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Covid-19 vaccine development

The document discusses the process of vaccine development, emphasizing how immunity is built in response to viral infections and detailing the types of vaccines, including whole virus, protein-based, DNA, RNA, and viral vector vaccines. It outlines the steps involved in vaccine development, from exploratory phases to preclinical testing and large-scale trials, while noting the accelerated timeline in response to the COVID-19 pandemic. The document further explains how vaccines work to stimulate the immune system and includes references to various vaccine types and their mechanisms.

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Covid-19 Pandemic: Vaccine Development Rachel Mackelprang, Ph.D. California State University Northridge Department of Biology rachel.mackelprang@csun.edu @rmackelprang
How we develop immunity Virus is ingested by specialized immune system cells called ‘antigen presenting cells’ Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
How we develop immunity Virus is ingested by specialized immune system cells called ‘antigen presenting cells’ T-helper cell Antigen presenting cells display pieces of the virus to activate T-helper cells Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
How we develop immunity Virus is ingested by specialized immune system cells called ‘antigen presenting cells’ T-helper cell Antigen presenting cells display pieces of the virus to activate T-helper cells T-cells activate other immune responses Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
How we develop immunity Virus is ingested by specialized immune system cells called ‘antigen presenting cells’ T-helper cell Antigen presenting cells display pieces of the virus to activate T-helper cells Cytotoxic T-cell Cytotoxic T-cells identify and destroy virus- infected cells T-cells activate other immune responses Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
How we develop immunity Virus is ingested by specialized immune system cells called ‘antigen presenting cells’ T-helper cell Antigen presenting cells display pieces of the virus to activate T-helper cells Cytotoxic T-cell Cytotoxic T-cells identify and destroy virus- infected cells B-cell B-cells make antibodies that block the virus from infecting more cells and mark it for destruction T-cells activate other immune responses Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
How we develop immunity Virus is ingested by specialized immune system cells called ‘antigen presenting cells’ T-helper cell Antigen presenting cells display pieces of the virus to activate T-helper cells Cytotoxic T-cell Cytotoxic T-cells identify and destroy virus- infected cells Long-lived ‘memory’ B and T cells that recognize the virus patrol the body for months or years, providing immunity B-cell B-cells make antibodies that block the virus from infecting more cells and mark it for destruction T-cells activate other immune responses Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
How vaccines work* Weakened virus, dead virus, or parts of the virus are introduced into the patient. Because it is inactive or in pieces, the patient doesn’t develop the disease. Image credits: https://www.bbc.com/news/world-48186856 The Amoeba Sisters: https://www.amoebasisters.com/ *simplified
How vaccines work* Image credit: The Amoeba Sisters: https:// www.amoebasisters.com/ Immune system cells mount a response to fight the attenuated virus *simplified
How vaccines work* The immune system retains memory of the pathogen and can mount an attack more quickly and efficiently. Image credit: The Amoeba Sisters: https:// www.amoebasisters.com/ *simplified
Types of vaccines: whole virus vaccines These vaccines use a weakened or inactivated virus to produce an immune response Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
Types of vaccines: whole virus vaccines These vaccines use a weakened or inactivated virus to produce an immune response The virus is weakened or inactivated Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
Types of vaccines: whole virus vaccines These vaccines use a weakened or inactivated virus to produce an immune response The virus is weakened or inactivated Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
Types of vaccines: whole virus vaccines These vaccines use a weakened or inactivated virus to produce an immune response Antigen presenting cells take up the virus, break it into pieces, and ‘present’ those pieces to other immune system cells. The virus is weakened or inactivated Immune response Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
Types of vaccines: whole virus vaccines These vaccines use a weakened or inactivated virus to produce an immune response Examples: MMR, smallpox, yellow fever, chickenpox, flu Antigen presenting cells take up the virus, break it into pieces, and ‘present’ those pieces to other immune system cells. The virus is weakened or inactivated Immune response Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
Types of vaccines: protein-based vaccines Instead of the entire virus, only certain components that best stimulate the immune system (called antigens) are used Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
Types of vaccines: protein-based vaccines Instead of the entire virus, only certain components that best stimulate the immune system (called antigens) are used Pieces of viral proteins (such as the virus spike or shell proteins) are administered Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
Types of vaccines: protein-based vaccines Instead of the entire virus, only certain components that best stimulate the immune system (called antigens) are used Pieces of viral proteins (such as the virus spike or shell proteins) are administered Immune response Antigen presenting cells take up the viral proteins, break them into pieces, and ‘present’ those pieces to other immune system cells. Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
