Are childhood vaccines well-tested?

In an episode of his new podcast, in which he interviews former CDC director Dr. Robert Redfield, Del Bigtree questions vaccine safety by saying some vaccines, like Hepatitis B for newborns, weren’t tested enough, didn’t use placebo groups, may not be needed for all babies, and that forcing parents to vaccinate makes people trust vaccines less.

Vaccines go through many years of testing before they are approved, not just a few days. The Hepatitis B vaccine was tested on thousands of people before being given to newborns.

The five-day monitoring claim mentioned in the video relies on package insert data, as opposed to actual clinical trial information. Vaccine inserts are legal documents and not medical or research documents. Looking at the actual clinical trial information for the Hep B vaccine shows that the “five days” were specifically for injection site non-serious adverse events (NSAEs). Researchers watched for serious events for the length of the study (5 months for that particular study), 14 days for systemic NSAEs (i.e., fevers), and five only days for the injection site NSAEs.

Hep B infection can lead to chronic Hep B. Chronic Hep B can last a lifetime and lead to serious illnesses such as cirrhosis and liver cancer. The younger you are when you get hepatitis B, the more likely it will become chronic. There is no cure for hepatitis B, but vaccines can prevent it.

Placebo groups are often used in vaccine studies, but not always, especially when there is already strong evidence that a vaccine works and is safe. Instead of giving some babies a fake shot, scientists compare new vaccines to older, well-tested vaccines or study real-world data. This helps protect babies from diseases while still making sure vaccines are safe.

The FDA and CDC do not approve vaccines based on guesses. The Hepatitis B vaccine was carefully studied in adults, children, and babies before being recommended for newborns.

The widespread implementation of Hep B vaccination programs, including the birth dose, has led to significant reductions in Hep B worldwide. By immunizing newborns, the goal is to achieve a high vaccination coverage rate and create a population with decreased Hep B transmission, ultimately reducing the burden of related diseases.