Logan Reed
As of September 2025, updated COVID-19 vaccines for the 2025-2026 season have been approved by the FDA, with limitations. The Moderna, Pfizer, and Novavax shots are currently available in the US, with Moderna's vaccine being the only one approved for high-risk children as young as 6 months. The updated vaccines have been reformulated to more closely match currently circulating strains, with monovalent vaccines targeting the LP.8.1 subvariant of the Omicron JN.1 lineage. While the vaccines are safe and effective, eligibility criteria and availability may vary by country and state, with some restrictions based on age and health status.
| Characteristics | Values |
|---|---|
| Date | September 10, 2025 |
| Vaccine Availability | The 2025-2026 COVID-19 vaccines are approved by the FDA and are available in the US |
| Limitations | Only available for "high-risk" individuals, including people over 65 and those with certain underlying conditions |
| Vaccine Manufacturers | Moderna, Pfizer, and Novavax |
| Vaccine Type | Moderna and Pfizer shots are mRNA vaccines; Novavax is the only protein-based, non-mRNA vaccine |
| Vaccine Eligibility | Moderna: high-risk individuals aged 6 months to 64; Pfizer: high-risk individuals aged 5 to 64; Novavax: high-risk individuals over 12 |
| Vaccine Availability Locations | Pharmacies, doctor's offices, and hospitals |
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What You'll Learn
Moderna and Pfizer's 2025-2026 vaccines
As of September 2025, the U.S. Food and Drug Administration (FDA) has approved the updated 2025-2026 COVID-19 vaccines from Pfizer and Moderna, with certain limitations. The approval is currently limited to "high-risk" individuals, including people aged 65 and above and those with specific underlying conditions that increase their risk for severe COVID-19.
The 2025-2026 Pfizer and Moderna vaccines are mRNA vaccines, which use genetic material called messenger RNA to trigger an immune response. These vaccines have been reformulated to more closely match the currently circulating strains and will specifically target the LP.8.1 subvariant of the Omicron JN.1 lineage, following guidance from the FDA. Studies from Moderna and Pfizer indicate that the LP.8.1 vaccines generate a stronger immune response compared to earlier shots targeting the JN.1 and KP.2 variants. Additionally, Pfizer's pre-clinical data demonstrates that its vaccine offers protection against multiple circulating variants, including XFG (Stratus) and NB.1.8.1 (Nimbus).
In terms of availability, Pfizer and Moderna announced that their updated vaccines would be shipped immediately to pharmacies, doctor's offices, and hospitals. However, the availability may vary depending on the location and timing of orders. The new COVID vaccines are expected to be available for eligible individuals in the fall of 2025.
Regarding eligibility, Moderna's updated vaccine has been approved for high-risk children as young as 6 months old. Meanwhile, Pfizer's vaccine is authorized for high-risk children over the age of 5, and Novavax is approved for high-risk children above 12 years old. For healthy individuals under 65 without any high-risk conditions, it is recommended to consult a doctor to determine eligibility for the COVID-19 vaccine.
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Novavax's non-mRNA vaccine
Novavax's Nuvaxovid is a protein-based, non-mRNA COVID vaccine available in the US. It is the only non-mRNA vaccine with full FDA approval in the country. The vaccine targets the JN.1 variant of SARS-CoV-2, which accounts for most global infections. Novavax's proprietary Matrix-M adjuvant enhances its protein-based formulation, providing a strong immune response without the complexities of mRNA or viral vectors.
Nuvaxovid has several key advantages over mRNA vaccines. Firstly, it has a favourable safety profile, with clinical trials and post-marketing data showing side effects comparable to other vaccines. The SHIELD-Utah study also found that Novavax's vaccine induced lower frequency and severity of short-term side effects and impact on daily life compared to the Pfizer-BioNTech mRNA vaccine. Secondly, Nuvaxovid is easier to store and distribute. Unlike mRNA vaccines, which require ultra-cold storage, Nuvaxovid can be stored at regular refrigerator temperatures, reducing logistical costs.
The cost structure of Nuvaxovid is another advantage. It is estimated to be 30-40% lower than mRNA vaccines, making it a compelling option for governments and insurers. Novavax's collaboration with Sanofi also ensures global scalability and affordability. However, the non-mRNA vaccine segment is projected to stabilise in volume despite a negative CAGR through 2030 as cost-conscious buyers prioritise affordability.
