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Nigeria among first countries to develop vaccine safety response plan — US CDC

Nigeria is among the first countries to develop a comprehensive Vaccine-Related Events (VRE) Response Plan, the United States Centers for Disease Control and Prevention (US CDC) has said.

The United States CDC Global Immunization Safety Team Lead, Dr Janet Gidudu, made this known on Thursday at the official launch of the Nigeria Vaccine-Related Events Response Plan and AEFI Surveillance Field Guide, held in Abuja, describing the development of the plan as a major step towards strengthening vaccine safety and public confidence in immunisation.

She said Nigeria’s experience would serve as an example for other countries, particularly in Africa, as efforts expand to establish systems capable of identifying, investigating and responding to vaccine-related events.

“You are going to hear more of it in other countries, so Nigeria, you are among the first ones that are developing these plans. So, we are going to look at your example as a good example,” Gidudu said.

The US CDC official stressed that vaccine safety could not be achieved by a single agency or group, urging stakeholders to work together to ensure that vaccines remained safe and public confidence in immunisation was protected.

“You cannot do vaccine safety alone. You cannot. As you heard from the people who have given the messages today,” she said.

Gidudu, who said she was originally from Uganda and had lived in the United States for more than 20 years, said African countries needed to generate their own vaccine safety data rather than relying predominantly on evidence from high-income countries.

“Previously, a lot of the information and data we’ve been using to make decisions around vaccine safety has been based on higher-income countries. The data has been coming from America, Europe and other higher-income countries, but now we must look at ourselves like here in Africa,” she said.

According to her, the strengthening of vaccine safety systems had become more important as African countries increasingly move towards local vaccine manufacturing.

“We must get safe vaccines, safe products for our children, especially, and everybody else. We must generate our own information, have our own systems, and take care of our own, and address any vaccine-related event plans,” Gidudu said.

She emphasised the importance of transparency and effective communication in maintaining public trust, particularly when adverse events or other concerns arise following vaccination.

“Whatever we do, from when a vaccine is being developed to when it’s given to somebody, everybody has to know it is safe, and especially that mother who brings their child to the clinic to know that this vaccine is safe,” she said.

“And it’s only safe when we do the right science, when we communicate the right science, and for sure, if there are any issues with the vaccine, we have to be transparent and tell the story, tell the correct story.”

Gidudu said the US CDC had supported Nigeria’s vaccine safety activities for several years, including during the rollout of the novel oral polio vaccine type 2 (nOPV2) and the COVID-19 vaccination response.

She disclosed that work on Nigeria’s VRE Response Plan began about two years ago and was preceded by a baseline assessment to identify gaps and inform the development of the framework.

“This plan belongs to you as a country. It’s going to be a living document. Let’s learn from it, let’s improve this plan, and let’s share our lessons learned with other countries so they can do a good job in Africa and the rest of the world,” she said.

She urged development partners, including UNICEF and Gavi, to support Nigeria in implementing the plan, warning against allowing it to remain a document on shelves.

“Please support Nigeria implement their plans. I’m throwing that advocacy there because I know when you take these messages to your respective agencies, they will dig in their pockets. Come on UNICEF, come on Gavi, come on everybody, let us work to support the country,” Gidudu said.

“Let this plan be actualised. Let it not stay on your shelves. I do not like work that doesn’t touch, that doesn’t translate to actionable work.”

The US CDC official explained that the new approach was designed to move away from separate response plans for individual vaccines towards an antigen-agnostic framework that could be adapted to any vaccine-related event.

“We want plans that can work across all vaccines, because we don’t know where the next outbreak might be,” she said, adding that the framework could be used during measles, polio and routine immunisation campaigns as well as future vaccination programmes.

Earlier, the Executive Director/CEO of the National Primary Health Care Development Agency (NPHCDA), Dr Muyi Aina, represented by the Director of Disease Control, Dr Garba Ahmed Rufai, said the launch represented an important milestone for Nigeria’s immunisation programme.

He said the increasing introduction of new vaccines and large-scale vaccination campaigns required the country to strengthen its ability to anticipate, detect, assess, manage and communicate vaccine-related events.

“Vaccines remain among the most effective public health interventions available to us. They save lives, prevent disability and protect communities from diseases that once caused enormous suffering,” Aina said.

He, however, noted that the success of vaccination programmes depended not only on the ability to deliver vaccines but also on maintaining public confidence and trust.

According to him, vaccine-related concerns can spread rapidly, sometimes faster than health authorities can establish the facts, making preparedness essential.

“Response, therefore, cannot be improvised after an event has occurred. We must be prepared before it happens. This is the fundamental purpose of the Vaccine-Related Events Response Plan,” he said.

Aina said the plan provides a coordinated framework for surveillance, investigation, clinical management, causality assessment, risk communication and community engagement.

He stressed that the framework was not solely an NPHCDA document, saying effective management of vaccine-related events required collaboration among NPHCDA, NAFDAC, NCDC, the Federal Ministry of Health and Social Welfare, states, local governments, health workers, clinicians, surveillance officers, communication teams, communities and development partners.

“When an event occurs, Nigerians should see one coordinated public health system responding with speed, competence, transparency and empathy,” he said.

Aina announced that NPHCDA, in collaboration with partners, would prioritise orientation and capacity building for stakeholders at national and subnational levels to ensure implementation across the 36 states and the Federal Capital Territory.

He called on state governments, State Primary Health Care Development Agencies and Boards, programme managers, surveillance officers, health workers and partners to take ownership of the framework and operationalise it at relevant levels.

“This is Nigeria’s plan, and its implementation must be nationally owned, nationally led, sustainably embedded within our health system,” Aina said.

Also speaking, AFENET Regional Coordinator and Nigeria Country Lead, Dr Patrick Nguku, said the organisation worked closely with NPHCDA, NCDC, NAFDAC, the Federal Ministry of Health and other government partners to undertake the baseline assessment, identify gaps and develop and validate the plan.

He described the framework as comprehensive, covering preparedness, protection, investigation, response, communication, recovery, evaluation and continuous education.

“This framework really provides a coordinated framework for preparedness, for protection, for investigation, for response, for communication, for recovery, for evaluation, for continuous education. It’s really comprehensive,” Nguku said.

He said AFENET had also supported activities including AEFI technical working committees, national data validation and harmonisation, causality assessments, supportive supervision and vaccine safety risk communication.

Nguku urged stakeholders to ensure the framework moved beyond being a national document to becoming a practical tool routinely used for vaccine safety preparedness and response.

“AFENET remains committed to supporting the Government of Nigeria to institutionalise this response plan, to strengthen the AEFI surveillance and response, and to build sustainable capacity and promote evidence-based vaccine safety practices at all levels,” he said.

Representing the National Agency for Food and Drug Administration and Control (NAFDAC), Asman Abubakar commended NPHCDA and AFENET for developing the plan and the AEFI Surveillance Field Guide.

He said NAFDAC, as the agency responsible for safety monitoring, would continue to collaborate with NPHCDA, AFENET and other partners to ensure vaccines remained safe for public use.

“Having this document in place is very important. And NAFDAC being the agency responsible for safety monitoring, this is a very commendable thing. We’ll continue collaborating with NPHCDA, AFENET, and also other partners to ensure that vaccines are still safe for public use,” Abubakar said.