NAFDAC to begin vaccine manufacturing after meeting WHO standard – NAFDAC DG

NEWS DIGEST – The Director-General of the National Agency for Food Administration and Control, NAFDAC, Dr Mojisola Adeyeye has assured Nigerians that vaccine manufacturing will begin soon with the construction of a vaccine lab in the Oshodi area of Lagos State.

Dr Adeyeye disclosed this while speaking at a press conference in Abuja following the World Health Organization’s Global Benchmarking Tool.

She said, “Without maturity level 3 we will not be able to manufacture vaccine that is the first immediate benefit now.

“We can manufacture our own vaccine because NAFDAC is stronger and we are building the vaccine lab in Oshodi by the middle of the year or early third quarter that lab will be ready.”

On the level of local manufacturing of vaccines, she added that the agency has attained maturity level 3 based on the evaluation of the Global benchmarking tools system, noting that the first immediate benefit is that Nigeria can now manufacture a home-grown vaccine.

She said, “In June 2019, WHO came to NAFDAC physically to start the benchmarking process and out of the 868 recommendations we were able to make over 600 and we had 147 left.

“They told us that we have attained maturity level 3 that was 25th of February but this should not be announced until we see the letter.”

Speaking at the Press Conference, the Chairman of NAFDAC Board, Mr Yusuf Suleiman described the new development as a ‘global achievement’.

“Whatever we do in Nigeria today is acceptable globally because of this achievement, that we have been able to announce today.

“The government of Nigeria has supported us in terms of investing in strengthening our regulatory capacity.”

The local vaccine manufacturing journey so far

According to the press release issued by the World Health Organization, Yesterday, WHO, announced that Egypt’s and Nigeria’s medical products regulatory agencies had reached maturity level 3. This means that these national bodies have been found to function well and that they could be eligible for inclusion into the transitional WHO Listed Authorities, a list that comprises the world’s regulators of reference – that is, regulatory authorities that should be globally recognized as meeting WHO and other international standards.

Egypt and Nigeria joined Ghana and Tanzania as effective regulatory systems on the African continent. Several other African regulators are currently under assessment.

WHO’s assessment of regulatory authorities is based on the ‘Global Benchmarking Tool’ – an evaluation tool that checks regulatory functions against a set of more than 260 indicators – covering core regulatory functions such as product authorization, testing of products, market surveillance and the ability to detect adverse events – to establish their level of maturity and functionality. Regulatory authorities that reach maturity levels 3 and 4 will be eligible for inclusion among WHO-listed authorities, after additional evaluation of their performance.

The benchmarking of Egypt and Nigeria’s regulators was carried out by a WHO-led team of international experts. In February and March 2022, WHO conducted a formal evaluation of the authorities and found them to perform well against most of the indicators in the Global Benchmarking Tool.

On the importance of regulatory oversight for local manufacturing, Egypt and Nigeria were also chosen in February 2022 as recipients of mRNA technology from the WHO mRNA Technology Transfer Hub. Effective and efficient regulatory oversight is critical to efforts to boost manufacturing capacity as they ensure that medical products entering the market are safe, effective and produced according to international quality standards.

“Egypt and Nigeria have come a long way to improve their regulatory work and performance,” said Mariangela Simao, WHO Assistant Director-General for Access to Health Products. “Given that medical products regulatory oversight and manufacturing must work in tandem, this is very good news for access to quality health products on the African continent.”

Regulation of medical products is extremely important for all health systems and for access to quality vaccines, medicines and other health products. Apart from ensuring the quality, safety and efficacy of medical products, regulatory authorities that function well also perform critical functions such as faster authorization of products and safety monitoring after authorization.

Fewer than 30 per cent of the world’s regulatory authorities are considered fully functioning and operational. For that reason, WHO has intensified efforts to bolster the capacity to regulate medical products in all regions.

WHO listed authorities

As of 30th March 2022, WHO announced a transitional WHO-Listed Authorities (WLAs) list. The introduction of a framework for designating and publicly listing a regulatory authority as a WLA aims to provide a transparent and evidence-based pathway for regulatory authorities to be globally recognized as meeting and applying WHO and other internationally recognized standards and guidelines, as well as good regulatory practices.

The designation of a regulatory authority as a WLA is intended to promote access and the supply of safe, effective and quality medical products. It also encourages the optimal use of limited resources by facilitating reliance on the work and decisions of mature and advanced agencies in the decision-making of other regulatory authorities, the WHO Prequalification Programme, and procurement bodies.

The transitional WLA combines pre-existing lists of Stringent Regulatory Authorities for medicines, highly performing regulatory authorities for vaccines, Regional Reference Authorities for medicines and vaccines in the Americas (AMRO/PAHO), national regulatory authorities operating at maturity levels 3 and 4, and vaccine producing countries with functional regulatory authorities. The WHO Listed Authorities framework will come into full effect pending successful pilots later this year.

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