The National Agency for Food and Drug Administration and Control (NAFDAC) has announced its Emergency Use Authorisation for the JYNNEOS vaccine in Nigeria.
This development comes as part of the country’s ongoing efforts to combat the Mpox outbreak, which began in 2022 and was first detected in the United Kingdom.
The outbreak was later declared a Public Health Emergency of International Concern by the World Health Organisation (WHO), underscoring the urgency of a global response.
NAFDAC, in a press statement on 31 August, explained that the Emergency Use Authorisation was first granted in August 2023 to ensure that Nigerians had timely access to a safe and effective vaccine against Mpox.
The agency stated that this authorisation was extended in July 2024 after additional data and conditions were fulfilled, demonstrating the vaccine’s continued safety and efficacy. NAFDAC emphasised that this decision was part of its mandate to protect public health in the country.
According to NAFDAC, the Emergency Use Authorisation process involved collaboration with international regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
“This partnership allowed NAFDAC to expedite the vaccine review process while maintaining rigorous evaluation standards. The agency also worked closely with the vaccine’s manufacturer, Bavarian Nordic A/S, and the National Primary Health Care Development Agency (NPHCDA) to ensure that the JYNNEOS vaccine was of the highest quality and could be effectively deployed in Nigeria.
The health agency noted that it evaluated the vaccine’s safety profile, particularly in vulnerable populations such as those with HIV and atopic dermatitis. Initially, the vaccine’s efficacy was determined through immunogenicity data and animal studies. However, the extension of the Emergency Use Authorisation was supported by real-world effectiveness data, which further validated the vaccine’s protective capabilities against Mpox.
NAFDAC reiterated its commitment to safeguarding public health in Nigeria through stringent regulation and oversight of vaccines and other medical products. The agency’s approach, which includes collaboration with international partners and an evidence-based evaluation process, continues to inspire confidence in the safety and efficacy of medical products available to Nigerians. The agency’s ongoing efforts are crucial as the country continues to face the challenges posed by infectious diseases.
 has announced its Emergency Use Authorisation for the JYNNEOS vaccine in Nigeria.){kind=link}