Why Aren’t Vaccines Regulated like Drugs?

Have you ever heard the argument that vaccines aren’t held to the same standards as drugs, food, or other products?

“Vaccines are not held to the same double blind gold standard of clinical testing as other pharmaceutical drugs because they are considered biological products under the Public Health Federal Food, Drug and Cosmetic Act. They meet the same standards as cosmetics.”

20 VACCINE “FACTS” you need to know to make an informed decision

Placebos, liability, testing – these are all arguments that anti-vaccine folks try to use to scare parents into thinking that vaccine development isn’t well regulated and vaccines aren’t held to the same standard as drugs.

Why Aren’t Vaccines Regulated like Drugs?

Would you be surprised to learn that part of their argument is true?

No, not the part that vaccine development isn’t well regulated!

“Current authority for the regulation of vaccines resides primarily in Section 351 of the Public Health Service Act and specific sections of the Federal Food, Drug and Cosmetic Act.”

Vaccine Product Approval Process

Federal regulations and rules ensure that our vaccines are safe.

• Public Health Service Act (42 USC 262-63) §351
• Food, Drug, and Cosmetic Act (21 USC 301-392)
• Title 21 Code of Federal Regulations (CFR) 600-680 – standards for biological products
• Title 21 CFR 314 (21 CFR 601.25[d][2], specific to biologicals – ensures adequate and well-controlled clinical trials
• Title 21 CFR 312 – investigational new drug application (IND)
• Title 21 CFR 210-211 – good manufacturing practices
• Title 21 CFR 58 – good laboratory practices
• Title 21 CFR 56 – institutional review boards
• Title 21 CFR 50 – protection of human subjects
• Prescription Drug User Fee Act (PDUFA) of 1992, 2002, and 2007
• Food and Drug Agency Modernization Act (FDAMA) of 1997
• Food and Drug Agency Amendments Act (FDAAA) of 2007

I meant the part that vaccines aren’t regulated like drugs.

While both vaccines and prescription drugs are regulated by the FDA, that work occurs within two different centers of the FDA:

• Center for Biologics Evaluation and Research (CBER) – vaccines
• Center for Drug Evaluation and Research (CDER) – over-the-counter and prescription drugs

Both centers work to make sure we have safe and effective vaccines and drugs to keep us healthy, even if there are some differences in how they do it.

“Vaccine clinical development follows the same general pathway as for drugs and other biologics.”

Vaccine Product Approval Process

That’s right, vaccines and drugs go through the same types of clinical trials.

After completing the three phases though, vaccine developers must then apply for a Biologics License Application (BLA), which is reviewed by a multidisciplinary FDA reviewer team. This is also when their manufacturing facility gets inspected.

“Following FDA’s review of a license application for a new indication, the sponsor and the FDA may present their findings to FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). This non-FDA expert committee (scientists, physicians, biostatisticians, and a consumer representative) provides advice to the Agency regarding the safety and efficacy of the vaccine for the proposed indication.”

Vaccine Product Approval Process

Once approved and licensed, the FDA and CDC continue to work to make sure the vaccine is safe, including having some vaccines undergo undergo Phase 4 studies and monitoring for side effects through VAERS and the Vaccine Safety Datalink.

And then, even after approval by the FDA, new vaccines aren’t put on the immunization schedule until a review and approval by the Advisory Committee on Immunization Practices (ACIP).

“Canada, like many other countries, exercises tight regulatory oversight over vaccines because they are usually given to very large numbers of healthy individuals. Vaccines in Canada are subject to the Food and Drugs Act and the Food and Drug Regulations. Vaccines are regulated under a specific set of regulations for a subset of drugs known as biologic drugs.”

The Regulation of Vaccines for Human Use in Canada

It is also important to keep in mind that this process doesn’t just happen in the United States.

Still wondering why vaccines aren’t regulated like drugs?

“Vaccine development differs from drug development in several important ways. First, because vaccines are preventive and are given to healthy individuals – often children – they require very large clinical trials, leading to increased research and development costs. Second, vaccines are biological products that can be very complex to manufacture and are subject to stringent quality control standards, resulting in much higher capital costs. Third, unlike drugs, vaccines have no secondary markets, making it unlikely that manufacturers will generate additional profits beyond the initial target markets. Finally, unlike generic drugs, which only need to demonstrate adherence to a pre-established development process, vaccines are biologicals that require full re-development to demonstrate their equivalence. (World Health Organization, 2014). Each manufacturer is required to invest in the full regulatory approval process for their vaccine products.

Myths and Facts about Vaccine Product Price and Procurement

It’s only because vaccines are more strictly regulated than drugs and other products.

Vaccines are safe and necessary.

More on Vaccine Regulation

• FDA – About the Center for Biologics Evaluation and Research (CBER)
• FDA – About the Center for Drug Evaluation and Research (CDER)
• FDA – The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective
• FDA – How Drugs are Developed and Approved
• FDA – Vaccine Product Approval Process
• CDC – Vaccine Testing and the Approval Process
• The Journey of Your Child’s Vaccine
• FDA – Vaccines and Related Biological Products Advisory Committee
• FDA – Pre-IND Consultation Program
• FDA – Investigational New Drug (IND) Application
• FDA – Therapeutic Biologics Applications (BLA)
• FDA – New Drug Application (NDA)
• CDC – Advisory Committee on Immunization Practices (ACIP)
• The Regulation of Vaccines for Human Use in Canada
• WHO – Vaccine Regulations
• WHO – Module 2: Vaccines and drugs: similarities and differences
• WHO – Myths and Facts about Vaccine Product Price and Procurement
• WHO – Ebola Vaccine Clinical Development Overview
• Are vaccines safe? (Australia)
• Food and Drug Administration Regulation and Evaluation of Vaccines
• Multiple Vaccine Oversight Committees Ensure Our Public Safety
• FDA Regulation of Prescription Drugs
• Vaccine Development, Testing, and Regulation
• The Regulatory Evaluation of Vaccines for Human Use.
• Pharmaceutical drug development – providing facts about vaccines
• Making Vaccines: Process of Vaccine Development
• The Development of the Immunization Schedule