Types of vaccines: protein-based vaccines Instead of the entire virus, only certain components that best stimulate the immune system (called antigens) are used Pieces of viral proteins (such as the virus spike or shell proteins) are administered Immune response Antigen presenting cells take up the viral proteins, break them into pieces, and ‘present’ those pieces to other immune system cells. Examples: hepatitis B, HPV, whooping cough, shingles Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
Types of vaccines: DNA vaccines Vaccines that use genetic instructions (in the form of DNA) to make a viral protein that prompts an immune response Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
Types of vaccines: DNA vaccines Vaccines that use genetic instructions (in the form of DNA) to make a viral protein that prompts an immune response DNA encoding viral proteins (e.g. the spike protein) is inserted into a circular piece of DNA called a plasmid Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
Types of vaccines: DNA vaccines Vaccines that use genetic instructions (in the form of DNA) to make a viral protein that prompts an immune response DNA encoding viral proteins (e.g. the spike protein) is inserted into a circular piece of DNA called a plasmid mRNA Our cells take up the DNA and use it to make viral proteins Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
Types of vaccines: DNA vaccines Vaccines that use genetic instructions (in the form of DNA) to make a viral protein that prompts an immune response DNA encoding viral proteins (e.g. the spike protein) is inserted into a circular piece of DNA called a plasmid Immune response Antigen presenting cells take up the viral proteins, break them into pieces, and ‘present’ those pieces to other immune system cells. mRNA Our cells take up the DNA and use it to make viral proteins Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
Types of vaccines: DNA vaccines Vaccines that use genetic instructions (in the form of DNA) to make a viral protein that prompts an immune response Examples: West Nile virus in horses None yet for human use DNA encoding viral proteins (e.g. the spike protein) is inserted into a circular piece of DNA called a plasmid Immune response Antigen presenting cells take up the viral proteins, break them into pieces, and ‘present’ those pieces to other immune system cells. mRNA Our cells take up the DNA and use it to make viral proteins Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
Types of vaccines: RNA vaccines Vaccines that use genetic instructions (in the form of RNA) to make a viral protein that prompts an immune response Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
Types of vaccines: RNA vaccines Vaccines that use genetic instructions (in the form of RNA) to make a viral protein that prompts an immune response RNA encoding viral proteins (e.g. the spike protein) is encased in a lipid coat so it can enter cells Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
Types of vaccines: RNA vaccines Vaccines that use genetic instructions (in the form of RNA) to make a viral protein that prompts an immune response RNA encoding viral proteins (e.g. the spike protein) is encased in a lipid coat so it can enter cells Our cells take up the RNA and use it to make viral proteins Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
Types of vaccines: RNA vaccines Vaccines that use genetic instructions (in the form of RNA) to make a viral protein that prompts an immune response Immune response Antigen presenting cells take up the viral proteins, break them into pieces, and ‘present’ those pieces to other immune system cells. RNA encoding viral proteins (e.g. the spike protein) is encased in a lipid coat so it can enter cells Our cells take up the RNA and use it to make viral proteins Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
Types of vaccines: RNA vaccines Vaccines that use genetic instructions (in the form of RNA) to make a viral protein that prompts an immune response RNA vaccines are still under development and none have yet been approved for use in humans Immune response Antigen presenting cells take up the viral proteins, break them into pieces, and ‘present’ those pieces to other immune system cells. RNA encoding viral proteins (e.g. the spike protein) is encased in a lipid coat so it can enter cells Our cells take up the RNA and use it to make viral proteins Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
Types of vaccines: viral vectors These vaccines use a different virus (that doesn’t cause disease) to deliver coronavirus genes into the cell and provoke an immune response Genes encoding viral proteins (e.g. the spike protein) are placed into a non-disease causing virus Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
Types of vaccines: viral vectors These vaccines use a different virus (that doesn’t cause disease) to deliver coronavirus genes into the cell and provoke an immune response Genes encoding viral proteins (e.g. the spike protein) are placed into a non-disease causing virus The non-disease causing virus replicates within our cells Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
Immune response Antigen presenting cells take up the virus, break it into pieces (which include pieces of coronavirus proteins), and ‘present’ those pieces to other immune system cells. Types of vaccines: viral vectors These vaccines use a different virus (that doesn’t cause disease) to deliver coronavirus genes into the cell and provoke an immune response Genes encoding viral proteins (e.g. the spike protein) are placed into a non-disease causing virus The non-disease causing virus replicates within our cells Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
