Chloe Ramirez
Vaccines are generally made up of seven different ingredients, including sugars, amino acids, gelatin, proteins, diluents, and adjuvants like aluminium salts. The specific ingredients and manufacturing processes can vary across different vaccines and countries. For instance, during the COVID-19 pandemic, countries like the United States, Switzerland, and Singapore were involved in the production of different components of the Moderna mRNA-1273 vaccine. The COVID-19 vaccine also highlighted the challenge of equitable access to vaccines, with some countries hoarding vaccines for their own populations, reducing the global supply.
| Characteristics | Values |
|---|---|
| Number of ingredients in a vaccine | Generally, vaccines are made up of seven different ingredients. |
| Greatest ingredient by volume | The greatest ingredient, by volume, in a vaccine is the diluent, which is usually sterile water. |
| Other common ingredients | Sugars (lactose, sucrose), amino acids (glycine), gelatin, proteins, aluminium salts, and formaldehyde. |
| Function of ingredients | Ingredients like aluminium salts help boost the body's response to the vaccine. Stabilizers prevent chemical reactions within the vaccine, while surfactants keep all the ingredients mixed together. |
| Manufacturing process | Centralized production involves manufacturing vaccines at scale in centrally located sites. Distributed manufacturing involves producing different components of the vaccine at different geographical locations and facilities. |
| Challenges | Shortages of skilled personnel, complex manufacturing and supply chain, and equitable distribution. |
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What You'll Learn
Centralised vs distributed manufacturing
While centralised production involves manufacturing vaccines and other health products at scale in centrally located sites, distributed manufacturing involves the production of different components of the vaccine in different geographical locations and facilities. For instance, while Lonza produces the active pharmaceutical ingredient for the Moderna mRNA-1273 vaccine in Switzerland, CordenPharma produces lipid nanoparticles required for the same vaccine in Colorado, USA, and the final fill-finish steps are carried out in Indiana, USA.
The COVID-19 pandemic highlighted significant gaps in equitable access to essential medical countermeasures such as vaccines. Manufacturing capacity for pandemic vaccines is concentrated in too few countries. One of the major hurdles to equitable vaccine distribution was "vaccine nationalism", where countries hoarded vaccines to vaccinate their own populations first, significantly reducing the global vaccine supply. Distributed manufacturing can help counter this issue by identifying small population countries with vaccine manufacturing capacity, as these countries could fulfil their domestic obligations quickly.
The vaccines industry has not changed appreciably in decades regarding technology, and large companies have withdrawn from production. The distributed manufacturing model aligns well with this, and the advent of synthetic biology promises much in terms of vaccine design. Biofoundries separate design from manufacturing, a hallmark of modern engineering. The combination of biodesign tools (BioCAD) and biofoundries is rapidly producing a new type of biology – digital biology – that could revolutionise the production of vaccines and many other areas of biomedicine.
The lower capital outlay of mRNA facilities is attractive for driving localised manufacturing, servicing individual countries or groups of countries. The BioSolve mRNA model scales down accurately 10-fold, to a facility serving 5 million patients per year, with a capital outlay of $10 million. 70% of that outlay is process equipment, including equipment needed for QC testing. So an extra $4 million outlay could give a 10-fold increase in production capacity. However, the supply chain for mRNA is less mature, more complex, and costly. Most of the costs for mRNA vaccine manufacture are associated with critical raw materials.
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Stabilisers and surfactants
Vaccines are generally made up of seven different ingredients. Their composition and creation are complex and detailed. The world will need billions of COVID-19 vaccine doses, but shortages of skilled personnel mean volume is a huge challenge.
Stabilisers are ingredients that prevent chemical reactions from taking place within the vaccine. Sugars (lactose, sucrose), amino acids (glycine), gelatin, and proteins are all used as stabilisers in vaccines. One of the often-used proteins is recombinant human albumin, which is made from yeast and resembles human serum but contains no human or other animal material.
Surfactants are another type of ingredient used in vaccines. While stabilisers stop vaccine components from mixing and reacting, surfactants ensure that all the ingredients remain mixed together. Without surfactants, there could be a separation of ingredients, leading to sediment or clumps forming within the vaccine.
Different manufacturing processes use different non-active ingredients. Trace elements of these non-active elements, known as residuals, may be present in the final vaccine. They are present in such tiny amounts that they are measured in parts per billion. Residuals may include things like yeast or egg protein, or even antibiotics.
