potential candidate vaccines were discovered and the proofs of concept were designed that paved the way for pre-clinical efficacy testing. Multiple-step clinical trials to ascertain that the vaccines were effective and safe at least for ‘emergency use’ in human subjects were carried out swiftly. The emergency usage regulatory approval and recommending the usage pattern involved accelerated review procedures. It immediately followed rapid scaling-up for increased production in order to meet the need to save as many human lives as possible across the globe. The approved vaccines were simultaneously evaluated for safety through dedicated pharmacovigilance systems. The future of vaccine development shall also focus on improving the worldwide access to vaccines, managing the virus variants and streamlining mass vaccination campaigns. Comprehending the research, development and administration phases to create and implement life saving vaccinations within the regulatory framework amid international health emergencies as encountered during the COVID-19 pandemic and the enormous collective endeavours are highlighted in this chapter.

Introduction
The discovery of antibiotics and their subsequent use in combating infectious diseaseswas amedical breakthroughin the 20th century, as it completely changed the treatment approach to infections in general and bacterial infections in particular. In 1928, Alexander Fleming discovered Penicillin that started the started the so-called “golden age of antibiotic”. However, later in course of time the underuse, overuse and misuse of antibiotics in medical and veterinary practice led toemergence of drug-resistant pathogens resulting in phenomenon called antimicrobial resistance (AMR). In last few decades AMR has evolved silently and now threatening the human and animal health and has acquired the potential to be a next pandemic. AMR develops in a microorganism (e.g., bacteria, viruses, fungi, parasites) when it accumulates genetic changes over time and fails to respond to antibiotic(s) leading to severe illness and mortality due to infection. Although, AMR is an evolutionary event occurring naturally in microbes, but inappropriate use of antibiotics in humans and animal medicine act as key driver to its spread. Global antibiotic consumption increased between 2016 and 2023, with total consumption rising by 16.3% to 34.3 billion defined daily doses (DDDs) in reporting countries and a projected 20.9% increase when extrapolated to nonreporting countries. World Health Organization (WHO) and other authorities have called for coordinated action to address antimicrobial resistance, a threat looming large on horizon. In 2021, there were an estimated 1.14 million deaths attributed directly to Antimicrobial Resistance (AMR), with globally another 4.71 million deaths associated with AMR infections. This dataindicates a significant global health burden, with prophecy that AMR deaths could increase dangerously by 2050 if current trends continue. Global Action Plan (GAP) of the WHO highlights the importance of “One Health approach” calling for the joint action in human health, food production, animals and environmental sectors, to achieve better results. In the year 2015, the WHO initiated the Global Antimicrobial Resistance and Use Surveillance System (GLASS)to collect, analyze and share AMR data received from all countries. The Global Action Plan on AMR lists five strategic objectives to contain AMR viz., 1. optimizing the use of antimicrobials, 2. preventing infections (including the use of vaccines), 3. strengthening surveillance and research, 4. improving awareness and understanding of AMR, and 5. investing in new medical products. Vaccines stimulate the body’s immune system to recognize and attack specific pathogens and thus can prevent AMR through several ways viz., 1. reduce the incidence of infections leading to reduction in morbidity and mortality, 2. vaccines can prevent secondary bacterial infections e.g. Streptococcus pneumoniae after an initial infection with influenza, 3. produce herd immunity, 4. Prevention of infections resulting in decrease in use of antibiotics that reduces development of AMR. Immunotherapeutics can both combat and be complicated by Antimicrobial Resistance (AMR). Other immunotherapies antibodies, and immune-boosting agents can directly fight AMR by preventing infections and reducing the need for antibiotics.

This chapter examines the principles, preparation and application of vaccines and biological products. It compares live attenuated, inactivated, toxoid, subunit, recombinant, vector, DNA and mRNA vaccines. Vaccine development phases, immunogenicity, safety, efficacy and post-marketing surveillance are introduced. The chapter discusses adjuvants, including alum, Freund’s adjuvants, liposomes, ISCOMs and delivery systems. Important veterinary vaccines for brucellosis, foot-and-mouth disease, anthrax, Newcastle disease, infectious bronchitis, goat pox, sheep pox and peste des petits ruminants are covered. Questions also address bacterins, toxoids, attenuation, booster requirements and reversion to virulence, providing practical knowledge of immunoprophylaxis in animal-health management.

