Why do some people think that the DTaP vaccine only had a four day clinical trial?
The usual suspects.
Did the DTaP Vaccine Only Have a Four Day Clinical Trial?
Of course, most vaccines undergo years and years of testing before they are finally approved.
So, did the DTaP vaccine only have a four day clinical trial?
Seems like that should be an easy thing to fact check…
Let’s take a look at the package insert for the DTaP vaccine:
Wait, was Jim Meehan talking about one of the other DTaP vaccines?
Did he get confused after reading the package insert for the Infanrix DTaP vaccine?
While it does mention something about “four days,” that clearly isn’t how long the clinical trial lasted!
But why did the trial only look at the 4 days after each dose?
Most vaccine reactions occur within a few hours or days of getting the vaccine!
Sure, some reactions might occur later, but they are more rare and there are typically other trials that look for those reactions.
“In a prospective, double-blind, multicenter trial in Germany, 22,505 healthy infants received three vaccinations of DTaP at age 3, 4, and 5 months. Serious adverse events were followed for 1 month after each vaccination, and neurologic events for 1 year or longer.”
Clinical experience of a tricomponent acellular pertussis vaccine combined with diphtheria and tetanus toxoids for primary vaccination in 22,505 infants
The package insert even mentions other trials that monitored kids for a longer period of time.
“In a German safety study that enrolled 22,505 infants (66,867 doses of INFANRIX administered as a 3-dose primary series at 3, 4, and 5 months of age), all subjects were monitored for unsolicited adverse events that occurred within 28 days following vaccination using report cards. In a subset of subjects (n=2,457), these cards were standardized diaries which solicited specific adverse reactions that occurred within 8 days of each vaccination in addition to unsolicited adverse events which occurred from enrollment until approximately 30 days following the third vaccination.”
And then there are the DTaP postmarking studies.
“No new or unexpected adverse events were detected.”
Safety Surveillance of Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) Vaccines
Like the studies that were used to approve the DTaP vaccines, the studies that continue to be done confirm that the DTaP vaccines are safe.
Safe and very necessary.
More on the DTaP Vaccines
- Vaccine Testing and Development Timeline and Myths
- Vaccine Fast Tracking
- Why Aren’t Vaccines Regulated like Drugs?
- How Long Do Side Effects of Immunizations Last?
- How Often Do Severe Events Occur After Vaccines?
- Is It a Vaccine Reaction?
- COVID-19 Vaccine Challenges
- COVID-19 Vaccine Update
- Are There Any Long-Term Studies On Vaccine Safety?
- Are Vaccines Evaluated for Mutagenicity, Carcinogenicity or Impairment of Fertility?
- Are Vaccines Causing Long-Term Health Problems?
- Are Vaccines Only Tested for 4 or 5 Days?
- Is the MMR Vaccine Licensing Being Called into Question?
- Did the FDA Admit That the Government Is Recommending Untested, Unlicensed Vaccines for Pregnant Women?
- FDA – Infanrix DTaP Vaccine
- FDA – Daptacel DTaP Vaccine
- IAC – Ask the Experts about DTaP Vaccines
- Safety Surveillance of Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) Vaccines
- Adapting Group Sequential Methods to Observational Postlicensure Vaccine Safety Surveillance: Results of a Pentavalent Combination DTaP-IPV-Hib Vaccine Safety Study
- Safety of diphtheria, tetanus, acellular pertussis and inactivated poliovirus (DTaP-IPV) vaccine
- Clinical experience of a tricomponent acellular pertussis vaccine combined with diphtheria and tetanus toxoids for primary vaccination in 22,505 infants