3.1 Biopharmaceutical Development Terms Quiz

• A medically attended Adverse Event (AE) must be reported within 28 days after vaccination.

• A serious Adverse Event (AE) is any undesirable medical event that requires hospitalization, causes persistent or serious disability, is life threatening, causes death, or is a congenital malformation.

• Reporting of AEs is required until the end of the study and may continue after study end if no other cause than the vaccine is suspected.

• Other AEs of special interest include Potential Immune Mediated Diseases (pIMDs) such as auto-immune diseases and inflammatory or neurological diseases, and Vaccine Enhanced Diseases (VEDs) like the severe natural RSV disease following RSV vaccination in 1967.

• The relationship between the vaccine and the AE must be assessed by investigators, and a reasonable possibility of causality exists if there is evidence suggesting a causal relationship.

• ADSMB or Safety Review Committee meetings are held to evaluate safety data, and "stopping rules" can be implemented if a certain number of severe adverse events are reached.

• Clinical vaccine trials involve regulation, ethical review boards, informed consent, protection of privacy, and reporting of adverse events.

• Vaccines in clinical trials are not commercially available, and require preparative steps such as mixing with solvents or adjuvants and precise record keeping.

• Genetically modified organisms (GMOs) are used in some vaccines, such as the adenoviral vector COVID-19 vaccines from J&J and AstraZeneca, and the mRNA COVID-19 vaccines from Pfizer and Moderna.

• GMOs can be used in humans through deliberate release or contained use. Deliberate release requires authorization and a case-by-case assessment of risks to human health and the environment. Contained use refers to activities in closed environments such as laboratories.

• Vaccines are managed with strict control of transportation, conservation conditions, and record keeping, and difficulties arise in blinding studies due to unblinded researchers.

• Remaining vaccines are controlled for destruction and cannot be used for other purposes.

• GMOs are organisms with altered genetic material and are used in vaccines through the use of vectors or mRNA.

• Deliberate release of GMOs requires authorization and risk assessment, while contained use is allowed in closed environments.

• Polio is an example of a disease that has been controlled through contained use.

• A Medically Attended Adverse Event (AE) is any undesirable medical event that requires hospitalization, causes persistent or serious disability, is life-threatening, or results in death or a congenital malformation. Reporting time for AEs is 28 days after vaccination.

• A Serious Adverse Event (SAE) must be reported until the end of the study, and may require follow-up after the study has ended if no other cause than the vaccine is identified.

• Other Adverse Events of Special Interest include Potential Immune Mediated Diseases (pIMDs) such as auto-immune diseases, inflammatory or neurological diseases, and Vaccine Enhanced Diseases.

• Reporting time for AEs related to the study vaccine is until the end of the study.

• Investigators must assess causality of any AE to the received vaccination, and if there is a reasonable possibility that the vaccine caused the AE, it is considered a suspected adverse reaction.

• Safety monitoring includes 'stopping rules' based on the number of adverse events of a certain severity, and meetings with Data Safety Monitoring Boards or Safety Review Committees to evaluate safety data.

• Clinical vaccine trials involve ethical review boards, study participants, data safety monitoring, study design, study procedures, vaccine management, and vaccines and vaccine management.

• Vaccine management involves preparing and administering study vaccines, which are not commercially available and require strict control of transportation and conservation conditions.

• GMOs (genetically modified organisms) are not used in all vaccines. For example, the J&J COVID-19 vaccine and Vaxzevria (AstraZeneca) use an adenoviral vector without natural Adenoviral DNA and insert COVID-19 Spike protein DNA, making them GMOs. Other vaccines, such as Comirnaty (Pfizer) and Spikevax (Moderna), do not use a vector and are not considered GMOs.

• Use of GMOs in humans can be classified as Deliberate Release or Contained Use. Deliberate release involves intentional introduction into the environment without specific containment measures, and is not possible without authorization. Contained use refers to activities involving GMOs in closed environments such as laboratories, and is a common practice in vaccine development.

• In the context of clinical trials, safety monitoring includes evaluation of adverse events, and investigators must assess causality of any adverse event to the study vaccine. Safety monitoring may involve stopping rules based on the number of adverse events, and meetings with Data Safety Monitoring Boards or Safety Review Committees to evaluate safety data.

