FDA Approved COVID Vaccines
As of 2025, the FDA has granted full approval or emergency use authorization to multiple COVID-19 vaccines. Comirnaty by Pfizer-BioNTech and Spikevax by Moderna remain the primary mRNA vaccines, while Novavax’s protein-based vaccine provides an alternative for patients avoiding mRNA technology. Updated formulations targeting newer variants have been authorized to match circulating strains. For the latest regulatory status and dosing schedules, see the FDA’s vaccines page COVID-19 Vaccines.
Real-world effectiveness data from the CDC shows that updated mRNA boosters reduce hospitalization risk by roughly 50 to 70 percent in adults over 65 compared to unvaccinated individuals. Novavax’s protein subunit vaccine has demonstrated comparable safety profiles in phase 3 trials. Vaccination rates vary by region, but updated doses remain recommended for high-risk groups including older adults and immunocompromised patients.
FDA Approved COVID Treatments
Paxlovid (nirmatrelvir and ritonavir) by Pfizer and Lagevrio (molnupiravir) by Merck remain the primary FDA authorized oral antivirals for mild-to-moderate COVID-19 in high-risk patients. Remdesivir (Veklury) by Gilead Sciences is approved for hospitalized patients and has shown a reduction in recovery time in clinical trials. Bebtelovimab and other monoclonal antibodies have been withdrawn or limited as viral mutations reduced their effectiveness against current variants.
Treatment Efficacy and Usage
Paxlovid reduces the risk of hospitalization or death by approximately 88 percent when started within five days of symptom onset in high-risk adults. Lagevrio shows a more modest reduction of severe outcomes, and remdesivir shortens recovery by about five days in hospitalized patients. Treatment guidelines now emphasize early testing and prompt antiviral initiation for eligible patients, especially those with weakened immune systems or chronic conditions.
FDA Approved COVID Tests
The FDA has authorized hundreds of at-home rapid antigen tests and laboratory-based PCR assays for SARS-CoV-2 detection. Common authorized brands include BinaxNOW, QuickVue, and Lucira, with molecular tests such as the Roche cobas and Abbott ID NOW platforms widely used in clinical settings. The FDA maintains an ongoing list of authorized tests that are updated as new variants emerge and test performance is reevaluated.
Testing Guidance and Accuracy
Rapid antigen tests perform best within the first few days of symptom onset and have a sensitivity of roughly 70 to 80 percent compared to PCR. Molecular tests remain the gold standard for confirming active infection, especially in asymptomatic or pre-symptomatic cases. The CDC recommends testing within 48 hours of exposure and repeating tests if the initial result is negative but symptoms persist, with many tests now covered by insurance or available at no cost through federal programs.