In the same announcement, Moderna reported positive interim phase 1/2 clinical data for its candidate vaccine targeting H5 avian influenza.
Contract awarded under Biden administration Moderna received the HHS contract for an H5 vaccine in a $176 million base award in July 2024 amid a rising number of H5N1 infections in US residents, mostly agricultural works.
On January 17 in the final days of the Biden administration, officials announced a $590 million contract to fund the development of vaccines against potential pandemic flu viruses.
Following the transition to the Trump administration, the HHS in early March signaled that it was evaluating the contract.
Moderna said it will explore alternatives for late-stage development of the H5 vaccine, consistent with its commitment to pandemic preparedness.
The US Department of Health and Human Services (HHS) has canceled a $590 million award Moderna received in January for the late-stage development of a candidate mRNA vaccine against H5 avian influenza and the development of other prepandemic vaccine candidates, the company announced yesterday. This is a shocking development in pandemic preparedness.
Positive interim phase 1/2 clinical data for Moderna’s candidate vaccine against H5 avian influenza was reported in the same announcement.
Under the Biden administration, the contract was awarded.
Amid an increase in H5N1 infections among US citizens, primarily in agricultural settings, Moderna was awarded a $176 million base award by HHS in July 2024 for an H5 vaccine. Officials announced a $590 million contract to finance the development of vaccines against potential pandemic flu viruses on January 17, in the closing days of the Biden administration.
Early in March after the Trump administration took office, HHS indicated it was reviewing the contract.
Alongside animal outbreaks in other nations and occasional H5N1 infections in a few Asian nations, including Cambodia and Vietnam, the action coincides with the ongoing spread of H5N1 in US dairy cattle, poultry flocks, wild birds, and other mammals.
HHS Secretary Robert F. Kennedy Jr. has influenced his recent policy decisions regarding COVID vaccines by aligning himself with organizations that are dubious of vaccines, particularly mRNA formulations.
In keeping with its dedication to pandemic preparedness, Moderna stated that it will investigate substitutes for mid-stage H5 vaccine development.
An insult to H5N1 readiness.
Several public health experts voiced their concerns and cautions in response to the announcement. The cancellation of the vaccine contract endangers American lives, according to Ashish Jha, MD, MPH, dean of the Brown University School of Public Health, who stated on X that the attack on mRNA vaccines is ridiculous because they have been studied and used extensively and have a good safety and efficacy record.
He declared, “We will come to regret this as the day we decided to put the lives of the American people at grave risk if Bird Flu starts spreading from person to person.”.
We will look back on this as the day we chose to seriously jeopardize the lives of Americans if bird flu begins to spread from person to person.
The decision, according to Krutika Kuppalli, MD, of the University of Texas Southwestern Medical Center’s infectious diseases and international medicine divisions, was “stunningly shortsighted” on BlueSky. According to her, the cancellation coincides with an increase in H5N1 threats and the announcement of a fatal H5N1 case from Cambodia yesterday. “This is going to backfire on us. challenging. “.”.
promising outcomes of clinical trials.
“The phase 1/2 study involved 300 healthy adults and evaluated at a 2-dose regimen,” Moderna said in reference to the clinical trial results. It stated that the results point to a strong, quick, and long-lasting immune response. With 2–1% of participants exhibiting hemagglutinin titers at a level thought to correlate with protection, pre-existing immunity was negligible at baseline. Three weeks following the second dose, on day forty-three, 97.9% of participants had titers that were 44.5% higher than baseline.
“Although the HHS funding termination creates uncertainty, we are pleased by the robust immune response and safety profile observed in this interim analysis of the Phase 1/2 study of our H5 avian flu vaccine and we will explore alternative paths forward for the program,” stated Stéphane Bancel, MBA, MS, CEO of Moderna. “”.
