Ruqayyah Snyder
The flu vaccine is designed to protect against the influenza virus, also known as the flu. In Australia, the flu vaccine is recommended for all Australians aged over six months, and is provided free of charge under the National Immunisation Program for certain high-risk groups. The vaccine is produced by growing the virus in a laboratory and then killing it with heat or chemicals, or by weakening it so that it can still stimulate an immune response without causing disease. The flu vaccine is typically administered via injection into a muscle and cannot give you the flu, despite common misconceptions. While most vaccines used in Australia are made overseas, the country does produce some influenza vaccines, such as the Afluria Quad™ vaccine.
| Characteristics | Values |
|---|---|
| Country of origin | Most Australian vaccines are made in other countries, such as China and India. The only vaccines made in Australia are some influenza vaccines and the Q Fever vaccine, which are made by Seqiris, a CSL company. |
| Regulation | Vaccines used in Australia are licensed in the USA, where manufacturers are not liable for any harm caused by the vaccines. |
| Ingredients and side effects | Information on ingredients and side effects is available on the Therapeutic Goods Administration website. |
| Type of vaccine | The flu vaccine is an inactivated quadrivalent vaccine, meaning it contains four types of viruses chosen annually by the Australian Influenza Vaccine Committee (AIVC). The viruses in the vaccine are not live, so the vaccine cannot give you the flu. |
| Administration | The vaccine is administered by a doctor, nurse, or trained pharmacist, as an injection into the muscle or under the skin. |
| Eligibility | The Australian Immunisation Handbook recommends influenza vaccination for specific groups, including Aboriginal and Torres Strait Islander people, pregnant women, and people with certain medical conditions. The vaccine is free under the National Immunisation Program (NIP) for eligible individuals aged 6 months and older. |
| Timing | It is recommended to get the annual influenza vaccine anytime from April onwards to be protected during the peak flu season, which is generally from June to September. |
| Safety | The flu vaccine does not contain live viruses, so it cannot give you the flu. Preservatives are no longer needed in vaccines given in Australia as they are produced in single-use sealed vials. |
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What You'll Learn
Regulatory approval
The Therapeutic Goods Administration (TGA) plays a crucial role in regulatory approval by evaluating and registering vaccines for use in Australia. The TGA website provides valuable information on vaccine ingredients and side effects, ensuring transparency and accessibility for healthcare professionals and the public. The TGA's registration of Afluria Quad™, a locally manufactured four-strain flu vaccine, in 2016, is a notable example of its role in approving flu vaccines for the Australian market.
The Australian Influenza Vaccine Committee (AIVC) is another key player in the regulatory process. The AIVC is responsible for selecting the specific virus strains to be included in the annual flu vaccine. This decision is based on extensive research and surveillance of circulating flu viruses to ensure the vaccine's effectiveness. The AIVC's recommendations guide vaccine manufacturers in producing timely and relevant flu vaccines each year.
While the regulatory approval process for flu vaccines in Australia involves multiple stakeholders, the ultimate goal is to ensure the safety, efficacy, and accessibility of these vaccines for the Australian population. The collaboration between government departments, advisory committees, and healthcare professionals helps maintain high standards and public trust in the country's immunisation programs.
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Egg-based manufacturing
The flu vaccine is made in a variety of ways, one of which is the traditional method of using eggs. This process is known as "egg-based manufacturing". Here is a detailed description of how the flu vaccine is produced using this method in Australia:
This method of vaccine production is labour-intensive and time-consuming, requiring a large number of eggs to produce sufficient quantities of the vaccine. As a result, other methods of vaccine production, such as cell-based manufacturing, have gained popularity.
In Australia, the flu vaccine is typically recommended for specific groups, including Aboriginal and Torres Strait Islander people, pregnant women, and individuals with certain medical conditions. The Australian Immunisation Handbook suggests annual flu vaccination for all Australians aged six months and older. The National Immunisation Program provides free vaccines for eligible individuals.
While the flu vaccine is generally safe and effective, it is essential to consult a healthcare professional for specific advice and to stay informed about the ingredients and potential side effects of any vaccine.
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Cell culture-based manufacturing
The selected cell line is then carefully cultured and maintained in a laboratory setting, providing the optimal environment for growth. Once the cell culture is established, the virus of interest, in this case, the influenza virus, is introduced into the culture. The virus infects the cells and begins to replicate, taking advantage of the host cell's machinery to produce more viral particles.
