www.thelancet.com Vol 370 July 14, 2007 Pages 129-30
Protective efficacy of a monovalent oral type 1 poliovirus vaccine
We the undersigned are shocked and dismayed that the Lancet should have published the paper on the protective efficacy of monovalent oral type 1 poliovirus vaccine by Grassly et al (April 21, p1356)1, having overlooked the serious ethical issues involved.
The article describes how the international oversight body on polio eradication recommended the rapid development licensing and introduction of a new monovalent type 1 oral vaccine for India. The WHO (and its organ, The National Polio Surveillance Project (NPSP), from where some of the authorship of this article was drawn) was party to this accelerated introduction of the new vaccine in the country. What was introduced, according to this article, was a new vaccine that was five times more potent than previous vaccines, presumably also with increased likelihood of adverse effects. No informed consent was taken nor was the public told that the vaccine was experimental. In fact the truth was carefully hidden from the public and the doctors in India. Efforts were made to give the impression that the monovalent vaccine was not new but just the monovalent vaccine used in the 1960s, before the introduction of the trivalent vaccine2. This was exactly what was stated and propagated to the public through an article published in the journal of the Indian Medical Association and circulated to 178,000 doctors in the country2.
The oversight body which introduced this vaccine should have monitored adverse effects also. Now the oversight body, who set up this massive experiment on human subjects without informed consent, have published a paper without ethics approval, saying it was not a prospective intervention study. In the absence of proper post-vaccination surveillance of adverse effects we have to rely on indirect evidence of possible adverse effects available from the NPSP3. Data from Uttar Pradesh (where Grassly and colleagues show improved vaccine efficacy) shows an increase in the incidence of non-polio acute flaccid paralysis since the introduction of the monovalent vaccine3.
Jacob Puliyel, C Sathyamala, D Banerji.
St Stephens Hospital, Delhi 110054, India (JP);
Public Report on Health,
Council for Social Development,
53 Lodhi Estate New Delhi (CS) and
Centre for Social Medicine and Community Health,
Jawaharlal Nehru University,
New Delhi, India (DB)