A US doctor has claimed whooping cough vaccines do not work and have never been tested for safety.
But his claim is false, and flies in the face of publicly available information from clinical trials.
Similar vaccines are approved for use in the US, where Dr Kory is based.
Whooping cough is a disease of the respiratory tract, and is highly infectious in unvaccinated people. Although death from whooping cough is rare for those aged 10 to 70, outbreaks can be large among unvaccinated populations, and infants are at the highest risk of infection and severe illness.
“What about whooping cough? Does the vaccine work? Is it safe? No. Has it ever been tested for safety? No,” he says (audio mark 20 min 21 sec).
The Facebook video has more than 28,000 views at the time of writing.
The 10 whooping cough vaccinations available in Australia are combination vaccines that additionally protect against diseases such as diphtheria and tetanus. They are: Infanrix, Infanrix hexa, Infanrix IPV, Quadracel, Tripacel, Boostrix, Boostrix-IPV, Adacel, Adacel Polio, and Hexaxim.
As they are combination vaccines, many of them have contain the same whopping cough vaccine component.
The efficacy and safety profiles of each vaccine are available from the TGA website, as listed below. This information directly contradicts Dr Kory’s claim.
- The efficacy of Infanrix was calculated to be 83.9 per cent based on one study and 88.7 per cent according to another (page 8 of the product information). The safety profile on page 5 is based on data from 11,400 subjects.
- Infanrix IPV has the same efficacy as Infanrix given the “the immune response to pertussis antigens” is the same (p12). Safety data from 13 clinical trials and more than 2400 administered doses is listed from page 5.
- Infanrix hexa also has the same efficacy as Infanrix given it contains the same whooping cough component (page 12). The safety profile on page 8 is based on data from more than 16,000 subjects.
- The same efficacy data applies to both Quadracel and Tripacel. Two trials show vaccine efficacy of around 85 per cent (page 9) The safety profiles are featured on page 6 and page 6 from clinical trials involving more than 20,000 people.
- The efficacy of Boostrix is listed from page 10 with safety data based on trials involving 2770 individuals on page 7. Boostrix-IPV efficacy details are featured from page 11 with safety data from a trial involving 341 pregnancy outcomes and a further study of 793 pregnancy outcomes on page 6.
- The efficacy details of Adacel and Adacel Polio are featured on page 11 and page 13. Safety data (page 5) was taken from four randomised controlled trials (310 pregnancy outcomes) and six observational studies (84,371 pregnancy outcomes).
- The efficacy of Hexaxim is summarised on page 10. The safety profile information is on page 8.
Experts and the TGA told AAP FactCheck the whooping cough vaccines are safe and effective.
The TGA said the views presented by Dr Kory “are inaccurate, misleading and dangerous”.
“All prescription medicines must undergo a full TGA premarket assessment to ensure they meet Australia’s high standards of safety, quality and efficacy before they are included in the Australian Register of Therapeutic Goods (ARTG) and made available for supply and use in Australia,” the regulatory agency said in an email.
“During this process, technical experts at the TGA rigorously evaluate a comprehensive dossier, which consists of clinical trial studies, non-clinical and toxicology studies, chemistry, manufacturing and risk management information.
“Medicines and vaccines are only approved by the TGA if this rigorous process is completed and the benefits are considered to be much greater than any potential risks.”
The page on diphtheria, tetanus, and pertussis immunisation states that “in systematic reviews of randomised trials, the clinical efficacy of acellular pertussis vaccines containing ≥3 pertussis antigens (table 1) was approximately 85 per cent in preventing typical pertussis.”
Dr Keith Chappell, a molecular virologist at the University of Queensland, said: “All vaccines used in humans go through rigorous testing for safety and efficacy. Information on the testing for each vaccine is summarised on the packaging insert in black and white for anyone to read.
“The whooping cough vaccine approximately has an efficacy of 85 per cent. Whooping cough is a life-threatening disease in infants and a decision to not vaccinate puts a baby’s life at risk.”
The claim whooping cough vaccines do not work and have never been tested for safety is false.
Product information for each of the 10 whooping cough vaccines available in Australia is listed on the TGA website. Efficacy percentages average in the mid-80s while safety data is based on trials involving thousands of individuals.
Experts and the TGA confirmed the vaccines are effective and have undergone safety testing.
False – The claim is inaccurate.