Nuvaxovid's regulatory distinction as the only non-mRNA vaccine with full FDA approval in the US is a critical differentiator in a market where trust is paramount. This approval positions Novavax to play a unique role in a diversifying vaccine market. The 2025 vaccine landscape is marked by a strategic shift away from overreliance on mRNA platforms, with their high production costs, logistical challenges, and public scepticism. While mRNA vaccines remain critical, Novavax's Nuvaxovid offers a compelling alternative, particularly for those seeking a non-mRNA option due to adverse reactions or other concerns.
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Vaccine eligibility and restrictions
Healthy individuals under 65 without any high-risk conditions may still be able to get the COVID-19 vaccine, but it may require a doctor's visit and an "off-label" prescription. Off-label prescriptions are legal and are based on a physician's judgement of the evidence rather than the vaccine's FDA license.
In other countries, eligibility for COVID-19 vaccines may include key workers, non-elderly clinically vulnerable groups, elderly groups, or other broad groups/ages.
The Advisory Committee on Immunization Practices (ACIP) in the United States reviews data and advises the federal government on vaccine usage for the general public. Their recommendations can shape national immunization schedules and insurance coverage. As of September 2025, the ACIP is expected to provide updated recommendations for the 2025-2026 COVID-19 vaccines.
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Vaccines for pregnant and breastfeeding women
Clinical trials for new medicines typically exclude pregnant women. However, since the approval of COVID-19 vaccines, over a quarter of a million women in the UK and US have been safely vaccinated. All the vaccines offered to pregnant women are safe in pregnancy and highly effective against COVID-19. The Pfizer-BioNTech, Sanofi Pasteur, and Moderna vaccines have been deemed safe for pregnant and breastfeeding women. Being fully vaccinated protects pregnant women from getting seriously ill with COVID-19 and lowers their risk of pregnancy complications linked to the illness. The vaccines also benefit the baby, as the antibodies produced by the mother are passed to the baby, offering protection after birth.
Pregnant women are recognised as a vulnerable group and are therefore prioritised for any COVID-19 vaccines that they are eligible for. It is recommended that pregnant women who have never been vaccinated get the full protection of the first and second doses before their third trimester or before giving birth. This is because of the higher risk of serious illness, pregnancy and birth complications if they become infected while unvaccinated.
The vaccines are safe and effective at all stages of pregnancy, and there is no need to wait until the second trimester to get vaccinated. Pregnant women can also safely get the COVID-19 vaccine at the same time as other vaccines, such as the flu jab or whooping cough vaccine.
Breastfeeding women can also safely get the COVID-19 vaccine. The vaccine does not reach the breast milk, but the antibodies produced by the mother will pass to the baby through their milk, offering protection to the baby.
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Vaccines for high-risk children
Vaccination is one of the most effective ways to protect children from 16 potentially harmful diseases. While the development of a coronavirus vaccine is ongoing, with the FDA approving updated 2025-2026 vaccines, the availability of vaccines for high-risk children varies.
High-risk children as young as 6 months old can receive the Moderna COVID-19 vaccine. Pfizer is authorised for high-risk children over the age of 5, and Novavax is approved for those over 12. The Novavax shot is the only protein-based, non-mRNA COVID-19 vaccine available in the US. These vaccines are safe and effective and have been widely available in the United States. However, their accessibility depends on age, health, and location.
For children under 5, rotavirus vaccines are crucial, as the virus is very dangerous and can even be deadly. Two or three doses are recommended, depending on the brand. Additionally, Haemophilus influenzae type b (Hib) vaccines are essential for children under 5, as they are most at risk for Hib disease, which can cause lifelong disabilities or even be fatal. Three to four doses of the Hib vaccine are recommended.
For children over 10, a dose of Penbraya (MenACWY–TT/MenB–FHbp) can be administered as an alternative to separate doses of MenACWY and MenB. This is recommended for children at increased risk of meningococcal disease, provided that at least 6 months have passed since their last Penbraya dose.
In the case of infants, the first dose of the hepatitis B vaccine should be administered within 24 hours of birth, as the disease can be passed from mother to child and can cause liver damage and liver cancer.
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Frequently asked questions
The FDA has approved updated COVID-19 vaccines for the 2025-2026 season, which are available from Pfizer, Moderna, and Novavax.
The new vaccines are approved for individuals aged 6 months to 64 years with at least one underlying condition that puts them at higher risk for complications from a coronavirus infection.
The new vaccines are available at pharmacies, doctor's offices, and hospitals.
Data shows that COVID-19 vaccines are safe and effective at preventing severe illness, hospitalization, and death.
It is recommended to stay up-to-date with the latest COVID-19 vaccines to ensure protection against currently circulating strains of the virus.
