What Milestones Does a Vaccine Need to Hit Before Approval?

The typical vaccine goes through six general stages of development before receiving approval for distribution.

1. The exploratory stage looks at the viability of a vaccine. Some diseases would not respond well to this treatment option, so the first effort must be to see if it would be effective.

2. The preclinical stage begins the developmental process so that the actual vaccine gets created. It includes the initial manufacturing to produce an item that is ready for trial.

3. Clinical development is a three-phase process that must get completed before governments can review and approve a vaccine. The first one involves small groups of individuals who receive the trial vaccination. If those results are encouraging, the second phase expands the clinical study to include people with specific characteristics. The final stage has the vaccine given to thousands of people to test for safety and efficacy.

4. Once a vaccine proves to be safe and effective, government agencies send it through a regulatory review process. The goal of this step is to review the evidence of safety and efficacy to ensure the shot doesn’t cause more harm than good. It receives approval only after this independent evaluation.

5. The manufacturing process begins after a vaccine receives approval. Some companies follow an “at risk” policy that has them produce doses before receiving authorization so that the item can get immediately distributed to the general public. If a denial happens instead, all of the vaccinations would need to be thrown away.

6. The final milestone involves quality control. The goal is to ensure that the vaccine can be as helpful as possible without increasing the risk of additional health problems.

The FDA Requires Specific Information for Vaccines

Sponsors of a new vaccine in the United States must follow a multi-step approval process that includes a new drug application, pre-licensure clinical trials, and a biologics license application. The government inspects the manufacturing facility before issuing an approval.

A presentation of findings to the Vaccines and Related Biological Products Advisory Committee is also mandatory.

The FDA also requires usability testing of the product labeling. Manufacturers can be required to provide the results of their tests for purity, potency, and safety, or be required to submit to third-party examination. 

All of this is important for the average citizen, but for those who work in the medical field, make sure to note the information here so you can pass it along. If you want more in depth information on the topic, check out our patient safety news sources you should be following.