Sarah Bennett
The US Food and Drug Administration (FDA) has approved the latest round of Covid-19 vaccines, but with limitations. The updated shots from Pfizer, Moderna, and Novavax are approved for all seniors, but access for younger adults and children is restricted to those with at least one high-risk health condition. This marks a shift from previous recommendations for everyone aged 6 months and older to receive annual coronavirus vaccines. The FDA's more limited approval has been criticized by some medical groups, who argue that it may block vaccine access for families who want to protect their children.
| Characteristics | Values |
|---|---|
| Date of Approval | 27 August 2025 |
| Manufacturer | Pfizer, Moderna, Novavax |
| Age Limit | 65 and older |
| Underlying Conditions | At least one underlying condition for ages 6 months to 64 years |
| High-Risk Children | Moderna approved for children as young as 6 months; Pfizer for children over 5; Novavax for children over 12 |
| Availability | Pharmacies, hospitals, and clinics |
| Limitations | Only for those at higher risk of severe illness |
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What You'll Learn
Approval for Moderna, Pfizer and Novavax vaccines
The US Food and Drug Administration (FDA) has approved the 2025-2026 COVID-19 vaccines with certain limitations. The approval is currently limited to high-risk individuals, including people aged 65 and older and those aged 6 months to 64 years with at least one underlying condition.
Moderna
Moderna's updated COVID-19 vaccines, Spikevax® and mNexspike®, have been approved by the FDA. Spikevax is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 6 months through 64 years with at least one underlying condition, and all adults aged 65 and older. The vaccine is supplied in single-dose prefilled syringes containing 0.25mL for children aged 6 months through 11 years, and 0.5mL for individuals aged 12 years and older.
Pfizer
The FDA has approved the Pfizer-BioNTech COVID-19 vaccine, COMIRNATY®, for use in adults aged 65 and older, as well as individuals aged 5 through 64 with at least one underlying condition. The approval is based on clinical trial data supporting the safety and efficacy of the vaccine, including improved immune responses against multiple circulating SARS-CoV-2 sublineages.
Novavax
The FDA has delayed approval of the Novavax COVID-19 vaccine, citing the need for additional clinical data on the vaccine's efficacy. Novavax is the only COVID-19 booster in the United States that does not use messenger RNA technology. While the FDA has not approved the Novavax vaccine, physicians have the authority to prescribe it "off-label" to patients if they deem it appropriate.
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Limitations on who can get the vaccine
The FDA has approved the 2025-2026 COVID-19 vaccines with certain limitations on who can receive them. The vaccines are approved for adults aged 65 and older and individuals aged 6 months to 64 years with at least one underlying condition that increases their risk of severe COVID-19. The CDC has identified several conditions that fall into this category, including diabetes, heart disease, asthma, kidney disease, cancer, and mental health disorders, as well as lifestyle factors such as physical inactivity and smoking.
For children, the vaccine options are more limited. Moderna's updated COVID vaccine is the only one approved for high-risk children as young as 6 months. Pfizer is authorized for high-risk children over the age of 5, and Novavax is available for those over 12. However, it's important to note that the CDC no longer recommends COVID-19 vaccines for healthy pregnant women, creating a grey area for pregnant individuals seeking vaccination.
The restrictions on vaccine eligibility have shifted from previous years, where annual coronavirus vaccines were recommended for everyone aged 6 months and older. The new limitations have raised concerns among medical groups like the American Academy of Pediatrics, citing potential barriers to vaccine access for families wishing to protect their children.
It's worth noting that physicians can prescribe COVID-19 vaccinations "off-label," meaning they can vaccinate patients based on evidence rather than strict adherence to FDA licensing. This provides some flexibility in vaccine administration, allowing doctors to make decisions based on individual patient needs.
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Vaccines for children
The US Food and Drug Administration (FDA) has approved updated COVID-19 vaccines with some restrictions for children. The FDA has limited the use of the new shots from Pfizer, Moderna, and Novavax for younger adults and children with at least one high-risk health condition. Moderna's updated COVID vaccine is the only one approved for high-risk children as young as 6 months. Pfizer is authorised for high-risk children over the age of 5, and Novavax is for those over 12.
In Australia, the Therapeutic Goods Administration (TGA) has approved the Pfizer vaccine for children aged 5 to 11 years. The TGA has approved a special paediatric dose for this age group, which is one-third of the size of the dose for people aged 12 and over. The Australian Technical Advisory Group on Immunisation (ATAGI) has recommended the Moderna (Spikevax) paediatric COVID-19 vaccine for children aged 6 months to under 5 years who have severe immunocompromise, disability, or multiple health conditions that increase the risk of severe COVID-19.
