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Despite Safety Concerns, FDA Approves Moderna’s mRNA Flu Shot

Despite Safety Concerns, FDA Approves Moderna’s mRNA Flu Shot

On Aug. 5, 2026, the U.S. Food and Drug Administration (FDA) approved Moderna’s seasonal flu shot, mFLUSIVA (mRNA-1010), making it the first messenger RNA platform for seasonal influenza in the United States. The decision permits health care providers to use mRNA technology for annual influenza vaccination in eligible age groups.1 FDA regulators approved mFLUSIVA to […]

Texas Attorney General Investigates AAP’s Financial Ties to Childhood Vaccine Recommendations

Texas Attorney General Investigates AAP’s Financial Ties to Childhood Vaccine Recommendations

When Texas Attorney General Ken Paxton launched a wide-sweeping investigation into financial incentives tied to childhood vaccinations in January, his office issued more than twenty civil investigative demands to pediatric providers, insurance companies, and vaccine manufacturers across the country. Seven months later, that investigation has expanded. Paxton’s office has now issued a civil investigative demand […]

Sanofi Sues Pfizer and Moderna Over COVID-19 mRNA Shot Technology

Sanofi Sues Pfizer and Moderna Over COVID-19 mRNA Shot Technology

More than six years after the introduction of COVID-19 shots, litigation over the technology behind the shots continues to expand. On July 15, 2026, Sanofi SA of France announced that it had filed two patent infringement lawsuits in the United States District Court for the District of New Jersey against Pfizer, Inc., BioNTech SE, and […]

First Trimester COVID-19 Shot Linked to Birth Defects in New Registry Study

First Trimester COVID-19 Shot Linked to Birth Defects in New Registry Study

A new registry-based cohort study out of Iran published in Sage Journals on June 15, 2026, has found a higher incidence of congenital anomalies, or birth defects, in babies born to women who received a COVID-19 shot within the first trimester of pregnancy compared with those who did not get vaccinated or were vaccinated after […]

FDA Panel Backs mFlusiva mRNA Flu Shot for Elderly

FDA Panel Backs mFlusiva mRNA Flu Shot for Elderly

Despite a number of significant limitations in the available safety and efficacy data for licensure review of Moderna, Inc.’s new mRNA influenza biologic mFlusiva, the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee ((VRBPAC) voted on June 18, 2026 to recommend fast-tracked licensure of the first mRNA product to target […]

FDA Set to Review Moderna’s mFlusiva mRNA Flu Shot

FDA Set to Review Moderna’s mFlusiva mRNA Flu Shot

An mRNA (messenger ribonucleic acid) influenza biologic developed by Moderna, Inc. is scheduled to be reviewed today by a U.S. Food and Drug Administration (FDA) advisory panel. The Vaccines and Related Biological Products Advisory Committee ((VRBPAC) will evaluate data on Moderna’s mFlusiva (formerly known as mRNA-1010) to determine if the product provides superior relative vaccine […]

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