This set of Immunology Multiple Choice Questions & Answers (MCQs) focuses on “Vaccines Production”.
1. In order to get license for a developed vaccine which of the following parameters are considered?
i) Process development
ii) Clinical development
iii) Assay development
iv) Project development
a) i and ii
b) i, ii and iii
c) i, ii, iii and iv
d) only ii
View Answer
Explanation: The development of vaccine is a very unique and complex process. It requires a lot of approval approaches which is very hectic. The actual research and development of new vaccine takes several years. When a vaccine is produced and ready to use, it has to be licensed for which three most important parameters have to be considered. They are as follows: 1) Process development (to produce an economically viable and stable vaccine), 2) Clinical development (to check the safety measures and its effects) and 3) Assay development (to carry out several trial tests to check the potency and stability of vaccine).
2. Which step of vaccine production ensures removal of all interfering material that may spoil the activity of vaccine?
a) Propagation
b) Isolation
c) Purification
d) Formulation
View Answer
Explanation: The production od vaccines is a long process as it requires 4 steps. Propagation, Isolation, Purification and Formulation out of which Purification method ensures removal of unnecessary materials which may further spoil the activity of vaccines. These materials may also cause side effects to humans, if vaccine is by chance licensed. Hence, this step is very important in order to purify it for future use and prevent any kind of damage.
3. Which type of cell is NOT used for the growth of virus or microbe?
a) Cells of chicken egg
b) Cell line (continuous)
c) Cultured human cell
d) Cell line (finite)
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Explanation: Virus grows within the cell due to which for the production of specific vaccines, the virus is propagated in cells like chicken egg or vero cells which shows a continuous cell line or even cultured human cell. Once the virus is propagated and grown, it should then be isolated from the cell and the cell-culture media that is used for its development.
4. What components are added to formulate vaccine after development of antigen?
a) Adjuvants and stabilizers
b) Stabilizers and preservatives
c) Adjuvants, Assays, Stabilizers
d) Adjuvants, Stabilizers, Preservatives
View Answer
Explanation: Once the antigen is developed the vaccine is formulated by adding adjuvants, stabilizers, and preservatives. The role of the adjuvant is to enhance the immune response of the antigen. The stabilizers increase the storage life of antigen and preservatives allow the use of multi dose vials. These components are used because it is difficult to develop and produce combination vaccines as there can be a possibility of interactions among different antigens and this can result in low or nearly no effectiveness.
5. Vaccine needs to be protected from air, water and human contamination.
a) True
b) False
View Answer
Explanation: The development of vaccine is very difficult and requires precautions. It is a very sensitive process and needs to be taken care of. Vaccines can be contaminated by microorganisms present in air or if contaminated water droplets interfere. As a result, demineralised water i.e. distilled water is strictly to be used for the development of vaccines. This entire process is carried out in sterile and aseptic area. Human contamination can also be one of the risk factors for the development of vaccines. Sneezing, coughing and non-sanitized hands are some of the errors which should be avoided.
6. After the vaccines are licensed, which of the following parameters is tested by regulators for demonstrating the identification of vaccine?
a) Safety testing
b) Identity testing
c) Purity testing
d) Sterility testing
View Answer
Explanation: After vaccines are licensed, manufacturing is controlled by regulators who have the authority to test, approve and release production batches of vaccines. They carry out several tests for different reasons. If all the tests are approved, the vaccine is ready for release. Identity testing is one of the tests which is carried out for checking which type of vaccine it is, what viruses and chemicals are used, how pure is the vaccine and its positive/negative effects.
7. Which of the following vaccine contains high level of protective antigens (PA)?
a) Chickenpox vaccine
b) Anthrax vaccine
c) Pfizer vaccine
d) Smallpox vaccine
View Answer
Explanation: Anthrax vaccine is licensed by United States of America and it contains highest levels of protective antigens (PA). Each dose of anthrax consists of 83kDa PA. These PAs are absorbed in alum. Anthrax vaccine also consists of small amounts of preservatives like benzethonium chloride and formaldehyde.