After a certain incubation period, the viruses are harvested from the cell culture. This step involves separating the viruses from the host cells and purifying them to obtain a concentrated viral solution. The purification process ensures that only the desired virus is isolated, and any impurities or unwanted substances are removed.
To ensure the safety and effectiveness of the vaccine, the harvested viruses undergo a critical step called inactivation. This process renders the virus non-infectious while preserving its ability to elicit an immune response. Inactivation can be achieved through various methods, such as heat treatment or chemical inactivation, depending on the specific virus and vaccine requirements.
The inactivated viruses are then formulated into a stable vaccine product, which may include adding adjuvants or other components to enhance the immune response. The final vaccine undergoes rigorous quality control testing to ensure its safety, potency, and purity before being released for distribution and use.
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Vaccine strain preparation
The flu vaccine is made using a virus that has been grown in a laboratory and then killed or weakened so that it is no longer infectious. This process is known as "inactivation" or "attenuation". In Australia, the flu vaccine is typically a quadrivalent vaccine, which means it contains four different types of viruses. The specific viruses included in the vaccine are selected annually by the Australian Influenza Vaccine Committee (AIVC), who decide which strains are most suitable for inclusion based on the types of influenza viruses that are currently circulating.
The flu vaccine can be administered as an injection into the muscle (intramuscular injection) or under the skin. It can also be sprayed into the nostrils, although this type of vaccine is only available overseas. The vaccine is produced in single-use sealed vials, so preservatives are not necessary. However, small amounts of stabilisers like gelatine, salts, sugars, and surfactants may be included.
The manufacturing process for the flu vaccine involves growing the selected viruses in a laboratory under specific conditions designed to weaken them. Once the viruses have been inactivated or attenuated, they are purified to remove any impurities or contaminants. This process ensures that only the desired viruses are included in the vaccine and that they are safe and effective for human use.
In Australia, the flu vaccine is manufactured by Seqirus, a transcontinental partner in pandemic preparedness and the world's second-largest influenza vaccine business. Their facility in Melbourne, Australia, is the only onshore influenza vaccine manufacturing facility in the country. Seqirus was created in 2015 by combining the expertise of bioCSL and the influenza vaccines business formerly owned by Novartis.
While most vaccines used in Australia are made overseas, particularly in China and India, Seqirus' local manufacturing facility ensures that some flu vaccines are produced domestically. This provides a level of self-sufficiency and supply chain security for Australia's flu vaccine supply.
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Vaccine composition updates
In Australia, the flu vaccine composition is updated annually by the Australian Influenza Vaccine Committee (AIVC). The AIVC selects the four types of viruses to be included in the vaccine for that year. The chosen viruses are those deemed most suitable to provide protection during the upcoming flu season. The annual update ensures that the vaccine remains effective against the constantly evolving influenza virus.
The flu vaccine composition for the 2017 Australian flu season, for example, included four strains: influenza A (H1N1) Michigan, influenza A (H3N2) Hong Kong, influenza B Brisbane, and influenza B Phuket. This vaccine was manufactured locally in Melbourne by Seqirus, a world-leading influenza vaccine manufacturer. Seqirus is the only company that manufactures flu vaccines in Australia.
The Australian Immunisation Handbook recommends annual flu vaccination for all Australians aged six months and older. The vaccine is funded by the National Immunisation Program (NIP) for specific groups, including Aboriginal and Torres Strait Islander people, pregnant women, and individuals with certain medical conditions.
It is recommended that individuals receive their flu vaccine anytime from April onwards to be protected during the peak flu season, which typically occurs from June to September in Australia. The highest level of protection is achieved in the first three to four months after vaccination. However, it is never too late to get vaccinated, as the influenza virus can circulate in the community year-round.
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Frequently asked questions
The Australian flu vaccine does not contain a live virus and therefore cannot give you the flu. The flu vaccine is made from a killed whole microorganism that has been grown in a laboratory and then killed by heat or chemicals so that it is no longer infectious.
Most Australian vaccines are made in other countries, such as China and India, and licensed in the USA. The only vaccines that are made in Australia are some influenza vaccines and the Q Fever vaccine, which are made by Seqirus, a CSL company.
The Australian Immunisation Handbook recommends influenza vaccination for specific groups, including Aboriginal and Torres Strait Islander people aged 6 months and older, pregnant women, and people aged 6 months and older with certain medical conditions. The Australian government funds a National Immunisation Program for Australians aged 65 and over.
