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Federal vaccine production laboratory rots away



Federal vaccine production laboratory rots away

Vaccine shortage: Killer diseases thrive

Despite the need for mass vaccination against killer diseases and global shortage of vaccines, rodents feast on Nigeria’s 69-year-old Vaccine Production Laboratory in Lagos, reports APPOLONIA ADEYEMI

Access to the Medical Lab as that facility is called by staff within Yaba locality tells the story. From the main entrance at the gate into the facility where vaccines were first produced in Nigeria, weeds have taken over. It is indeed an isolated facility. Although the building is painted white, exposure to persistent rain for over 50 years has washed the paints off, leaving the structure abandoned.

This is the current state of the Federal Vaccine Production Laboratory (FVPL), Yaba, Lagos, where the production of human vaccines started with the introduction of smallpox and yellow fever (YF) vaccines in 1947. When smallpox was declared eradicated in 1980 by the World Health Organisation (WHO), the production of smallpox vaccine was stopped, but FVPL continued to produce YF vaccines until 1986.

The first batch of YF vaccine employed to control the 1986 yellow fever outbreak in Nigeria was the locally produced in Yaba.

However, when the epidemic escalated, spreading through many states in Nigeria, the local production of about five million doses annually and the poor thermo-stability of the vaccine, prompted Nigeria to seek assistance, collaboration and funding for increased production from five to 20 million doses.

An international advisory team led by WHO provided guidelines for upgrading the Yaba facility and building a new one to meet the projected annual production of 20 million YF doses.

The Canadian agency IDRC provided funding, while staff of the FVPL were sent to the Oswaldo Cruz Foundation Laboratories in Brazil for training. Giving an insight into why the plan to upgrade that facility was not feasible, a foremost virologist and President of the Nigerian Academy of Science (NAS), Prof. Oyewale Tomori, blamed it on poor planning, excruciating government bureaucracy and conflict of interests.

It means that the upgrading of the old FPVL did not materialise and the new facility was not completed.

This setback warranted other agencies to take responsibility of procuring needed vaccines for the prevention of diseases in Nigeria. A vaccine is a biological preparation that provides active acquired immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing micro-organism and it is often made from weakened or killed forms of the microbe, its toxins or one of its surface proteins.

The agent stimulates the body’s immune system to recognise the agent as a threat, destroys  it, and keeps a record of it, so that the immune system can more easily recognise and destroy any of these micro-organisms that it later encounters.

The effectiveness of vaccination has been widely studied and verified; for example, the influenza vaccine, the Human Papiloma Virus (HPV) vaccine, and the chicken pox vaccine.

Vaccination is the most effective method of preventing infectious diseases; widespread immunity due to vaccination is largely responsible for the worldwide eradication of smallpox and the restriction of diseases such as, polio, measles, and tetanus from various parts of the world.

WHO reports that licensed vaccines are currently available to prevent or contribute to the prevention and control of 25 infections. In another example, in 2012 Nigeria accounted for more than half of all polio cases worldwide. Efforts made to completely eradicate polio from Nigeria resulted in the immunisation of every child under five across the country.

To further corroborate the effectiveness of vaccines in tackling childhood killer diseases, the Partnership for Advocacy in Child and Family Health (PACFAH), while commemorating the 2016 Africa Vaccination Week in April, observed that Nigeria had recorded significant progress in reducing childhood mortality and that vaccines were the significant contributor.

“New vaccines such as the Pentavalent vaccine have been introduced and Routine Immunisation (RI) coverage has improved significantly from about 48 per cent to 50 per cent in 2012 and 2013, to coverage of 87 per cent nationwide in 2014.”

Although the Federal Government plans to introduce five new life-saving vaccines between 2014 and 2018, PACFA, a non-profit organisation, stated that the updated Routine Immunisation programme could save 1.2 million lives between 2015 and 2020, compared with the current programme.

“We are cautioning that delaying introduction of the new vaccines by one year will result in about 5,000 more deaths between 2015 and 2020; delaying by two years would result in 50,000 more deaths within the same period; and, choosing not to introduce or sustain key vaccines will result in fewer lives saved,” says PACFAH in a statement.

No doubt, vaccines are crucial life-saving measures for both children and adults. But concerns are already being raised about the future supply of vaccines. Stephen Jarrett, deputy director, UNICEF Supply Division, said UNICEF met around 40 per cent of the global demand for children’s vaccines. In 2002, UNICEF procured over two billion doses of vaccine for nearly 100 developing countries.

