L2.7.6: Development and Testing of Vaccines

• Development and Testing of Vaccines

  ● Before a vaccine is released, several steps and clinical trials are taken in order to evaluate its safety and potential to prevent disease.
• PHASE 1

  ○ Vaccine is given to a small number of volunteers to assess its safety, confirm if it generates an immune response and determine the right dosage
• PHASE 2

  ○ Vaccine is usually given to hundreds of volunteers, who are closely monitored for any side effects

  ➢ Participants have the same characteristics as those in phase 1 (Same age, sex, etc.)

  ○ Data are also collected whenever a possible disease may occur
• PHASE 3

  ○ Vaccine is given to thousands of volunteers

  ○ Determines if the vaccine is safe and effective against the disease it is designed to protect against
• After PHASE 3, there are still a series of steps that are required including:

  1. Review of Efficacy

  2. Review of Safety

  3. Manufacturing

  4. Monitoring of Public Health Policy Approvals
• EMERGENCY USE OF AUTHORIZATION (EUA)

  ● Manufacturers must apply for this, so that vaccine may be authorized for use in the country.

  ● It is a risk based procedure in order to assess unlicensed vaccines

  ➢ Development is still ongoing
• EMERGENCY USE OF AUTHORIZATION (EUA)

  ● Used during public health emergencies of international concerns

  ● Based on an essential set of available quality, safety, and efficacy performance data.

  ● Example: Covid-19 pandemic (Sinovac, Pfizer, Etc.)

  * The DOH and FDA are responsible for approving vaccines.