Lexi Webster
As of September 2024, new COVID vaccines may be coming to Australia. These include the Pfizer and Moderna mRNA vaccines, which have been granted emergency use authorisation by the FDA. The Novavax shot, a more traditional adjuvanted protein-based vaccine, is also being considered. The Therapeutic Goods Administration (TGA) is reviewing data on the vaccines' immune responses to newer variants before approving updated boosters. While the safety profile of the vaccines is not expected to change, their safety and efficacy will continue to be monitored even after approval and rollout.
| Characteristics | Values |
|---|---|
| Date of search | 2024-09-09 |
| Latest vaccine update | June 2024 |
| FDA advice | Vaccine manufacturers advised to update COVID vaccines to target JN.1 |
| FDA recommendation | Targeting KP.2 strain (FLiRT) is preferable |
| Moderna and Pfizer response | Able to develop vaccines targeted to KP.2 |
| FDA action | Granted emergency use authorisation for Moderna and Pfizer's KP.2 vaccines |
| Novavax status | Updated booster not yet before the TGA |
| Uptake of COVID boosters | Well below where it needs to be |
| Example | Only 31.8% of people aged 75+ had received a COVID vaccine in the previous six months (August 2024) |
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What You'll Learn
- The FDA has advised manufacturers to target the KP.2 strain (FLiRT)
- Moderna and Pfizer will develop KP.2 vaccines (FDA-approved)
- The Novavax shot is a traditional vaccine (adjuvanted protein-based)
- The Therapeutic Goods Administration is considering a fifth iteration (targeting the JN.1 omicron subvariant)
- The SARS-CoV-2 virus has continued to change quickly, affecting immunity
The FDA has advised manufacturers to target the KP.2 strain (FLiRT)
In June 2024, the FDA advised vaccine manufacturers to update their COVID vaccines to target the JN.1 variant. However, it later recommended that it would be preferable for vaccines to target the KP.2 strain (FLiRT) instead. KP.2 is a descendant of the JN.1 variant, which is itself an offshoot of the Omicron variant.
The KP.2 strain appears to be spreading faster than its predecessor, and it was classified by the World Health Organization as a Variant Under Monitoring in May 2024. This classification signals to public health authorities that a COVID-19 variant may require prioritised attention and monitoring. KP.2 has been shown to be more transmissible than the JN.1 variant, and it has the ability to evade immunity, infecting people who have received the most updated vaccines.
Moderna and Pfizer have both stated that they will be able to develop vaccines targeted at KP.2, and the FDA has granted emergency use authorisation for these companies' KP.2 vaccines. The difference between a JN.1 booster and a KP.2 booster is expected to be minimal, and both should provide significantly updated protection against currently circulating subvariants compared to the XBB vaccines. Therefore, the FDA's recommendation to target the KP.2 strain is a strategic decision to address the evolving nature of SARS-CoV-2 and ensure that the vaccines remain effective in protecting the public against COVID-19.
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Moderna and Pfizer will develop KP.2 vaccines (FDA-approved)
Moderna and Pfizer have developed KP.2 vaccines that have been approved by the FDA. These vaccines target the KP.2 variant, an offshoot of the Omicron strain that was dominant in the U.S. in May 2024. The KP.2 variant features immune-evasive spike mutations nicknamed "FLiRT". The FDA's decision to target the KP.2 variant reflects a shift in strategy based on the evolving virus landscape. Initially, the agency recommended targeting the JN.1 lineage, but as KP.2-related variants gained prevalence, they opted for KP.2 owing to its close relationship to these emerging strains.
The updated mRNA COVID-19 vaccines include Comirnaty and Spikevax, both of which are approved for individuals aged 12 and older. The Moderna COVID-19 vaccine and Pfizer-BioNTech COVID-19 vaccine are also approved for children aged 6 months through 4 years who have previously been vaccinated against COVID-19. The timing and number of doses administered depend on the previous COVID-19 vaccine received. The FDA noted that "mRNA COVID-19 vaccines have been updated with this formula to more closely target currently circulating variants and provide better protection against serious consequences of COVID-19, including hospitalization and death."
The approval and emergency use authorization for the vaccines cover a monovalent (single) component based on the KP.2 variant. This decision comes as the number of SARS-CoV-2 variants continues to diversify. The FDA advised manufacturers that the preferred JN.1-lineage for the COVID-19 vaccines (2024-2025 formula) is the KP.2 strain if feasible. Moderna and Pfizer said they would be able to develop vaccines targeted to KP.2, and the FDA has granted emergency use authorization for these companies' KP.2 vaccines. The difference between a JN.1 booster and a KP.2 booster is likely to be minimal, and both should provide significantly updated protection against currently circulating subvariants compared to the XBB vaccines.
The COVID-19 vaccines from Pfizer and Moderna are mRNA vaccines. These vaccines work by giving our bodies instructions to make SARS-CoV-2 spike proteins (proteins on the surface of the virus that it uses to attach to our cells). Then, when we encounter SARS-CoV-2, our immune system is ready to respond. The vaccines' safety and efficacy will continue to be monitored even after they are approved and rolled out.
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The Novavax shot is a traditional vaccine (adjuvanted protein-based)
The Novavax shot is a recombinant spike (S) protein nanoparticle vaccine combined with the Matrix-M adjuvant. The Matrix-M adjuvant enhances the body's immune response in a targeted and efficient way, significantly improving both the magnitude and the duration of the immune response. The adjuvant is derived from saponin extracts from the bark of the soapbark tree. Saponins are known to possess antimicrobial properties.
