Vaccines that don't arrive

The vaccine market is an oligopoly centered around four large companies. If a laboratory runs into production problems, countries have few alternatives to satisfy demand.

By Miguel Ángel Gavilanes

February 16, 2017

In Coffee Bay, on the Indian Ocean coast of South Africa, some 250 kilometres south of Durban, a mother takes her son to be vaccinated at the closest public clinic, in Mapuzi. She has tried three times now, but there are never vaccines available. After these three unsuccessful trips, she gives up and does not return to the clinic again. Her baby had only received the vaccines given to him at birth.

When the child becomes ill, his chastened mother decides to take a taxi and visit a private clinic in Mqanduli, 65 kilometres away. The doctor gives them a prescription for the child’s cough and sends them home. The child’s health does not improve, however, and his mother decides to take him to the hospital. But it is too late. The baby dies before they arrive. “The mother could not clearly describe the symptoms, although I suspect that her son died from pneumonia”, said Karl le Roux, doctor and researcher from Zithuele hospital. In 2013, during a study that analysed immunization and the impact of vaccine shortages in the community, le Roux interviewed this mother in the rondavel (a traditional South African hut) where they lived, near to the estuary of the river Mthatha. “It’s more likely that the baby could have survived” if they had gone to hospital straight away, considered the doctor, adding that “it is very difficult to know whether this was a pneumonia that was vaccine-preventable”. Due to the vaccine stockouts the mother “lost faith in the public health sector”, said le Roux.

Lack of vaccines is one of the biggest problems for immunization in South Africa. The shortage of antigens is influenced by external problems, such as issues with pharmaceutical production, and internal problems, such as poor management of stock, poor training, or staff shortages. It is a complex subject, in which the causes converge but there are many parties at fault.

Everyone agrees that these shortages are a global problem, due to the fact that the vaccines are developed by just a handful of companies, those with sufficient human and financial capacity. If one of these companies has production problems, countries have few alternatives to satisfy their needs. In cases of high demand, the market becomes saturated and the companies are unable to fulfill orders from countries. Whilst certain, this excuse restricts liability to uncontrollable, external, factors. Internal factors are not addressed and are only reported by healthcare staff.

On a global level, according to World Health Organization data (WHO), 97 countries reported they were left without at least one of the essential vaccines in 2015 (the last year for which data is available) either on a national level on in certain areas. In Africa, 66% of countries acknowledged supply disruption. In America and Europe, one in every two countries admitted having suffered this problem. Taking into account the fact that not all countries communicate this information to the WHO, the real number of countries without vaccines at any moment could be greater still.

Out of stock against tuberculosis

The anti-tuberculosis BCG vaccine is a prime example of supply problems, caused by a production failures in one of the main labs of this vaccine, Statens Serum Institute, based in Denmark. Due to global shortages, in 2015 54 countries reported stock shortages. The majority of these countries are in Africa (21) and Europe (14). In 2015, UNICEF, who supply the vaccine to countries where tuberculosis is endemic, reported a global supply shortage of 16.5 million doses. Beyond the crisis that year, many countries have been lacking the BCG vaccine for over a decade.

Stockouts of anti tuberculosis vaccine

Number of years in the last decade in which stockouts were reported to the WHO

Currently, stock problems with the tuberculosis vaccine persist, even in countries that had never previously reported a shortage of the antigen to the WHO, such as Spain, Australia and France. In the latter case, where the vaccine is no longer obligatory since 2007, Sanofi Pasteur (the French pharmaceutical company specialised in vaccines) diverted stock destined for the Polish market in order to satisfy domestic demand. This diversion was introduced as an “interim measure” in March 2016.

In South Africa, the BCG vaccine is especially relevant, and its shortage is “a real problem”, according to Doctor Anban Pillay, Deputy Director of the Department of Health. Although its effectiveness is limited against pulmonary tuberculosis, its most common manifestation, the WHO recommends its administration to new born babies in countries where the incidence (morbility) of tuberculosis is high. In South Africa, morbility is huge: with 834 cases for every 100,000 people, the country has the highest rates of this disease, often compounded by the impact of HIV.

Tuberculosis incidence

Cases per 100,000 inhabitants in 2015

By ourselves we could never solve the BCG problem”, acknowledged the Deputy Director of the Department of Health. To tackle it, the last World Health Assembly passed a resolution to deal with the lack of medicines and vaccines. The document advocates the development of a new centralised repository of stockout data. With that, “the WHO is suppossed to go to manufacturers and say ‘here is the entire volume of the world, can you please start producing to be sure that you get the business?’”, explains Anban Pillay.

Anban Pillay, from the National Department of Health of South Africa. | Video: Serusha Govender.

The BCG vaccine supply crisis is worsened by the concentration of production in few companies. And low profit margins make it an unattractive venture for other laboratories which have the capacity to produce it, appoints Pillay. The oligopoly of the global vaccine industry is even more concentrated: Sanofi Pasteur, Merck, Pfizer and GlaxoSmithKline add up to around 80% of the global sales.