8. Which of the following is NOT used as a stabilizer to keep vaccines stable?
a) Sucrose
b) Sorbitol
c) Gentamycin
d) Monosodium glutamate
View Answer
Explanation: Stabilizers are used to stabilize the vaccines. For eg: in Flu vaccine, sucrose, sorbitol and monosodium glutamate are some of the stabilizers used. They prevent vaccines from losing potency and protects them when exposed to heat and light. On the other hand, Gentamycin is an antibiotic used in Flu vaccine. It is added in very small amounts to protect the vaccine from contamination.
9. Which strain is grown for MMR vaccine?
a) Rubella
b) Adenovirus
c) Hepatitis B
d) Canine
View Answer
Explanation: The MMR vaccine was first discovered in UK and it contains of various ingredients necessary for fulfilling the parameters. Apart from active antigens, MMR vaccine also consists of highly purified gelatine, sorbitol, polysorbate80 and recombinant human serum albumin. The Rubella strain is mainly used for MMR vaccine and it is grown in laboratories using human cell strains in order to check its effect. Along with rubella strain, measle and mumps strain are also used which are grown in culture containing chick embryo cells.
10. Which of the following company is one of the largest vaccine manufacturing company?
a) Bharat Biotech
b) Serum Institute of India
c) Zydus Cadila
d) Panacea Biotec
View Answer
Explanation: Serum Institute of India is one of the largest companies as this institute manufactures large amounts of vaccines. This institute is located in Pune, India. It was found by Crus Poonawalla. Currently, this institute is working hard to develop vaccine against COVID-19. They are currently working on vaccine named ChAdOx1 nCoV-19 in collaboration with AstraZeneca.
11. Which clinical trial phase checks the safety and dose ranges which has to be completed within 1-3 years?
a) Phase I
b) Phase II
c) Phase III
d) Phase IV
View Answer
Explanation: Clinical development of vaccine is one of the most important parameters in order to license vaccine. After being tested in animals, vaccines are found to be safe to be tested in humans. To license vaccine, three phases of clinical testing is required: Phase I checks the safety and immunogenicity trials take place which needs to be completed under 1 year. However, in phase 2 the same process is carried out along with checking dose range but this takes almost 1-3 years.
12. Which of the following process requires mixing of various solutions for manufacturing of vaccine?
a) Propagation
b) Isolation
c) Formulation
d) Purification
View Answer
Explanation: Formulation involves the mixing of the purified product in solutions to obtain a desired concentration. It may also include the addition of preservatives to some vaccines, to ensure the sterility of the product over a longer period of time, or to prevent cross contamination during dose extraction from vials. At the end of this manufacturing process, vaccines are typically filled in syringes and shipped to healthcare providers.
13. The adjuvant AS04 is used in which of the following vaccine?
a) Anthrax
b) DT
c) Cervarix
d) Hep-A
View Answer
Explanation: AS04 is an adjuvant added in vaccine Cervarix. AS04 consists of Monophosphoryl lipid A and Aluminium salt. Adjuvants are included in some vaccines that help in creating a stronger immune response in people. Adjuvants enhance the effectiveness of the vaccine to work better against the infection caused.
14. Which of the following is NOT a type of (influenza) flu vaccine?
a) Egg-based flu vaccine
b) Cell-based flu vaccine
c) Recombinant flu vaccine
d) Thimerosal flu vaccine
View Answer
Explanation: Egg-based flu vaccine, cell-based flu vaccine and recombinant flu vaccine are the three major types of flu vaccine that are widely tested and accepted. These vaccines were first approved by the United States of America. They used several technologies to test these three types where egg-based flu vaccine requires chicken eggs to help in making live attenuated vaccines. Cell-based flu vaccines are produced by using animal cells whereas recombinant flu vaccines use the recombinant technologies.
15. Which of the following is used as a preservative in most vaccines?
a) Thimerosal
b) Adenine
c) Sorbitol
d) Sucrose
View Answer
Explanation: Thimerosal is a preservative used in majority of vaccines worldwide. It is a mercuric-based compound which helps in prevention of growth of bacteria or fungus. The basic principle of preservatives is to keep the vaccines away from contamination by any external or chemical factors. This preservative is so strong in its activity that it even kills the contaminant.
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