Regulators in Nigeria Grant Approval to Oxford's Malaria Vaccine

Nigeria has granted provisional approval to Oxford University's R21 malaria vaccine, its medicines regulator said Monday, making it the second country to do so after Ghana last week.

The approvals are unusual as they have come before the publication of final-stage trial data for the vaccine.

"A provisional approval of the R21 Malaria Vaccine was recommended, and this shall be done in line with the WHO's Malaria Vaccine Implementation Guideline," Nigeria's National Agency for Food and Drug Administration and Control (NAFDAC) said.

Malaria, a mosquito-borne disease, kills more than 600,000 people each year, most of them African babies and children.

Nigeria, the continent's most populous nation, is the world's worst-affected country with 27% of global cases and 32% of global deaths, according to a 2021 World Health Organization (WHO) report.

It was unclear when the R21 vaccine may be rolled out in Nigeria or Ghana as other regulatory bodies, including the WHO, are still assessing its safety and effectiveness.

Childhood vaccines in the poorest parts of Africa are typically co-funded by international organizations such as Gavi, the vaccine alliance, only after getting WHO approval.

"While granting the approval, the Agency has also communicated the need for expansion of the clinical trial conducted to include a phase 4 clinical trial/Pharmacovigilance study to be carried out in Nigeria," NAFDAC's director-general, Mojisola Christianah Adeyeye, said in a statement.

Mid-stage data from the R21 trial involving more than 400 young children were published in September, showing vaccine efficacy of 70% to 80% at 12 months following the fourth dose.

Data from an ongoing phase 3 clinical trial involving 4,800 children in Burkina Faso, Kenya, Mali and Tanzania are due to be published in the coming months.

Oxford has a deal with the Serum Institute of India to produce up to 200 million doses of R21 annually.

The first malaria vaccine, Mosquirix from British drugmaker GSK GSK.L, was endorsed by the WHO last year, but a lack of funding is thwarting GSK's capacity to produce enough doses.

By MacDonald Dzirutwe, Reuters

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Flights disrupted in Nigeria due to strike by aviation workers strike over pay

Domestic flights in Nigeria were being disrupted on Monday, local airlines said, as aviation employees in Lagos blocked roads to the country's busiest local airport to begin a two-day strike in protest over working conditions and wages.

The strike is likely to add to problems in a sector that regularly faces jet fuel shortages, which often ground local flights and where international carriers struggle to repatriate revenue from ticket sales due to dollar shortages.

Air Peace, which also flies international and regional routes and has the largest fleet, told passengers that "flights across our network will consequently be disrupted" due to the strike. It did not say how many flights were delayed or cancelled.

United Nigeria said passengers in and out of the commercial capital of Lagos would be disrupted but hoped for a quick resolution to the impasse.

In Lagos, chanting workers blocked roads to the domestic terminal, creating a traffic jam and forcing passengers to finish their journey on foot. International flights were not affected.

Police and army personnel watched from a distance.

Lagos handles dozens of local flights daily.

"It is time for us to release aviation workers from the bondage of this imperialist aviation management that we have been having for years," Abdulrasaq Saidu, secretary general of the Association of Nigerian Aviation Professionals, said.

The Ministry of Aviation said it was trying to meet the workers' demands and urged them to return to work, adding the strike would "affect flight schedules, lead to economic losses and negatively impact on our rating globally."

Unions for pilots, engineers, control tower operators and other airport workers say they are protesting against unpaid wages, government failure to implement an industry minimum wage and plans to demolish the Lagos offices of some aviation agencies to allow for expansion of the airport.

The workers have threatened an indefinite strike later this month if their grievances are not addressed. 

By Seun Sanni and MacDonald Dzirutwe, Reuters

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Over 4,000 suspected lassa fever infections recorded in Nigeria this year

Nigeria has continued to experience a spread of Lassa fever, with an increase in the number of suspected cases recorded as of 2 April compared to that reported for the same period in 2022.

The latest situation report released by the Nigeria Centre for Disease Control (NCDC) Thursday shows that Nigeria has recorded 4,338 suspected cases in 2023.

According to the NCDC, from week 1 to week 13 2023, 846 confirmed infections and 148 deaths were reported with a case fatality rate (CFR) of 17.5 per cent which is lower than the CFR for the same period in 2022 (19.1 per cent).

The week 13 report, spanning 27 March to 2 April also revealed that the number of new confirmed cases decreased from 39 infections in week 12 of 2023 to 23, while the number of fatalities increased from two to four.

NCDC stated in the report that in total for 2023, “25 states have recorded at least one confirmed case across 99 Local Government Areas”, of which 72 per cent of all confirmed cases were reported from Ondo, Edo and Bauchi states.

Of the 72 per cent recorded, NCDC noted that Ondo State accounted for 32 per cent, while Edo and Bauchi states reported 29 and 11 per cent respectively.

NCDC added that one new healthcare worker was affected in the reporting week 13.
Lassa fever

Lassa fever is an acute viral hemorrhagic (excessive bleeding) illness transmitted to humans through contact with food or household items contaminated by infected rodents or contaminated persons.

Its symptoms include fever, headache, sore throat, general body weakness, cough, nausea, vomiting, diarrhoea, muscle pains, chest pain, and in severe cases, unexplainable bleeding from ears, eyes, nose, mouth, and other body openings.

The NCDC noted in the report that the challenges with response to Lassa fever in the country include late presentation of cases leading to an increase in CFR, poor health-seeking behaviour due to the high cost of treatment and clinical management of the infection, poor environmental sanitation conditions, and poor awareness observed in high-burden communities.

By Mariam Ileyemi, Premium Times

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