The FDA revoked the Emergency Use Authorizations for the original Pfizer-BioNTech and Moderna COVID-19 vaccines on August 27, 2025. This doesn’t mean these companies stopped making COVID vaccines. It means the specific formulations first rolled out in 2020 and 2021 are no longer available. Updated versions from both Pfizer and Moderna, designed to target newer variants, are fully approved and widely available today.
What the FDA Actually Revoked
The revocation applied to the original Emergency Use Authorizations for three products: Pfizer-BioNTech COVID-19 Vaccine, Moderna COVID-19 Vaccine, and Novavax COVID-19 Vaccine, Adjuvanted. These were the formulations built around the original SARS-CoV-2 strain from 2020. The FDA emphasized that safety concerns were not the reason for pulling them. Instead, the agency pointed to two main factors: fully approved COVID-19 vaccines now exist for the populations those EUAs covered, and widespread immunity from both vaccination and prior infection has significantly reduced severe outcomes, hospitalizations, and deaths.
An Emergency Use Authorization is a temporary measure. It allows an unapproved product to be used during a public health emergency when no adequate approved alternatives exist. Once fully approved vaccines became available for people 65 and older, and for those 6 months through 64 with high-risk conditions, the legal basis for keeping the old EUAs in place essentially disappeared. The FDA determined that revoking them was the appropriate step to protect public health.
Why the Original Formulas Were Replaced
The virus kept changing. By late 2023, the dominant circulating variants looked very different from the strain the original vaccines targeted. The JN.1 variant, for example, carried more than 30 mutations in its spike protein compared to the XBB.1.5 lineage that was circulating just months earlier. Each round of mutations made it easier for the virus to partially dodge the immune response generated by older vaccine formulas.
Researchers observed consistent patterns of waning effectiveness after each generation of COVID vaccines, especially against milder outcomes like symptomatic infection. This wasn’t a flaw unique to the original shots. It’s a predictable feature of vaccines targeting a rapidly evolving virus. But it meant that a formula designed around a strain from early 2020 offered progressively less protection as the virus accumulated changes year after year.
The FDA responded by directing manufacturers to update their formulas regularly, similar to the annual process used for flu vaccines. In June 2024, the agency advised that the 2024-2025 vaccines should target the JN.1 lineage. As the virus continued evolving over the summer, the FDA refined that guidance and recommended the KP.2 strain as the preferred target. The goal was straightforward: get the vaccine as close a match as possible to whatever was actually making people sick.
What’s Available Now
Both Pfizer and Moderna have current, fully approved COVID-19 vaccines on the market for the 2025-2026 season. These are not emergency-authorized products. They went through the standard approval process.
- Moderna Spikevax: Approved for anyone 6 months and older.
- Moderna mNexspike: Approved for anyone 12 years and older.
- Pfizer-BioNTech Comirnaty: Approved for anyone 5 years and older.
- Novavax: Approved for people 12 years and older.
For children aged 6 months through 4 years, only the Moderna Spikevax vaccine is currently approved. The Pfizer-BioNTech vaccine is no longer authorized for that youngest age group. For everyone 12 and older, there’s no preference for one vaccine over another when multiple options are available for your age group.
EUA vs. Full Approval
This distinction matters because it’s central to the question. An Emergency Use Authorization lets the FDA fast-track access to a medical product during a crisis, before long-term data is complete. It requires that the known and potential benefits outweigh the known and potential risks, but the evidence bar is lower than for full approval. Recipients must also be told that the product is authorized rather than approved, and that they can refuse it.
Full approval, called a Biologics License Application for vaccines, requires more extensive data on safety, effectiveness, and manufacturing consistency. Pfizer’s original formula (Comirnaty) received full approval for people 16 and older back in August 2021. Moderna followed a similar path. But even after those approvals, the EUAs remained in place to cover additional age groups and situations not included in the full approval. Once updated, fully approved vaccines covered those populations, the old EUAs had served their purpose.
What This Means in Practice
If you’ve been putting off getting a COVID vaccine because of confusion about authorization status, the current vaccines from Pfizer, Moderna, and Novavax all carry full FDA approval for their recommended age groups. The CDC recommends a 2025-2026 COVID-19 vaccine for people 6 months and older, with the decision framed as an individual choice rather than a blanket directive. People who are moderately or severely immunocompromised have separate, more detailed recommendations for timing and number of doses.
The revocation of the old authorizations is a regulatory housekeeping step, not a safety alarm. It reflects the fact that the pandemic’s vaccine landscape has matured from emergency measures into a routine vaccination framework, with updated formulas replacing outdated ones on a regular cycle.