FDA Vaccine Approval Process

FDA Vaccine Approval Process – Overview

It takes years to get FDA approval from the company producing vaccines for general use by the public. The Food and Drug Administration department approves a newly developed vaccine after it completes several approval processes.

Vaccines must have fewer side effects and be effective and safe for general use. The FDA Vaccine Approval Process helps you understand the different stages of FDA Approval of a vaccine.

The FDA Vaccine Approval Process

FDA Vaccine Approval Process

FDA Vaccine Approval Process Stages

Only FDA-approved vaccines and drugs are allowed for general use by the public. Without approval, selling or prescribing such medications is illegal. Therefore, vaccine development is done in different stages.

While vaccines and drugs, including cancer drugs, undergo rigorous FDA approval processes, the specifics of these processes can vary due to the different nature and use of vaccines compared to therapeutic drugs. The FDA can grant Emergency Use Authorization (EUA) for vaccines and medications during public health emergencies based on the best available evidence before all the formal FDA approval stages are completed. The entire FDA Vaccine Approval Process is given here.

Stage 1: Discovery

In this stage, researchers first study the diseases for which they develop a vaccine or a drug. This stage, also known as the Research stage, requires a team of researchers.

After that, the team of researchers starts developing a plan to treat it with a vaccine. But first, the team mimics the effects of that particular virus directly on the human immune system.

Once the team discovers a new vaccine, it will proceed to the next stage, which is a three-phase trial stage.

Stage 2: Three-phase Trials

The three-phase trials are mandatory for all types of drugs and vaccines before the FDA approves them. Each trial phase collects data on the vaccine’s effectiveness and safety. After passing through the three-phase trials, the vaccine will be sent for final FDA Approval.

Phase 1:

This phase collects data on the dosage and safety of the vaccine, which will be given to humans for testing. Several volunteers come forward in this phase and allow the company to try out the newly discovered vaccine on them. The duration of Phase 1 clinical trials can vary widely depending on the specific vaccine or drug, with some being completed in a shorter timeframe, especially under expedited conditions such as a public health emergency.

Phase 2:

Phase 2 is a clinical trial test where the team collects data on the safety and efficacy of the vaccine. It takes several months to collect the safety data of the vaccines. The duration of Phase 2 clinical trials varies and may be expedited or extended based on preliminary results, the disease being targeted, and regulatory guidance.

Phase 3:

This stage conducts clinical tests to measure the vaccine’s effects and safety. Phase 3 clinical trials require more volunteers than the first two stages. Their duration can vary significantly based on enrollment rates, the occurrence rate of the endpoint within the study population, and other factors, with some trials potentially being completed in less time under urgent conditions.

After completing all three phases of clinical trials in a different group of people, the vaccine will be sent for final FDA Approval.

Stage 3: FDA Approval

The U.S. Food and Drug Administration and the Center for Biologics Evaluation and Research approve new vaccines and are responsible for regulating newly developed vaccines in the U.S. The standard FDA Vaccine Approval Process is given below.

The newly developed vaccine sponsor must follow multiple approval processes in different stages. The sponsor must pass through all the stages to get the final FDA Approval for public use. The multiple approval processes are as follows:

  • An Investigational New Drug (IND) application is submitted to the FDA before beginning clinical trials, and a Biologics License Application (BLA) is the correct term for the application submitted for vaccines seeking FDA approval
  • BLA i.e. Biologics License Application
  • Inspection of the Manufacturing facility by the team
  • The results from all phases of clinical trials, along with manufacturing and facility data, are compiled into the BLA for review by the FDA
  • Usability of Testing and Labeling

These are the multiple approval processes that a sponsor must pass through to make his vaccine available for general use. After approving a newly developed vaccine, the FDA monitors the production and other data to ensure safety.

Tracking of the Side Effects Post Approval

The government also runs a VAERS program for the Vaccine Adverse Event Reporting System. It is a vaccine surveillance program co-sponsored by the government’s FDA and CDC departments.

This program monitors the side effects of the newly approved vaccines. The program collects all data from patients and analyzes them thoroughly. Patients, doctors, pharmacists, and individuals can submit their reports to the department. The department has an official website where reports from such individuals can be received.

Moreover, the department continues inspecting the vaccine manufacturing department to ensure the sponsor follows the guidelines.

No vaccine is 100% effective or has no side effects. Therefore, the department also collects data to study the vaccine’s side effects. The clinical trial phases already describe the medications’ side effects, but the department still monitors them.

The FDA, specifically its Center for Biologics Evaluation and Research (CBER), regulates vaccines. The CDC, Centers for Medicare & Medicaid Services (CMS), and other entities have distinct roles and do not regulate vaccines.

However, a Biological Products Advisory Committee helps the department understand the safety norms of the vaccines and other inputs.

Sponsors conduct pre-clinical and clinical trials (Phase 1-3) under FDA oversight. The FDA reviews the data from these trials to decide on approval. The FDA also conducts clinical trials from the beginning to match the data presented by the vaccine sponsor.

FDA approval indicates that the benefits of a drug or vaccine outweigh its risks for the intended population and use. Still, it is not necessarily more effective or has fewer side effects than non-approved interventions. Drugs and vaccines approved by the U.S. Food and Drug Administration Department have FDA-approved labeling. This label is more than enough to trust the drug or vaccine, as the trusted department approves it by the government.

The Bottom Line:

The FDA department controls everything, from the development of the vaccine to its approval for use. Vaccine development is done in several phases, and approval from the department takes several years.

The above article explains the entire FDA Vaccine Approval Process, including the multiple processes that the manufacturer has to go through. Thanks to modern science and new technologies, the process has become faster.

See Also

FDA-Approved Medications for Pediatric Anxiety

FDA Approval Process

FDA Grants

Current Version
November 2, 2022
Written By
Shubham Grover
March 17, 2024
Updated By
Andrea Morales G.

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