Two leading pediatricians  in India have urged the   World Health Organization (WHO)  to urgently revise its manual on classification of "Adverse Events Following Immunization (AEFI)," warning that the new guidelines put children's life at risk.

This needs to be done "urgently in the interest of child safety,"  doctors Jacob Puliyel at St Stephen's Hospital in Delhi, and Pathik Naik of  Children Hospital in Surat, say in a report published in the prestigious journal ‘F1000Research’

Under  WHO's revised   manual on AEFI,  only those adverse  reactions observed during  clinical trials of a vaccine,    should be  classified as   vaccine related.     All new serious adverse reactions including deaths  seen during post-marketing of the vaccine   should be considered  as ‘coincidental'  or ‘unclassifiable’, and the vaccine should not be blamed.

The WHO has also changed the  definition of  "causal association," the authors say. Under the revised guidelines,  if there is an alternate explanation for the adverse event, or another factor is involved, causative association with vaccine should not be made.   "In other words,  if after vaccination,  a child with an underlying congenital heart disease  develops    cardiac failure, it would not be considered causally related to the vaccine."

The revised classification by WHO  "is a major step backward for patient safety,"

the authors say.  "This could embolden vaccine manufacturers to be more reckless with regard to adverse reactions," they warn.

Puliyel and Naik note that the Global Advisory Committee on Vaccine Safety has documented many deaths in children with pre-existing heart disease after they were administered the pentavalent vaccine (combined diphtheria, tetanus, pertussis, Hib, and hepatitis-B vaccine).    "Under  WHO's  new definition of causal association, these deaths would not be acknowledged as related to  vaccination." 

Both Sri Lanka and Vietnam governments withdrew  the pentavalent vaccine following the deaths of  five children in Sri Lanka and 12 in Vietnam soon  after vaccination.  But  WHO investigating teams declared that the deaths were ‘unlikely’ to be related to vaccination, the report says.   

The authors point out that  a new study in India,    showed that the switch from DPT (diphtheria, tetanus, pertussis)  to pentavalent vaccine almost doubled the deaths following vaccination. "A large number of these deaths could have been avoided had the AEFI manual not been revised."

According to their  report, the consequence of India adopting WHO's new classification   can be seen from the causality assessment of 132 serious AEFI cases uploaded on the website of the Ministry of Health and Family Welfare.  Of the total AEFI cases,  54   babies died and 78 survived,   "but not even one death was classified as vaccine-related. Nearly all the deaths were simply classified as unclassifiable or coincidental."  

Vaccines are drugs used as a preventive measure, given to   healthy persons.  . Adverse events following immunization   must be monitored more carefully than other drugs, the authors note. "A credible immunization safety evaluation and monitoring system is essential for the success of immunization programmes."   

Adverse reaction and deaths may not show up as significantly increased in small safety studies. However, records of all deaths and serious adverse events following vaccinations should be maintained and periodically reviewed for safety signals.     

According to the authors,  WHO's  new AEFI classification scheme "that allows for an outright denial of any new causative association with vaccination" could fall foul of Article 2 of the  European Convention on Human Rights. Adverse reaction and deaths may not show up as significantly increased in small safety studies. However, records of all deaths and serious adverse events following vaccinations should be maintained and periodically reviewed for safety signals.     

"Paradoxically, the AEFI algorithm is said to be for vaccine safety," says Puliyel. "Perhaps we need a scheme for public safety rather than vaccine safety." (END)

Jacob Puliyel MD MRCP M Phil

[email protected]

[This press release has been written with help from an experienced science reporter]

The article can be accessed here.

 https://f1000research.com/articles/7-243/v2

How to cite: Puliyel J and Naik P. Revised World Health Organization (WHO)’s causality assessment of adverse events following immunization—a critique. F1000Research2018, 7:243 (doi: 10.12688/f1000research.13694.2)