Investigating vaccine deaths to be managed primarily by national government: WHO
A national policy for vaccines is now being discussed by the government of India. One of the policy initiatives is to change the way adverse events following immunisation (AEFI) are classified. The standard method used is the Brighton classification system, which is endorsed by the Wotld Health Organisation WHO also. However, the classification proposed by the government seems to suggest that if a vaccine is tested in a lab following an adverse event and it is found that the vaccine is not contaminated, then the adverse event will be declared to be unrelated to the vaccine. This seems contrary to the standard WHO recommendation. The WHO elaborated on its stance on AEFI classication when asked about the govermment’s proposed changes in the classification system.
Here is what WHO had to say:
Is the WHO still going by the Brighton classification of Adverse Effects Following Immunization? When did WHO accept the Brighton classification?
The Brighton Collaboration is an independent network which provides, through working groups of experts with relevant experience in patient care, public health, clinical trials, safety surveillance and safety assessment, standardized clinical case definitions for adverse events following immunisation, or AEFI (such as anaphylaxis, fever and fatigue). Brighton case definitions for diseases or clinical syndromes and associated guidelines are intended to enhance data comparability within and across clinical trials, surveillance systems, and post-licensure clinical studies. They neither provide a causal assessment of a given adverse event with immunisation, nor are they intended to establish criteria for management of patients. The case definitions are designed to define the levels of diagnostic certainty of reported adverse events following immunisation.
WHO has been supporting the work of the Brighton Collaboration for over a decade and continues to do so. FYI, BC milestones can be found here.
How are AEFIs classified according to the Brighton classification if the WHO is still using it? Or, has the WHO come up with a new classification method? Is yes, please share the new method, its classification system and rationale?
See this link for more information on the work of the Brighton Collaboration. The WHO continues to recommend that national and sub-national immunisation managers use the WHO Aide-Mémoire on AEFI causality assessment as a guide to systematic, standardised causality assessment for serious AEFI. The categorisation outlined within this document is just one of a number of classification schemes used by regulatory and safety expert groups, and furthermore is not intended to be used without consideration of other factors. As is standard procedure in causality assessments, it is important that each case is assessed based on available clinical, laboratory and autopsy findings for each case, epidemiological factors, and the current vaccine safety knowledge with respect to similar clinical events reported following immunisation.
Isn’t Brighton classification the standard one used by majority of the countries around the world, especially the developed countries?
The WHO does not collect information on which countries are using the case definitions established by the Brighton Collaboration. For information on how the Brighton Collaboration communicates about its work, see here. While the WHO provides support to countries in capacity building for effective monitoring and management of serious AEFIs, through guidelines and training, it is ultimately the responsibility of national authorities to initiate and manage investigations. The WHO can and does provide support in conducting such investigations when requested by national authorities.
The government of India seems to be looking at a different system of classification in its draft vaccine policy. Does WHO endorse the new system? Or is the government of India trying to water down the classification system on its own? Will the WHO intervene to ensure that the Government of India continues to use the classification standards used across the world?
The National Vaccine Policy is being drafted by the Government of India, WHO will provide its comments to the government when requested.