India has put on hold its plans to introduce five-in-one or pentavalent vaccines under the national immunisation programme, after doubts were raised over the need for universal vaccination for some of the diseases covered by the vaccine.
The move has dampened the hopes of at least five vaccine makers who were expecting bulk orders from the central government.
The Geneva-based Global Alliance for Vaccines and Immunisation (Gavi) had already committed a grant of $165 million (about Rs 770 crore) to immunise over 18 million children with the pentavalent vaccine in 10 states of the country.
Sanofi Aventis, Shantha Biotech, Serum Institute of India, Bharat Biotech and Panacea Biotech are among the major companies that had introduced pentavalent vaccines in the domestic market.
The pentavalent vaccine protects against diphtheria, tetanus, pertussis (whooping cough), hepatitis B, and Haemophilus influenzae Type B (often known as Hib) which causes some severe forms of pneumonia and meningitis.
The government has asked an expert committee headed by Indian Council of Medical Research (ICMR) chief V M Katoch to analyse the prevalence of the diseases covered by the vaccine in the country, and the mortality rates, before a large-scale immunisation drive is launched.
Gavi had announced in August last year that it would fund the first two years of pentavalent vaccine introduction in India after the National Technical Advisory Group on Immunisation (NTAGI) under the health ministry recommended the inclusion of these vaccines in the national immunisation programme.
NTAGI has members drawn from various ministries, professional bodies and research organisations, including ICMR.
NTAGI had not taken into account a major study carried out by ICMR, with Gavi support, to understand the incidence of deaths among children under five years due to pneumonia.
“NTAGI had made a recommendation that omitted data from a ICMR Gavi multi-centric study that showed the actual incidence of death due to pneumonia was 1/50 of what was projected by NTAGI to recommend the introduction of pentavalent vaccine,” Jacob Puliyel, Head, pediatrics department, St Stephens Hospital, Delhi said.
“Because of selective reporting, the death rate was projected as 14 per 1,000 while the ICMR-Gavi study had found the incidence of death among children aged under five to be 0.3 per 1,000 children. That one study negates the need for two vaccines NTAGI was trying to promote through the introduction of pentavalent vaccine,” Puliyel said.
Health ministry officials said NTAGI has only an advisory role and the government is now reviewing its recommendation.
“It is true that Gavi has agreed to fund the programme. But, we need approvals from the expenditure finance committee and the Cabinet before it can actually be rolled out. The ministry will decide whether to approach EFC and the Cabinet after the review committee submits its report”, a senior ministry official said.
The Katoch committee is to hold its first meeting on February 16.