Vaccination is an important component of preventive veterinary medicine and herd health. This chapter explains the practical role of vaccines in stimulating protective immunity and preventing important infectious diseases. Successful vaccination depends on appropriate vaccine selection, quality, handling, administration, timing and maintenance of the cold chain. Vaccination should form part of an integrated disease-control programme involving biosecurity, sanitation and disease monitoring. Species-specific vaccination schedules are presented for dogs, cats, cattle, buffaloes, small ruminants, swine and equines. The chapter provides practical guidance for implementing vaccination programmes and emphasizes appropriate scheduling and management to improve disease prevention and animal health.

Source: A Colour Handbook on Practicals in Veterinary Medicine, J. P. Varshney, Sujata Turkar and Sarita Devi. The chapter sequence is taken from the book's Contents, while the introductions are concise summaries grounded in the corresponding chapter material.

Diseases of livestock cause massive economic losses in terms of reduced productivity and production and some of them have zoonotic potential posing a serious risk to public health. Vaccination is the most efficient and cost-effective method of controlling infectious diseases both in humans and animals. The eradication of smallpox and rinderpest from the globe; the elimination of hog cholera and brucellosis from many countries; and the control of diseases such as foot-and-mouth disease, canine distemper, rabies, influenza, and pseudorabies would not have been possible without the use of effective vaccines. Vaccination not only protects the vaccinated animals but also reduces disease among non-vaccinated animals through herd immunity. They also reduce antimicrobial usage and minimize the risk of antimicrobial resistance. Vaccines Vaccines are prepared antigens to be used to prevent diseases caused by bacteria, viruses, fungi, mycoplasma, protozoa, and parasites.

A. Answer the following.

Q.1.     How many types of polio virus are there ?
Ans.    There are 3 serotypes of polio virus namely polio virus type 1, 2 and 3.

Q.2.     Who first developed inactivated polio vaccine ?
Ans.    Jonas Salk.

Q.3.     Who first developed attenuated oral polio vaccine ?
Ans.     Sabin.

Q.4.     What are the different inactivating agents used to inactivate viruses in preparing vaccines ?
Ans.    Formaldehyde, b-propiolactone and ethylenimines.

In its original concept, vaccination aims to mimic the development of naturally acquired immunity by inoculation of nonpathogenic but still immunogenic components of the pathogen in question, or closely related organisms. The term “vaccine” (from the Latin term “vacca,” meaning cow) was first coined by Edward Jenner to describe the inoculation of humans with the cowpox virus to confer protection against the related human smallpox virus and illustrates the close relationship between human and animal infectious disease sciences. The famous proverb saying ‘Prevention is better than cure’ implies perfectly to the vaccines. Vaccines have proven to be boon for animals which can be regard a potential weapons against infectious diseases caused mainly by bacteria and viruses. The major aims of veterinary vaccines are to improve the health and welfare of companion animals, increase production of livestock in a cost-effective manner, and prevent animal-to-human transmission from both domestic animals and wildlife. Vaccines have long been used to combat infectious disease; however the last decade has witnessed a revolution in the approach to vaccine design and development. Apart from improving animal health and productivity, veterinary vaccines have a significant impact on public health through reductions in the use of veterinary pharmaceuticals and hormones and their residues in the human food chain.

One of the most promising areas of veterinary research these days is cancer immunotherapy and the development of CMT vaccines. DNA vaccines, also known as gene vaccines, are designed to transfer functional genes to target cells, allowing them to express functional proteins. Because endonucleases may easily access bare DNA, it requires a reliable and safe delivery route, which might be biological or non-biological. Different delivery strategies have been tried in human breast tumors to transport tumor antigens such Mucin-1 (MUC-1), Twist, HER-2, mammaglobin-1 and p53, as well as immunostimulatory molecules like IL-12 and IL-6. There have been various studies/ trials in canine animals using different molecules like IL-12, HER-2 and IFN-γ as vaccine candidates, with no clinically relevant outcomes or longlasting cell mediated and humoral immune response outcomes

One of the greatest achievements in science is the development of vaccines. Vaccines have been revolutionary for the prevention of infectious diseases. They have prevented a large number of deaths caused, every year, by dreadful diseases like smallpox, polio, hepatitis etc. Diseases like smallpox and polio have been successfully eradicated by vaccination.

