Moderna's $760m-plus flu vaccine contracts are nixed by HHS
A banner from Moderna's 2023 campaign to highlight the power of mRNA to transform medicine.
In January, Moderna was celebrating a $590 million contract with the US government to develop pandemic flu vaccines, one of the last actions by the Biden administration. Now – despite positive clinical results and an ongoing outbreak of bird flu in poultry and cattle in the US – the programme has been cancelled.
The award from the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services (HHS) now led by Robert F Kennedy Jr, was the latest stage of a years-long collaboration between the US and Moderna that also included a $176 million contract to develop an H5N1 bird flu shot last year.
Kennedy has made no secret of his scepticism about the safety of mRNA vaccines for COVID-19, a technology which underpins Moderna's vaccine pipeline, while reports have emerged of NIH officials urging scientists to remove references to mRNA from grant applications.
Meanwhile, Trump administration officials had previously told Moderna that all contacts from the prior administration were under review.
News of the cancellation came as Moderna revealed positive interim data from a phase 1/2 trial of its pandemic influenza vaccine, mRNA-1018, which targets the H5N8 bird flu subtype as well as another strain known as H7N9.
The initial data readout – focusing on H5N8 and involving 300 healthy adults – demonstrated a "rapid, potent, and durable immune response" after two doses of the shot, said the company.
It went on to say that it had "previously expected to advance the programme to late-stage development with…HHS," but will now "explore alternatives for late-stage development and manufacturing of the H5 programme consistent with the company's strategic commitment to pandemic preparedness."
Moderna's chief executive, Stéphane Bancel, said: "These clinical data in pandemic influenza underscore the critical role mRNA technology has played as a countermeasure to emerging health threats."
An HHS spokesperson told Reuters that Moderna's programme "did not meet the scientific standards or safety expectations required for continued federal investment."
The decision comes as H5N1 continues to affect wild birds, domestic poultry, cattle, and other animals, with 70 human cases reported since the current outbreak began last year and the first US fatality recorded in January.
Ashish Jha of Brown University School of Public Health, who served as the White House COVID-19 response coordinator from 2022 to 2023, said that the move is an "attack on mRNA vaccines [that] is beyond absurd."
He pointed out that it was President Trump's Operation Warp Speed that brought mRNA vaccines to the US public, adding that these shots have been administered nearly 2 billion times to hundreds of millions of people around the world, making them one of the most widely used and studied vaccines in human history.
"They are safe and work well," he asserted. "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."
Amanda Jezek, senior vice president, public policy and government relations at the Infectious Diseases Society of America (IDSA), told pharmaphorum: "Federal investments in the development of vaccines for avian flu and other outbreak threats are crucial to protect the health of Americans. This is the latest in a series of steps the administration has taken that are likely to limit vaccine innovation and access, weakening our nation’s health and preparedness."
