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03-29-2024     3 رجب 1440

Covid-19 Vaccine: Bypass to a Long Road -1

November 24, 2020 | Umar Bin Abdul Aziz

Globally, as of 22 November 2020, there have been 57,882,183 confirmed cases of covid-19, including 1,377,395 deaths, reported to WHO.Vaccine research is at the forefront of everyone’s minds as we collectively await a breakthrough in the fight against coronavirus disease 2019 (COVID-19). On average, a vaccine takes between (12-36) months to (10-20) years for its manufacture before it is ready for distribution. Today, researchers are working at unprecedented speed to cut this timeline down to within 12 and 18 months.

Is this fast-track approach safe? Can we count on the efficacy of a vaccine that is developed this quickly?
We don’t know the answers to those questions yet. Even WHO says “There are many strict protections in place to help ensure that COVID-19 vaccines will be safe? Like all vaccines, COVID-19 vaccines should go through a rigorous, multi-stage testing process, including large (phase iii) trials that involve tens of thousands of people.”
Successful manufacturing of high-quality vaccines requires international standardization of starting materials, production and quality control testing, and the setting of high expectations for regulatory oversight of the entire manufacturing process from start to finish, all while recognizing that this field is in constant change.
Many potential vaccines for covid-19 are being studied, and several large clinical trials may report results later this year. If a vaccine is proven safe and effective, it must be approved by national regulators, manufactured to exacting standards, and distributed.
Keeping all these points in mind let’s take a step back and review the vaccine development process from beginning to end.


1. Exploratory Stage (2 – 4 years)

 

The first step is the exploratory stage in which natural or synthetic antigens that may prevent or treat disease are identified in a laboratory setting. These antigens include live-attenuated viral components, inactivated viral components, recombinant (DNA), conjugate (combined weakened and strong antigens), subunit (no live component of the viral particle), toxoid, and monoclonal antibodies. Gene-based vaccines use genetic engineering to carry nucleic acids (DNA or RNA) that hold instructions for making the viral protein which trigger an immune response.


2. Pre-Clinical Stage (1 – 2 years)


Tissue-culture and animal testing are conducted next to evaluate the safety of the vaccine and its ability to elicit an immune response. During this stage, researchers:
Assess the immune response that could occur in humans
Determine a starting dose for clinical trials
Improve the efficacy of candidate vaccines


3. Investigational New Drug (IND) Application Stage


Once the vaccine successfully completes the pre-clinical stage, an IND application is submitted by the research sponsor (typically a private company) to the Food and Drug Administration (FDA). The application will include:
Description of the vaccine
Manufacturing and testing methods
Quality control tests for release
Summary of the laboratory reports
Description of the proposed study protocol
Information about the vaccine’s safety
Vaccine’s ability to elicit a protective immune response in animal testing
The FDA has 30 days to approve the application, then the vaccine moves on to human clinical trials. Prior to initiating these trials, the protocol must be reviewed by each research site’s institutional review board (IRB). The IRB is an independent committee that reviews and approves research involving human subjects, ensuring the protocol does not infringe on the rights and safety of the participants. Every clinical study protocol must include a detailed informed consent.


4. Clinical Development: Three Phases


Phase I Vaccine Trials (Several months)
Phase I human trials involve a small sample size, typically between 20 and 80 subjects. During this phase, researchers may know whether a vaccine or placebo has been given to a study subject. The primary goals are:
Assess the safety of the vaccine
Evaluate the extent of the immune response
Phase II Vaccine Trial (Several months to 2 years)
Phase II trials involve a larger sample size, usually several hundred study participants and often include the target demographic. These trials are randomized, controlled studies, typically dose-ranging, and include a placebo group. The primary goals are to further evaluate:
Safety
Immunogenicity and Efficacy
Proposed dosesSchedule of immunization


Method of delivery


Phase III Vaccine Trials (1 to 4 years)
Phase III trials are large studies involving thousands to tens of thousands of people. These are randomized, double-blinded studies that test the experimental vaccine against a placebo. Phase III goals are:
Assess vaccine safety in a large group of people, monitoring for rare side effects that may not appear in a smaller sample size
Evaluate efficacy:
Does the vaccine prevent disease?
Does the vaccine prevent infection with the pathogen?
Does the vaccine incite production of antibodies or other types of immune responses related to the pathogen?


5.Approval and Licensure


Following positive results from Phase III, the vaccine researchers will submit a Biologics License Application (BLA) to the FDA’s Center for Biologics Evaluation and Research (CBER). This includes the efficacy and safety information needed to make a risk/benefit assessment. During this phase, the FDA will inspect the factory where the vaccine will be manufactured and approve the vaccine label. Product labeling is extremely important as it provides clinicians with accurate information on the vaccine’s proper use as well as the benefits and risks that must be communicated to patients and family members.
After licensure, the FDA will monitor vaccine production, periodically inspect facilities, and review the manufacturer’s tests for strength, safety and purity. Manufacturers may also be required to submit samples of each vaccine lot to the FDA for testing. FDA monitoring will continue as long as the manufacturer holds a license for the vaccine product.