• Clinical vaccine trials involve ethical review boards, study participants, data safety monitoring, study design, study procedures, vaccine management, and vaccines and vaccine management.

• Vaccine management includes preparing and administering study vaccines, which are not commercially available and require strict control of transportation and conservation conditions.

• GMOs (genetically modified organisms) are not used in all vaccines. For example, the J&J COVID-19 vaccine and Vaxzevria (AstraZeneca) use an adenoviral vector without natural Adenoviral DNA and insert COVID-19 Spike protein DNA, making them GMOs. Other vaccines, such as Comirnaty (Pfizer) and Spikevax (Moderna), do not use a vector and are not considered GMOs.

• Use of GMOs in humans can be classified as Deliberate Release or Contained Use. Deliberate release involves intentional introduction into the environment without specific containment measures, and is not possible without authorization. Contained use refers to activities involving GMOs in closed environments such as laboratories, and is a common practice in vaccine development.

• In the context of clinical trials, safety monitoring includes evaluation of adverse events, and investigators must assess causality of any adverse event to the study vaccine. Safety monitoring may involve stopping rules based on the number of adverse events, and meetings with Data Safety Monitoring Boards or Safety Review Committees to evaluate safety data.

• Clinical trials involve ethical review boards, study participants, data safety monitoring, study design, study procedures, vaccine management, and vaccines and vaccine management.

• Vaccine management involves preparing and administering study vaccines, which are not commercially available and require strict control of transportation and conservation conditions.

• GMOs (genetically modified organisms) are not used in all vaccines. For example, the J&J COVID-19 vaccine and Vaxzevria (AstraZeneca) use an adenoviral vector without natural Adenoviral DNA and insert COVID-19 Spike protein DNA, making them GMOs. Other vaccines, such as Comirnaty (Pfizer) and Spikevax (Moderna), do not use a vector and are not considered GMOs.

• Use of GMOs in humans can be classified as Deliberate Release or Contained Use. Deliberate release involves intentional introduction into the environment without specific containment measures, and is not possible without authorization. Contained use refers to activities involving GMOs in closed environments such as laboratories, and is a common practice in vaccine development.

• Study participants have rights and duties, including informed consent, liability and insurance, and protection of privacy and personal data.

• Blood samples are collected for safety and immunogenicity evaluation during the study, and the day of sampling needs to be carefully defined based on the immune response.

• Study design may involve a staggered design, and safety monitoring includes Data Safety Monitoring Board or Safety Review Committee meetings to evaluate safety data.

• Vaccines and vaccine management include study vaccines that are not commercially available, and require precise registration, controlled destruction, and labeling in the three languages.

• GMOs (genetically modified organisms) are not used in all vaccines, and use in humans can be classified as Deliberate Release or Contained Use.

• Clinical trials involve ethical review boards, study participants, data safety monitoring, study design, study procedures, vaccine management, and vaccines and vaccine management.

• Vaccine management involves preparing and administering study vaccines, which are not commercially available and require strict control of transportation and conservation conditions.

• Use of GMOs in humans can be classified as Deliberate Release or Contained Use, with deliberate release involving intentional introduction into the environment without specific containment measures and contained use referring to activities involving GMOs in closed environments.

• Study participants have rights and duties, including informed consent, liability and insurance, and protection of privacy and personal data.

• Blood samples are collected for safety and immunogenicity evaluation, and the day of sampling needs to be carefully defined based on the immune response.

• Study design may involve a staggered design, and safety monitoring includes Data Safety Monitoring Board or Safety Review Committee meetings to evaluate safety data.

• Vaccines and vaccine management include study vaccines that are not commercially available, and require precise registration, controlled destruction, and labeling in the three languages.

• GMOs (genetically modified organisms) are not used in all vaccines, and use in humans can be classified as Deliberate Release or Contained Use.

• Clinical trials involve ethical review boards, study participants, data safety monitoring, study design, study procedures, vaccine management, and vaccines and vaccine management.

• Vaccine management involves preparing and administering study vaccines, which are not commercially available and require strict control of transportation and conservation conditions.

• Use of GMOs in humans can be classified as Deliberate Release or Contained Use, with deliberate release involving intentional introduction into the environment without specific containment measures and contained use referring to activities involving GMOs in closed environments.

• Study participants have rights and duties, including informed consent, liability and insurance, and protection of privacy and personal data.

