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.

The vaccines must have less side effects and be effective and safe for general use. The FDA Vaccine Approval Process helps you understand the different stages for 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 to use for general use by the public. Without approval, selling or prescribing such medications is illegal. Therefore, vaccine development is done in different stages.

Vaccines and cancer drugs follow a similar process to get FDA approval. In some cases, EUA i.e., Emergency Use Authorization granted for some medications if they are effective. 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, the vaccine will go to the next stage or we can say a three-phase trial stage.

Stage 2: Three-phase Trials

Before the FDA approves, the three-phase trials are mandatory for all types of drugs and vaccines. Each trial phase collects data on the effectiveness and safety of the vaccine. 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. The vaccine will be given to humans for testing. In this phase, several volunteers come forward and allow the company to try out the newly discovered vaccine on them. This phase may take up to 1.5 to 2 years.

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. Therefore, the clinical trials phase may take up to 2 years.

Phase 3:

This stage conducts clinical tests to see the effects and safety measurements of the vaccine. Phase 3 clinical trials require more volunteers than the first two stages. Therefore, this stage may require up to 3 years.

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 department and the Center for Biologics Evaluation and Research approve new vaccines. They 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:

  • New Drug Application for Investigation of the new drug or vaccine
  • Pre-licensure for clinical trials
  • BLA i.e. Biologics License Application
  • Inspection of the Manufacturing facility by the team
  • Presentation of Findings to the Authority
  • 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, FDA continues monitoring the production and other data to ensure safety.

Tracking of the Side Effects Post Approval

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

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 all types of individuals can submit their reports to the department. The department has an official website to receive reports from such individuals.

Moreover, the department continues inspecting the manufacturing department of the vaccines and whether the sponsor is following the guidelines.

No vaccine is 100% effective or has no side effects. Therefore, the department also studies the vaccine’s side effects by collecting data. The clinical trial phases already describe the medications’ side effects, but the department still keeps an eye on them.

The FDA includes several groups that regulate such medications and vaccines. The department includes the Centers for Diseases Control and Prevention, Centers for Medical Services, Centers for Medicaid, and many others.

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

FDA conducts a pre-clinical trial starting from phase 1 before the approval of the vaccine or the drug. They also conduct clinical trials from the beginning to match the data presented by the sponsor of the vaccine.

FDA-approved drugs and vaccines are more effective and have fewer side effects. FDA Approved labeling is there on the drugs and vaccines approved by the U.S. Food and Drugs Administration Department. This label is more than enough to trust the drug or the vaccine as the trusted department approves it by the government.

The Bottom Line:

The FDA department controls everything, starting from the development of the vaccine to approving the use of the vaccine. Vaccine development is done in several phases, requiring several years to get approval from the department.

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

See Also

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FDA Approval Process

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