Immune response Antigen presenting cells take up the virus, break it into pieces (which include pieces of coronavirus proteins), and ‘present’ those pieces to other immune system cells. Types of vaccines: viral vectors These vaccines use a different virus (that doesn’t cause disease) to deliver coronavirus genes into the cell and provoke an immune response Example: Newly approved Ebola vaccine Genes encoding viral proteins (e.g. the spike protein) are placed into a non-disease causing virus The non-disease causing virus replicates within our cells Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
Stages of vaccine development Exploratory Preclinical Phase I Phase II Phase III Approval Surveillance Safety & dosage testing Expanded safety trials Large-scale efficacy tests Approved for limited use Animal trials Usually it takes years to develop a vaccine, but scientists are racing to produce a safe and effective vaccine by next year 1-10 years 2-3 years 2-4 years > 1 year https://www.who.int/biologicals/BS2287_Clinical_guidelines_final_LINE_NOs_20_July_2016.pdf?ua=1 https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
Stages of vaccine development* Exploratory Preclinical Phase I Phase II Phase III Approval Surveillance Safety & dosage testing Expanded safety trials Large-scale efficacy tests Approved for limited use Animal trials Usually it takes years to develop a vaccine, but scientists are racing to produce a safe and effective vaccine by next year 135+ 21 13 8 2 0 1-10 years 2-3 years 2-4 years > 1 year *August 23rd 2020 https://www.who.int/biologicals/BS2287_Clinical_guidelines_final_LINE_NOs_20_July_2016.pdf?ua=1 https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
Stages of vaccine development* Exploratory Preclinical Phase I Phase II Phase III Approval Surveillance Safety & dosage testing Expanded safety trials Large-scale efficacy tests Approved for limited use Animal trials Usually it takes years to develop a vaccine, but scientists are racing to produce a safe and effective vaccine by next year 135+ 21 13 8 2 0 Preclinical testing: scientists give the vaccine to animals such as mice or monkeys to see if it produces an immune response *August 23rd 2020 https://www.who.int/biologicals/BS2287_Clinical_guidelines_final_LINE_NOs_20_July_2016.pdf?ua=1 https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
Stages of vaccine development* Exploratory Preclinical Phase I Phase II Phase III Approval Surveillance Safety & dosage testing Expanded safety trials Large-scale efficacy tests Approved for limited use Animal trials Usually it takes years to develop a vaccine, but scientists are racing to produce a safe and effective vaccine by next year 135+ 21 13 8 2 0 Phase I safety trials: scientists give the vaccine to a small number of people to test safety and dosage and to confirm that it stimulates the immune system *August 23rd 2020 https://www.who.int/biologicals/BS2287_Clinical_guidelines_final_LINE_NOs_20_July_2016.pdf?ua=1 https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
Stages of vaccine development* Exploratory Preclinical Phase I Phase II Phase III Approval Surveillance Safety & dosage testing Expanded safety trials Large-scale efficacy tests Approved for limited use Animal trials Usually it takes years to develop a vaccine, but scientists are racing to produce a safe and effective vaccine by next year 135+ 21 13 8 2 0 Phase II expanded trials: scientists give the vaccine to hundreds of people split into groups, such as children and the elderly, to see if the vaccine acts differently in them. These trials further test the vaccine’s safety and ability to stimulate the immune system. *August 23rd 2020 https://www.who.int/biologicals/BS2287_Clinical_guidelines_final_LINE_NOs_20_July_2016.pdf?ua=1 https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
Stages of vaccine development* Exploratory Preclinical Phase I Phase II Phase III Approval Surveillance Safety & dosage testing Expanded safety trials Large-scale efficacy tests Approved for limited use Animal trials Usually it takes years to develop a vaccine, but scientists are racing to produce a safe and effective vaccine by next year 135+ 21 13 8 2 0 Phase II expanded trials: To accelerate the vaccine development timeline, there are several vaccines combining Phase I and II trials *August 23rd 2020 https://www.who.int/biologicals/BS2287_Clinical_guidelines_final_LINE_NOs_20_July_2016.pdf?ua=1 https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
Stages of vaccine development* Exploratory Preclinical Phase I Phase II Phase III Approval Surveillance Safety & dosage testing Expanded safety trials Large-scale efficacy tests Approved for limited use Animal trials Usually it takes years to develop a vaccine, but scientists are racing to produce a safe and effective vaccine by next year 135+ 21 13 8 2 0 Phase III efficacy trials: scientists give the vaccine to thousands of people and wait to see how many become infected compared with volunteers who received a placebo. These trials can determine if the vaccine protects against the coronavirus *August 23rd 2020 https://www.who.int/biologicals/BS2287_Clinical_guidelines_final_LINE_NOs_20_July_2016.pdf?ua=1 https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
Stages of vaccine development* Exploratory Preclinical Phase I Phase II Phase III Approval Surveillance Safety & dosage testing Expanded safety trials Large-scale efficacy tests Approved for limited use Animal trials Usually it takes years to develop a vaccine, but scientists are racing to produce a safe and effective vaccine by next year 135+ 21 13 8 2 0 Approval: Regulators in each country review the trial results and decide whether to approve the vaccine or not. During a pandemic, a vaccine may receive emergency use authorization before getting formal approval. *August 23rd 2020 https://www.who.int/biologicals/BS2287_Clinical_guidelines_final_LINE_NOs_20_July_2016.pdf?ua=1 https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
