Pfizer has got a pneumonia vaccine patent. Will this hurt India’s immunisation programme?

On August 11, the Delhi Patent Office granted a patent to Pfizer’s vaccine against pneumonia. 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. 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, the Union health ministry said.

Currently, the government’s pneumonia vaccine programme is being funded by the Global Alliance of Vaccines and Immunisation or GAVI, an international organisation created to increase access to vaccines for children. The alliance will continue its financial support of the pneumonia programme for the next three years.

But how critical is the vaccine to controlling pneumonia in India?

Dr Yogesh Jain from the Jan Swasthya Sahyog, a non-profit public health organisation in Chhattisgarh, said that if pneumonia is detected early, it is easy to treat. “We need a better programme to detect and treat pneumonia,” he said.

This would make the government programme less reliant on an expensive vaccine.

“The vaccine is currently very expensive,” said Jain. If the government has to pay market prices for the vaccine, it will take the money away from programmes tackling malaria or tuberculosis, he added.

Pfizer and GlaxoSmithKline have the duopoly on the pneumonia vaccine market, said the international medical non-profit Médecins Sans Frontières. While Pfizer’s vaccine, called PCV13 and marketed as Prevnar13, is supposed to provide protection against 13 strains of the the streptococcus pneumoniae bacteria, GlaxoSmithKline’s product can provide protection against 10 strains. GlaxoSmithKline also has a patent for its vaccine for another decade.

“In the period of exclusivity, the price of the product is determined by the producer,” said Zakir Thomas, an expert in Intellectual Property Rights. “There is no competition in the market which will help the price come down.”

In 2016, MSF challenged Pfizer’s patent application after a similar such application was revoked by the European Patent Office, the organisation said in a statement. The organisation added that the pneumonia vaccine patents are being legally challenged in South Korea and before the United States Patent Trademark Appeal Board.

The pneumonia burden

Pneumonia caused nearly 175,000 child deaths in India in 2013, according to a report by the John Hopkins Bloomberg School of Public Health. 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 five years of age in India. The health ministry said that the introduction of the vaccine will substantially reduce the country’s disease burden.

“The affordability of this vaccine has always been a concern,” said Dr Rohit Agrawal from the Indian Academy of Pediatrics. “The irony is the poorest of the poor need this vaccine more.”

In 2007, Wyeth LLC, a subsidiary of Pfizer Incorporated, filed a patent application with the Delhi Patent Office for its multivalent pneumococcal vaccine. MSF and a pharmaceutical company in Delhi, Panacea Biotech, opposed the application. Panacea Biotech is in the process conducting trials for its pneumonia vaccine. The company is yet to respond to queries by Scroll.in about the possible impact of Pfizer’s patent on their vaccine.

Once a patent is granted to a drug manufacturer, other drug makers can make and market similar products only if they are granted a compulsory licence by the government. The government can adopt this process for essential and life-saving drugs if the patented invention is not available to the public at a reasonable price. However, the government can only grant a compulsory licence three years after the patent is granted. So far, only one compulsory licence has been granted in India.

Basis of the patent

Wyeth claimed, as the basis of its patent application, that its vaccine had the advantage of being able to provide protection against 13 strains of the pneumonia bacterium using a single protein carrier. A Pfizer spokesperson said, “Supported by extensive clinical research and real-world experience, each dose of PCV13 requires 400 different raw materials, 580 manufacturing steps, 678 quality tests and two and a half years to produce.”

MSF, however, claimed that Pfizer should not have been granted a patent simply for producing a vaccine for a larger number of strains since their method was not innovative enough.

Leena Menghaney, South Asia head for MSF’s Access Campaign, said: “The method Pfizer is trying to patent is too obvious to deserve a patent under Indian law, and is just a way to guarantee an extended market monopoly for the corporation for many years to come.”

Dr Amulya Panda from National Institute of Immunology in an affidavit to the Delhi Patent Office said that the process of conjugating serotypes in a specific protein that has been employed in the manufacture of the PCV3 vaccine is already well known. In his view, the claims made by Wyeth are not inventive and are insufficient basis for a patent.

Currently, the Pfizer vaccine is what most pediatricians in India prescribe for protection against pneumonia. The Pfizer vaccine also acts against penicillin-resistant bacteria. The World Health Organisation has approved the use of both vaccines to prevent pneumonia in children.

GAVI support for three years

The Global Alliance of Vaccines and Immunisation has committed Rs 2.79 crores this year for the roll out of pneumococcal vaccine across India as part of the Universal Immunisation Programme. For 2018, and 2019, GAVI has pledged Rs 8.10 crores and Rs 7.09 crores respectively.

These funds are limited and cannot cover the entire country’s programme, said Dr Pradeep Haldar, deputy commissioner of the health ministry’s immunisation division.

“We will not be purchasing this vaccine for three years,” said Haldar. “After three years, we will buy the vaccine from the market.”

The government has not yet decided how it will procure the vaccine from the market once GAVI withdraws its financial support, said Haldar. However, he is confident that the price of the vaccine will come down in three years. He cited the example of the pentavalent vaccine – used against diphtheria, tetanus, whooping cough, hepatitis B and Haemophilus influenzae type B – the price of which stabilised over two years. But, the pentavalent vaccine is not under patent.

A Pfizer spokesperson said that the company “remains committed towards further enhancing access of this vaccine in India, both in the market as well as through partnership with the Government to expand introduction in the public programme”.