To develop safe and effective vaccines usually takes more than five to ten years on average. If we look back in the past, the fastest approved MMR(measles, mumps, and rubella) vaccination for Mumps took close to four years to get all the necessary permissions and licensing.
Despite promising reports about potential coronavirus vaccines being developed worldwide, it could still take an estimated six months or twice of it to develop one. We are on the way to developing quicker vaccines than it was in the past. During its outbreaks, more resources and funding will be available, which will speed up the process.
Development process of vaccination involves heavy loads of skills. Along the way, fully approved vaccination has to go through several stages like exploratory stage, pre-clinical stage,clinical stages for three phases of humans trials and many more and if any of these vaccine “candidates” shows to be unsafe or ineffective, researchers have to return to the laboratory to make a new vaccine candidate that is why vaccine development can be long and has uncertain processes.
Any kind of vaccination has to go through these stages of vaccine development to get approval:
According to reports or sources, development of a novel corona-virus vaccine is being led by experts who are already developing vaccines for other corona-viruses like SARS(Severe Acute Respiratory Syndrome) and MERS(Middle East respiratory Syndrome).
After a vaccination is developed it has to go through some stages. The general stages of the development cycle of vaccination are:
- Exploratory stage
- Pre-clinical stage
- Clinical stage
- Regulatory review and approval
- Quality Control
Exploratory stage: This research-intensive phase of the vaccine development process in which scientists identify “natural or synthetic antigens that might help to prevent or treat a disease”. Antigens might include weakened strains of particular viruses.
Pre-clinical stage: In this stage, medical professionals use tissue-culture or cell-culture systems and animal testing to determine whether the candidate vaccine will produce immunity. Usually this testing is carried out in animals to give an idea of response in humans. By these researchers can see how effective the vaccine is at prevailing the disease. Many vaccines don’t make it to the next stage of the development because they either fail to produce immunity or have some harmful side effects.
Clinical stage (trials on humans): This is the stage where many promising potential vaccines failed to perform. At this stage, a sponsor submits an application for an Investigational New Drug(INA) to the Food and Drug Administration(FDA). Once the proposal has been approved there, vaccines are ready to go through three phases of a clinical-trials for testing in humans:
Phase I, small groups of people(less than 100) receive the trial vaccine. Here, the goal is to determine whether the candidate vaccine is safe and learn more about the responses provokes among test subjects.
Phase II, the clinical study is expanded and vaccines are given to a group of more than hundred people. Here aim is to deliver more information about safety, immunogenicity, dose size and immunization.
Phase III, Vaccination is given to thousands or tens of thousands of humans test subjects because sometimes side-effects don’t appear in smaller groups and here they can see the effectiveness of the candidate vaccine.
Regulatory review and approval: Once a vaccine passes through all phases of clinical development, the vaccine developer has to submit the Biological License Application(BLA) to the FDA.
Manufacturing: After the license approval major drug manufacturers provide the infrastructure, personnel, equipment and manufacturing capacity necessities to create mass quantities of vaccines.
Quality-Control: Once licensed, all of these processes are carefully monitored such as performance, safety and effectiveness of vaccines through the Vaccine Adverse Event Reporting System(VAERS) and the vaccine safety Datalink. Policy must be developed to decide to prioritise those who should be vaccinated, such as in the most high-risk groups and locations. However, this process requires the skills and input of numerous stakeholders from medical professionals to lab researchers to policy makers.
Scientists, researchers and medical professionals are doing their work and sooner or later vaccines will be available for us. Until this we have to do our work and be a responsible citizen of mother Earth. Maintain social distance, wear masks and wash hands frequently.