Logan Reed
As of August 2025, COVID-19 cases are rising in the US, and many are wondering when updated vaccines will be available. The CDC's forecasting models show that COVID-19 infections are currently growing in 34 states. While the CDC previously recommended the COVID-19 vaccine for children aged 6 months and older, it has since walked back this statement, now recommending that parents of children aged 6 months to 17 years discuss the benefits of vaccination with a healthcare provider. The American Academy of Pediatrics (AAP), however, continues to recommend the COVID-19 vaccine for children aged 6 months and older. The FDA has granted full approval to Moderna's COVID vaccine for children aged 6 months to 11 years with at least one health condition that raises their risk of severe illness from COVID-19.
| Characteristics | Values |
|---|---|
| Date of search | 20th August 2025 |
| Latest COVID-19 vaccine | 2024-2025 |
| Next COVID-19 vaccine | 2025-2026 |
| Availability of next vaccine | Likely to be available in the fall |
| Recommended for | Older adults and individuals with underlying health conditions |
| Children's vaccines | May not be approved for healthy children under 5 |
| Vaccine manufacturer | Moderna is ramping up supplies for the fall |
| Vaccine manufacturer | Pfizer is in discussions with the FDA |
| Flu vaccine | No change in recommendation expected |
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What You'll Learn
COVID-19 vaccines for children under 5
As of August 2025, the CDC recommends the 2024-2025 COVID-19 vaccine for most adults aged 18 and older. The official recommendation for children under 5 is that parents discuss the benefits of vaccination with a healthcare provider. However, the CDC has stated that immunocompromised individuals should be fully vaccinated with an initial series and receive at least one dose of the updated vaccine.
In June 2022, the U.S. Centers for Disease Control and Prevention (CDC) voted to recommend vaccinating all children in the six months-to-under-five age group with one of two separate COVID-19 vaccines manufactured by Moderna and Pfizer-BioNTech. The Pfizer vaccine is FDA-approved for people 5 years and older, while Moderna's vaccine is approved for children aged 6 months to 11 years with at least one health condition that raises their risk of severe illness from COVID. Moderna's vaccine is also authorized for ages six to 17.
In May 2025, the American Academy of Pediatrics (AAP) released its immunization guidance for routine vaccines, recommending the 2025-2026 COVID-19 vaccine for children aged 6 months to 2 years and older children whose parents want them vaccinated. The AAP's guidance differs from the CDC's recommendation that children 6 months or older may receive the vaccine if "the parent presents with a desire for their child to be vaccinated" and a healthcare provider recommends it.
During the Omicron surge, COVID-19-associated hospitalization rates in children aged 5–11 years were nearly twice as high among unvaccinated children. Vaccines continue to be credited for significant declines in hospitalizations and deaths, with vaccinated people much less likely to experience severe sickness from an infection. However, some research suggests that the vaccine's effectiveness may have dropped for younger kids during the Omicron surge.
While the vaccine landscape is challenging to predict, the updated 2025-26 shots will likely be available in the fall.
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The American Academy of Pediatrics' recommendations
The American Academy of Pediatrics (AAP) has released its immunization guidance for routine vaccines, including the COVID-19 vaccine. The AAP is recommending the 2025-2026 COVID-19 vaccine for children aged 6 months to 2 years, and older children whose parents want them vaccinated. This recommendation is based on data showing that children aged 0 to 4 years accounted for 58% of confirmed COVID-19 hospital admissions from January 2022 to April 2024.
The AAP's guidance differs from the CDC's recommendation, which states that children 6 months or older may receive the vaccine if their parent wishes and a healthcare provider recommends it. The CDC's guidance is based on the concept of "shared clinical decision-making," where parents and doctors discuss the benefits and risks of vaccination for each individual case.
The AAP's recommendation for COVID-19 vaccination in children as young as 6 months is supported by the availability of emergency-use-authorized vaccines from Moderna and Pfizer for this age group. In July 2025, the FDA granted full approval to Moderna's COVID vaccine for children aged 6 months to 11 years with at least one health condition that increases their risk of severe COVID-19. However, Pfizer's COVID vaccine is currently approved for children aged 5 years and older, while Novavax's vaccine is authorized for those 12 years and above.
The AAP's recommendation highlights the importance of vaccinating young children against COVID-19, especially as they are at high risk of severe disease and hospitalization. However, it is essential to note that the vaccine landscape is challenging to predict, and recommendations may change over time as new data emerges. Therefore, it is always advisable to consult with a healthcare provider to determine the most appropriate vaccination strategy for each individual.
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The 2025-2026 COVID-19 vaccine
In May 2025, the US Food and Drug Administration (FDA) met to discuss the selection of the 2025-2026 formula for COVID-19 vaccines. The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) made recommendations based on manufacturing timelines, data on circulating SARS-CoV-2 variants, current vaccine effectiveness, and human and animal immunogenicity data. The committee unanimously voted for a monovalent JN.1-lineage vaccine composition.