Stages of vaccine development* Exploratory Preclinical Phase I Phase II Phase III Approval Surveillance Safety & dosage testing Expanded safety trials Large-scale efficacy tests Approved for limited use Animal trials Usually it takes years to develop a vaccine, but scientists are racing to produce a safe and effective vaccine by next year 135+ 21 13 8 2 0 There is 1 vaccine that is currently in Phase III trials and has limited approval for use in the Chinese military as a “specially needed drug.” https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31605-6/fulltext *August 23rd 2020 https://www.who.int/biologicals/BS2287_Clinical_guidelines_final_LINE_NOs_20_July_2016.pdf?ua=1 https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
Stages of vaccine development* Exploratory Preclinical Phase I Phase II Phase III Approval Surveillance Safety & dosage testing Expanded safety trials Large-scale efficacy tests Approved for limited use Animal trials Usually it takes years to develop a vaccine, but scientists are racing to produce a safe and effective vaccine by next year 135+ 21 13 8 2 0 Russia approved a vaccine that has completed Phase II trials (but hasn’t begun Phase III). However, trial data have not been published and vaccine experts worry about about safety and efficacy. https://edition.cnn.com/2020/08/11/europe/russia-coronavirus-vaccine-putin-intl/index.html https://www.bbc.com/news/world-europe-53751017 *August 23rd 2020 https://www.who.int/biologicals/BS2287_Clinical_guidelines_final_LINE_NOs_20_July_2016.pdf?ua=1 https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
Example of a promising candidate mRNA vaccine. Teaches human cells to build the spike proteins, which triggers an immune response. Results from phase I trial: https://www.nejm.org/doi/pdf/10.1056/NEJMoa2022483?articleTools=true
Example of a promising candidate mRNA vaccine. Teaches human cells to build the spike proteins, which triggers an immune response. Phase I trial results published on July 14th 2020 Safety & dosage testing Results from phase I trial: https://www.nejm.org/doi/pdf/10.1056/NEJMoa2022483?articleTools=true
Example of a promising candidate mRNA vaccine. Teaches human cells to build the spike proteins, which triggers an immune response. Phase I trial results published on July 14th 2020 Safety & dosage testing Generally safe and well-tolerated, but ~1/2 had some mild/moderate side effects (e.g., fatigue, headache, chills). High dose that caused the strongest side effects won’t be used in subsequent trials. Results from phase I trial: https://www.nejm.org/doi/pdf/10.1056/NEJMoa2022483?articleTools=true
Example of a promising candidate mRNA vaccine. Teaches human cells to build the spike proteins, which triggers an immune response. Phase I trial results published on July 14th 2020 Safety & dosage testing Generally safe and well-tolerated, but ~1/2 had some mild/moderate side effects (e.g., fatigue, headache, chills). High dose that caused the strongest side effects won’t be used in subsequent trials. Phase II is ongoing. Phase III trials started July 27th, 2020 with a target of 30,000 individuals. Large-scale efficacy tests Results from phase I trial: https://www.nejm.org/doi/pdf/10.1056/NEJMoa2022483?articleTools=true
Moderna vaccine: phase I experiment Results from phase I trial: https://www.nejm.org/doi/pdf/10.1056/NEJMoa2022483?articleTools=true 45 healthy adults 18-55 years of age 25 µg dose 100 µg dose 250 µg dose 15 individuals 15 individuals 15 individuals Day1 Z 25 µg dose 100 µg dose 250 µg dose Day29
Moderna vaccine: phase I results* Key result: the vaccine provoked a strong immune response Antibodiesproduced Less More Pre-injection Recovered patient All results from phase I trial: https://www.nejm.org/doi/pdf/10.1056/NEJMoa2022483?articleTools=true *Simplified. See linked paper for full results
Moderna vaccine: phase I results* Key result: the vaccine provoked a strong immune response Antibodiesproduced Less More Pre-injection Recovered patient After 1st dose All results from phase I trial: https://www.nejm.org/doi/pdf/10.1056/NEJMoa2022483?articleTools=true *Simplified. See linked paper for full results
Moderna vaccine: phase I results* Key result: the vaccine provoked a strong immune response Antibodiesproduced Less More Pre-injection Recovered patient After 1st dose After 2nd dose All results from phase I trial: https://www.nejm.org/doi/pdf/10.1056/NEJMoa2022483?articleTools=true *Simplified. See linked paper for full results
Moderna vaccine: phase I results* Key result: the vaccine provoked a strong immune response Antibodiesproduced Less More Pre-injection Recovered patient After 1st dose After 2nd dose All results from phase I trial: https://www.nejm.org/doi/pdf/10.1056/NEJMoa2022483?articleTools=true *Simplified. See linked paper for full results Note that Phase I trials do not evaluate efficacy. Producing an immune response does not guarantee immunity if exposed to the virus. Phase III trials are designed for efficacy testing.

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Covid-19 vaccine development

  • 1.
    Covid-19 Pandemic: Vaccine Development RachelMackelprang, Ph.D. California State University Northridge Department of Biology rachel.mackelprang@csun.edu @rmackelprang
  • 2.
    How we developimmunity Virus is ingested by specialized immune system cells called ‘antigen presenting cells’ Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
  • 3.