• Blood samples are collected for safety and immunogenicity evaluation, and the day of sampling needs to be carefully defined based on the immune response.

• Study design may involve a staggered design, and safety monitoring includes Data Safety Monitoring Board or Safety Review Committee meetings to evaluate safety data.

• Vaccines and vaccine management include study vaccines that are not commercially available, and require precise registration, controlled destruction, and labeling in the three languages.

• GMOs (genetically modified organisms) are not used in all vaccines, and use in humans can be classified as Deliberate Release or Contained Use.

• Clinical trials involve ethical review boards, study participants, data safety monitoring, study design, study procedures, vaccine management, and vaccines and vaccine management.

• Vaccine management involves preparing and administering study vaccines, which are not commercially available and require strict control of transportation and conservation conditions.

• Use of GMOs in humans can be classified as Deliberate Release or Contained Use, with deliberate release involving intentional introduction into the environment without specific containment measures and contained use referring to activities involving GMO

• A Medically Attended Adverse Event (AE) is any undesirable medical event that requires hospitalization, causes persistent or serious disability, is life-threatening, or results in death or a congenital malformation. Reporting time for AEs is 28 days after vaccination.

• A Serious Adverse Event (SAE) must be reported until the end of the study, and may require follow-up after the study has ended if no other cause than the vaccine is identified.

• Other Adverse Events of Special Interest include Potential Immune Mediated Diseases (pIMDs) such as auto-immune diseases, inflammatory or neurological diseases, and Vaccine Enhanced Diseases.

• Reporting time for AEs related to the study vaccine is until the end of the study.

• Investigators must assess causality of any AE to the received vaccination, and if there is a reasonable possibility that the vaccine caused the AE, it is considered a suspected adverse reaction.

• Safety monitoring includes 'stopping rules' based on the number of adverse events of a certain severity, and meetings with Data Safety Monitoring Boards or Safety Review Committees to evaluate safety data.

• Clinical vaccine trials involve ethical review boards, study participants, data safety monitoring, study design, study procedures, vaccine management, and vaccines and vaccine management.

• Vaccine management involves preparing and administering study vaccines, which are not commercially available and require strict control of transportation and conservation conditions.

• GMOs (genetically modified organisms) are not used in all vaccines. For example, the J&J COVID-19 vaccine and Vaxzevria (AstraZeneca) use an adenoviral vector without natural Adenoviral DNA and insert COVID-19 Spike protein DNA, making them GMOs. Other vaccines, such as Comirnaty (Pfizer) and Spikevax (Moderna), do not use a vector and are not considered GMOs.

• Use of GMOs in humans can be classified as Deliberate Release or Contained Use. Deliberate release involves intentional introduction into the environment without specific containment measures, and is not possible without authorization. Contained use refers to activities involving GMOs in closed environments such as laboratories, and is a common practice in vaccine development.

• In the context of clinical trials, safety monitoring includes evaluation of adverse events, and investigators must assess causality of any adverse event to the study vaccine. Safety monitoring may involve stopping rules based on the number of adverse events, and meetings with Data Safety Monitoring Boards or Safety Review Committees to evaluate safety data.

• Clinical vaccine trials involve ethical review boards, study participants, data safety monitoring, study design, study procedures, vaccine management, and vaccines and vaccine management.

• Vaccine management includes preparing and administering study vaccines, which are not commercially available and require strict control of transportation and conservation conditions.

• GMOs (genetically modified organisms) are not used in all vaccines. For example, the J&J COVID-19 vaccine and Vaxzevria (AstraZeneca) use an adenoviral vector without natural Adenoviral DNA and insert COVID-19 Spike protein DNA, making them GMOs. Other vaccines, such as Comirnaty (Pfizer) and Spikevax (Moderna), do not use a vector and are not considered GMOs.

• Use of GMOs in humans can be classified as Deliberate Release or Contained Use. Deliberate release involves intentional introduction into the environment without specific containment measures, and is not possible without authorization. Contained use refers to activities involving GMOs in closed environments such as laboratories, and is a common practice in vaccine development.

• In the context of clinical trials, safety monitoring includes evaluation of adverse events, and investigators must assess causality of any adverse event to the study vaccine. Safety monitoring may involve stopping rules based on the number of adverse events, and meetings with Data Safety Monitoring Boards or Safety Review Committees to evaluate safety data.

