Question

Claim: The hepatitis b vaccine given to babies did not have a proper clinical trial and therefore is not safe.

Source: https://www.tiktok.com/@speakupforourkids3/video/7199751736922311938?q=hepatitis%20b%20no%20trial%20babies&t=1676645056155

Answer 1

The claim that the hepatitis B vaccine given to babies did not have a proper clinical trial and therefore is not safe is false. The Hepatitis B vaccine has been tested extensively in clinical trials before being approved for use in infants and is considered safe by medical experts.

 

In fact, according to the Centers for Disease Control and Prevention (CDC), the hepatitis B vaccine has been studied extensively and is considered safe for all age groups, including infants. The vaccine has been used for more than 35 years and has been given to millions of people worldwide with very few serious side effects.

 

The claim in the source you provided is not accurate and lacks credible evidence. The video on TikTok that you linked to does not provide any reputable sources to support its claim. Additionally, the person who posted the video is not identified as an expert in the field, so their credibility is also uncertain.

 

In conclusion, the claim that the Hepatitis B vaccine given to babies did not have a proper clinical trial and is not safe is ultimately false. The vaccine has been tested extensively in clinical trials and is considered safe by medical experts. It is important to rely on reputable sources and scientific evidence when evaluating health-related claims.

Source: https://www.cdc.gov/vaccinesafety/vaccines/hepatitis-b-vaccine.html

Answer 2

Somewhat true.  

To start, the term "proper" in regard to length of clinical trials is subjective. There is no required length needed for clinical trials, although most usually take more than a month, there is no requirement. This is backed up by Cancer Research UK, "There is no typical length of time it takes for a drug to be tested and approved. It might take 10 to 15 years or more to complete all 3 phases of clinical trials before the licensing stage. But this time span varies a lot." (https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/how-clinical-trials-are-planned-and-organised/how-long-it-takes-for-a-new-drug-to-go-through-clinical-trials) Although most trials have gone way over 5 days, unlike the Hepatitis B vaccine, there is no "proper" length of time for clinical trials. 

Within the video provided, the man walks us through the FDA website to find clinical trials of the Hepatitis B vaccine, upon digging into these clinical trials, under section 6.1 every hepatitis B vaccine has had little time under clinical trials. Here are the links to each Hepatitis B packet, all provided by the FDA:
https://www.fda.gov/media/74274/download
https://www.fda.gov/media/154561/download
https://www.fda.gov/media/119403/download
https://www.fda.gov/media/108745/download
All do state little time to host clinical trials, most spanning from 5-8 days, this backs up the claim made in the video provided. 

Upon further digging at the first Hepatitis B vaccine, which was the main example given from the video provided, we can see that the length of the clinical trials here is false. Recombivax HB is manufactured by MERCK, and it was approved by the FDA in 1986 (https://www.merck.com/company-overview/history/) According to Clinicaltrials.gov which is the US National Library of Medicine, hosts this clinical trial done by MERCK for Recombivax HB, which states how the clinical trial was done in 1980, "Randomized, double-blind, fixed-sample. A total of 549 subjects were allocated to the vaccine group, in which they were treated with highly purified formalin-inactivated virus subunits derived from the plasma of chronic carriers of hepatitis B. A total of 534 were allocated to the placebo group. Both groups received injections at 0, 1 month, and 6 months unless evidence of infection developed before the series was completed." (https://clinicaltrials.gov/ct2/show/NCT00000583) As seen within this quote, the clinical trial was completed over the course of 6 months, which is inaccurate to the length provided from the FDA. The abstract for the entire clinical trial can be found here: https://www.nejm.org/doi/10.1056/NEJM198010093031501?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed. To tackle the claim on safety, within the abstract it can be seen that the vaccine was "found to be safe, and the incidence of side effects was low. " 

Overall, this claim from the video is inaccurate just for this specific Recombivax HB because the original creator of this vaccine conducted clinical trials longing more than the 5 days it was claimed to be, as provided by the video. Unfortunately, this will still be marked as somewhat true because there does not seem to be enough evidence to contradict the claim of length of the other vaccines. 

Answer 3

<!--StartFragment-->Based on various sources, specifically, the Original Articles, and an article from the Children's Hospital of Philadelphia, there are many records of hepatitis B vaccines, and the vaccine has long reduced the number of deaths in children and all other individuals through the vaccination against hepatitis B viruses. There is a history of cases treated through this immunization, and the worse effect being the children and people unvaccinated at risk of catching this virus at a high-stake, according to statistics and reports from the above mentioned sources. However, there aren't any true proper uncontrolled, random clinical trials recorded in the history of books thus far. This fact doesn't make the claim entirely true still, in that there have been many historical researches unfound or unnamed, with a trial of the virus' vaccine a possibility among them. According to the Original Articles, in 1981, a controlled, randomized, double-blinded trial in 1083 homosexual men from New York was conducted with a purified, formalin-inactivated hepatitis B vaccine, which was prepared from HBsAG positive plasma, and resulted to be a safe immunogenic. This trial was conducted by the Lindsley F. Kimball Research Institute of New York Blood Center, and the Division of Epidemiology, Columbia University School of Public Health. This research trial was conducted for a time span of over two years, with neutral standing results. This is evidence enough to falsify the posted claim, ensuring this vaccine is safe for use among babies and other individuals. The problem is, one trial, one research project on it's own that wasn't as recent is not enough data and recorded evidence to falsify or agree with a scientific claim such as that the hepatitis B vaccine is safe and efficacious. We need more websurfing, researching to nullify or agree with the posted claim. The part of the claim stating that the hepatitis B vaccine is unsafe however, does not entirely tie with the other part of the claim regarding clinical trials. The fact that matters is this vaccine is a prevention of liver disease that could kill children if they ever get infected by the hepB virus. This vaccine comes with harsh side effects, brining in many other health risks, however, reduces the risk of a cell host catching a viral bacteriophage and therefore reducing death in an individual. This data was collected from the Children's Hospital of Philadelphia article. In short, there is not enough research conducted on this claim to falsify or say this claim is correct, however, there is more evidence against than with this claim. <!--EndFragment-->

Comments

Interesting explanation! It sounds like you found research both for and against the claim. However, is there any legitimate authority that says the vaccine is safe? The CDC currently advises it to infants and above, which would make the claim seem exaggerated or false? https://www.cdc.gov/hepatitis/hbv/vaccchildren.htm#guidelines