    How we developimmunity Virus is ingested by specialized immune system cells called ‘antigen presenting cells’ T-helper cell Antigen presenting cells display pieces of the virus to activate T-helper cells Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
  • 4.
    How we developimmunity Virus is ingested by specialized immune system cells called ‘antigen presenting cells’ T-helper cell Antigen presenting cells display pieces of the virus to activate T-helper cells T-cells activate other immune responses Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
  • 5.
    How we developimmunity Virus is ingested by specialized immune system cells called ‘antigen presenting cells’ T-helper cell Antigen presenting cells display pieces of the virus to activate T-helper cells Cytotoxic T-cell Cytotoxic T-cells identify and destroy virus- infected cells T-cells activate other immune responses Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
  • 6.
    How we developimmunity Virus is ingested by specialized immune system cells called ‘antigen presenting cells’ T-helper cell Antigen presenting cells display pieces of the virus to activate T-helper cells Cytotoxic T-cell Cytotoxic T-cells identify and destroy virus- infected cells B-cell B-cells make antibodies that block the virus from infecting more cells and mark it for destruction T-cells activate other immune responses Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
  • 7.
    How we developimmunity Virus is ingested by specialized immune system cells called ‘antigen presenting cells’ T-helper cell Antigen presenting cells display pieces of the virus to activate T-helper cells Cytotoxic T-cell Cytotoxic T-cells identify and destroy virus- infected cells Long-lived ‘memory’ B and T cells that recognize the virus patrol the body for months or years, providing immunity B-cell B-cells make antibodies that block the virus from infecting more cells and mark it for destruction T-cells activate other immune responses Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
  • 8.
    How vaccines work* Weakenedvirus, dead virus, or parts of the virus are introduced into the patient. Because it is inactive or in pieces, the patient doesn’t develop the disease. Image credits: https://www.bbc.com/news/world-48186856 The Amoeba Sisters: https://www.amoebasisters.com/ *simplified
  • 9.
    How vaccines work* Imagecredit: The Amoeba Sisters: https:// www.amoebasisters.com/ Immune system cells mount a response to fight the attenuated virus *simplified
  • 10.
    How vaccines work* Theimmune system retains memory of the pathogen and can mount an attack more quickly and efficiently. Image credit: The Amoeba Sisters: https:// www.amoebasisters.com/ *simplified
  • 11.
    Types of vaccines:whole virus vaccines These vaccines use a weakened or inactivated virus to produce an immune response Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
  • 12.
    Types of vaccines:whole virus vaccines These vaccines use a weakened or inactivated virus to produce an immune response The virus is weakened or inactivated Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
  • 13.
    Types of vaccines:whole virus vaccines These vaccines use a weakened or inactivated virus to produce an immune response The virus is weakened or inactivated Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
  • 14.
    Types of vaccines:whole virus vaccines These vaccines use a weakened or inactivated virus to produce an immune response Antigen presenting cells take up the virus, break it into pieces, and ‘present’ those pieces to other immune system cells. The virus is weakened or inactivated Immune response Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
  • 15.
    Types of vaccines:whole virus vaccines These vaccines use a weakened or inactivated virus to produce an immune response Examples: MMR, smallpox, yellow fever, chickenpox, flu Antigen presenting cells take up the virus, break it into pieces, and ‘present’ those pieces to other immune system cells. The virus is weakened or inactivated Immune response Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
  • 16.
    Types of vaccines:protein-based vaccines Instead of the entire virus, only certain components that best stimulate the immune system (called antigens) are used Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
  • 17.
    Types of vaccines:protein-based vaccines Instead of the entire virus, only certain components that best stimulate the immune system (called antigens) are used Pieces of viral proteins (such as the virus spike or shell proteins) are administered Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
  • 18.
    Types of vaccines:protein-based vaccines Instead of the entire virus, only certain components that best stimulate the immune system (called antigens) are used Pieces of viral proteins (such as the virus spike or shell proteins) are administered Immune response Antigen presenting cells take up the viral proteins, break them into pieces, and ‘present’ those pieces to other immune system cells. Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
  • 19.
    Types of vaccines:protein-based vaccines Instead of the entire virus, only certain components that best stimulate the immune system (called antigens) are used Pieces of viral proteins (such as the virus spike or shell proteins) are administered Immune response Antigen presenting cells take up the viral proteins, break them into pieces, and ‘present’ those pieces to other immune system cells. Examples: hepatitis B, HPV, whooping cough, shingles Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
  • 20.
    Types of vaccines:DNA vaccines Vaccines that use genetic instructions (in the form of DNA) to make a viral protein that prompts an immune response Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
  • 21.
    Types of vaccines:DNA vaccines Vaccines that use genetic instructions (in the form of DNA) to make a viral protein that prompts an immune response DNA encoding viral proteins (e.g. the spike protein) is inserted into a circular piece of DNA called a plasmid Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
  • 22.
