INSIGHTi

Supply Chain Considerations for COVID-19
Vaccine Manufacturing
November 23, 2020
The development of a vaccine for the Coronavirus Disease 2019 (COVID-19) pandemic has been of
concern to Congress, as vaccination can be one of the most effective methods of preventing disease
spread. On November 18, 2020, Pfizer/BioNTech announced that an interim analysis found its newly
developed vaccine to be “95% effective against COVID-19” and has since filed for an Emergency Use
Authorization (EUA) from the U.S. Food and Drug Administration. On November 16, 2020, Moderna
announced that its vaccine, tentatively evaluated as 94.5% effective, will also be submitted for an EUA.
According to media reports, “Moderna said it would have 20 million doses ready by the end of 2020;
Pfizer said it would have about 50 million by then.” Providing COVID-19 vaccines—complex, specially
manufactured and distributed products—involves significant supply chain considerations. Needed
supplies may be limited in quantity and face global competition. This Insight provides an overview of
selected supplies required to manufacture vaccines and ancillary vaccination materials that may pose
supply chain challenges and describes the federal government’s role in this process. It does not cover
particular contracts issued, or supplies potentially required for transportation, distribution, and
administration of eventual vaccines.
Federal Role in COVID-19 Vaccine Manufacturing
Through Operation Warp Speed (OWS), a public-private partnership engaged in deploying
countermeasures against COVID-19, the federal government has entered into contractual agreements with
medical supply and pharmaceutical companies to procure necessary supplies for countermeasure
manufacturing. OWS has also invested in manufacturers’ production capabilities, partly by financing new
factory construction. While investigational vaccines are still undergoing late-stage clinical trials,
production of vaccination supplies has begun. Any shortages may hamper vaccine distribution efforts and
delay the vaccination campaign timeline. Materials of concern include those used to contain the vaccine,
inject it into the body, increase the body’s immune response, and ensure vaccine safety. Vaccine
manufacturers stated in a congressional hearing, “we believe we have a path to be able to have all the
necessary materials for a vaccine program, should we be successful.” Yet, throughout the pandemic,
transparent, up-to-date reporting on the medical supply chain to federal agencies has, in general, been an
issue, particularly for drug ingredients or supplies required for manufacturing.
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Medical-Grade Glass Vials
Medical-grade glass vials store vaccine doses during transport and are tempered to protect the vaccine
from temperature fluctuations. They are also specifically engineered not to interact with the vaccine itself,
thus protecting the formula from degradation or inactivation. Given that multiple doses of vaccine per
person may be required to ensure immunity, hundreds of millions of vials may be required to meet global
demand. The federal government has entered into contracts to procure or produce medical-grade glass
vials, but potential shortages of vials may delay the vaccination campaign. The federal government has
also entered into contracts for glass vial alternatives, such as plastic vials or prefilled syringes. Plastic
vials have a thin glass coating on the inside of the vial to protect vaccine purity in transport. Prefilled
syringes are filled with vaccine and transported to administration sites where they can be used.
Needles and Syringes
Needles and syringes are used to physically inject the vaccine into the body, where the formula can then
elicit an immune response to confer disease immunity to the recipient. As these are single-use supplies,
used needles cannot be repurposed and must be appropriately disposed of. Just as with glass vials, OWS
has entered into public-private contracts with domestic suppliers for needle and syringe production.
Vaccine Potency and Adjuvant
Adjuvant is a vaccine ingredient that interacts with immune mechanisms to increase the speed and
magnitude of the body’s response to an antigen (a substance that initiates an immune response and the
production of antibodies). The use of adjuvant reduces the amount of antigen required per dose of
vaccine, allowing the same amount of antigen to go toward creating more doses. There are many different
formulations of adjuvants, each optimized for a particular class of vaccine. The MF59 adjuvant used for
influenza vaccine, for example, contains the oil squalene, which is sourced best from shark livers. While
there are alternative sources of squalene, production capabilities of these alternatives may not be
sufficient to meet demand. Plant sources, for example, yield far less squalene than shark liver, and
synthetic versions have yet to be evaluated for safety and efficacy. Squalene’s sourcing from scarce
animal products may raise environmental concerns as well, given the scale of vaccine production required
to meet global demands. Neither Pfizer/BioNTech nor Moderna are using this type of adjuvant in their
vaccines, but other COVID-19 vaccines supported by OWS plan to use squalene adjuvants; potential
supply shortages may thus affect vaccination timelines.
Vaccine Quality Control Testing
Limulus Amoebocyte Lysate (LAL), an enzyme found in the blood of horseshoe crabs, is used to evaluate
vaccine safety by detecting whether a sample has bacterial contamination. Similar to concerns about
squalene harvesting from sharks, ramping up LAL harvest from animal sources raises potential
environmental implications. While there is one approved synthetic variety of LAL, production capabilities
may need to be evaluated.
Considerations for Congress
A lack of needed supplies may hinder efforts to manufacture and distribute vaccines, as some cannot be
manufactured without ingredients like LAL, and vaccines, in general, cannot be distributed without items
such as needles and syringes. It may be important, therefore, to ensure continuity of supplies by
addressing potential shortages early. Congress may benefit from regular, publicly available updates on
whether supply companies are meeting their production deadlines. This includes deadlines for contracts
currently in place and for factory improvements to increase production capacity. Congress may also

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consider whether additional contracts may be required to fully meet demand for these supplies. Lastly,
Congress may consider evaluating whether there is adequate monitoring of supply chain integrity, as any
interruptions in manufacturing may hamper the vaccination campaign. These efforts may help ensure
timely rollout of the vaccine(s) following licensure or authorization by the Food and Drug Administration.

Author Information

Simi V. Siddalingaiah

Analyst in Health Economics




Disclaimer
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