In the UK, NHS Scotland is offering the coronavirus vaccine to children aged 6 months to 11 years who are at higher risk of coronavirus. The vaccine helps to build up immunity so that the child's body can fight off the virus more easily.
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Vaccines for high-risk groups
The US Food and Drug Administration (FDA) has approved updated COVID-19 vaccines for the fall of 2025, but eligibility is restricted to high-risk groups. This decision marks a shift in the agency's approach, as previous vaccine approvals were for a broader age range, including all people aged 12 and older, and under emergency use authorization, babies and children aged 6 months to 11 years.
The FDA's updated approval is limited to seniors and individuals at high risk of severe infections, specifically targeting those aged 65 and older, and younger people with underlying conditions that increase their vulnerability to COVID-19. Moderna's Spikevax vaccine, approved for individuals 6 months through 64 years of age with at least one underlying condition, falls into this category. Similarly, Pfizer's Comirnaty vaccine is authorized for individuals aged 5 and above who are at high risk.
The FDA's focus on high-risk groups reflects a strategic shift towards targeted vaccination strategies, emphasizing the prioritization of populations at the greatest risk of hospitalization and death. This decision is based on the understanding that COVID-19 disproportionately affects older adults, with this demographic accounting for a significant percentage of hospitalizations and deaths in the US.
While the FDA's updated approval prioritizes high-risk groups, it's important to recognize that COVID-19 vaccines are also crucial for other age groups, including young children, pregnant women, and healthy adults. The vaccines have undergone rigorous testing and continue to be closely monitored for safety and effectiveness.
Additionally, the FDA's decision to limit approvals to high-risk groups may have implications for insurance coverage. A COVID-19 vaccine dose without insurance coverage may incur significant costs for individuals, further emphasizing the importance of vaccination for those at high risk.
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FDA approval process
The US Food and Drug Administration (FDA) approved the 2025-2026 COVID-19 vaccines for adults aged 65 and older and individuals aged 6 months to 64 years with at least one underlying high-risk condition. The vaccines were developed by Pfizer, Moderna, and Novavax, and they target coronavirus subtypes related to emerging variants.
The FDA approval process for drugs involves rigorous evaluation by the Center for Drug Evaluation and Research (CDER), a science-led organisation. The process can take 12 to 15 years and includes the following key steps:
- Analysis of the Target Condition and Available Treatments: FDA reviewers analyse the condition the drug intends to treat and evaluate existing treatments. This context helps weigh the drug's risks and benefits.
- Risk Management Strategies: The FDA-approved drug label clearly describes the benefits and risks of the drug and how they can be managed. If more risk mitigation is required, a Risk Management and Mitigation Strategy (REMS) may be implemented.
- Structured Framework for Approval: The FDA follows a structured framework to determine if a drug's benefits outweigh its known and potential risks for the intended population.
- Fast Track and Breakthrough Therapy: The FDA employs approaches like Fast Track to expedite the development and review of drugs treating serious conditions and filling an unmet medical need. Breakthrough Therapy designation is given to drugs that show substantial improvement over existing therapies for serious conditions.
- Accelerated Approval: This process allows promising therapies for serious conditions to reach the market faster. It uses a "surrogate endpoint" to predict clinical benefit, but standard endpoints must still be proven post-approval.
- Encouraging Development: The FDA encourages the development of drugs that are the first treatment for an illness or offer significant benefits over existing options. These designations ensure that treatments for serious conditions reach patients as soon as possible while maintaining benefit-risk assessments.
- Post-Approval Follow-up: Even after approval, the FDA continues to monitor the safety and effectiveness of new drugs to ensure they remain suitable for their intended use.
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Frequently asked questions
Yes, the FDA has approved the latest round of Covid-19 vaccines in the U.S., but only for those at higher risk of severe illness from the virus.
The FDA-approved Covid-19 vaccines are available for adults 65 and older and individuals aged 6 months to 64 years with at least one underlying condition that puts them at high risk.
The CDC has a list of conditions that increase the risk for severe Covid, including diabetes, heart disease, asthma, kidney disease, cancer, obesity, and mental health disorders.
Yes, the FDA has approved vaccines from Pfizer, Moderna, and Novavax. Moderna's vaccine is the only one approved for children as young as 6 months, while Novavax's vaccine is only for those 12 and older.
