Dear Editor:
Worldwide awareness has already been there about coronavirus (COVID-19). The whole world is waiting for the vaccine against the virus. The healthcare professional around the world are also trying to do the same. From China to USA, from Russia to Australia, all are working for the development of vaccines. But, yet the most upcoming news from the WHO says, it is approximately 18 months pending for the vaccine.

Vaccine stimulates immunity to COVID-19. Complex process means a lot of steps for vaccine where lengthy regulatory protocols are required. During the development of any vaccine no point must be overlooked. This is essential for the safety and health security of people.

Vaccine development involves a lot of institutions and research facilities. A single institute or research foundation cannot offer the vaccine development. It needs a lot of sophisticated and controlled environment facilities. For the development of any vaccine, two things are very important, first to find the virus and second is the host behaviour (host is the living subject, that carries the specific virus).

An animal model (as initial human model is not allowed) has to be prepared. After that animal test, the vaccine will be a candidate for volunteers’ investigation in another facility. After the successful clinical trial, vaccines are going to licensed phase and regulatory steps. After the authority approval, finally vaccine comes to market, with the condition of post marketing studies along with proper Pharmaco-vigilance activity.

Vaccine development needs preclinical and clinical steps. After the preclinical steps, the vaccine needs a lot of regulatory documentations, so that it may use to controlled group of volunteers, which is known as clinical steps. After finishing the clinical trial, the vaccine goes to pre licensed phase. After passing all the requirements, vaccines are allowed to be marketed and for vaccination.

In case of a pandemic event, the vaccine needs urgent and special approval process known as emergency development and approval. The pandemic is the situation where the disease has spread in a large region. Although the standard procedures of vaccine development are different in various countries like USA, UK or EU, but the basic guidelines is almost identical.

In case of the EU, there are two processes for pandemic situation, the mock up process and the emergency procedure. By mock up and emergency procedure, the vaccine will be given a ‘conditional approval’, which means its benefits outweigh its risks.

A complicated challenge is manufacturing proteins from the virus. These proteins are specially designed to elicit an immune response when administered, allowing a person’s immune system to protect against future infection. This protein synthesis needs years. But recent technology offers better and fast working of protein synthesis and further processing. (References: Understanding Modern Vaccines: Perspectives in Vaccinology, Elsevier, 2011).

Nazmul Islam Dawn
Pharmacist
Email: nazmul.dawn@gmail.com