Reviving local production of vaccines

*Three years after inauguration, Biovaccines project still at planning stage
*FG signs MoU for market access for technology transfer with partners

The excitement that greeted the announcement on Monday of a Coronavirus (COVID-19) vaccine, which prevented more than 90 per cent of symptomatic infections in a study of tens of thousands of volunteers, has served as a reminder that Nigeria still does not have the capacity to locally produce vaccines.

The Federal Government had in 2017 inaugurated an initiative to begin local production of essential vaccines. May and Baker Plc., an indigenous pharmaceutical industry had signed a Memorandum of Understanding (MoU) with the Federal Government, which was vetted by the Federal Executive Council (FEC) to immediately begin local production of vaccines.

According to the MoU, the project, handled through Biovaccines Nigeria Limited (BVNL, will build local capacity in vaccine production as well as develop a centre of excellence for research and development of vaccine technology and other biologics.

Nigeria was expected to roll out its first locally produced vaccines in July 2019, beginning with the drugs against yellow fever, tetanus toxoid and hepatitis B after resuscitating a manufacturing line at the defunct National Vaccine Production Laboratory (NVPL) in Yaba, Lagos, which was acquired by BVNL.

Stakeholders said the project would help Nigeria to better respond to emergencies like epidemic of Cerebro Spinal Meningitis (CSM), yellow fever, COVID-19 among others, generate increased internal revenue and increase the Gross Domestic Product (GDP) of the country.

But three years after, Nigeria’s quest to get its first set of locally manufactured vaccines is still at a teething stage.

The Guardian investigation revealed that the firm floated to achieve this target, Biovaccines Nigeria Limited, has yet to start building the state-of-the-art pharmaceutical manufacturing facility needed for the vaccines.

Also, the factory, when completed, would have to be prequalified by the World Health Organisation (WHO) before it starts producing vaccines.

What a paradox. Nigeria was not only producing vaccines for smallpox, yellow fever, and anti-rabies vaccines, between 1940 and 1991, but also exported to Cameroon, Central African Republic and a few other countries.

However, in 1991 the NVPL in Yaba, Lagos, stopped production ostensibly because the government wanted to reactivate and upgrade the facility, which did not take place until today.

Unfortunately, Nigeria spends over N7 billion annually importing vaccines into the country, with about 80 percent cost of vaccines being subsided by Global vaccine initiative (GAVI).

Why is Biovaccines yet to meet its mandate of locally producing vaccines?
Project Manager, Biovaccines Nigeria, Everest Okeakpu, told The Guardian: “The Biovaccines initiative is well on track with its mandate to revive local vaccines production, and achieving vaccine security for our country. We did have and continue to experience delays due to the lockdown and restriction measures instituted globally to contain the COVID-19 pandemic, with the consequent uncertainties.

“More so, with the current rising cases and second wave currently blowing through some parts of Europe and America. However, the outbreak has further underscored the need to quickly set up the BIovaccines Nigeria limited (BVNL) facility to help fill in the huge gap that will arise as a result of the large volumes of the COVID-19 vaccines that will be required to vaccinate people simultaneously in the different parts of the world.”

Okeakpu said following the revised GAVI transition plan (2018-2028) for Nigeria, the Board of BVNL revised and approved a business plan to align with this new projection. He, however, said the implementation of the plan is well underway.

Okeakpu said the Minister for Health, Dr. Osagie Ehanire, on behalf of the Federal Government, on Thursday, November 5, 2020, signed an MoU for market access conditional for technology transfer with BVNL. “We are now concluding negotiations with our would-be tech-transfer partners, most of whom are also manufacturers for COVID-19 vaccines,” he said.

He said Biovaccines has started procurement for architectural, structural and conceptual, basic and detailed engineering services for the construction of a Greenfield.

Okeakpu said that by the end of first quarter of next year, they would have been done with ground breaking. “For projects of this nature, it would usually take about three to four years to go through faculty construction and equipment procurement; facility and equipment commissioning and qualification; process optimization and media fill validation; facility certification; process validation and product registration. But, BVNL is working not only to compress this timeline but also fast tracking some of them by already importing modular facility to be ready for filling and finishing the COVID-19 vaccine locally. BVNL is working with the Federal Ministry of Health to secure COVID-19 vaccines supply for our country through some of her partners,” he said.

Okeakpu said the BVNL Board, under the leadership of its Chairman, Professor Oyewale Tomori, is pleased to announce that with the continued support of the Muhammadu Buhari administration, the other benefits of this effort, viz Job creation, foreign exchange earnings from export, development of biotechnological base, ability to develop novel vaccines for fighting Africa-specific diseases, security of quality vaccines, dealing efficiently with pandemic diseases and outbreaks, socio-economic development and enduring partnership opportunities may no longer be far off. “The future is indeed very bright and has come early,” he said.

Chairman, Pharmaceutical Manufacturers Group of the Manufacturers Association of Nigeria (PMG-MAN), Dr. Fidelis Ayebae, told The Guardian: “It is increasingly clear that we now must collaborate with either the Russians or Pfizer for our people’s needs.”

A public health physician and former Chief Medical Director of Lagos University Teaching Hospital (LUTH) Idi-Araba, Prof. Akin Osibogun, told The Guardian: “If we are able to develop an effective vaccine, that will be a game changer for this pandemic, no doubt.”

A virologist/vaccinologist and Chief Executive Officer (CEO) of Innovative Biotech, Keffi, Nasarawa State, and Innovative Biotech, United States of America (USA), Dr. Simon Agwale, told The Guardian that Africa has traditionally lagged in vaccine development and manufacturing and less than one per cent of all the vaccines used in Africa are sourced from within Africa, a situation that makes the continent vulnerable to epidemics and pandemics.

Agwale, a former researcher at the University of Jos, National Institute for Pharmaceutical Research and Development, as well as medical institutions in Brazil, Germany, United Kingdom and the United States, said the development and/or manufacture of a COVID-19 vaccine in Nigeria creates a strategic long-term benefit for the country to be pandemic ready. He said understanding the current vaccine landscape, tracking of other countries development and development of partnerships is amongst the essential aspects for successful vaccine development and manufacture in Africa.

To this end, Agwale said the Economic Community of West Africa States (ECOWAS)/West Africa Health Organisation (WAHO) has decided to appoint a subgroup to lead in coordinating discussions, activities and plans for advancing vaccine manufacturing capacity with an initial focus on COVID-19 in the West African sub-region.

Agwale, who also chairs the Africa COVID-19 Vaccine Manufacturing Task Team, said there is presently no functional human vaccine manufacturing facility in Nigeria, but Vom Veterinary Institute produces animal vaccines.

He said Innovative Biotech Nigeria is currently partnering with two United States companies to develop and manufacture COVID-19 vaccines for clinical trials and use in the country and Africa with a plan to set-up a factory in Nigeria to enable us domesticate vaccine production in the country. “We are planning to manufacture the initial doses here in the US and then later transfer the entire technology to Nigeria to enable us produce the COVID-19 vaccine and other vaccines that are important to our country and Africa,” he said.