The Novavax vaccine is stable and has a shelf life of 9 months when stored at standard refrigerated temperatures of between 2–8°C. It can be administered as a two-dose primary series, three weeks apart to individuals 18 years or older.
The Novavax vaccine is a more traditional way of making a vaccine. However, the updated Novavax booster does not yet seem to have an application before the Therapeutic Goods Administration (TGA) and is likely to be some time away for those in Australia.
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The Therapeutic Goods Administration is considering a fifth iteration (targeting the JN.1 omicron subvariant)
The SARS-CoV-2 virus, which causes COVID-19, has continued to evolve rapidly, affecting how well immunity generated from vaccination and past infection protects us. This issue is often referred to as "immune evasion". To address this, Australia has updated its COVID-19 vaccines four times already. The Therapeutic Goods Administration (TGA) is now considering a fifth iteration—targeting the JN.1 omicron subvariant.
The TGA is Australia's national drug regulator, responsible for evaluating the safety and efficacy of vaccines. In September 2024, pharmaceutical companies Pfizer and Moderna submitted applications to the TGA for COVID-19 jabs targeting the Omicron sub-variant JN.1. The updated Pfizer jab was approved by UK health authorities in July 2024, and the FDA granted emergency use authorisation for Moderna and Pfizer's KP.2 vaccines.
The initial COVID-19 vaccines targeted the original strain of SARS-CoV-2. The first update included the original strain and added an early omicron subvariant, BA.1. This was then changed to BA.4/5 with the original strain. In late 2023, Australia reverted to a single-component vaccine targeting the Omicron subvariant XBB.1.5. However, the virus continued to evolve, and a new subvariant, JN.1, was detected in August 2023, driving a significant wave of infections in Australia.
The JN.1 subvariant has since been largely replaced by its descendants, FLiRT (including KP.1.1, KP.2, and JN.1.7) and FLuQE (KP.3). While these subvariants are more transmissible, they are not believed to cause more severe disease. Vaccines targeting JN.1 are expected to offer good protection against these newer subvariants, as they are all descendants of JN.1. The WHO recommended using vaccines targeting the JN.1 lineage as early as April 2024, anticipating the virus's continued evolution.
The updated boosters targeting JN.1 are not expected to change the well-established safety profile of COVID-19 vaccines. However, vaccine safety and efficacy will continue to be monitored even after approval and rollout, as is standard practice. The Novavax shot, a traditional adjuvanted protein-based vaccine, does not yet seem to have an application before the TGA and is likely to arrive later in Australia.
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The SARS-CoV-2 virus has continued to change quickly, affecting immunity
The SARS-CoV-2 virus has continued to change quite quickly, and this has impacted how well immunity generated from both vaccination and past infection protects us. This issue is often referred to as "immune evasion". The constant evolution of the virus has led to the emergence of new variants and subvariants, such as the omicron subvariant XBB.1.5 and the more recent JN.1 omicron subvariant.
To address the challenge posed by the rapidly changing virus, Australia has already updated its vaccines four times. The initial vaccines targeted the original strain of SARS-CoV-2. The first update included the original strain and added the early omicron subvariant BA.1. This was followed by another update that introduced the BA.4/5 subvariants. However, the virus continued to evolve, and in August 2023, the JN.1 omicron subvariant emerged, driving a significant wave of infections in Australia.
In response to the evolving nature of the virus, the Therapeutic Goods Administration (TGA) in Australia is considering the fifth iteration of the COVID-19 vaccine, specifically targeting the JN.1 omicron subvariant. While this updated vaccine is expected to provide improved protection against the newer subvariants, it is important to note that the vaccines' safety and efficacy will continue to be monitored even after their approval and rollout.
The SARS-CoV-2 infection causes severe immune disruption in recovered patients. Studies have shown that the cytokine milieu and metabolic environment in COVID-19 patients shape the signaling of the B-cell population. This disruption in immune regulation can lead to a condition known as a "cytokine storm," where the inflammatory response is uncontrolled, contributing to severe SARS-CoV-2 infections and potentially affecting further immune responses.
Additionally, SARS-CoV-2 infections can cause immunodeficiency in recovered patients by downregulating CD19 expression in B cells and enhancing B-cell metabolism. This results in decreased expression of the critical immune regulator CD19, impacting the immune system's ability to respond effectively. Furthermore, studies have found that the genes related to metabolism and metabolic products were dysregulated in recovered patients, indicating that COVID-19 affects the whole-body metabolism.
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Frequently asked questions
The FDA has approved Moderna and Pfizer's KP.2 vaccines for emergency use. However, the Therapeutic Goods Administration (TGA) is considering the fifth iteration of a COVID vaccine, a shot targeting the JN.1 omicron subvariant.
The difference between the two boosters is expected to be minimal. Both boosters should provide significantly updated protection against currently circulating subvariants compared with the XBB vaccines.
The Pfizer and Moderna vaccines are mRNA vaccines. They give our bodies instructions to make SARS-CoV-2 spike proteins (proteins on the surface of the virus that it uses to attach to our cells). When we encounter SARS-CoV-2, our immune system is ready to respond.
COVID vaccines are constantly monitored for safety. Regulators carefully review data on immune responses generated by the new vaccines against newer variants before approving updated boosters.
The Novavax shot is an adjuvanted protein-based vaccine. The proteins are manufactured in a lab, and a component called an adjuvant is added to improve the body's immune response.
