When You Ask for Vaccine Advice in an Anti-Vaccine Facebook Group…
While most of us are used to hearing about meningococcal meningitis being a big risk for teens and young adults, it is important to realize that rates of disease are also high for infants, with a second peak during adolescence.
So why don’t we routinely vaccinate infants against meningococcal disease?
internal organ dysfunction or failure – yellow fever vaccine-associated viscerotropic disease (YEL-AVD)
About 1 in 55,000 for severe allergic reactions, 1 in 125,000 for severe nervous system reactions, and 1 in 250,000 for life-threatening severe illness with organ failure.
And the risks are likely higher if you are older than age 60 years, although YEL-AND and YEL-AVD are not reported to happen with booster doses of the yellow fever vaccine.
“People aged ≥60 years may be at increased risk for serious adverse events (serious disease or, very rarely, death) following vaccination, compared with younger persons. This is particularly true if they are receiving their first yellow fever vaccination. Travelers aged ≥60 years should discuss with their healthcare provider the risks and benefits of the vaccine given their travel plans.”
Yellow Fever Frequently Asked Questions
Why would you get the yellow fever vaccine if you were older than aged 60 years and you knew there was a higher risk of severe side effects?
Yellow fever itself is a life threatening disease without a cure and a case fatality rate of up to 50%, and again, YEL-AVD is not common, occurring in about 0.4/100,000 doses.
So you would typically want to get vaccinated if you were traveling to an area where yellow fever was a risk.
“Since January 2018, 10 travel-related cases of yellow fever, including four deaths, have been reported in international travelers returning from Brazil. None of the 10 travelers had received yellow fever vaccination.”
Fatal Yellow Fever in Travelers to Brazil, 2018
In addition to outbreaks, yellow fever is still endemic in forty-seven countries in Africa and Central and South America, leading to 170,000 severe cases and 60,000 deaths in recent years, including some deaths in unvaccinated travelers returning from these areas. Did you read about these deaths in the paper?
I will not travel out of the country without getting caught up on my vaccines. Remember, most outbreaks are started when an intentionally unvaccinated person travels out of the country, gets exposed to a vaccine-preventable disease, comes home while they are still in the incubation period and not showing symptoms, and then eventually get sick, exposing others.
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
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], 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.
“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.
almost 80% of all compensated awards by the NVICP come as a “result of a negotiated settlement between the parties in which HHS has not concluded, based upon review of the evidence, that the alleged vaccine(s) caused the alleged injury.”
the NVICP settlements are funded by an excise tax on vaccines
the NVICP cases are published by the U.S. Court of Federal Claims, so all information is disclosed to the public and no safety concerns are hidden
So what does the National Vaccine Injury Compensation Program (VICP) really prove?