“We have already had several temporary vaccine shortages and it seems to be becoming a global problem,” Jarrett added.

The shortage of meningitis B vaccine has been reported in the United Kingdom. As at May 16, new jabs were sent to private clinics so parents could get their children vaccinated following a global shortage. A spokeswoman for GlaxoSmithKline (GSK) which produces the drug recently confirmed that new stocks of the jab Bexsero would be available from June 2016. A global shortage meant the jab has been unavailable since the start of the year.

UK is not the only country experiencing shortage of vaccine. Nigeria has also experienced shortage of some vaccines including measles and yellow fever vaccines. In February 2014, the Nigerian Science Academy (NAS) warned of shortage of measles vaccines and alerted that the country risked the scarcity of measles vaccine, which could result in hundreds of under-five deaths, if urgent action was not taken, as the current stock would run out by mid-April of that year. NAS in a statement, therefore, called on the government to urgently release money for the importation of the vaccines to avoid the negative experiences of the last three years.

In 2013, Nigeria experienced a major measles vaccine shortage resulting in 57,892 measles cases with 348 deaths.

The current outbreak of yellow fever in Angola and Democratic Republic of Congo (DRC) and the shortage of YF vaccines in those countries are the manifestations that global vaccine shortage is real.

Three years ago, the National Primary Health Care Development Agency (NPHCDA) warned that as many as 101 million Nigerians were at risk of a possible outbreak of yellow fever, if a mass vaccination campaign was not carried out. Tomori, Chairman of Nigeria’s Expert Review Committee on polio, said: “If we have not done a mass vaccination campaign, it means we have a large number of people who are vulnerable.”

The warning came amidst a recent outbreak of yellow fever in six districts of Cameroon bordering Cross River State, which places Nigeria at risk because it is the only country among 13 in West Africa yet to conduct mass vaccination. However, explaining global shortage of vaccines, Jarreth said in the last five to six years, industrialised countries started to use different vaccines than those used in most developing countries. Two examples of this are the vaccines for pertussis (whooping cough) and measles.

For example, the price for a dose of combined measles, mumps and rubella vaccine (MMR) can be as high as $28 in the United States, while UNICEF buys a single dose of measles vaccine that costs 10 cents.

A third vaccine, Bacille Calmette-Guérin (BCG), which is used for childhood tuberculosis, is no longer in use by many industrialised countries because of the relatively low prevalence of the disease in their own environment. The question is why does Nigeria not look inwards to produce needed vaccines? Why does it choose to depend 100 per cent on imported vaccines that are manufactured abroad?

Tomori told the New Telegraph that there were plans to re-start local vaccine production. He said: “Every administration in Nigeria since 2004 has vowed to start producing vaccine locally but those pronouncements have ended as mere statements.

“In 2005, Biovaccines Nigeria Limited, a joint partnership venture between the Federal Government and May and Baker Nigeria Plc, was set up. The hope was that Nigeria would save at least US$4 billion annually through local production of vaccines.

“The change of government in 2007 saw the death of the project. By that time the board was dissolved, some efforts had been made to get the project started. A parcel of land had been acquired in Ota, Ogun State on which to build the production facilities that would meet the WHO standards. In addition, discussions with an external partner vaccine- manufacturing company had reached final stages before the board was dissolved and never re-constituted. “As long as government has its bureaucratic two left hands in the project of vaccine production, it will never take off.” Tomori also advised that Nigeria should change from the public-private partnership (PPP) to a fully private venture for vaccine production.

“Vaccine production is too serious and delicate a project to be incapacitated by a board consisting of people whose main intent is not vaccine production but a minting factory for selfish acquisition.

“Nigeria needs a strong, independent and competent national regulatory and control system, a revamped National Agency for Food and Drug Administration and Control (NAFDAC), and a company with a viable business plan to guarantee good vaccine production,” On their part, drug producers, under the auspices of the Pharmaceutical Manufacturers Group of Manufacturers Association of Nigeria (PMGMAN) at a recent forum with the theme: “Production of Medicines in Nigeria – Time for Critical Interventions,” said the provision of basic drugs in the country has become a national security issue.

“Drug is so critical because it is at the root of the health of the citizenry. So if drug supply is affected just like food supply is affected there is crisis immediately in the country,” Okey Akpa, chairman of PMGMAN noted.

