GLOBAL VIEW


Prevention plan


Pfizer’s vaccine PCV13 has been granted a patent for use in India but is unlikely to solve the pneumonia crisis


I


n 2016, India recorded nearly 300,000 deaths from pneumonia and diarrhoea. Pneumonia is the second largest killer of children in the country after diarrhoea. There are seven- pneumonia related and five diarrhoea-related deaths per 1000 live births, according to the Pneumonia and Diarrhoea Progress Report of 2016.


Published annually by the International


Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health in the US, the report notes that in 2015 these two diseases claimed the lives of nearly 1.5m children globally under the age of five. Nearly 16 years after the introduction of the


pneumococcal conjugate vaccines in 2000, its authors reported that five countries with the highest pneumonia burden – India, Indonesia, Chad, China and Somalia – were still not using the vaccines in their routine immunisation programmes. Taking heed, in 2017, India started with


a partial introduction of the pneumococcal conjugate vaccine (PCV) that protects against Haemophilus influenzae type b (Hib) pneumonia in five states. In May, the government revised the vaccination schedule for children and prioritised immunisation by introducing new vaccines into the country’s immunisation programme.


India included the pneumonia vaccine as


part of its Universal Immunisation Programme (UIP), which is one of the largest vaccine programmes in the world. The UIP aims to protect nearly 27m newborns against 12 preventable diseases every year, including severe forms of pneumococcal disease, such as pneumonia and meningitis. In the first phase, the UIP will cover approximately 5.15m babies: 20% of around 26m children of India’s birth cohort.


Earlier, these vaccines were accessible in the


private sector only to those who could afford the US$177/child price tag for all three doses. By making them available under the UIP, the government ensured equitable access to all who needed them most. India granted US drug giant Pfizer a


patent for its blockbuster pneumonia vaccine Prevenar13 (PCV13) in August 2017. Pfizer subsidiary Wyeth internationally applied for a patent for Prevenar13 in 2006, but its application was opposed both by Indian vaccine


maker Panacea Biotec and Medecins Sans Frontieres (MSF). PCV13 provides protection against 13 strains


of Streptococcus pneumoniae bacteria. This vaccine and GSK’s Synflorix are the only two pneumococcal conjugate vaccines available in India. Three months before being granted the


patent, PCV13 was only available to children in three states: Himachal Pradesh, Bihar and Uttar Pradesh. However, it will now be rolled out across all states in a special multi-dose vial format to enhance efficiencies in public immunisation programmes. However, MSF calls the patent granting a ‘major setback’ to improved access to an affordable pneumococcal conjugate vaccine. It argues that the patent allows Pfizer a monopoly to control the PCV13 market in India until 2026, and blocks Indian manufacturers from supplying a lower-priced version of the vaccine. In 2015, MSF had globally launched its ‘A


Fair Shot’ campaign to push for Pfizer and GSK to reduce the price of pneumonia vaccines to $5/child for all three doses. MSF is urging the government to issue a compulsory licence for the vaccine. The group had first challenged the patent and filed a patent opposition in March 2016, the first time that a vaccine (biosimilar) patent was challenged in India. Pfizer’s PCV13 and GSK’s Synflorix are priced


at approximately $59/dose and $28/dose, respectively, with three doses needed for full vaccination. However, PCV13 is to be rolled out in India given the ‘commodity assistance’ from GAVI, the global vaccine alliance. GAVI has committed $500m to India between 2016 and 2021. It is to purchase PCV13 at ca$7.61/child for a full vaccination. There are fears, however, that after GAVI pulls out in 2021, the Indian government may have to bear the full vaccine cost. In 2013- 2014, the US government was buying the same vaccine from Pfizer at ca$320 for a single child’s vaccination. The granting of the patent in India has also doused the expectations of Indian drug manufacturers like Serum Institute of India, Aurobindo Pharma and Panacea Biotec, which previously had an incentive to make a cheaper vaccine for the local market and for export. Pfizer’s patent allows it to continue controlling the PCV market in India until 2026.


A. Nair is a business journalist based in Mumbai, India


India


There are fears that, after GAVI pulls out in 2021, the Indian government may have to bear the full vaccine cost.


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