For individuals who fall outside of the conditions listed under the new CDC recommendations, the cost of updated vaccines may depend on whether their insurance covers the shot, with some payers fully covering vaccination, others requiring a copay, and others not covering any of the $140 cost.
News
Article
FDA Authorizes New COVID Vaccines with Restrictions on Eligibility
Author(s):
Key Takeaways
- Updated COVID-19 vaccines are authorized for high-risk adults, targeting the LP.8.1 sublineage of SARS-CoV-2, from Moderna, Pfizer-BioNTech, and Novavax.
- The authorization ends emergency use authorizations and mandates, focusing on availability for vulnerable populations.
FDA approves COVID-19 vaccines from Moderna, Pfizer-BioNTech, and Novavax targeting the LP.8.1 sublineage of SARS-CoV-2, with eligibility limited to adults aged 65 years and older and those with underlying medical conditions that place them with a high risk for severe disease.
Image Credit: © JHVEPhoto - stock.adobe.com
The FDA has authorized the use of updated COVID-19 vaccines for the upcoming fall season, with eligibility limited to adults aged 65 years and older as well as individuals who have at least one underlying medical condition that places them with a high risk for severe COVID-19.1,2
FDA authorizes updated COVID-19 vaccines for high-risk adults ahead of fall season
The regulatory action was announced today by Health and Human Services Secretary Robert F Kennedy Jr in a post on the social media platform X. The authorization for immunizations targeting the LP.8.1 sublineage of SARS-CoV-2 applies to vaccines from Moderna for individuals aged 6 months and above, Pfizer-BioNTech for those aged 5 years and above, and Novavax for those aged 12 years and above.
"Protecting people at increased risk of severe outcomes from COVID-19 is imperative to public health as COVID-19 was responsible for up to 4 million outpatient visits and nearly half of a million hospitalizations last year," Stéphane Bancel, CEO of Moderna, said in a press release. "We are proud to help ensure Americans will have the latest protection against currently circulating strains this respiratory virus season."1
RFK announces end of emergency authorizations and mandates
Prior guidance had recommended vaccination for all individuals aged 6 months and above. In his social media post announcing the new vaccination guidelines, Kennedy wrote:
“I promised 4 things:
1. to end covid vaccine mandates.
2. to keep vaccines available to people who want them, especially the vulnerable.
3. to demand placebo-controlled trials from companies.
4. to end the emergency.
In a series of FDA actions today we accomplished all four goals. The emergency use authorizations for Covid vaccines, once used to justify broad mandates on the general public during the Biden administration, are now rescinded.”
Health and Human Services Secretary Robert F. Kennedy Jr. announces new COVID-19 vaccination approvals in post on the social media platform X.
Previously on May 27, Kennedy announced in another social media post on X that the COVID vaccine would no longer be part of the CDC’s recommended immunization schedule for healthy children and pregnant women, stating that that it’s “common sense and it’s good science.” Kennedy noted in the video that the vaccine would only be recommended for individuals over 65 years of age and those with existing health problems.
For individuals who fall outside of the conditions listed under the new CDC recommendations, the cost of updated vaccines may depend on whether their insurance covers the shot, with some payers fully covering vaccination, others requiring a copay, and others not covering any of the $140 cost.
CDC identifies medical conditions qualifying for vaccination
Preexisting conditions that fall under the CDC’s recommendations include:
- Asthma
- Cancer
- Hematologic malignancies
- Cerebrovascular disease
- Chronic kidney disease
- People receiving dialysis
- Chronic lung diseases limited to:
- Bronchiectasis
- COPD (Chronic obstructive pulmonary disease)
- Interstitial lung disease
- Pulmonary embolism
- Pulmonary hypertension
- Chronic liver diseases limited to:
- Cirrhosis
- Non-alcoholic fatty liver disease
- Alcoholic liver disease
- Autoimmune hepatitis
- Cystic fibrosis
- Diabetes mellitus, type 1 and type 2
- Disabilities, including Down syndrome
- Heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies
- HIV
- Mental health conditions limited to:
- Mood disorders, including depression
- Schizophrenia spectrum disorders
- Neurologic conditions limited to dementia and Parkinson’s Disease
- Obesity (BMI >30 kg/m2 or >95th percentile in children)
- Physical inactivity
- Pregnancy and recent pregnancy
- Primary immunodeficiencies
- Smoking, current and former
- Solid organ or blood stem cell transplantation
- Tuberculosis
- Use of corticosteroids or other immunosuppressive medications
“The American people demanded science, safety, and common sense. This framework delivers all three,” Kennedy wrote in his social media post on X.
CDC review and leadership shift to guide future recommendations
The CDC Advisory Committee on Immunization Practices will review the FDA decision and issue updated vaccination recommendations. Earlier this week, the CDC appointed Retsef Levi to lead the agency’s COVID-19 workgroup. Levi has previously criticized mRNA vaccines, including both the Moderna and Pfizer shots, stating that they may cause harm and death, especially in younger children.
"While individual members may hold initial personal views, the task force’s work will be guided by data, transparency, open-mindedness, and open deliberation, not by any single opinion,” HHS spokesman Andrew Nixon said in a statement to The New York Times. “We are confident this process will produce policy recommendations that put patients’ health and safety first."
References
1. Moderna Receives U.S. FDA Approval for Updated COVID-19 Vaccines Targeting LP.8.1 Variant of SARS-CoV-2. Moderna. News release. August 27, 2025. Accessed August 27, 2025. https://feeds.issuerdirect.com/news-release.html
2. Pfizer and BioNTech’s COMIRNATY® Receives U.S. FDA Approval for Adults 65 and Older and Individuals Ages 5 through 64 at Increased Risk for Severe COVID-19. Pfizer. News release. August 27, 2025. Accessed August 27, 2025. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontechs-comirnatyr-receives-us-fda-approval
Newsletter
Stay current in clinical research with Applied Clinical Trials, providing expert insights, regulatory updates, and practical strategies for successful clinical trial design and execution.
Related Videos
Related Content