Akpa cited the disappointment Nigeria got when the country requested for Zmapp, the experimental Ebola drug from the United States during the heat of the Ebola outbreak. He said: “For us, countries use what is at their disposal to achieve their own means. We do not wish that the drug need of Nigeria is controlled by any other country and to meet our drug needs based on importation is a risk we must think about.”

Akpa added that Nigeria’s pharmaceutical industry had the capacity to meet 70 per cent of Nigerian medicine needed in line with the national drug policy and thereby improve access to treatment in general. National Chairman of the Association of Community Pharmacists of Nigeria (ACPN), Dr. Albert Alkali, also said it would be a wonderful thing for Nigeria to resume local vaccine production. According to him, it will amount to having drug security.

He said: “We cannot be depending on imported products. Vaccines are the best thing for this country to produce. Prevention is better than cure. “If we can have the mass population of this country vaccinated, especially the children, against major killer diseases, it will provide national security and we will not be tied down by the bureaucracy of other countries in the attempt to import any drug.”

Alkali said vaccine production was not something that the nation’s scientists could not do. “The National Institute of Pharmaceutical Research (NIPRD) can come in with input; the various faculty of pharmacies in conjunction with the Food and Drug Department of the Federal Ministry of Health and other collaborators would similarly contribute their ideas,” the chairman of ACPN said.

Considering that currently the nation is doing local production of anti-snake venom, Alkali said drawing from that experience Nigeria could embark on the production of vaccines locally. Besides, producing the vaccines locally could afford Nigeria the capability to monitor the production especially the cold chain system that would ensure the potency of the product, he added.

Alkali maintained that local vaccine production would as well remove the suspicion of local communities over some allegations that foreign producing countries use vaccines to cut the reproductive potential of the peoples of the receiving countries.

For many years in Nigeria, citizens from many local communities in the North had rejected the administration of polio and other vaccines on their kids, while alleging foul play by foreign partners which thrive to make the products available. Although it took concerted efforts of the Federal and State Governments, key stakeholders and top religious and traditional leaders in those regions to reduce doubts in the minds of those rejecting vaccine doses.

However, with local production of vaccines, there would be no further room for suspicion.

Besides, manufacturing the vaccines in the country would instil confidence in the process which, if finally achieved, would help to re-position the country in its rightful place among the comity of nations.

While producing vaccines locally is a better option, delay or not starting production would mean that the nation would continue to depend on foreign sources and at great foreign exchange costs until “we place more emphasis on national interest, which is best for the country,” said Tomori, who is also the president of the Nigerian Academy of Science.

He added: “It is not as if we can produce all the vaccines we need, but we certainly can focus on producing some of the vaccines against childhood diseases and those diseases that are endemic in Nigeria.” Again, there can be no better time to begin this vaccine production that has potential to boost the confidence of the citizens on the medications than now.

This is given that Nigeria, over the years, has enjoyed the Global Alliance for Vaccine Initiative (GAVI) funding support for immunisation which contributed to the significant reduction of under-five mortality rate.

According to Tomori, on the average, Nigeria provides about US$80 million, representing about 25 per cent of all the funds needed.

The rest comes from other foreign donors.

“Between 2001 and 2016, GAVI committed US$675.2 million to support of immunisation activities in Nigeria (vaccines, cold chain system, immunisation activities, health system etc.); disbursed US$565.4 million, an average of US$35.0 million per year,” he said.

GAVI was created in 2000 to assure equal access to new and underused vaccines for children living in the world’s poorest countries, thereby saving children’s lives and protecting people’s health by increasing access to immunisation.

By helping to increase demand for GAVI-funded vaccines, the price of vaccines was reduced for developing countries while encouraging countries to contribute to the cost of vaccines they receive to ensure sustainability.

However, Nigeria is gradually transiting from being a GAVIsupport nation to an independent nation that is regarded buoyant enough to pay its full bill for vaccines.

Tomori said: “In 2014, we rebased our economy and our gross national income went up to US$2,970, much higher than the US$1,500, the eligibility threshold for GAVI support.

The implication of this ‘promotion’ is that we now have to ensure that we must include in our annual budget at least an additional amount equal to what GAVI is providing now.

“This amount will continue to increase to cater for the 7.2 million annual birth cohorts – that is the number of children born per year in Nigeria.”


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