After the FDA’s decision to reject a review of Moderna’s mRNA-1010 flu shot, executives explain what Americans will miss out on as other nations embrace the technology.

Original title: “Moderna’s mRNA Tech Could Boost Flu Shot Efficacy. Americans Will Have To Wait”

The mRNA specialist reiterated its financial estimates for 2026 amid a challenging U.S. regulatory environment where its influenza vaccine just hit a major setback.

Original title: “Moderna shares jump as company affirms growth outlook”

The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.

Original title: “Moderna’s Outright Flu Refusal Just the Latest Case of Crossed FDA Signals”

Vinay Prasad, the FDA's Center for Biologics Evaluation and Research head, is accused of interpersonal impropriety as pushback builds against his decision to reject Moderna’s influenza vaccine candidate.

Original title: “FDA’s Prasad Weathers Personal Controversy, Internal Strife Amid Moderna Imbroglio”

Moderna’s mRNA-1010 was expected to contribute $1 billion to the company’s coffers by 2028. That plan is now out the window after the FDA refused to even look at the application.

Original title: “Flu Vaccine Rejection Imperils Moderna’s Breakeven Plans”

The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.

Original title: “All the Ways Moderna’s Flu Vaccine Rejection Letter Shocked Us”

After receiving a letter directly from CBER Director Vinay Prasad, Moderna said the FDA had previously signed off on the use of a licensed flu vaccine as a comparator for a Phase 3 study of mRNA-1010.

Original title: “FDA Refuses To Review Moderna’s mRNA Flu Vaccine, Claims Trial Inadequacies”

H5 bird flu is causing outbreaks in wild birds and poultry, other animals and sporadic human cases.

Original title: “H5 Bird Flu: Current Situation”

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Pfizer Inc. for the Lucira by Pfizer COVID-19 & Flu Test and Lucira by Pfizer COVID-19 & Flu Home Test. FDA revoked the Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holder. The revocations, which include an explanation of the reasons for each revocation, are reprinted at the end of this document

Original title: “Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability”

A person with severe avian influenza A(H5N1) illness ("H5N1 bird flu") has passed away.

Original title: “First H5 Bird Flu Death Reported in United States”

December 18, 2024-- A patient has been hospitalized with a severe case of avian influenza A(H5N1)

Original title: “CDC Confirms First Severe Case of H5N1 Bird Flu in the United States”

The Centers for Disease Control and Prevention (CDC) has confirmed a human infection with avian influenza A(H5N1) (H5N1 bird flu) in a child in California.

Original title: “CDC confirms H5N1 Bird Flu Infection in a Child in California”

The Centers for Disease Control and Prevention (CDC) has confirmed a third human case of H5 bird flu in California.

Original title: “CDC Confirms 3rd Human Case of H5 Bird Flu in California”

CDC Confirms New Human Cases of H5 Bird Flu in California

Original title: “CDC Confirms New Human Cases of H5 Bird Flu in California”

CDC Confirms Human H5 Bird Flu Case in Missouri

Original title: “CDC Confirms Human H5 Bird Flu Case in Missouri”

Media Statement - Three additional human cases of highly pathogenic avian influenza (HPAI) A(H5) ("H5 bird flu") virus infection have been confirmed by the Centers for Disease Control and Prevention (CDC) in association with a second poultry farm in Northeast Colorado/Weld County.

Original title: “CDC Confirms Three Human Cases of H5 Bird Flu Among Colorado Poultry Workers”

Four human cases of highly pathogenic avian influenza (HPAI) A(H5) ("H5 bird flu") virus infection in the state of Colorado have been confirmed by the Centers for Disease Control and Prevention (CDC).

Original title: “CDC Confirms Human Cases of H5 Bird Flu Among Colorado Poultry Workers”

The state of Colorado has announced that three people have tested presumptive positive for highly pathogenic avian influenza (HPAI) A(H5) ("H5 bird flu") virus infection.

Original title: “Colorado Reports Three Presumptive Positive H5 Cases in Poultry Workers”

A human case of highly pathogenic avian influenza (HPAI) A(H5) ("H5 bird flu") virus infection in the United States has been identified in the state of Colorado.

Original title: “CDC Reports Fourth Human Case of H5 Bird Flu Tied to Dairy Cow Outbreak”

CDC has released a graphic novel to help young people understand the potential health risks of human influenza viruses that normally circulate in swine and can cause disease in people (known as variant flu infections).

Original title: “CDC Releases Graphic Novel on Variant Flu Dangers”