    Types of vaccines:DNA vaccines Vaccines that use genetic instructions (in the form of DNA) to make a viral protein that prompts an immune response DNA encoding viral proteins (e.g. the spike protein) is inserted into a circular piece of DNA called a plasmid mRNA Our cells take up the DNA and use it to make viral proteins Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
  • 23.
    Types of vaccines:DNA vaccines Vaccines that use genetic instructions (in the form of DNA) to make a viral protein that prompts an immune response DNA encoding viral proteins (e.g. the spike protein) is inserted into a circular piece of DNA called a plasmid Immune response Antigen presenting cells take up the viral proteins, break them into pieces, and ‘present’ those pieces to other immune system cells. mRNA Our cells take up the DNA and use it to make viral proteins Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
  • 24.
    Types of vaccines:DNA vaccines Vaccines that use genetic instructions (in the form of DNA) to make a viral protein that prompts an immune response Examples: West Nile virus in horses None yet for human use DNA encoding viral proteins (e.g. the spike protein) is inserted into a circular piece of DNA called a plasmid Immune response Antigen presenting cells take up the viral proteins, break them into pieces, and ‘present’ those pieces to other immune system cells. mRNA Our cells take up the DNA and use it to make viral proteins Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
  • 25.
    Types of vaccines:RNA vaccines Vaccines that use genetic instructions (in the form of RNA) to make a viral protein that prompts an immune response Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
  • 26.
    Types of vaccines:RNA vaccines Vaccines that use genetic instructions (in the form of RNA) to make a viral protein that prompts an immune response RNA encoding viral proteins (e.g. the spike protein) is encased in a lipid coat so it can enter cells Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
  • 27.
    Types of vaccines:RNA vaccines Vaccines that use genetic instructions (in the form of RNA) to make a viral protein that prompts an immune response RNA encoding viral proteins (e.g. the spike protein) is encased in a lipid coat so it can enter cells Our cells take up the RNA and use it to make viral proteins Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
  • 28.
    Types of vaccines:RNA vaccines Vaccines that use genetic instructions (in the form of RNA) to make a viral protein that prompts an immune response Immune response Antigen presenting cells take up the viral proteins, break them into pieces, and ‘present’ those pieces to other immune system cells. RNA encoding viral proteins (e.g. the spike protein) is encased in a lipid coat so it can enter cells Our cells take up the RNA and use it to make viral proteins Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
  • 29.
    Types of vaccines:RNA vaccines Vaccines that use genetic instructions (in the form of RNA) to make a viral protein that prompts an immune response RNA vaccines are still under development and none have yet been approved for use in humans Immune response Antigen presenting cells take up the viral proteins, break them into pieces, and ‘present’ those pieces to other immune system cells. RNA encoding viral proteins (e.g. the spike protein) is encased in a lipid coat so it can enter cells Our cells take up the RNA and use it to make viral proteins Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
  • 30.
    Types of vaccines:viral vectors These vaccines use a different virus (that doesn’t cause disease) to deliver coronavirus genes into the cell and provoke an immune response Genes encoding viral proteins (e.g. the spike protein) are placed into a non-disease causing virus Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
  • 31.
    Types of vaccines:viral vectors These vaccines use a different virus (that doesn’t cause disease) to deliver coronavirus genes into the cell and provoke an immune response Genes encoding viral proteins (e.g. the spike protein) are placed into a non-disease causing virus The non-disease causing virus replicates within our cells Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
  • 32.
    Immune response Antigen presenting cellstake up the virus, break it into pieces (which include pieces of coronavirus proteins), and ‘present’ those pieces to other immune system cells. Types of vaccines: viral vectors These vaccines use a different virus (that doesn’t cause disease) to deliver coronavirus genes into the cell and provoke an immune response Genes encoding viral proteins (e.g. the spike protein) are placed into a non-disease causing virus The non-disease causing virus replicates within our cells Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
  • 33.
    Immune response Antigen presenting cellstake up the virus, break it into pieces (which include pieces of coronavirus proteins), and ‘present’ those pieces to other immune system cells. Types of vaccines: viral vectors These vaccines use a different virus (that doesn’t cause disease) to deliver coronavirus genes into the cell and provoke an immune response Example: Newly approved Ebola vaccine Genes encoding viral proteins (e.g. the spike protein) are placed into a non-disease causing virus The non-disease causing virus replicates within our cells Content: https://www.nature.com/articles/d41586-020-01221-y Virus image: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
  • 34.
    Stages of vaccinedevelopment Exploratory Preclinical Phase I Phase II Phase III Approval Surveillance Safety & dosage testing Expanded safety trials Large-scale efficacy tests Approved for limited use Animal trials Usually it takes years to develop a vaccine, but scientists are racing to produce a safe and effective vaccine by next year 1-10 years 2-3 years 2-4 years > 1 year https://www.who.int/biologicals/BS2287_Clinical_guidelines_final_LINE_NOs_20_July_2016.pdf?ua=1 https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
  • 35.