Bexsero stockout in the EU

Bexsero, the only vaccine available in the European Union against Meningitis B, the most common serogroup in the continent, is currently suffering distribution problems. The antigen, produced by GlaxoSmithKline (GSK) is approved in over 35 countries, including the EU member states, Argentina, Chile, Uruguay, Canada, Brazil and the USA. Meanwhile the latter country has an alternative, Trumemba. In Spain, where the vaccine is recommended but unsubsidised, pharmacies have waiting lists of up to six months to obtain a dose (at a retail price of 105€). GSK Spain asserts that they will receive new doses in the second quarter of 2017. Other GSK subsidiaries have also reported manufacturing problems, like Australia and the United Kingdom, due to “unanticipated global demand”.

Lack of control in South Africa

In South Africa, provinces that default on their payments for vaccines are another of the broken links in the supply chain, according to Shabir Madhi, director of the National Institute for Communicable Diseases (NICD).

The South African government negotiates the prices, and Biovac, a public-private partnership, receives the raw materials from the labs. In their premises in Cape Town, they fill vials and distribute the orders received from provinces. Both Madhi and Pillay claim that Biovac has frozen supply to certain provinces which have not paid past orders.

Morena Makhoana, CEO of The Biovac Institute. | Vídeo: Anne Gonschorek.

Once vaccines have been distributed to South African local facilities, the stock management problems begin to arise. Karl le Roux, doctor and researcher from Zithuele hospital, analysed the causes and effects of vaccines stockouts in the OR Tambo district, in the Eastern Cape province. According to his research, the shortages are due to a lack of space in the clinics, inadequate stock management systems, overworked staff and poorly trained nurses (that make orders for inadequate quantities), lack of responsibility in the provincial storage and theft.

Moreover, bad road conditions and the distance from storage facilities to healthcare centres are even more important in rural areas. Le Roux tells, for example, that there are 90 kilometres of very poor roads between Zithuele hospital and its medicine depot.

For this rural doctor, “it is frustrating not being able to offer a patient what you know they need”. As soon as there is a shortage of vaccines, the centres are swamped as patients have to return. Le Roux’s research shows that the lack of vaccines in clinics resulted in 56% of children not completing their immunization courses, according to their mothers.

Unreliable data

Johann Van der Heever, who managed the South African immunization programme for 11 years, blames the lack of control squarely on the Department of Health: “You have to staff the chain adequately, you have to provide equipment, supervision and monitoring which is a function of the National Department”.

Johann van der Heever, former Manager of the immunization program of South Africa. | Video: Serusha Govender.

In an article in the South African Medical Journal magazine, which cites Van der Heever’s criticisms of the national immunization programme and condemns the government’s neglect, the national cold-chain manager (a critical system for the conservation of the antigens) admits that they were only able to inspect between 5% and 10% of the facilities. Van der Heever regrets that, despite the fact that controlling the deterioration of vaccines was one of his priorities, the wastage is unknown, as it “requires very good supervision and support”.

“One of the big problems that we have is that manufacturers have been aware that they have a shortage, but they have not been willing to share that information, unlike in the United States or in Europe, where they are obliged by law”, alleges the Deputy Director of the Department of Health, Anban Pillay. Given the time required to produce each vaccine, both internal and external information is imperative in order to avoid stockouts. “You can only be foresighted if you have the information”, states the healthcare manager.

The only way to gather real knowledge is through the Stop Stockouts Project (SSP), a platform that monitors the lack of medicines and vaccines in South Africa. Behind the project are organisations such as Médecins Sans Frontières, the Treatment Action Campaign and the Rural Health Advocacy Project, which created the campaign in light of the persistent lack of antiretroviral drugs in the country with the highest number of HIV cases in the world (over 6.9 million people): one in five adults is seropositive.

At the end of each year, SSP conducts a telephone interview about vaccines and stockouts with over 2,400 of the 3,547 healthcare centres that they have identified across the country. Whilst Jacob Zuma’s government only reported to the WHO in 2015 stock issues with the BCG vaccine, Stop Stockouts recorded that 9% of healthcare centres contacted did not have the combined vaccine (composed of the DPT vaccine and the ones against Polio, Hib and Hepatitis B) available; 4% did not have the rotavirus vaccine available and 3% had a shortage of measles vaccines.

Data is indispensable to control the existence of vaccines in stores, to know when to make an efficient order for a clinic and to design effective vaccination campaigns that avoid possible outbreaks in communities with low immunization rates. Coordinated administration and the shouldering of responsibilities is vital to avoid shortages and stockouts of vaccines nationwide. But above all, South Africa cannot allow its people to lose faith in its healthcare system.

South Africa: managing in the dark

Shabir Madhi, Executive Director of the National Institute of Contagious Diseases. | Video: Serusha Govender. Edition: Miguel Ángel Gavilanes.

Problems with data in South Africa do not only affect stock levels; the most basic data, such as immunization rates, are not reliable. The lack of an up-to-date and detailed survey on vaccination coverage makes it impossible to control and avoid possible outbreaks, according to Shabir Madhi of the National Institute of Contagious Diseases in South Africa, as it is not known in which areas immunization is lower than recommended. “We do not know the actual coverage against measles,” laments Madhi. In addition, the WHO reduces by more than 20 points the levels of coverage that South Africa presents to them. Madhi, who estimates that the real figure must be between both values, urges to carry out a new survey to solve this situation.

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