COVID-19 Vaccine: Development Process and current Status

Source: FDA

Vaccines provide active acquired immunity to infectious diseases. Vaccines are used as a prophylaxis to prevent against infectious diseases by studying the biological behavior and mode of transmission.

Over the years, vaccines has been and continues to offer a remarkable contribution to improving our healthcare system. In the light of the the COVID-19 pandemic, there was a great need for vaccines to help eradicate the effects of the coconavirus.

The first case of the novel SARS-CoV 2 (COVID-19) was first identified in Wuhan, China last december. Prior to this development, there were reported cases of idiopathic pneumonia in China. Only a few days later, Chinese health authorities confirmed that this cluster was associated with coronavirus (Hiu et al, 2020). In the beginning of this year, the virus rapidly spread to other parts of the world, after which it was declared a national pandemic by the World Health Organization (WHO) in March of 2020 (Karia et al, 2020). There is is still a significant need of vaccines to eradicate the spread of the coronavirus.

Development Process

Vaccines undergo series of steps before it is marketed and made available for consumption.

The first step is the exploratory stage where the scientists goes into an in depth research and exploration to understand how the infectious organism causes disease. The next step is the pre-clinical stage during which the vaccine is being tested in animal subjects to know whether it will be safe if administered in human beings. The clinical development stage is when the vaccine is being tested on humans, also known as clinical trials. This clinical trial takes places in three different steps called phase 1, 2, 3 and 4. Phase 3 is when the researches compare the immune response of people who received the vaccines versus who received the control. Phase 4 involves research studies to test for continued safety, efficacy, and other potential uses of the vaccine.

After trial phase, the FDA who oversees and regulates vaccine development recognizes the urgent need for a safe and effective vaccines.

A normal vaccine development takes at least 5 years in the pre-clinical stage. But due to the fact that the coronavirus came with a wave of urgency, the FDA expedited the delopement process.

In the manufacturing stage, companies can submit their interest to create vaccines.

The FDA can now access the details of the vaccine manufacturing company to determine whether they are fit to efficiently develop vaccines. They assess the details of the manufacturing facilities and their scientific ability to successfully produce a vaccine to protect against infectious diseases.

The coronavirus vaccine was manufactures by four main manufacturing companies namely: Johnson & Johnson, AstraZeneca, Pfizer, and Moderna. These companies are required to submit a Biologics License Application (BLA) to the FDA in order to distribute and market the vaccine.

The quality control step lasts over a long period of time as the FDA and CDC continues to address the need for effective and quality vaccines.

Current Status

The vaccine for COVID-19 is approved and available for use in states across the United States.
There is a lot of scrutiny and concerns about the safety and effectiveness of the vaccine, especially the fact that it was developed in less than one year.

However, the CDC and the FDA worked together to create the Vaccine Adverse Event Reporting System (VAERS) website. Here, they closely monitor and track evidence of adverse events related to vaccines. This will be a great way to report any issues with a vaccine (if any) so that the necessary action can be taken.
Also, the CDC approved an app based tool called V-Safe, that utilizes surveys and messaging system to provide personalized health check-in after COVID-19 vaccination.