    Stages of vaccinedevelopment* Exploratory Preclinical Phase I Phase II Phase III Approval Surveillance Safety & dosage testing Expanded safety trials Large-scale efficacy tests Approved for limited use Animal trials Usually it takes years to develop a vaccine, but scientists are racing to produce a safe and effective vaccine by next year 135+ 21 13 8 2 0 1-10 years 2-3 years 2-4 years > 1 year *August 23rd 2020 https://www.who.int/biologicals/BS2287_Clinical_guidelines_final_LINE_NOs_20_July_2016.pdf?ua=1 https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
  • 36.
    Stages of vaccinedevelopment* Exploratory Preclinical Phase I Phase II Phase III Approval Surveillance Safety & dosage testing Expanded safety trials Large-scale efficacy tests Approved for limited use Animal trials Usually it takes years to develop a vaccine, but scientists are racing to produce a safe and effective vaccine by next year 135+ 21 13 8 2 0 Preclinical testing: scientists give the vaccine to animals such as mice or monkeys to see if it produces an immune response *August 23rd 2020 https://www.who.int/biologicals/BS2287_Clinical_guidelines_final_LINE_NOs_20_July_2016.pdf?ua=1 https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
  • 37.
    Stages of vaccinedevelopment* Exploratory Preclinical Phase I Phase II Phase III Approval Surveillance Safety & dosage testing Expanded safety trials Large-scale efficacy tests Approved for limited use Animal trials Usually it takes years to develop a vaccine, but scientists are racing to produce a safe and effective vaccine by next year 135+ 21 13 8 2 0 Phase I safety trials: scientists give the vaccine to a small number of people to test safety and dosage and to confirm that it stimulates the immune system *August 23rd 2020 https://www.who.int/biologicals/BS2287_Clinical_guidelines_final_LINE_NOs_20_July_2016.pdf?ua=1 https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
  • 38.
    Stages of vaccinedevelopment* Exploratory Preclinical Phase I Phase II Phase III Approval Surveillance Safety & dosage testing Expanded safety trials Large-scale efficacy tests Approved for limited use Animal trials Usually it takes years to develop a vaccine, but scientists are racing to produce a safe and effective vaccine by next year 135+ 21 13 8 2 0 Phase II expanded trials: scientists give the vaccine to hundreds of people split into groups, such as children and the elderly, to see if the vaccine acts differently in them. These trials further test the vaccine’s safety and ability to stimulate the immune system. *August 23rd 2020 https://www.who.int/biologicals/BS2287_Clinical_guidelines_final_LINE_NOs_20_July_2016.pdf?ua=1 https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
  • 39.
    Stages of vaccinedevelopment* Exploratory Preclinical Phase I Phase II Phase III Approval Surveillance Safety & dosage testing Expanded safety trials Large-scale efficacy tests Approved for limited use Animal trials Usually it takes years to develop a vaccine, but scientists are racing to produce a safe and effective vaccine by next year 135+ 21 13 8 2 0 Phase II expanded trials: To accelerate the vaccine development timeline, there are several vaccines combining Phase I and II trials *August 23rd 2020 https://www.who.int/biologicals/BS2287_Clinical_guidelines_final_LINE_NOs_20_July_2016.pdf?ua=1 https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
  • 40.
    Stages of vaccinedevelopment* Exploratory Preclinical Phase I Phase II Phase III Approval Surveillance Safety & dosage testing Expanded safety trials Large-scale efficacy tests Approved for limited use Animal trials Usually it takes years to develop a vaccine, but scientists are racing to produce a safe and effective vaccine by next year 135+ 21 13 8 2 0 Phase III efficacy trials: scientists give the vaccine to thousands of people and wait to see how many become infected compared with volunteers who received a placebo. These trials can determine if the vaccine protects against the coronavirus *August 23rd 2020 https://www.who.int/biologicals/BS2287_Clinical_guidelines_final_LINE_NOs_20_July_2016.pdf?ua=1 https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
  • 41.
    Stages of vaccinedevelopment* Exploratory Preclinical Phase I Phase II Phase III Approval Surveillance Safety & dosage testing Expanded safety trials Large-scale efficacy tests Approved for limited use Animal trials Usually it takes years to develop a vaccine, but scientists are racing to produce a safe and effective vaccine by next year 135+ 21 13 8 2 0 Approval: Regulators in each country review the trial results and decide whether to approve the vaccine or not. During a pandemic, a vaccine may receive emergency use authorization before getting formal approval. *August 23rd 2020 https://www.who.int/biologicals/BS2287_Clinical_guidelines_final_LINE_NOs_20_July_2016.pdf?ua=1 https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
  • 42.
