The U.S. Food and Drug Administration (FDA) has approved Moderna Inc.’s supplemental Biologics License Application (sBLA) for Spikevax, the company’s COVID-19 vaccine, in children six months through 11 years of age who are at increased risk for COVID-19 disease.

The company’s COVID-19 vaccine, mRNA-1273, was previously available for pediatric populations under Emergency Use Authorization.

Also Read: Moderna’s mRNA Flu Vaccine Outperforms Standard Shots

“COVID-19 continues to pose a significant potential threat to children, especially those with underlying medical conditions. Vaccination can be an important tool for protecting our youngest against severe disease and hospitalization,” said Stéphane Bancel, CEO of Moderna ( MRNA ). “We appreciate the FDA’s diligent scientific review and approval of Spikevax for pediatric populations at increased risk for COVID-19 disease.”

Moderna ( MRNA ) expects to have its updated Spikevax vaccine available for eligible populations in the U.S. for the 2025-2026 respiratory virus season.

Pfizer Inc. ( PFE ) and BioNTech SE ( BNTX ) have requested that London's Court of Appeal reverse a previous decision that found their COVID-19 vaccine to be in violation of a Moderna ( MRNA ) patent.

In July 2024, the High Court's ruling declared one of Moderna's ( MRNA ) mRNA technology patents invalid but upheld another, confirming that Pfizer ( PFE ) and BioNTech's Comirnaty vaccine had infringed on it.

Reuters reported that Pfizer ( PFE ) and Moderna ( MRNA ) are trying to challenge a ruling that upheld a patent, after Judge Richard Meade allowed them to appeal his decision.

They argue that Moderna’s mRNA technology was simply a clear next step based on earlier research, so the patent shouldn’t be valid. However, Moderna ( MRNA ) believes the judge made the right decision and that the ruling should remain in place.

An alliance of medical and public health organizations filed a lawsuit on Monday against Secretary of Health and Human Services Robert F. Kennedy Jr.

The plaintiffs contend that Kennedy has launched an "assault on science, public health, and evidence-based medicine" through unilateral and arbitrary changes to COVID-19 vaccine recommendations for children and pregnant individuals.

According to a recent media report, Dr. Vinay Prasad, the U.S. Food and Drug Administration's (FDA) top vaccine official, overruled agency scientists to limit the approval of two COVID-19 vaccines, despite internal recommendations to clear them for broader use.

FDA scientists had recommended full approval for updated COVID vaccines from Novavax Inc. ( NVAX ) and Moderna ( MRNA ) for individuals aged 12 and older, citing favorable risk-benefit analyses.

But Prasad restricted the shots to those at higher risk, seniors and people with underlying health conditions, arguing that declining hospitalization and death rates from COVID-19 shifted the balance of risks and benefits.

Price Action: MRNA stock is up 3.60% at $33.97 at the last check on Thursday.

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