Where do some folks get the idea that vaccines are only tested for 4.5 days?

The usual suspects…

Are Vaccines Only Tested for 4 or 5 Days?

But who gave them the idea to put it on their sign?

Again, the usual suspects…

Before we actually look to see if the original clinical trials for the hepatitis B vaccines only “solicited adverse reactions” for four or five days after vaccination, lets see what the safety studies have shown since these vaccines were approved in the 1980s.

• Lack of association between hepatitis B birth immunization and neonatal death: a population-based study from the vaccine safety datalink project – found no significant difference in the proportion of HBV-vaccinated (31%) and unvaccinated (35%) neonates dying of unexpected causes
• Adverse events after hepatitis A B combination vaccine – a detailed medical and epidemiological review of VAERS reports did not suggest a clear pattern of evidence supporting a causal relationship with the vaccine
• Safety of neonatal hepatitis B vaccine administration – found no evidence that newborn hepatitis B vaccination is associated with an increase in the number of febrile episodes, sepsis evaluations or allergic or neurologic events
• Hepatitis B vaccination and first central nervous system demyelinating events: reanalysis of a case-control study using the self-controlled case series method – found no strong association between HB vaccination and a first episode of CNS demyelinating disease, or between HB vaccination and definite or probable MS, within 2 months or 1 year of vaccination.
• Hepatitis B vaccine and risk of autoimmune thyroid disease: a Vaccine Safety Datalink study – did not observe an increased risk of Graves’ disease or Hashimoto’s thyroiditis, following ever receiving a hepatitis B vaccine

These and other studies have shown that the hepatitis B vaccines are safe.

What about the idea that we only know what happens in the first four or five days after the vaccine is given?

Hepatitis B Vaccine Safety Testing

That’s not true. There are plenty of long term studies and safety studies typically collect safety information for weeks and months after a child is vaccinated.

“Open-ended diaries were provided to the parent(s) or guardian of the child before the vaccination program began in which to record any health problems that occurred 1 month before and 1 month following each of the 3 doses of vaccine, whether or not a health professional was consulted.”

De Serres et al on Importance of attributable risk in monitoring adverse events after immunization: hepatitis B vaccination in children.

Still, it is important to note that the further you get from a vaccination, the less likely that an adverse event is actually going to be caused by the vaccine though.

Consider the study by De Serres, Importance of attributable risk in monitoring adverse events after immunization: hepatitis B vaccination in children, in which they looked at the reports of adverse events both before and after vaccination and concluded that “postimmunization incidence systematically overestimates the risk of adverse events.”

It is also very important to note that like other vaccines, the hepatitis B vaccine was well tested before it was approved.

And many of the studies did include a placebo group.

Unfortunately, a lot of the folks in the placebo groups ended up getting hepatitis B.

In one study, Hepatitis B vaccine: efficacy in high-risk settings, a two-year study, which included an unvaccinated control group – “The control group was comprised of 31 patients and 24 staff members who had not been in contact with HBV until they entered the units and who did not wish to be vaccinated.”

Importantly, this study found “no local or general reaction to the immunization. A monthly biological and clinical survey of the vaccinated subjects showed no evidence of complication due to vaccination, especially no sign of auto­immunity.”

So why do we still hear the myth that vaccines are only tested for 4.5 days?

Anti-vax folks need to convince their followers that vaccines aren’t safe.

A careful look at all that went into the development of the hepatitis B vaccines shows that they are.

It also shows that vaccines are very necessary.

More on Hepatitis B Vaccine Safety Testing

• Why Aren’t Vaccines Regulated like Drugs?
• Are Vaccines Evaluated for Mutagenicity, Carcinogenicity or Impairment of Fertility?
• What to Do If Your Child Is Exposed to Hepatitis B
• Do Preemies Frequently Crash After They Get Their Hep B Shot?
• First Day Deaths and the Hepatitis B Vaccine
• Did Your Hepatitis B Antibody Test Come Back Negative?
• Are More People Dying of Viral Hepatitis?
• Don’t Skip Your Baby’s Hepatitis B Shot
• More Questions to Help You Become a Vaccine Skeptic
• CDC – Hepatitis B Vaccine Safety
• Study – Importance of attributable risk in monitoring adverse events after immunization: hepatitis B vaccination in children.
• Study – Hepatitis B vaccine in medical staff of hemodialysis units: efficacy and subtype cross-protection.
• Study – Hepatitis B vaccine: demonstration of efficacy in a controlled clinical trial in a high-risk population in the United States – a placebo-controlled, randomized, double-blind trial
• Review – Large-scale efficacy trials of hepatitis B vaccines in the USA: baseline data and protocols.
• Review – Hepatitis B vaccines: present status.
• Study – Safety of hepatitis-B vaccines: no evidence of autoimmunity.