    Stages of vaccinedevelopment* Exploratory Preclinical Phase I Phase II Phase III Approval Surveillance Safety & dosage testing Expanded safety trials Large-scale efficacy tests Approved for limited use Animal trials Usually it takes years to develop a vaccine, but scientists are racing to produce a safe and effective vaccine by next year 135+ 21 13 8 2 0 There is 1 vaccine that is currently in Phase III trials and has limited approval for use in the Chinese military as a “specially needed drug.” https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31605-6/fulltext *August 23rd 2020 https://www.who.int/biologicals/BS2287_Clinical_guidelines_final_LINE_NOs_20_July_2016.pdf?ua=1 https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
  • 43.
    Stages of vaccinedevelopment* Exploratory Preclinical Phase I Phase II Phase III Approval Surveillance Safety & dosage testing Expanded safety trials Large-scale efficacy tests Approved for limited use Animal trials Usually it takes years to develop a vaccine, but scientists are racing to produce a safe and effective vaccine by next year 135+ 21 13 8 2 0 Russia approved a vaccine that has completed Phase II trials (but hasn’t begun Phase III). However, trial data have not been published and vaccine experts worry about about safety and efficacy. https://edition.cnn.com/2020/08/11/europe/russia-coronavirus-vaccine-putin-intl/index.html https://www.bbc.com/news/world-europe-53751017 *August 23rd 2020 https://www.who.int/biologicals/BS2287_Clinical_guidelines_final_LINE_NOs_20_July_2016.pdf?ua=1 https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
  • 44.
    Example of apromising candidate mRNA vaccine. Teaches human cells to build the spike proteins, which triggers an immune response. Results from phase I trial: https://www.nejm.org/doi/pdf/10.1056/NEJMoa2022483?articleTools=true
  • 45.
    Example of apromising candidate mRNA vaccine. Teaches human cells to build the spike proteins, which triggers an immune response. Phase I trial results published on July 14th 2020 Safety & dosage testing Results from phase I trial: https://www.nejm.org/doi/pdf/10.1056/NEJMoa2022483?articleTools=true
  • 46.
    Example of apromising candidate mRNA vaccine. Teaches human cells to build the spike proteins, which triggers an immune response. Phase I trial results published on July 14th 2020 Safety & dosage testing Generally safe and well-tolerated, but ~1/2 had some mild/moderate side effects (e.g., fatigue, headache, chills). High dose that caused the strongest side effects won’t be used in subsequent trials. Results from phase I trial: https://www.nejm.org/doi/pdf/10.1056/NEJMoa2022483?articleTools=true
  • 47.
    Example of apromising candidate mRNA vaccine. Teaches human cells to build the spike proteins, which triggers an immune response. Phase I trial results published on July 14th 2020 Safety & dosage testing Generally safe and well-tolerated, but ~1/2 had some mild/moderate side effects (e.g., fatigue, headache, chills). High dose that caused the strongest side effects won’t be used in subsequent trials. Phase II is ongoing. Phase III trials started July 27th, 2020 with a target of 30,000 individuals. Large-scale efficacy tests Results from phase I trial: https://www.nejm.org/doi/pdf/10.1056/NEJMoa2022483?articleTools=true
  • 48.
    Moderna vaccine: phaseI experiment Results from phase I trial: https://www.nejm.org/doi/pdf/10.1056/NEJMoa2022483?articleTools=true 45 healthy adults 18-55 years of age 25 µg dose 100 µg dose 250 µg dose 15 individuals 15 individuals 15 individuals Day1 Z 25 µg dose 100 µg dose 250 µg dose Day29
  • 49.
    Moderna vaccine: phaseI results* Key result: the vaccine provoked a strong immune response Antibodiesproduced Less More Pre-injection Recovered patient All results from phase I trial: https://www.nejm.org/doi/pdf/10.1056/NEJMoa2022483?articleTools=true *Simplified. See linked paper for full results
  • 50.
    Moderna vaccine: phaseI results* Key result: the vaccine provoked a strong immune response Antibodiesproduced Less More Pre-injection Recovered patient After 1st dose All results from phase I trial: https://www.nejm.org/doi/pdf/10.1056/NEJMoa2022483?articleTools=true *Simplified. See linked paper for full results
  • 51.
    Moderna vaccine: phaseI results* Key result: the vaccine provoked a strong immune response Antibodiesproduced Less More Pre-injection Recovered patient After 1st dose After 2nd dose All results from phase I trial: https://www.nejm.org/doi/pdf/10.1056/NEJMoa2022483?articleTools=true *Simplified. See linked paper for full results
  • 52.
    Moderna vaccine: phaseI results* Key result: the vaccine provoked a strong immune response Antibodiesproduced Less More Pre-injection Recovered patient After 1st dose After 2nd dose All results from phase I trial: https://www.nejm.org/doi/pdf/10.1056/NEJMoa2022483?articleTools=true *Simplified. See linked paper for full results Note that Phase I trials do not evaluate efficacy. Producing an immune response does not guarantee immunity if exposed to the virus. Phase III trials are designed for efficacy testing.