1. INOCULATION VACCINES ACTIVATE THE IMMUNE SYSTEM AGAINST COVID 1
2. WHAT DOES IT TAKE TO DEVELOP 1 NEW COVID-19 VACCINE?
In the previous part, the vaccine research and pre-clinical trial stage was covered. This part presents the remaining stages of the vaccine production process.
2.3 The clinical trial stage
The company or organization (usually private) files a registration application with the Regulatory Authority. The manufacturing and testing procedures, a summary of the laboratory reports, and a description of the proposed studies are included. The review board, representing the organization where the clinical trial will take place, must approve the clinical protocol. For the FDA, this registration process takes about 30 days.
After the registration application has been approved, the vaccine must pass through three clinical trial stages. The trials are carried out to evaluate 3 factors: safety, immunogenicity, and protection efficacy in human subjects
For the Covid-19 vaccine (vaccine) specifically, regarding the Korean MFDS COVID-19 vaccine approval process, the time from the pre-clinical development stage to release is shortened as much as possible vaccine, including a rolling review of the licensing dossier, though it still has to go through the full steps. Today, Vietnam has 2 vaccine types going through the stage 2 and 3 clinical trials: the Covivac vaccine researched by the Institute of Vaccines and Medical Biologicals (IVAC), and the NanoCovax vaccine researched by Nanogen Pharmaceutical Biotechnology Joint Stock Company and the Military Medical Academy.
a. The stage 1 trial
Scale: a small group of adults, usually 20–80 subjects. If the vaccine is intended for children, researchers first test adults, then progressively lower the age of the trial subjects until the target is reached. The Phase I trial is an open trial: both the researchers and the subjects know in advance whether the vaccine or the placebo is administered.
The objective: of the stage 1 vaccine trial: to assess the safety of the vaccine and identify the type and level of immune response the vaccine produces.
b. The stage 2 trial
Scale: a larger group of several hundred individuals joins the Phase II trial. Some individuals may belong to the at-risk groups for the disease. These trials are randomized and well-controlled, and also include a placebo group.The objective: of the Phase II vaccine trial is to study the safety, immunogenicity, proposed dosage, immunization schedule, and distribution method of the vaccine.
c. The stage 3 trial
Scale: vaccines successful in the stage 2 trial move on to larger trials, participating thousands to tens of thousands of people. The Phase III trials are randomized and are blinded: the person being injected and the person injecting do not know whether they are giving the placebo or the vaccine (vaccines) (the placebo may be saline, a vaccine for a different disease, or some other substance).The objective: to assess the safety of the vaccine (vaccine) in a large group of people and the rare side effects. The vaccine's effectiveness is also tested. These factors may include: 1) Does that vaccine prevent the disease?
2) Does it prevent infection with the pathogen?
3) Does it stimulate the body to produce antibodies or other types of immune responses related to the pathogen?
2.4 Vaccine review and regulatory approval
After a successful Phase III trial, the vaccine research unit files the Biologics License Application (with the FDA), and domestically it is managed by the Ministry of Health. Afterwards, the approval organization inspects the vaccine manufacturing plant and approves the vaccine labeling. Once licensed, the approval organization continues to monitor vaccine production, including inspecting facilities and reviewing the manufacturer's tests of multiple vaccine lots for potency, safety, and purity. The approval organization (the FDA) has the right to carry out the manufacturer's vaccine (vaccine) tests itself.Post-licensing vaccine surveillance: Many vaccine surveillance systems operate after they have been approved, such as:
- Phase IV trials,
- The Vaccine Adverse Event Reporting System
- Vaccine safety data linkage.
Phase IV trials are optional studies that pharmaceutical companies can conduct after the vaccine is released. The manufacturer can continue testing the vaccine for safety, effectiveness, and other potential uses.For the Covid-19 vaccine, for example with the Astra Zeneca vaccine, post-licensing surveillance recorded several signals related to blood clotting, some cases of anaphylactic shock, etc.
2.5 Vaccine production and quality control
After approval, the Vaccine is mass-produced. Once the vaccine is put into vials or syringes, it is sealed with a sterile stopper. All the processes described above must follow the prescribed standard procedures. Good manufacturing includes: product with a quality check, fully equipped infrastructure and analytical operations. Finally, the vaccine is labeled and distributed worldwide.Strict quality control processes must be carried out regularly. Every abnormality monitoring event must be recorded and preventive and corrective actions taken.
References:
CDC Amerricahttps://www.cdc.gov/vaccines/basics/test-approve.html
The history of Vaccine: https://www.historyofvaccines.org/content/articles/vaccine-development-testing-and-regulation
Journal of Preventive Medicine: http://www.tapchiyhocduphong.vn/tin-tuc/dien-dan-y-hoc-du-phong/thu-nghiem-lam-sang-vac-xin-khau-quan-trong-bao-dam-tinh-an-toan-cua-tiem-chung--o81E21038.html