Were Hepatitis B Vaccines Approved With Invalid Trials?

Why do some people think that the hepatitis B vaccines were approved using invalid trials?

It is not true that the hepatitis B vaccines were approved with invalid trials. — Folks who push misinformation and scare parents away from vaccinating and protecting their kids are morally and ethically bankrupt!

The usual suspects…

Apparently, Aaron Siri and the Informed Consent Action Network, founded by Del Bigtree, think that it is “morally and ethically bankrupt” to license a vaccine that has prevents nearly 6,800 perinatal hepatitis B infections each year.

A vaccine that keeps these babies from developing chronic hepatitis B infections.

A vaccine that keeps these babies from eventually dying from cirrhosis or hepatocellular carcinoma (liver cancer).

Wait, who is morally and ethically bankrupt???

Were Hepatitis B Vaccines Approved With Invalid Trials?

Anti-vaccine influencers have long claimed that vaccines are only tested for 4 or 5 days before getting licensed.

It is one of the their anti-vaccine arguments or points that have been refuted a thousand times already.

It simply isn’t true.

Vaccines are safe, with few risks, and very necessary.

They are studied together, in placebo controlled trials, in trials with saline as the placebo, and in long term studies.

And they have more than 5 days of safety monitoring in their clinical trials.

“Hence, the claim that Engerix-B and Recombivax HB were licensed by the FDA based on only a few days of safety data after each injection sounded like science fiction. ICAN simply found the claim not credible. That was until ICAN reviewed the package insert for each of these two products issued by their manufacturer and subsequently approved by the FDA, which each described their pre-licensure clinical trials. To ICAN’s amazement, they appeared to indicate that safety in these clinical trials was only reviewed for a few days after the injection of each into babies.”
Petition for Administrative Action to Require Clinical Trial of Engerix-B and Recombivax-Hb to Assess the Safety of These Products

Engerix-B (1989) and Recombivax HB (1986) are recombinant vaccines that replaced the first plasma-derived hepatitis B vaccine that had been licensed in 1981.

Although they were at first only given to those at high-risk for infection, beginning in 1991, all newborns began to get vaccinated and protected.

If Aaron Siri and Del Bigtree had done a little more research and looked beyond the package insert, they would have found that these hepatitis B vaccines were well studied before they were approved.

“Clinical studies with Engerix-B were initiated in February 1984. Through July 1, 1988, over 10,000 persons had participated in 87 studies (see Table 1). In addition to safety and imnunogenicity studies, protective efficacy was assessed in certain high-risk populations such as neonates born to mothers who were carriers of HBV with HBsAg in the blood.”
Energix-B Summary for Basis of Approval

The symptom checklist in some of the trials may have only recorded adverse reactions immediately post-vaccination and for the next four days, but since they got three doses over six months, if their symptoms lasted much longer, you would expect higher rates of adverse effects on the second and third dose.

Something that wasn’t seen.

Something that wasn’t seen even when studies looked for it!

“In the second randomized phase parents were instructed to complete the cards, and 3 to 7 days postvaccination a research nurse who was unaware of the vaccine assignment collected safety information by telephone interview. Hospitalizations were ascertained by parental interview, physician reports and review of the medical records at the time of each visit. Health problems within 1 month of the third vaccine dose were assessed by a postcard sent to the parent.”
Comparative safety and immunogenicity of two recombinant hepatitis B vaccines given to infants at two, four and six months of age

Since the infants in the above study got their third dose at six months, does that mean that they stopped looking for reactions soon after that?

“Eight subjects were hospitalized during the two phases of the study, three in the SmithKline Beecham group and five in the Merck group. Four were admitted with respiratory illnesses, two with gastroenteritis, one with a viral syndrome and one with an inguinal hernia. These hospitalizations occurred 15 to 243 days after vaccination.”
Comparative safety and immunogenicity of two recombinant hepatitis B vaccines given to infants at two, four and six months of age

Nope!

Anyway, since these hepatitis B vaccines were first approved, they have been replaced with preservative free versions – to remove thimerosal.

And they again underwent phase III, double-blind, randomized, comparative, multicenter studies of their immunogenicity and safety!

The goals of one of those studies, in “healthy infants in their first two weeks of life,” was to:

To assess the incidence and intensity of solicited local adverse events that occur during the four-day follow-up period (Days 0-3) after each vaccination
To assess the incidence, intensity and causal relationship to vaccination of solicited general adverse events that occur during the four-day follow-up period (Days 0-3) after each vaccination
To assess the nature, incidence and causal relationship to vaccination of unsolicited adverse events that occur during the 31-day follow-up period (Days 0-30) after each vaccination
To assess the occurrence, nature and causal relationship to vaccination of serious adverse events (SAEs) that occur during the entire study period (through six months after the last dose of vaccine).

So these children were essentially monitored for side effects for at least a year!

Oh, and the study found no serious adverse events that were associated with the vaccine!

Hepatitis B Post-Marketing Vaccine Studies

There have also been many other post-marketing studies that clearly show the hepatitis B vaccines are safe in children.

“Our systematic literature review summarized 30 years of clinical and post-marketing data reported for GSK HepB.”
The immunogenicity of GSK’s recombinant hepatitis B vaccine in children: a systematic review of 30 years of experience

One review found that “GSK HepB had a clinically acceptable safety profile in all of the populations studied. HBV vaccines have demonstrated long-term impacts on rates of fulminant hepatitis, chronic liver disease and hepatocellular carcinoma. GSK HepB will continue to contribute to global HBV control for the foreseeable future.”

Also consider this study that also monitored for symptoms before the hepatitis B vaccine was given.

“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.”
Importance of attributable risk in monitoring adverse events after immunization: hepatitis B vaccination in children.

It found that although many kids had symptoms after they got their vaccine doses, they mostly weren’t different from the symptoms they reported in the month before they got their vaccine, even their first dose!

Many other reports and studies have confirmed the “excellent safety profile” of the hepatitis B vaccines.

“Numerous long-term studies have found no evidence of serious adverse events causally linked to hepatitis B vaccination. Data do not indicate a causal association between hepatitis B vaccine and neurological disease (including Guillain-Barré syndrome and multiple sclerosis), diabetes mellitus, demyelinating disorders, chronic fatigue syndrome, arthritis, autoimmune disorders, asthma, hair loss, or sudden infant death syndrome.”
Hepatitis B vaccines: WHO position paper – July 2017

WHO’s Global Advisory Committee on Vaccine Safety has also issued several reports and has concluded that the hepatitis B vaccines are safe.

Hepatitis B Vaccines are Safe

That should put to rest the idea that the hepatitis B vaccines were only studied for 4 days, right?

Probably not…

Antivaccine-influencers will likely move the goal posts and say that these studies didn’t include a saline placebo.

Studies that are unethical to do and would just end up putting babies at risk to get hepatitis B…

Still, maybe Aaron Siri and Del Bigtree will stop harassing the FDA now, as they certainly have better things to do than respond to their lawsuits.

Lawsuits that just seem designed to get their anti-vaccine organizations attention.

More on Hepatitis B Vaccines

Last Updated on July 23, 2024

Aaron Siri and the Informed Consent Action Network

Were Hepatitis B Vaccines Approved With Invalid Trials?

Hepatitis B Post-Marketing Vaccine Studies

Hepatitis B Vaccines are Safe

More on Hepatitis B Vaccines

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