How will a new vaccine be officially recognized as safe and accepted for use?
Recently, many people have published research on the type of vaccine that is needed for the prevention and protection against the deadly disease COVID-19. China, where the disease outbreak earliest, now has just announced through its embassy in Phnom Penh, Cambodia, much to the surprise of everyone, that they have discovered a vaccine, and they continued sharing the new information. In addition, Lok Chum Teav Ou Vandin, Secretary of State of the Health Ministry also announced that Cambodia is ready to receive the vaccine that China has discovered to save the lives of Cambodians as long as the WHO (World Health Organization) officially recognizes the vaccine.
Whether the coronavirus vaccine or other vaccine is available after experts have discovered it, does not mean that it can be used immediately. It takes longer to recognize it globally, to make sure it is very effective in preventing the disease.
The general stages of the development cycle of a vaccine are:
• Exploratory stage
• Pre-clinical stage
• Clinical development
• Regulatory review and approval
• Quality control
Clinical development is a three-phase process. During Phase I, small groups of people receive the trial vaccine. In Phase II, the clinical study is expanded and vaccine is given to people who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended. In Phase III, the vaccine is given to thousands of people and tested for efficacy and safety.
Many vaccines undergo Phase IV formal, ongoing studies after the vaccine is approved and licensed.
Ensuring the safety and quality of vaccines is one of WHO’s highest priorities. So, distributing a new vaccine is a critical step.
Vaccine and immunization quality and safety:
National authorities must work closely with the WHO to ensure that global standards are developed and made readily available to assess the quality, safety and immunogenicity of biological products of vaccines.
Norms and standards:
WHO provides advice to procurement agencies and countries on the acceptability, in principle of vaccines. This is done through a pre-qualification process which includes a thorough review of the evidence generated by the manufacturer on the efficacy, immunogenicity and safety of the product. It also includes a visit to the production site in close coordination with the national regulatory agency of the country where the production site is located.
WHO works with National Regulatory Authorities (NRAs) in countries which produce or procure vaccines to help them reach international quality standards before the release of vaccines
National Regulatory Authorities (NRAs):
WHO works closely with national experts and authorities to support vaccine safety. It has also established the Global Advisory Committee on Vaccine Safety (GACVS), an independent advisory body that reviews the scientific evidence with regards to any type of issue relating to the safety of vaccine product.
Vaccine safety and Injection safety:
The WHO strategy for the safe and appropriate use of injections worldwide has four objectives: (1) formulating national policies and plans for the safe and appropriate use of injections, (2) ensuring quality and safety of injection equipment, (3) facilitating equitable access to injection equipment and (4) achieving appropriate, rational and cost effective use of injections. Ensuring the safety of immunization related injections interests with that of injection safety. Further information on this area can be found below.
Until a vaccine is developed, including the new coronavirus vaccine any country announces has been discovered so far must go through this serious procedure before they will be able to distribute.