One of the greatest achievements in science is the development of vaccines. Vaccines have been revolutionary for the prevention of infectious diseases. They have prevented a large number of deaths caused, every year, by dreadful diseases like smallpox, polio, hepatitis etc. Diseases like smallpox and polio have been successfully eradicated by vaccination. Normally, when the body encounters a microbe, both humoral and cytotoxic immune responses are induced to neutralize its effect. In addition to eliminate the invader, body forms memory cells which help the body to protect itself from the same pathogen, in future. Vaccines not only function to kill the pathogens but they also stimulate the body to form memory cells which provide immunity against a specific pathogen

A vacuum cleaner, also known as a sweeper or hoover, is a device that uses an air pump (a centrifugal fan in all but some of the very oldest models), to create a partial vacuum to suck up dust and dirt from fl oors and from other surfaces such as upholstery and draperies.The dirt is collected by either a dustbag or a cyclone for later disposal. Vacuum cleaners, which are used in homes as well as in industry, exist in a variety of sizes and models—small battery-powered hand-held devices, wheeled canister models for home use, domestic central vacuum cleaners, huge stationary industrial appliances that can handle several hundred litres of dust before being emptied, and self-propelled vacuum trucks for recovery of large spills or removal of contaminated soil.

Abstract

Drying is an age old practice of food preservation. Removal of moisture from the food materials is usually carried out at atmospheric pressure and elevated temperature. In the presence of oxygen, drying can cause oxidation of some compounds leading to quality deterioration. Drying at higher temperature adds to the losses and can be responsible for enzymatic and non enzymatic browning, loss of aroma, nutrients, antioxidants, pigments etc. On the other hand, drying under sub atmospheric pressure helps in retaining the themosensitive compounds present in natural foods as drying can be accomplished in oxygen free environment. Under vacuum, evaporation of moisture can be possible at lower temperatures.

There is ever increase in the demand for good quality food product with improved quality and shelf life. Over the years, packaging have brought out a revolution in the marketing and distribution of food products including fish. Among the food categories, seafood ranks 3^rd with respect to consumption which explains the importance of fish. Fish is a vital source of food for people. It is the most important single source of high-quality protein, providing approximately 16% of the animal protein consumed by the world’s population (Food and Agriculture Organisation (FAO), United Nations, 1997). By any measure, fishes are amoung the world’s most important natural resources. Annual exploitation from wild populations exceeds 90 million tones, and total annual trade exceeds $ US 55 billion. Additionally, with over 25000 known species, the biodiversity and ecological roles of fish are being increasingly recognized in aquatic conservation, ecosystem management, restoration and aquatic environmental regulation.

Like any other food commodities, fish is one of the highly perishable items which undergoes spoilage if sufficient care is not taken. Various preservation methods have been in place to overcome the spoilage of fish. Chilling and refrigeration is the most preferred preservation method as it helps in preserving fresh like quality. Chilling or icing is reducing the temperature of fish so as to prolong the lag phase of bacteria and helps in reducing the spoilage rate. Fish being one of the most perishable foods, its freshness is rapidly lost even when stored under chilled conditions. Further, consumers demands to have fish in as fresh a state as possible so that the characteristics flavours are retained. Bulk transportation of fresh fish in ice has several limitations like limited extension of shelf life, unnecessary expenditure on freight due to ice, difficulty in handling and maintaining hygienic conditions due to leaching of ice melt water with leaching losses of soluble nutrients and flavouring compounds. Proper packaging will help in improving the keeping quality of fish. Packaging is an important aspect for improving the shelf life and marketability. Packaging enhances the consumer acceptability and hence saleability of the product. Traditionally, food packaging is meant for protection, communication, convenience and containment. The package is used to protect the product from the deteriorative effects of the external environmental conditionals like heat, light, presence or absence of moisture, pressure, microorganisms, and gaseous emissions and so on. Packaging is an integral part of the food processing and plays an important role in preventing or reducing the generation of waste in the supply of food. Packaging assists the preservation of the world’s resources through the prevention of product spoilage and wastage, and by protecting products until they have performed their function. Basic requirements of a package are good marketing properties, reasonable price, technical feasibility, utility for food contact, low environmental stress, and suitability for recycling. Simply packing fish is suitable packaging material will enhance the shelf life of chilled and refrigerated fish to 7 to 15 days depending on fish species. However, in the normal packaging the spoilage process will be accelerated due to presence of O₂ in the normal air packing. Alteration in the package atmosphere will help in overcoming the problem of shelf life, which can be achieved by vacuum packaging or modified atmosphere packaging.

