Prevenar 13, an advanced pneumococcal conjugate vaccine to protect infants and young children from pneumococcus, a bacteria that causes pneumonia, meningitis and sepsis has been launched in India.
Prevenar 13 provides the broadest serotype coverage of any pneumococcal conjugate vaccine, according to Kewal Handa, managing director, Wyeth (now part of Wyeth).
Prevnar 13 includes the seven serotypes in Prevenar plus six additional serotypes, which together represent the most prevalent invasive disease-causing strains in children, he stated.
Prevenar 13 vaccine covers serotypes 1 and 5 that are associated with complicated pneumonia. Further, it covers serotype 19A which has globally emerged a a leading cause of pneumococcal disease in children less than 5 years of age.
Prevenar 13 is administered in a 3-dose series for infants.
Currently, the cost of Prevenar 13 vaccine is Rs 3,800 in India and few emerging markets for the full 3-dose series.
Prevenar 13 has studied in more than 7,000 infants and young children worldwide.
The data from these trials have established the safety and efficacy of Prevenar 13 for the prevention of invasive pneumococccal disease in infants and young children, Wyeth (Pfizer) said in a press release.
Clinical trial data showed that Prevenar 13 can be administered with all routine paediatric vaccines.
Prevenar 13 covers approximately 75 per cent of disease-causing serotypes in India. Preventing this group of diseases is of utmost importance for two reasons – pneumococcal diseases are difficult to diagnose in the Indian context and, secondly, the bacteria are developing resistance to antibiotics, stated Dr Nitin Shah, consultant paediatrician at the P D Hinduja Hospital in Mumbai.
More than 30 lakh doses of Prevenar have been distributed worldwide, since its launch in 2000 in US.
Prevenar is part of the national immunization program in more than 47 countries. The vaccine is currently available in 98 countries.
More than two million children die from pneumonia every year. Only about half of children sick with pneumonia receive appropriate medical care and fewer than 20 per cent of children with pneumonia receive the recommended treatment of antibiotics, according to Dr Shah.
The World Health Organization (WHO) has sought the inclusion of Prevenar in the National Immunization programs of developing countries as a high priority especially where under 5 mortality is more than 50 per 1,000 live births or where more than 50,000 children die annually. In India the under five mortality is 69 per 1,000 live births and 4.10 lakh children die annually just from pneumonia.
It has to be recalled that clinical trials of Prevenar vaccine trials by the domestic unit of Wyeth Inc. were suspended by India’s drug regulator after reports of death of an infant on whom the vaccine was tested in a trial site in Bangalore last year.
The child had a pre-existing cardiac disorder. The inclusion of an infant with a cardiac condition in the Wyeth vaccine test violated India’s drug testing rules, said the Drug Controller General of India (DCGI) as a reason for suspending all the Prevnar trials across the country.
Wyeth’s phase III trial was part of global clinical trials to assess the safety, tolerability and immunogenicity of the improvised version of pneumococcal conjugate vaccine that fights 13 strains of bacteria compared with seven strains in the company’s current Prevnar.
The vaccine trial was comparing efficacy of Prevenar and the new variant.
Wyeth. however, had maintained that the child who died had been administered Prevenar and not the new 13-strain variant.
“The event occurred in the control group, which used the current worldwide standard vaccine for prevention of pneumococcal disease and which has been administered safely more than 200 million times worldwide during the past seven years,” a company spokesperson had said.
However, the ban on Prevnar trials was lifted in May this year and allowed Wyeth and its CRO GVK Biosciences Pvt. Ltd, the Hyderbad-based clinical research organization to carry on with the trials
Similarly, Prevnar (Prevenar) vaccine batch was suspended in The Netherlands following the death of three infants in November last year.
On batch of Prevenar (Prevnar is sold under the brand name Prevenar in EU countries), has been pulled out the Netherland’s market after three infants died within two weeks of getting the vaccine, Dutch health institute RIVM said.
Prevnar is a vaccine to provide immunity against the invasive pneumococcal disease in infants is marketed by Wyeth, which has just been acquired by the world’s largest drug maker Pfizer, worldwide.
Wyeth has ordered the suspension of Prevenar vaccines with batch number D66977, following the reports of infant deaths.
Even though about 5 to 10 deaths are reported annually after babies get vaccines on average, the three cases of infant deaths in a short period is unusual, RIVM sources were quoted as saying.