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Diluents
The World Health Organization (WHO) provides guidance on the proper handling and storage of vaccine diluents. According to WHO guidelines, diluents should be stored at a temperature of between +2°C and +8°C unless otherwise specified by the manufacturer. If the diluent is packaged with the vaccine, it should always be stored together with the vaccine within the specified temperature range. However, if the diluent is not packaged with the vaccine, it can be stored at room temperature only if the manufacturer's instructions permit it. In such cases, the manufacturer's instructions for cooling the diluent before mixing it with the vaccine must be followed. Importantly, diluents should never be frozen.
The use of diluents in vaccines is crucial to ensure the vaccine's effectiveness and safety. Diluents help to achieve the correct concentration of the vaccine, enabling it to induce the desired immune response in the recipient. Additionally, diluents can act as a buffer, maintaining the vaccine's pH level and preventing it from becoming too acidic or alkaline. This is essential for preserving the integrity of the vaccine and ensuring it remains effective.
Furthermore, diluents can also contain surfactants, which help to keep all the ingredients in the vaccine mixed together. Surfactants prevent the separation of ingredients, avoiding the formation of sediment or clumps within the vaccine solution. This ensures that the vaccine is uniformly combined and maintains its intended consistency.
The use of diluents in vaccines is carefully regulated and monitored to ensure safety and efficacy. Healthcare workers and vaccinators are trained to select the correct diluent specified by the manufacturer and to properly handle and store both the diluent and the reconstituted vaccine to prevent contamination and ensure its potency.
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Adjuvants
The action mechanisms of adjuvants are still being elucidated, but they can be categorized as immunostimulants and delivery systems. Immunostimulants are danger signal molecules that promote the maturation and activation of antigen-presenting cells (APCs) by targeting Toll-like receptors (TLRs) and other pattern recognition receptors (PRRs). This enhances adaptive immune responses. On the other hand, delivery systems act as carrier materials, prolonging the bioavailability of antigens and targeting them to lymph nodes or APCs.
While adjuvants offer many benefits, adjuvanted vaccines can cause more local and systemic reactions, such as redness, swelling, fever, and body aches. Therefore, safety is of utmost importance when selecting an adjuvant, and vaccines containing adjuvants undergo rigorous testing and monitoring to ensure their safety and effectiveness.
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Vaccine nationalism
During the COVID-19 pandemic, vaccine nationalism has been prevalent, with wealthy countries such as the United States, the United Kingdom, and Israel signing deals with pharmaceutical companies to secure vaccines for their citizens. This has resulted in a patchwork of agreements that affect vaccine pricing and availability for lower-income countries. For instance, the United States' Operation Warp Speed program used wartime powers to require manufacturers to fill government orders first, amounting to a de facto ban on vaccine exports initially.
The consequences of vaccine nationalism are significant and far-reaching. Firstly, it prolongs the pandemic by hindering global vaccination efforts and delaying the rollout in developing nations. Researchers at Northeastern University in Boston found that monopolization of vaccines by wealthy nations could result in almost twice as many deaths globally compared to equal distribution. This is because allowing the virus to remain rampant in some regions increases the likelihood of new, more dangerous variants emerging, which may not be neutralized by existing vaccines.
Secondly, vaccine nationalism has substantial economic implications. While it may seem beneficial for individual countries to prioritize their populations, their economies are interconnected with the rest of the world. Key sectors such as travel, tourism, and transportation rely on a globally connected world to fully recover. A RAND Europe report estimates that the lack of global access to vaccines could result in a loss of up to $1.2 trillion per year for the world economy. Similarly, the Organization for Economic Cooperation and Development (OECD) warns that the global economy could lose $9.2 trillion if developing countries are left behind in the vaccine rollout.
Initiatives like Covax aim to distribute vaccines to lower-income economies, but they have struggled to secure enough doses due to vaccine nationalism. This has led to delays in immunization campaigns in these countries, hindering global progress in ending the pandemic.
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Frequently asked questions
Generally, vaccines are made up of seven different ingredients. The greatest ingredient by volume is the diluent, usually sterile water, which is used to dilute the vaccine to the right concentration. Vaccines also contain sugars (lactose, sucrose), amino acids (glycine), gelatin, and proteins, which are used as stabilizers to prevent chemical reactions within the vaccine. Some vaccines also contain small amounts of aluminium salts to help trigger a stronger immune response.
Yes, different countries use different ingredients in their vaccines. For example, the US uses vaccines that are approved by the FDA, while other countries may use vaccines that are approved by different regulatory bodies. Additionally, some countries may have different manufacturing processes that use different non-active ingredients, resulting in trace elements of these non-active ingredients in the final vaccine.
There are several reasons why countries may use different ingredients in their vaccines. One reason could be the availability of certain resources or manufacturing capabilities within a country. Another reason could be the specific requirements or regulations that a country has for vaccine approval. Additionally, some countries may prioritize different aspects of vaccine development, such as stability or safety, which could influence the ingredients used.