Vaginal prolapse in cow is a condition in which there is protrusion of whole or part of vagina including sometimes the part of cervix through the vulva. It occurs in cow mostly during last 2-3 months of gestation. It occurs due to excess secretion of estrogen from placenta, hypocalcaemia, inadequate exercise, bulky food like roughages etc. Sometimes occurs in non pregnant cows due to cystic ovaries, severe straining due to vaginal irritation etc.

1. Introduction

Valeriana jatamansi Jones is considered to be highly endangered medicinal plant found mainly in northern part of Himalayan region. Although it is also found in all temperate regions of world except in Australia (Jain, 1968; Polunin and Stainton, 1987; Bennet, 1987). It is grown in Himachal Pradesh, northern part of U.P., Sikkim and newly introduced in West Bengal Darjeeling region by us. It is enlisted in the endangered category by IUCN (Kaul and Honda, 2000) and it is enlisted as an endangered species in the national medicinal plant board, New Delhi (www.nmbp.nic.in). The plant was reported to be found in fragmented populations in different places of Kashmir Himalayan hilly region like Dara, Sonamarg, Harwan, Gulmarg, Ferozpur, Pahelgum, Yusmarg, Shajnar (Naqashi and Dar, 1982-86). It is found to be in the margin of extinction from the world though it is widespread in the temperate regions of whole world except Australia (Nayar and Sastri, 1998). Indiscriminate collection of rhizomes from the plants made potential threat of its existence in some previously founded localities (Wyatt, 1981; Nayar and Sastri, 1998; Airi et al, 2000; Nautiyal et al, 2003, CAMP, 2003).

ABSTRACT

Butea monosperma (Lam.) Taub, knownas ’Flameof the Forest’is used in Indian traditional system of medicine, such as Siddha Ayurveda, and Unani due to its medicinal properties. It is used in treatment of diabetes, diarrhoea, sore throat and reported to possess several biological activities such as anti-asthmatic, anti-diabetic, antifertility, anti-tumor and osteogenic. Recent studies revealed the phytochemicals responsible for osteogenic activity in the bark of B. monosperma. An ultra-performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) method was developed for identification and simultaneous quantitation of bioactive compounds from B. monosperma. Validation of the developed method was performed according to international conference on harmonization guidelines. Quantitative interpretation showed significant variations in the content of bioactive compounds in different parts of the plant and samples collected from three geographical regions. Principal component analysis was also used to study the quantitative variations of markers.

Review of Health Claims

Regulators of different countries have different procedures and views to review health claims of traditional medicine, herbal medicines, botanicals, functional foods, nutraceuticals, health products, diatory supplements and such other natural forms of materials intended to use for health promotion. However, if such products carry any therapeutic or health benefit claims then the regulators may provide general guidance and demand for sufficient evidence base in support of such claims. For instance, U. S. Food and Drug Administration, Center for Food Safety and Applied Nutrition (CFSAN) provides general guidance to review of health claims in functional foods and dietary supplements. Ethnopharmacological preparations involving herbal medicine and traditional medicines prepared from natural ingredients also will need similar process. The scientific review process for health claims of such products is comprehensive and mainly focuses on review of individual studies³²⁴

Validation of IDM technologies is ultimate test for IDM knitted with available technologies under ground realities of the field. Since IDM is multidisciplinary, multiorganizational and multi-locational participatory approach, involvement of all the stakeholders, including farmers and field technicians is to be ensured. The following guidelines have been used as spirit behind the methodology of IDM validation.

• General considerations

 • Steps in validation

 • Step1- Feasibility studies

 • Step 2- Assay development and standardization

 • Step 3- Determining assay performance characteristics

 • Step 4- Monitoring validity of assay performance

 • Step 5- Maintenance and enhancement of validation criteria

 • Measurement of uncertainity of a diagnostic test

Lanolin, commonly known as Wool grease is primarily a lipid secretion from sebaceous glands of wool bearing animals. The role of Lanolin in nature is to protect wool and skin of animal from climate and the environment. It is an excellent emollient, self-emulsifying and dermatological safe for skin applications. Lanolin is a complex matrix since it is a mixture of high molecularweight esters of fatty acids with fatty alcohols, sterols, tri-terpene alcohols; diesters, long-chain alcohols & diols, long-chain fatty acids and hydroxy acids and is therefore difficult for effective matrix clean-up. Because of its water proofing and antimicrobial properties, lanolin is used mainly in cosmetic and pharmaceutical applications.