Like a few other vaccines, Gardasil underwent Fast Track approval by the FDA.
“This is the first vaccine licensed specifically to prevent cervical cancer. Its rapid approval underscores FDA’s commitment to help make safe and effective vaccines available as quickly as possible. Not only have vaccines dramatically reduced the toll of diseases in infants and children, like polio and measles, but they are playing an increasing role protecting and improving the lives of adolescents and adults.”
Jesse Goodman, MD, MPH, Director of FDA’s Center for Biologics Evaluation and Research
But that doesn’t mean that any corners were cut in getting it quickly approved or that the vaccine isn’t safe.
Vaccine Fast Tracking
The Fast Track process can help get new drugs and vaccines approved more quickly by the FDA because they have:
- more frequent meetings with the FDA to discuss the drug’s development plan and to help ensure the collection of appropriate data needed to support drug approval
- more frequent written communication from the FDA about such things as the design of the proposed clinical trials and the use of biomarkers
- eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
- a Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA.
In very simple terms, it is kind of like having a VIP pass at an amusement park. It gets you a guide and helps you jump to the front of many of the lines, but you still don’t get to operate the rides yourself.
Which vaccines have had Fast Track approval?
They include Gardasil, Vaxchora, a cholera vaccine, the MenB vaccines, and FluBlock, the flu vaccine that is made in insect cells.
Others that have Fast Track designation include vaccines for anthrax (NuThrax anthrax vaccine adsorbed with CPG 7909 adjuvant), chikungunya, Clostridium difficile (Clostridium difficile toxoid vaccine), malaria, RSV, Zika, Ebola, Invasive
Staphylococcus aureus infections in surgical populations, Shigella (Flexyn2a), and Lyme disease. None are approved yet though.
And that all of these vaccines have Fast Track designation is a good reminder that it isn’t a guarantee of approval.
“With Fast Track designation, early and frequent communication between the FDA and the biopharmaceutical company is encouraged throughout the entire drug development and review process to help to quickly resolve any questions or issues that arise, potentially leading to an earlier approval and access by patients.”
Encouraging Vaccine Innovation: Promoting the Development of Vaccines that Minimize the Burden of Infectious Diseases in the 21st Century
It just puts them on a Fast Track to get approved if they meet all of the FDA requirements for safety and efficacy.
The ability to develop and approve new vaccines quickly is also important as we continue to face new emerging disease threats. Faced with a deadly global pandemic, everyone will be glad that we have the ability to Fast Track vaccines and other drugs.
More on Vaccine Fast Tracking
- HHS – Encouraging Vaccine Innovation: Promoting the Development of Vaccines that Minimize the Burden of Infectious Diseases in the 21st Century
- FDA – FDA Licenses New Vaccine for Prevention of Cervical Cancer and Other Diseases in Females Caused by Human Papillomavirus. Rapid Approval Marks Major Advancement in Public Health
- Food and Drug Administration Regulation and Evaluation of Vaccines
- FDA – Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review
- FDA – Fast Track
- FDA – FDA approves vaccine to prevent cholera for travelers
- Vaccines in a hurry.
- FDA Grants PaxVax Fast Track Designation for its Chikungunya Vaccine
- U.S. FDA Grants Fast Track Designation to Novavax’ RSV F Vaccine for Older Adults
- Valneva Receives FDA Fast Track Designation for its Lyme Disease …
- Fast-Track Development of Ebola Vaccines: Principles and Target Product Criteria
- Fast Tracking the Vaccine Licensure Process to Control an Epidemic of Serogroup B Meningococcal Disease in New Zealand
- I get an email about Gardasil
- Study – Vaccine development: From concept to early clinical testing
- Vaccine Trials: Methods and Best Practices
- Vaccine Development, Testing, and Regulation
- Debunking myths about vaccine testing and safety
- Vaccines aren’t tested – myth vs. science
- Fast-Track Zika Vaccine Development — Is It Possible?