Abstract
The most effective treatment for diphtheria is swift administration of diphtheria antitoxin (DAT) with conjunct antibiotic therapy. DAT is an equine immunoglobulin preparation and listed among the World Health Organization Essential Medicines. Essential Medicines should be available in functioning health systems at all times in adequate amounts, in appropriate dosage forms, with assured quality, and at prices individuals and the community can afford. However, DAT is in scarce supply and frequently unavailable to patients because of discontinued production in several countries, low economic viability, and high regulatory requirements for the safe manufacture of blood-derived products. DAT is also a cornerstone of diphtheria diagnostics but several diagnostic reference laboratories across the European Union (EU) and elsewhere routinely face problems in sourcing DAT for toxigenicity testing. Overall, global access to DAT for both therapeutic and diagnostic applications seems inadequate. Therefore--besides efforts to improve the current supply of DAT--accelerated research and development of alternatives including monoclonal antibodies for therapy and molecular-based methods for diagnostics are required. Given the rarity of the disease, it would be useful to organise a small stockpile centrally for all EU countries and to maintain an inventory of DAT availability within and between countries.
Highlights
Diphtheria is an acute bacterial infection of pharynx, larynx, tonsils, nose and occasionally other mucous membranes or skin [1]
We identified references for this review through searches in PubMed and Google Scholar databases with the terms ‘diphtheria’, ’antiserum’, ‘passive immunity/immunization’, ‘World Health Organization (WHO) Essential Medicines’, and ‘monoclonal antibodies’
Diphtheria continues to be a health threat and lack of access to diphtheria antitoxin (DAT) substantially increases the likelihood of mortality, highlighted recently in outbreaks in southeast Asia and in the 1990s during the epidemic in the eastern part of the WHO European Region
Summary
Diphtheria is an acute bacterial infection of pharynx, larynx, tonsils, nose and occasionally other mucous membranes or skin [1]. Serum therapy was born in 1890 when Behring and Kitasato [8] showed that passive immunisation with tetanus and diphtheria antisera could protect against these bacterial diseases (Figure 1). Following Geissler’s first successful DAT treatment of an infected child, Pasteur Institute scientist Emile Roux carried out a large-scale trial of DAT therapy in 1894 in Paris (Figure 1) This trial demonstrated distinct differences between the mortality rates in 448 treated children (24,5%) and in 520 untreated children (60%), respectively [9,11]. Being aware of recent changes in production of DAT that could bring about a lack of antitoxin for treatment Table 1 Sera and immunoglobulins included in the World Health Organization Essential Medicines List for Children [13].
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