FDA Refuses to Review Moderna’s mRNA Influenza Shot License Application
The U.S. Food and Drug Administration (FDA) has declined to accept for review Moderna’s Biologics License Application (BLA) for its mRNA-based seasonal influenza shot, citing concerns about the completeness of the submission. The decision highlights the agency’s commitment to maintaining clear evidentiary standards for approving the licensing of new vaccines.1 On Feb. 3, 2026, the […]
American Medical Association Launches Its Own Vaccine Review Process
The American Medical Association (AMA), a medical trade advocacy association, is partnering with a vaccine research group to launch what it describes as an independent, “evidence-based review process” for respiratory vaccines for the next flu season—a role traditionally carried out by the U.S. Centers for Disease Control and Prevention (CDC).1 2 According to a prepared […]
Polio Vaccine Questioned by Chair of CDC Advisory Committee
In a podcast interview released on Jan. 22, 2026, pediatric cardiologist Kirk Milhoan, MD, PhD questioned the need for the polio vaccine.1 2 3 4 5 6 7 Dr. Milhoan, who is chair of the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP), said: As you look at polio, […]
Moderna Secures CEPI Funding for mRNA Bird Flu Vaccine After U.S. Cancels Funding
Moderna secured new funding from an international organization for its experimental mRNA bird flu vaccine after the U.S. Department of Health and Human Services (DHHS) pulled back approximately $700 million in previously committed funding last year. The biotechnology company said that it will receive up to $54.3 million from the Coalition for Epidemic Preparedness Innovations […]
CDC Awards $1.6 Million Grant to Study Hepatitis B Vaccination in Newborns
The U.S. Centers for Disease Control and Prevention (CDC) has awarded a $1.6 million federal grant to Danish researchers to study hepatitis B vaccination in newborns, with a stated focus on determining the optimal timing and delivery of the vaccine routinely administered in the U.S. to infants on their first day after birth. Researchers from […]
CDC Changes Hepatitis B Vaccine Birth Dose Recommendation for Newborns
The U.S. Centers for Disease Control and Prevention (CDC) has stopped recommending that all newborns receive the hepatitis B vaccine at birth, marking a significant shift in a policy that has been in place for decades. The change followed a vote by members at a Dec. 5, 2025 meeting of the Advisory Committee on Immunization […]