RFK Jr. makes sure we WILL NOT BE READY for a bird flu epidemic
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.
The move comes amid continued circulation of H5N1 in US
dairy cattle, poultry flocks, wild birds, and other mammals, as well as animal
outbreaks in other countries and sporadic H5N1 infections in a few Asian
countries, such as Cambodia and Vietnam.
HHS secretary Robert F. Kennedy, Jr., is allied with groups
that are skeptical about vaccines, especially mRNA formulations, which has
shaped his recent policy decisions about COVID vaccines.
Moderna said it will explore alternatives for late-stage development of the H5 vaccine, consistent with its commitment to pandemic preparedness.
A blow to H5N1 preparedness
The announcement prompted concerns and warnings from several
public health experts. Ashish Jha, MD, MPH, dean of the Brown University School
of Public Health, said on X that the vaccine contract
cancellation puts American lives at risk and that the attack on mRNA vaccines
is absurd, given that they have been widely administered and studied, with a
good safety and effectiveness track record.
“If Bird Flu starts spreading from people to people, we will come to regret this as the day we decided to put the lives of the American people at grave risk,” he said.
Krutika Kuppalli, MD, with the divisions of international
medicine and infectious diseases at the University of Texas Southwestern
Medical Center, on BlueSky called
the move “stunningly shortsighted.” She said the cancellation
comes amid rising H5N1 threats, along with news yesterday of a fatal H5N1 case
form Cambodia. “This will come back to bite us. Hard.”
Promising clinical trial results
Regarding the clinical trial findings, Moderna said the
phase 1/2 study involved 300 healthy adults and evaluated at 2-dose regimen. It
said the findings suggest a rapid, potent, and durable immune response.
Pre-existing immunity was minimal at baseline, with 2.1% of participants
showing hemagglutinin titers at a level considered to correlate with
protection. At day 43, which was 3 weeks after the second dose, 97.9% of
participants had a 44.5-fold increase in titers from baseline,
Stéphane Bancel, MBA, MS, Moderna’s chief executive officer, said, “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.”