• Clinical trials involve ethical review boards, study participants, data safety monitoring, study design, study procedures, vaccine management, and vaccines and vaccine management.

• Vaccine management involves preparing and administering study vaccines, which are not commercially available and require strict control of transportation and conservation conditions.

• GMOs (genetically modified organisms) are not used in all vaccines. For example, the J&J COVID-19 vaccine and Vaxzevria (AstraZeneca) use an adenoviral vector without natural Adenoviral DNA and insert COVID-19 Spike protein DNA, making them GMOs. Other vaccines, such as Comirnaty (Pfizer) and Spikevax (Moderna), do not use a vector and are not considered GMOs.

• Use of GMOs in humans can be classified as Deliberate Release or Contained Use. Deliberate release involves intentional introduction into the environment without specific containment measures, and is not possible without authorization. Contained use refers to activities involving GMOs in closed environments such as laboratories, and is a common practice in vaccine development.

• Study participants have rights and duties, including informed consent, liability and insurance, and protection of privacy and personal data.

• Blood samples are collected for safety and immunogenicity evaluation during the study, and the day of sampling needs to be carefully defined based on the immune response.

• Study design may involve a staggered design, and safety monitoring includes Data Safety Monitoring Board or Safety Review Committee meetings to evaluate safety data.

• Vaccines and vaccine management include study vaccines that are not commercially available, and require precise registration, controlled destruction, and labeling in the three languages.

• GMOs (genetically modified organisms) are not used in all vaccines, and use in humans can be classified as Deliberate Release or Contained Use.

• Clinical trials involve ethical review boards, study participants, data safety monitoring, study design, study procedures, vaccine management, and vaccines and vaccine management.

• Vaccine management involves preparing and administering study vaccines, which are not commercially available and require strict control of transportation and conservation conditions.

• Use of GMOs in humans can be classified as Deliberate Release or Contained Use, with deliberate release involving intentional introduction into the environment without specific containment measures and contained use referring to activities involving GMOs in closed environments.

• Study participants have rights and duties, including informed consent, liability and insurance, and protection of privacy and personal data.

• Blood samples are collected for safety and immunogenicity evaluation, and the day of sampling needs to be carefully defined based on the immune response.

• Study design may involve a staggered design, and safety monitoring includes Data Safety Monitoring Board or Safety Review Committee meetings to evaluate safety data.

• Vaccines and vaccine management include study vaccines that are not commercially available, and require precise registration, controlled destruction, and labeling in the three languages.

• GMOs (genetically modified organisms) are not used in all vaccines, and use in humans can be classified as Deliberate Release or Contained Use.

• Clinical trials involve ethical review boards, study participants, data safety monitoring, study design, study procedures, vaccine management, and vaccines and vaccine management.

• Vaccine management involves preparing and administering study vaccines, which are not commercially available and require strict control of transportation and conservation conditions.

• Use of GMOs in humans can be classified as Deliberate Release or Contained Use, with deliberate release involving intentional introduction into the environment without specific containment measures and contained use referring to activities involving GMOs in closed environments.

• Study participants have rights and duties, including informed consent, liability and insurance, and protection of privacy and personal data.

• Blood samples are collected for safety and immunogenicity evaluation, and the day of sampling needs to be carefully defined based on the immune response.

• Study design may involve a staggered design, and safety monitoring includes Data Safety Monitoring Board or Safety Review Committee meetings to evaluate safety data.

• Vaccines and vaccine management include study vaccines that are not commercially available, and require precise registration, controlled destruction, and labeling in the three languages.

• GMOs (genetically modified organisms) are not used in all vaccines, and use in humans can be classified as Deliberate Release or Contained Use.

• Clinical trials involve ethical review boards, study participants, data safety monitoring, study design, study procedures, vaccine management, and vaccines and vaccine management.

• Vaccine management involves preparing and administering study vaccines, which are not commercially available and require strict control of transportation and conservation conditions.

• Use of GMOs in humans can be classified as Deliberate Release or Contained Use, with deliberate release involving intentional introduction into the environment without specific containment measures and contained use referring to activities involving GMO

Test your knowledge of biopharmaceutical development terms, including subject completion and withdrawal, first in human safety, dose and schedule finding, regulatory submission, immunology in animal models, toxicology, clinical trial phases, and more.