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Pfizer’s Pneumonia Vaccine Patent Major Blow Immunisation Programme

Hopes for improved access to an affordable pneumococcal vaccine that safeguards both children and adults from pneumonia, has suffered a major blow in the wake of the Indian patent office granting a patent to the US drug major Pfizer, for its PCV13 product, marketed as Prevnar13.

Pneumonia caused by the streptococcus pneumoniae bacteria accounts for approximately 16% of all the pneumonia cases and 30% of all the pneumonia-related deaths in children under the age of five in India. Pneumonia caused nearly 175,000 child deaths in India in 2013, according to a report by the John Hopkins Bloomberg School of Public Health.

The pneumococcal conjugate vaccine or PCV against pneumonia, which has been in the market for seven years, is being sold for an exorbitant Rs 11,400 for three doses. Domestic vaccine manufacturers had announced that they could supply PCV for a much lower price.

Further, the vaccine was recently introduced in India’s Universal Immunisation Programme and the government currently gets international funding to buy it.

But Pfizer’s patent, which lasts till 2026, gives the company exclusive rights to sell the vaccine at a price that it determines.

This could make the the vaccine unaffordable for the government, which will have to procure it from

the market without financial assistance starting from 2019.

In May, the Union Health Ministry rolled out the vaccine in three states. The vaccine is currently being administered to approximately 21 lakh children in Himachal Pradesh, in 17 districts in Bihar and six districts in Uttar Pradesh. Next year, the government plans to start administering the vaccine in Madhya Pradesh and Rajasthan and will expand the programme to the rest of the country in a phased manner.

A lower-priced PCV vaccine is critically important to increase vaccine coverage across the entire country in the coming years.

“It’s unfair and unacceptable that almost a million children die each year from pneumonia, even though a life-saving vaccine is available. Children everywhere have a right to be protected from pneumonia, but many governments can’t afford the prices set by Pfizer,” said Dr Prince Mathew, Asia regional coordinator for MSF. “We urgently need additional manufacturers to rapidly introduce competition with the aim of lowering vaccine prices.”
Since Pfizer’s patent allows it to continue controlling the PCV market in India until 2026, manufacturers will have to find new routes to develop a non-infringing PCV vaccine which may delay the availability of competing products in the pipeline from domestic producers.

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