The syringe shortage, explained

In low- and middle-income countries (LMICs), nearly all vaccines are administered with a 0.5-mL autodisable (AD) syringe. Designed for safety and ease of use, the AD syringe injects once and then—as the name implies—autodisables to prevent reuse (and the spread of bloodborne pathogens).

For this reason, AD syringes have been the accepted standard in LMICs for more than 20 years and are jointly recommended by the World Health Organization, the United Nations Children’s Fund (UNICEF), and the United Nations Population Fund.

Two PATH experts—Tara Herrick, MPA, senior market analytics officer, and Courtney Jarrahian, MS, portfolio leader for Packaging and Delivery Technologies—explain what’s behind the AD syringe shortage, and its implications for global vaccination goals.

A: Our most recent model estimates that between now and mid-2022, LMICs will be short by 1.2 to 2.2 billion AD syringes. There are several factors that contribute to the uncertainty in our gap estimate, including the precise timing of COVID-19 vaccine availability, health system capacity to administer vaccines, export restrictions, supply chain delays, and delays in completing planned manufacturing expansions.

Though there is uncertainty, even the lower bound of the estimate—a shortage of 1.2 billion syringes—represents a substantial gap that will have real human consequences. Our team at PATH is developing mitigation strategies to help fill the gap and avoid delays in COVID-19 vaccination and routine immunization schedules.

A: The biggest factor is simply scale. The world wasn’t ready for a mass vaccination campaign of this size. In most countries, equipment like syringes for vaccination are purchased to meet the needs of routine childhood immunization programs—not entire populations, and certainly not two or three times over. Thanks to a great deal of investment, COVID-19 vaccine development happened at an accelerated rate, but with syringes, manufacturing and investment have lagged.

A: Yes, even though capable manufacturers are scaling up production to make more syringes, the demand is still too great. In LMICs, the syringe shortage is jeopardizing critical childhood immunization programs for life-threatening illnesses—like measles, tetanus, and diphtheria. Though PATH has been an integral part of global vaccination efforts against COVID-19, progress against the pandemic should not come at the cost of childhood immunization.

A: While there have been some reports from high-income countries of shortages of the low-dead-volume syringes used for the Pfizer-BioNTech vaccines, the critical shortage is specifically of AD syringes. Though these are the standard for health systems in LMICs, health systems in high-income countries often use prefilled syringes for routine vaccinations, and sharps-injury protection syringes for COVID-19 vaccines. These syringes are more costly than the AD syringes and generally don’t have autodisable features.

A: Prior to COVID-19, manufacturers supplied roughly 2 billion AD syringes per year. AD syringe production has already tripled since the pandemic began, but it still won’t be enough. The scale of the COVID-19 vaccination effort is simply too great for current manufacturing capacity—plus there are other supply chain bottlenecks to contend with.

For example, currently, there are 11 different COVID-19 vaccines in the COVAX portfolio. But the Pfizer-BioNTech vaccine—which makes up an increasing percentage of those doses—requires a different syringe. Instead of the standard 0.5-mL AD syringe, it takes a new low-dead-volume 0.3-mL AD syringe.

Right now, only seven AD syringe manufacturers are World Health Organization approved to produce the syringe required to administer the Pfizer-BioNTech vaccine. The process of adapting manufacturing lines and getting approvals for a new AD syringe size can take months, and since this is a new design, not all syringe manufacturers are sanctioned.

That means every time a vaccine maker launches a new vaccine with special sizes and unique delivery requirements, the global vaccine inequity gap grows wider and the logistical challenges faced by health workers and immunization programs grow more complex.

A: Right now, all countries donating COVID-19 vaccines—whether through mechanisms like COVAX or directly to other countries—should work in tandem with global procurement agencies like UNICEF to bundle their doses together with essential equipment like the appropriate syringes. Without the appropriate syringes, these vaccines could sit unused or expire waiting for the correct syringes to arrive.

At PATH, we’re working to close the gap in several ways. We are:

• Assessing the market for a different type of syringe called “reuse prevention”. This syringe has safety features that are similar to an AD syringe, but it is not fixed dose and thus requires measurement of the dose by the person administering the vaccine. In addition to understanding the market, we are gathering data on the countries in which these syringes may be suitable for use.
• Partnering with UNICEF and other global stakeholders to characterize supply chain challenges and develop strategies to help ensure that syringes and vaccines arrive together. This may include prepositioning supply as it is produced and revising procurement mechanisms.
• Working to bolster supply capacity, particularly for manufacturers operating in LMICs. At present, there are only two AD syringe suppliers on the African continent, so bringing in additional local production capacity is important, such as the recent investment by the Bill & Melinda Gates Foundation in a Kenyan AD syringe manufacturer.
  

The global community can play a significant role in addressing these challenges as well, by encouraging vaccine manufacturers to formulate new COVID-19 vaccines, boosters, and pediatric doses to match existing 0.5-mL fixed-dose AD syringes. This would streamline logistics, manufacturing, and vaccination campaigns:

• For health workers, it would simplify the selection of the correct syringe to deliver a vaccine dose and help ensure the right-sized AD syringe is available when and where it is needed.
• For manufacturers, it would avoid the need to invest in production equipment for new syringe sizes and maximize efficiency by avoiding the need to switch lines back and forth between production of different-sized AD syringes.
• For procurement agencies, it would help streamline advanced procurement and distribution of AD syringes, as vaccine shipments would not need to be matched with the corresponding syringe type.

As we have seen many times during the pandemic response, investment in local manufacturing is also critical. Strengthening manufacturing capacity in Africa and South America will not only create greater access to lifesaving devices and medicine, it will also create a more vibrant economy—and most importantly—better public health.