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The designation addresses the unmet need for prevention of H5N1, which remains a global health risk, and a phase 1 trial of the vaccine was initiated in November 2024. The FDA granted fast track designation for a self-amplifying mRNA vaccine candidate (ARCT-2304) for active immunization to protect against influenza A H5N1 subtype, also known as bird flu. The designation addresses the unmet need for prevention of H5N1, which remains a global health risk, and a phase 1 trial (NCT06602531) of the vaccine was initiated in November 2024. H5N1, Influenza, Bird flu, Immunization The designation addresses the unmet need for prevention...

The process will ensure vaccines are ready to distribute if needed.Federal health officials announced Friday they are providing $72 million to vaccine manufacturers to help ensure currently available bird flu vaccines are ready-to-use, if needed. There are currently no recommendations for anyone in the U.S. to be vaccinated against bird flu, but officials from the U.S. Department of Health & Human Services (HHS) noted this is being done out of "an abundance of caution." The funds will allow for pharmaceutical companies CSL Seqirus, Sanofi, and GSK to "fill and finish"-- a process to fill vaccines from bulk storage into ready-to-use...

The Centers for Disease Control and Prevention will spend $5 million to vaccinate livestock workers against the seasonal flu in an effort to prevent possible interaction with bird flu, officials said today, July 30. If someone gets both the H5N1 (highly pathogenic avian influenza) and seasonal flu, the result could be “an exchange of genetic material” that could do what scientists call “reassortment” and the development of a new influenza virus, said Nirav Shah, the principal deputy director at CDC. Shah spoke to reporters in a call organized by the Health and Human Services Department. The $5 million will go...

The U.S. government is closing in on a deal to fund a late-stage trial for an mRNA pandemic bird flu vaccine made by Moderna, the Financial Times reported Thursday, as the country battles an H5N1 outbreak in cattle and poultry farms. Citing unnamed people close to the discussion, the Financial Times reported federal funding worth “several tens of millions of dollars” will come from the Biomedical Advanced Research and Development Authority (BARDA) likely sometime next month. The purported deal with the federal agency also includes a commitment to purchase a stockpile of doses if the trials prove successful. The government...

Moderna stock spiked in Wednesday trading, climbing 13.7% over the course of the day amid swelling concerns over the avian influenza outbreak in U.S. cattle...Moderna confirmed to Barron's that the company is in discussions with the federal government about "advancing our pandemic flu candidate." Pfizer did not immediately respond to a request for comment.

Article EXCERPT:Federal health officials said the government is also pursuing an mRNA bird flu vaccine, based on the same technology as Pfizer’s and Moderna’s COVID-19 vaccines.Chin-Hong said this type of vaccine could potentially be updated more quickly to match the currently circulating strains of the virus. But these vaccines have their own challenges, he said, such as needing to be stored at extremely cold temperatures.In addition, given that these vaccines would be a new use of the mRNA vaccine technology, the FDA may require clinical trials which could delay the roll-out to the greater population.There are other options for dealing...

On Thursday (April 4), the Centers for Disease Control and Prevention (CDC) said it had begun work on a vaccine against H7N9, a new bird-flu virus causing illness in China. So far, health officials have reported that 16 people have become sick with the virus, six of whom died. Currently, the virus does not appear to spread between people. The CDC plans to "build" the virus to use it in its vaccine, rather than wait for a sample to ship from China, the New York Times reported. Using the H7N9 genetic sequence as a blueprint, CDC researchers will synthesize genes...

AP MEDICAL WRITER ATLANTA -- With new versions of bird flu emerging, U.S. health officials announced Monday that scientists must stir up a different vaccine recipe to try to protect people. That's not unexpected because flu viruses - whether in birds or people - are constantly changing. Federal health officials are merely trying "to keep right on the virus's tail and keep our vaccines as up to date as much as we can," said Dr. William Schaffner, a Vanderbilt University vaccine expert. But despite its mutations, the continent-hopping bird flu virus seems content slaying wild birds and farm chickens, causing...