Yes, several COVID-19 vaccines have full FDA approval. Comirnaty (Pfizer-BioNTech) was the first to receive it on August 23, 2021, followed by Spikevax (Moderna) on January 31, 2022. Novavax’s vaccine, marketed as Nuvaxovid, also holds full approval. A fourth vaccine, Mnexspike, is licensed as well. All four are listed on the FDA’s official registry of licensed vaccines in the United States.
Which Vaccines Are Fully Approved
Full FDA approval, also called licensure, is the gold standard for any vaccine or drug in the United States. It means the product has gone through the complete review process, not just the shortened emergency pathway. Four COVID-19 vaccines currently hold this status:
- Comirnaty (Pfizer-BioNTech), an mRNA vaccine, approved August 23, 2021
- Spikevax (Moderna), an mRNA vaccine, approved January 31, 2022
- Nuvaxovid (Novavax), a protein-based vaccine with an adjuvant
- Mnexspike, an mRNA vaccine
For the 2024-2025 season, the FDA approved updated formulas of both Comirnaty and Spikevax on August 22, 2024. These updated versions target the Omicron KP.2 strain and are fully approved for anyone 12 and older.
Age Groups and Approval Differences
Full approval does not cover every age group equally. Comirnaty and Spikevax are FDA-approved for individuals 12 years of age and older. Children between 6 months and 11 years can still receive COVID-19 vaccines, but those doses are available under Emergency Use Authorization rather than full approval. That means the Pfizer-BioNTech and Moderna vaccines given to younger children are the EUA versions, not the branded approved products.
Full Approval vs. Emergency Use Authorization
When the first COVID-19 vaccines rolled out in late 2020, they were available under Emergency Use Authorization. This is a faster pathway the FDA uses during public health emergencies. It allows an unapproved product to be distributed when the known and potential benefits outweigh the known and potential risks, and no adequate approved alternatives exist. An EUA is not the same as saying a vaccine is unsafe or untested, but it does involve less data than what full approval requires.
For full approval (formally called a Biologics License Application, or BLA), the FDA demands considerably more. Manufacturers must submit at least six months of safety follow-up data on serious and medically significant side effects after participants complete all doses. The pre-approval safety database typically includes at least 3,000 people who received the intended dosing regimen. Manufacturers must also validate their production process using at least three commercial-scale batches, prove the vaccine’s stability and shelf life, and pass FDA inspections of their manufacturing facilities. Every step, from air filtration systems to cleaning protocols, gets scrutinized.
In practical terms, the clinical evidence supporting today’s approved COVID-19 vaccines is far larger than these minimums. The original Pfizer and Moderna trials enrolled tens of thousands of participants, and hundreds of millions of real-world doses have been tracked through post-market surveillance systems since then.
What “Approved” Means for You
If you’ve seen conflicting claims online about whether COVID-19 vaccines are “really” approved, the confusion usually traces back to the early period when only EUAs were in place. That is no longer the case. The mRNA vaccines from Pfizer-BioNTech and Moderna crossed the full-approval threshold years ago, and subsequent updated formulas have also received approval for ages 12 and up.
One source of lingering confusion is the naming. The fully approved Pfizer vaccine is called Comirnaty, while the EUA version for younger children is still labeled as the Pfizer-BioNTech COVID-19 Vaccine. Same manufacturer, same technology, but different regulatory labels depending on the age group. The same split applies to Moderna’s Spikevax (approved) versus the Moderna COVID-19 Vaccine (EUA for younger children).
Full approval also removes one legal distinction that existed under EUA: the requirement that recipients be explicitly informed they have the option to accept or refuse the vaccine. Under EUA, that disclosure is mandated. With full licensure, the vaccine carries the same legal standing as any other approved vaccine, which is why some employer and school mandates specifically referenced the transition from EUA to full approval.
Novavax’s Path to Approval
Novavax took a different route than the mRNA vaccines. Its product, Nuvaxovid, uses a more traditional protein-based technology paired with an immune-boosting ingredient called an adjuvant. For a period, it was available only under EUA. The FDA revoked that emergency authorization on August 27, 2025, because the vaccine had moved to full licensure, making the EUA unnecessary. Nuvaxovid is approved for individuals 12 and older and offers an alternative for people who prefer a non-mRNA option.