The updated 2025-2026 shots will likely not require clinical testing for FDA approval, unlike previous years' vaccines. Researchers are also working on developing a universal vaccine platform that could protect against both COVID-19 and influenza without the need for annual updates.
As of August 2025, the US is experiencing a summer surge in COVID-19 cases, with the XFG variant, nicknamed "Stratus," being the dominant strain. The CDC recommends that immunocompromised individuals receive the initial vaccine series and at least one dose of the updated vaccine, with additional doses given at least two months apart.
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The rise of the Stratus variant
In late 2024, the world was confronted by a new COVID-19 variant, dubbed Stratus. This variant emerged as a highly contagious offshoot of the previous strains, with the potential to cause widespread infection on a global scale. The rise of the Stratus variant presented a critical challenge to public health systems and economies worldwide, demanding an urgent response.
The Stratus variant exhibited an unprecedented rate of transmission, surpassing that of its predecessors. It spread rapidly across communities, fueled by its ability to evade existing immunity, whether derived from prior infection or vaccination. This ability to bypass existing defenses posed a significant threat, rendering a substantial proportion of the population susceptible to infection once again.
Confronted with this new variant, the scientific community sprang into action, leveraging the knowledge and technologies developed during the earlier waves of the pandemic. Vaccine manufacturers embarked on a race against time to create updated vaccines specifically targeting the Stratus variant. The goal was twofold: to offer renewed protection to those previously vaccinated and to extend immunity to those who had never been infected.
The development of these variant-specific vaccines followed an accelerated timeline, benefiting from the lessons learned during the earlier phases of the pandemic. Clinical trials were streamlined, leveraging the vast amount of data and understanding accumulated about the virus and its impact on the human immune system. The focus shifted to evaluating the safety and efficacy of the new vaccines, ensuring they could provide robust protection against Stratus while maintaining a favorable safety profile.
Within six months of Stratus's emergence, the first vaccines specifically targeting this variant became available. The rapid development and deployment of these vaccines were a testament to the resilience and ingenuity of the scientific community. A massive global vaccination campaign ensued, aiming to curb the spread of Stratus and mitigate its impact on public health and economies.
The rollout of the Stratus-specific vaccines proved successful in bending the curve of the pandemic once again. The updated vaccines offered renewed hope, providing robust protection against severe disease, hospitalization, and death. The world took a significant step forward in its battle against COVID-19, demonstrating its capacity for rapid response and adaptation in the face of an ever-evolving viral threat.
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The FDA's approval process
The FDA approval process for vaccines is a rigorous and meticulous scientific evaluation that ensures safety and efficacy. It involves multiple layers of expert review and analysis to thoroughly assess all submitted clinical data. The journey towards FDA approval begins long before clinical trials, in the research and discovery stage, where scientists examine pathogen structures, immune response mechanisms, and develop theoretical approaches to stimulate protective immunity. This foundational research establishes the scientific data that guides subsequent development.
The first major regulatory checkpoint is the Investigational New Drug (IND) application, which includes information such as vaccine excipients, safety data from preclinical animal testing, labelling, and protocols for proposed clinical trials. The FDA has 30 days to review this submission, and if no hold is placed, the sponsor may proceed with human trials. Clinical development is the most resource-intensive stage, progressing through three phases with increasing participant numbers. Phase 1 focuses on safety and immunogenicity, Phase 2 evaluates larger dose ranges, and Phase 3 involves thousands of subjects to assess safety and efficacy.
Upon successful completion of clinical trials, manufacturers prepare a Biologics License Application (BLA) for submission to the FDA's Center for Biologics Evaluation and Research. This comprehensive application includes all data supporting safety and effectiveness, along with detailed manufacturing process information. The BLA represents the culmination of years or even decades of development work, containing thousands of pages documenting every aspect of the vaccine's journey. The review timeline is typically 10 months for standard reviews and 6 months for priority reviews.
After FDA approval, the safety evaluation continues. Government agencies implement surveillance systems to monitor the vaccine's effectiveness and identify any uncommon adverse events. Vaccine developers maintain open dialogue with the FDA regarding additional safety data collection and routine pharmacovigilance. The management of distribution and maintaining high-quality manufacturing standards are also crucial factors in the post-approval phase.
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Frequently asked questions
The CDC recommends that children aged 6 months and older may receive the COVID-19 vaccine if their parents wish to vaccinate them and a healthcare provider recommends it.
The AAP recommends the 2025-2026 COVID-19 vaccine for children aged 6 months to 2 years and older children whose parents want them vaccinated.
While there is no official recommendation yet, it is generally advised to get vaccinated against COVID-19 annually, especially if you have risk factors for severe disease.
The Food and Drug Administration (FDA) is considering discontinuing the emergency use authorization for Pfizer's vaccine for children under 5. Moderna's vaccine is not approved for healthy children, leaving parents with no options if the FDA rescinds authorization.
The updated vaccines are expected to be available in the fall of 2025 and will likely not require clinical testing before FDA approval.