6. Post-Licensure Monitoring of Vaccines

Phase IV Trials


Until a vaccine is administered to the general population, every potential adverse event can’t be anticipated. Phase IV studies are optional trials conducted after the vaccine is on the market and include testing for safety, efficacy, and other possible uses. (To Be Continued)

 

 

Omarbarkan4u@gmail.Com

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Covid-19 Vaccine: Bypass to a Long Road -1

November 24, 2020 | Umar Bin Abdul Aziz

Globally, as of 22 November 2020, there have been 57,882,183 confirmed cases of covid-19, including 1,377,395 deaths, reported to WHO.Vaccine research is at the forefront of everyone’s minds as we collectively await a breakthrough in the fight against coronavirus disease 2019 (COVID-19). On average, a vaccine takes between (12-36) months to (10-20) years for its manufacture before it is ready for distribution. Today, researchers are working at unprecedented speed to cut this timeline down to within 12 and 18 months.

Is this fast-track approach safe? Can we count on the efficacy of a vaccine that is developed this quickly?
We don’t know the answers to those questions yet. Even WHO says “There are many strict protections in place to help ensure that COVID-19 vaccines will be safe? Like all vaccines, COVID-19 vaccines should go through a rigorous, multi-stage testing process, including large (phase iii) trials that involve tens of thousands of people.”
Successful manufacturing of high-quality vaccines requires international standardization of starting materials, production and quality control testing, and the setting of high expectations for regulatory oversight of the entire manufacturing process from start to finish, all while recognizing that this field is in constant change.
Many potential vaccines for covid-19 are being studied, and several large clinical trials may report results later this year. If a vaccine is proven safe and effective, it must be approved by national regulators, manufactured to exacting standards, and distributed.
Keeping all these points in mind let’s take a step back and review the vaccine development process from beginning to end.


1. Exploratory Stage (2 – 4 years)

 

The first step is the exploratory stage in which natural or synthetic antigens that may prevent or treat disease are identified in a laboratory setting. These antigens include live-attenuated viral components, inactivated viral components, recombinant (DNA), conjugate (combined weakened and strong antigens), subunit (no live component of the viral particle), toxoid, and monoclonal antibodies. Gene-based vaccines use genetic engineering to carry nucleic acids (DNA or RNA) that hold instructions for making the viral protein which trigger an immune response.


2. Pre-Clinical Stage (1 – 2 years)


Tissue-culture and animal testing are conducted next to evaluate the safety of the vaccine and its ability to elicit an immune response. During this stage, researchers:
Assess the immune response that could occur in humans
Determine a starting dose for clinical trials
Improve the efficacy of candidate vaccines


3. Investigational New Drug (IND) Application Stage


Once the vaccine successfully completes the pre-clinical stage, an IND application is submitted by the research sponsor (typically a private company) to the Food and Drug Administration (FDA). The application will include:
Description of the vaccine
Manufacturing and testing methods
Quality control tests for release
Summary of the laboratory reports
Description of the proposed study protocol
Information about the vaccine’s safety
Vaccine’s ability to elicit a protective immune response in animal testing
The FDA has 30 days to approve the application, then the vaccine moves on to human clinical trials. Prior to initiating these trials, the protocol must be reviewed by each research site’s institutional review board (IRB). The IRB is an independent committee that reviews and approves research involving human subjects, ensuring the protocol does not infringe on the rights and safety of the participants. Every clinical study protocol must include a detailed informed consent.


4. Clinical Development: Three Phases


Phase I Vaccine Trials (Several months)
Phase I human trials involve a small sample size, typically between 20 and 80 subjects. During this phase, researchers may know whether a vaccine or placebo has been given to a study subject. The primary goals are:
Assess the safety of the vaccine
Evaluate the extent of the immune response
Phase II Vaccine Trial (Several months to 2 years)
Phase II trials involve a larger sample size, usually several hundred study participants and often include the target demographic. These trials are randomized, controlled studies, typically dose-ranging, and include a placebo group. The primary goals are to further evaluate:
Safety
Immunogenicity and Efficacy
Proposed dosesSchedule of immunization


Method of delivery


Phase III Vaccine Trials (1 to 4 years)
Phase III trials are large studies involving thousands to tens of thousands of people. These are randomized, double-blinded studies that test the experimental vaccine against a placebo. Phase III goals are:
Assess vaccine safety in a large group of people, monitoring for rare side effects that may not appear in a smaller sample size
Evaluate efficacy:
Does the vaccine prevent disease?
Does the vaccine prevent infection with the pathogen?
Does the vaccine incite production of antibodies or other types of immune responses related to the pathogen?


5.Approval and Licensure


Following positive results from Phase III, the vaccine researchers will submit a Biologics License Application (BLA) to the FDA’s Center for Biologics Evaluation and Research (CBER). This includes the efficacy and safety information needed to make a risk/benefit assessment. During this phase, the FDA will inspect the factory where the vaccine will be manufactured and approve the vaccine label. Product labeling is extremely important as it provides clinicians with accurate information on the vaccine’s proper use as well as the benefits and risks that must be communicated to patients and family members.
After licensure, the FDA will monitor vaccine production, periodically inspect facilities, and review the manufacturer’s tests for strength, safety and purity. Manufacturers may also be required to submit samples of each vaccine lot to the FDA for testing. FDA monitoring will continue as long as the manufacturer holds a license for the vaccine product.


6. Post-Licensure Monitoring of Vaccines

Phase IV Trials


Until a vaccine is administered to the general population, every potential adverse event can’t be anticipated. Phase IV studies are optional trials conducted after the vaccine is on the market and include testing for safety, efficacy, and other possible uses. (To Be Continued)

 

 

Omarbarkan4u@gmail.Com


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