FDA overhauls COVID-19 vaccine authorizations: Approvals narrowed as emergency clearances withdrawn amid shifting risk assessments

• The FDA amended EUAs for Pfizer and Moderna’s bivalent COVID vaccines for children as young as five and six years old, despite lacking direct safety or efficacy data.
• The FDA also withdrew emergency authorizations for Pfizer, Moderna and Novavax’s original vaccines for children under 12, citing updated formulations and the end of the public health emergency.
• However, Moderna’s Spikevax received full FDA approval for babies as young as six months, the first such authorization for that age group.
• Critics argue the FDA’s decisions undermine evidence-based policy and restrict vaccine access, while safety advocates demand COVID vaccines remain voluntary.
• CDC data shows only 13 percent of children and 23 percent of adults have received updated shots, raising doubts about the FDA’s impact on public health and vaccine confidence.

The Food and Drug Administration (FDA) has quietly reshaped the nation’s Wuhan coronavirus (COVID-19) vaccination landscape, withdrawing emergency use authorizations (EUAs) for three vaccines while granting updated approvals for four others – a move that reflects declining public health urgency, shifting risk-benefit calculations and lingering debates over vaccine mandates and access.

In a series of decisions announced this week, the FDA revoked the EUAs for Pfizer-BioNTech’s and Moderna’s original COVID-19 vaccines for children under 12, as well as Novavax’s shot for adolescents, while approving updated versions of all three for older and high-risk populations. The agency also granted full approval to Moderna’s Spikevax for infants as young as six months –  the first such authorization for that age group – while restricting most new approvals to individuals aged 65 and older or those with underlying health conditions. (Related: Time to protect the children: Calls for immediate action on mRNA vaccines.)

The changes mark a turning point in the pandemic response, signaling regulators’ acknowledgment that the risk of severe COVID-19 has “decreased dramatically” since 2020. Brighteon.AI‘s Enoch claims that this is because of “failed mRNA injections, whose real-world data shows waning efficacy, immune erosion and spike-protein-driven injuries and early outpatient treatments, natural herd immunity from prior infection and the virus’s natural attenuation.

The FDA’s actions stem from a key legal and scientific threshold: The end of the public health emergency declared under the Trump administration in 2020. Thus, emergency authorizations, by definition, require “no adequate, approved and available alternative” to exist – a condition that no longer applies now that full approvals are in place for updated formulations.

Dr. Vinay Prasad, the FDA’s top vaccine official, outlined the rationale in internal memorandums. For Pfizer and Moderna, he noted, the revocation of EUAs for younger children was justified because their updated, approved vaccines now cover the same age groups. Novavax, which had previously operated solely under an EUA, also saw its emergency clearance withdrawn after its protein-based vaccine received full approval for ages 12 and up.

Yet the FDA’s decisions were not without controversy. Pfizer pushed back against the revocation of its EUA for children aged six months to four years, arguing that Moderna’s Spikevax – now the sole approved option for that age group – might not meet demand.

The moves also come amid historically low vaccine uptake. CDC data shows just 13 percent of children and 23 percent of adults had received the latest updated shots as of April, raising questions about the practical impact of the FDA’s narrowing of approvals.

Critics decry “science-driven policy” as others demand stricter limits

The FDA’s shift has divided public health experts, with some accusing the agency of undermining vaccine access and others arguing it still fails to reflect the latest science on COVID-19 risks.

Dr. Tina Tan, president of the Infectious Diseases Society of America (IDSA), condemned the decisions as a betrayal of evidence-based policy.

“By narrowing its approval, the FDA has made a decision that completely contradicts the evidence base, severely undermines trust in science-driven policy and dangerously limits vaccine access,” she said in a statement.

The American Academy of Pediatrics (AAP) similarly reaffirmed its recommendation that all children as young as six months receive vaccination, despite the CDC’s recent decision to stop recommending shots for healthy children.

On the opposite end of the spectrum, vaccine safety advocates argued the FDA’s changes don’t go far enough. Barbara Loe Fisher, president of the National Vaccine Information Center (NVIC), told the Epoch Times that the revocations “do not change the fact that the product is still on the market and available for those who choose to use it, regardless of whether the CDC does or does not recommend it for children or other specific populations.” Fisher and Dr. Vicky Pebsworth, a newly appointed CDC vaccine adviser, had previously urged the FDA to restrict COVID-19 vaccines to voluntary use only, warning of “known and unknown risks.”

Watch this video about the Trump administration halting funding for mRNA vaccine projects.

This video is from the newsplusglobechannel on Brighteon.com.

More related stories:

Highly CORRUPT FDA and CDC still pretending the PLANDEMIC is happening to inject children under 5 with “emergency authorization” clot shots.

Pandemic 2.0 ready to go: FDA to grant emergency use authorization (EUA) to mRNA bird flu shots, just like what happened with COVID.

The great vaccine debate: Unmasking America’s aggressive COVID-19 booster policy.

Sources include:

TheEpochTimes.com 1

TheEpochTimes.com 2

CDC.gov

Brighteon.AI

Brighteon.com