Reusable syringes are risky. They’re more likely to cause infection, and have been linked to the transmission of blood-borne diseases like HIV, and hepatitis B and C. They’re also able to be used, resold, and reused.

That’s why Kenya’s immunisation system strictly recommends the use of auto-disable (AD) syringes, explains Beatrice Njeri, a nurse at the Beyond Zero Clinic, Lindi Ward, in Nairobi’s Kibra informal settlement. Designed to prevent reuse by locking automatically after a single injection, AD syringes are the gold standard as far as vaccination safety goes, Njeri explains.

But recently, global supplies of AD syringes ran problematically low. 

Average syringe transport times are expected to decrease by up to 80–90% on the continent.

– Roneek R. Vora, director, Revital Healthcare (EPZ) Limited

“The 0.5 ml Auto-Disable (AD) syringes used for child immunisation were also used to administer COVID-19 doses – except for Pfizer doses administered using the 0.3 ml syringes – leading to a major global shortage of syringes. Vaccines were available, but syringes were not, interrupting routine immunisation,” explains Roneek R. Vora, a director at Revital Healthcare (EPZ) Limited, the Kenyan medical supply manufacturer that’s making it its business to shore up supply.

Supply choke

In 2021, UNICEF was projecting a global auto-disable syringe shortfall of approximately 2.2 billion for both COVID-19 and routine immunisation. The demand for syringes was already on a steady increase due to the Malaria Vaccine Implementation Programme (MVIP), the pilot programme for the world’s first malaria vaccine that had been running in Ghana, Kenya and Malawi since 2019.

That shortage imperiled Kenya’s routine immunisation programme, confirms Josephat Kinuthia of Nairobi City County department of health.

That was until Revital Healthcare, based in Kilifi County, Kenya, and the only manufacturer in Africa producing 0.5 ml AD syringes, rapidly stepped up production to help meet local, regional and global demand.

“We broke barriers”

Vora, who is also a founding member of the Kenyan Ministry of Health’s End Malaria Council & Fund, says, “We broke barriers by exporting these syringes to more than 35 countries including India – despite India being a syringe production powerhouse – [as well as] Pakistan and four European countries, and to other African countries.”

In pre-pandemic times, predicting AD syringe demand for vaccination was informed largely by population growth – a straightforward projection. Syringes were shipped, typically by sea, within one to two months of placing an order in China and India.

But amid the pandemic’s urgency, the unprecedentedly high demand for syringes meant that countries had to airfreight syringes, with the cost of transport amounting to as much as five to 10 times the cost of the syringes themselves.

Revital’s location, executives suggest, helps loosen that bind for African health systems. Average syringe transport times are expected to decrease by up to 80–90% on the continent, Vora claimed in a September 2023 statement.

Public health gains at risk

Due to widespread use of AD syringes, in 2011 the global immunisation community, including Gavi, announced that infections resulting from the reuse of syringes for immunisation had been reduced to practically zero in sub-Saharan Africa.

A global AD syringe shortage threatened these gains, as health providers in densely populated areas, such as Nairobi’s Kasarani catchment area, turned to reusable syringes to keep routine immunisation on track.

Gladwell Karinga, a businesswoman in the area, found the difference unsettling when her nine-month-old received the measles and yellow fever vaccines in February 2022. “When the nurse pulled back the syringe, the needle detached from the plastic handle and the needle remained in my baby’s arm. The nurse pulled it out with a cotton wool and the baby was very distraught from the pain.”

The injection may have been safe – just because a needle is potentially reusable does not mean it’s being reused – but nurse Njeri explains that experiences like Karinga’s can still cost the health establishment in terms of trust. “When [parents] see syringes malfunction, we start to experience low confidence levels and people keep away,” she says.

“AD syringes are easier to dispose of and highly accurate, as they come as a fixed dose.”

– Virginia N Wanjiku, clinical officer, Kiambu Level 5 Hospital

 “The 2 ml/ 2cc disposable reuse syringes are not user-friendly,” says Virginia N Wanjiku, a clinical officer at Kiambu Level 5 Hospital. “Health providers have to assemble the needle and the syringe themselves and the needle has to be removed and disposed of separately in a sharps bin. In busy health facilities, a health provider can very easily dispose of the syringe without removing the needle risking injury due to incorrect sharps disposal.

“AD syringes are easier to dispose of and highly accurate, as they come as a fixed dose. They are designed to contain a 0.5 ml dose of the vaccine and this is what a child needs, except for BCG, which should be 0.3 ml. Reusable are usually 2 ml and it is up to the health provider to withdraw the correct amount from the vaccine vial. This, again, is prone to error and more so in busy and understaffed public health facilities,” she adds.

Africa’s first patented – and first WHO-prequalified – AD syringe

In October 2021, the Bill & Melinda Gates Foundation awarded Revital a US$ 3.9 million grant to expand its manufacturing capacity. Following the World Health Organization’s mid-2023 prequalification of Revital’s “early-activation” auto-disable syringe, the company projects being able to produce more than 300 million AD syringes annually.

Vora explains: “The major difference between early and late activation syringe is that with the early activation syringe, if you take the barrel back and go even 1 mm or 2 mm forward, you cannot [push] the barrel back [again]. If you try and take it back even from 0.1 ml or 0.2 ml, or 0.3 ml, or 0.4 ml, or even 0.5 ml (maximum doses), the barrel will automatically break at any given point.”

Revital’s version is Africa’s first patented syringe – a real milestone, not just an idle boast, Vora would argue. “Local manufacturers are critical at all times, but even more so during an emergency. Many countries rely on China and India for their medical supply and it was a crisis when these countries banned exportation of vaccines, syringes and other medical devices. We managed to step in and close the supply gap. Our products were cheaper, for we eliminated unnecessary importation cost and the turnaround time between placing an order and delivery was significantly shorter,” she says.

It’s not just about speed, but also about sustainably meeting demand. Revital expects to meet as much as half of the routine vaccination AD syringe needs on the continent.