Originally published by our sister publication Infectious Disease Special Edition
By IDSE News Staff
The Department of Health and Human Services has pulled funding for Moderna to continue development of its investigational avian influenza vaccine and canceled a purchasing agreement, according to the company.
Moderna “had previously expected to advance the program to late-stage development with the U.S. Department of Health and Human Services (HHS); however, today Moderna received notice that HHS will terminate the award for the late-stage development and right to purchase pre-pandemic influenza vaccines,” the company wrote in a statement released May 28.
This news comes after positive results of the vaccine, mRNA-1018, with interim data focused on a vaccine candidate targeting the H5 avian influenza virus subtype.
“While the termination of funding from HHS adds 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,” said Stéphane Bancel, the CEO of Moderna, in the press statement. “These clinical data in pandemic influenza underscore the critical role mRNA technology has played as a countermeasure to emerging health threats.”
At the same time, the threats of H5N1 bird flu have continued to mount. More individuals in the United States have been infected with the virus, especially those in close contact with dairy cows. But it’s not just cows catching H5N1—scientists are finding more species contracting the virus, which could be bad news for humans.
Encouragingly, the early Moderna data have been positive.
In the phase 1/2 study, a two-dose regimen of mRNA-1018 showed a rapid, potent and durable immune response in approximately 300 healthy adults 18 years of age and older, according to Moderna. At baseline, few study participants had preexisting immunity, with only 2.1% showing hemagglutination inhibition antibody titers of at least 1:40, which correlates with protection. Three weeks following the second vaccination, 97.8% of participants had titers of at least 1:40.
The vaccine was generally well tolerated, with no dose-limiting tolerability concerns. The majority of adverse reactions were grade 1 or 2, and they did not increase significantly with the number of doses or between the two doses. The researchers expect to submit data for presentation at an upcoming scientific meeting, the press statement said.
Because of these positive data and the global need for a vaccine, Moderna said it will seek funding for late-stage development and manufacturing.
Based on a Moderna press release.