How Long is a Vaccine Tested Before FDA Approval?

Vaccines protect us from diseases by teaching our immune systems how to create antibodies. Once an immune system has learned how to combat a disease, it can provide protection for life. 

The history of vaccines dates back to the late 1700s when smallpox immunization was discovered. Today, there are over 25 safe vaccines that can prevent diseases and protect health, helping to mitigate outbreaks. 

Before a vaccine can be approved for public use, it must be tested and monitored. In this article, we will outline how long a vaccine is tested for; honing in on the vaccine testing process and the path to Food and Drug Administration (FDA) approval.

Who is the FDA?

The FDA is a federal agency that protects public health in the United States, ensuring the safety of foods, drugs, biologics, and other products. A consumer protection agency has been part of the US government since 1848, although the body didn’t become known as the FDA until 1930.

What Does the FDA Do?

The FDA is responsible for ensuring the safety and efficacy of biologics such as vaccines, as well as foods, drugs, medical devices, cosmetics, and electronics, among other products. In this role, not only does the FDA serve to protect public health in the United States, but it also works with foreign governments and regulatory bodies to harmonize safety laws.

Vaccine safety, quality, and effectiveness are overseen by the FDA in the US. Under the guise of its Centre for Biologics Evaluation and Research (CBER), the FDA ensures that “rigorous scientific and regulatory processes” are used in vaccine development. The body advises vaccine developers on scientific and regulatory matters, and evaluates the safety and effectiveness of vaccines after an Investigational New Drug application (IND) is submitted by companies or researchers. IND application approval is needed before clinical development of a vaccine can begin.

Vaccine Approval Process

In the US, approval is needed from the FDA before a vaccine can be released into the healthcare system. However, before a vaccine reaches the FDA, there are several processes that laboratories typically undertake. These include the research, exploration, and discovery of a potential vaccine, which can take several years, and testing phases to obtain proof of concept (evidence that an immune response can be caused in animals).

Before a vaccine is tested on humans in clinical trials, it must be approved by the FDA. The FDA will review Biological License Applications (BLA) submitted by companies including clinical and pre-clinical data, as well as manufacturing details.

The FDA also uses the following processes to test vaccines:

VRBPAC

The FDA has a Vaccines and Related Biological Products Advisory Committee (VRBPAC) which provides input on scientific data related to vaccine safety, effectiveness, and usage. The VRBPAC is composed of independent experts on science and public health. Proposed vaccines are discussed by committee members in a public forum.

Large-Scale Manufacturing

Following the confirmation of FDA approval, a company is permitted to produce large batches of a vaccine for public distribution. Throughout the rollout of the vaccine, the FDA continues to monitor manufacturing activities, making regular inspections of production facilities to ensure that FDA regulations are being adhered to. This monitoring will continue for the duration of time a manufacturer holds a license for a vaccine.

Tracking Vaccine Quality

Samples of every vaccine lot produced by manufacturers will be tested by the FDA as part of its real-time vaccine quality monitoring. Tests will typically report on the safety, purity, and potency of a vaccine. As consistency is tracked against each lot, the FDA can verify that the vaccine product is still safe and reliable for public use.

Fast-Tracked Vaccines

Sometimes vaccines need to be fast-tracked. This is usually when they are essential to providing preventative healthcare to respond to emerging infectious diseases. A notable example of this was during the COVID-19 pandemic.

The FDA has set processes for the fast tracking of vaccines. These involve rigorous standards – based on the normal process for developing vaccines – ensuring that fast-tracked vaccines are both safe and efficacious. The utilization of global resources is often highly significant when fast-tracking vaccine development in response to significant outbreaks.

How Long Does Vaccine Testing for FDA Approval Take?

Returning to the question posed at the start of this piece; the time it takes for a vaccine to be tested and approved can vary greatly, depending on several factors. A typical timeline for vaccine development and approval has been estimated at 5 to 10 years. However, it may take longer for clinical trials to determine that the vaccine is safe and efficacious and for the regulatory process for approval to be completed. The time it takes to manufacture a sufficient number of vaccine doses for public distribution must also be taken into account.

Why Cerba Research?

Cerba Research provides the state-of-the-art technology and standardized protocols needed for vaccine development. A trusted vaccine lab partner for the biotech, pharmaceutical, and academic communities, Cerba Research offers full support for trial programs – from early preclinical to late-stage research. We provide a broad variety of preclinical models, virus assays, immunoassays, and molecular assays in our BSL3 containment laboratories.