US govt gives $176m to Moderna for bird flu vaccine

The US government has signed a $176 million deal with Moderna to develop an mRNA-based pandemic influenza vaccine, as reports emerge of a fifth human case of H5N1 flu linked to ongoing outbreaks in poultry and dairy cows.

The award from the Biomedical Advanced Research and Development Authority (BARDA) will be used to accelerate the development of pandemic flu vaccines, according to Moderna, and specifically “support late-stage development for an mRNA-based vaccine to enable the licensure of a pre-pandemic vaccine against H5 influenza virus.”

The agreement also includes additional options to respond to future public health threats, said the Cambridge, Massachusetts-based biotech.

Pre-pandemic flu vaccines – sometimes referred to as ‘zoonotic’ shots – are designed to cover a strain that is emerging and that may have pandemic potential.

In 2023, Moderna started a phase 1/2 study of an experimental pandemic influenza vaccines collectively known as mRNA-1018, which are designed to provide protection against H5 and H7 avian influenza virus strains.

The study in healthy adults 18 years of age and older is split into two stages, with part A evaluating four vaccine candidates against H5N8, H7N9, H5 only, and H7 only, and part B zeroing in on a single vaccine candidate (H5 only). It is due to generate results later this year that, if positive, will set up a phase 3 programme.

“mRNA vaccine technology offers advantages in efficacy, speed of development, and production scalability and reliability in addressing infectious disease outbreaks, as demonstrated during the COVID-19 pandemic,” said Stéphane Bancel, Moderna’s chief executive.

“We are pleased to continue our collaboration with BARDA to expedite our development efforts for mRNA-based pandemic influenza vaccines and support the global public health community in preparedness against potential outbreaks.”

In May, the US government also expanded a pandemic flu vaccine agreement with CSL Seqirus, asking the company to complete fill-and-finish activities on a stockpile of 4.8 million pre-pandemic H5N1 doses matched to the currently circulating strain.

Widespread in wild birds around the world, H5N1 was detected earlier this year in dairy cows in the US and has since spread to more than 138 herds in 12 states. There have been four cases in humans after exposure to cows, adding to a single case reported in 2022 after exposure to poultry. Outbreaks in poultry have been seen in 48 states.

All told, there have been around 900 human cases of H5N1 reported since 2003, and the mortality rate from infection is estimated to be around 50% – which is considerably higher than COVID-19, at around 4%, and seasonal flu at 1%. So far, cases in the US have been relatively mild.

Last month, the World Health Organization (WHO) reported the first known case of a human case of influenza H5N2, which was fatal, although the infected man had underlying health conditions.

Photo by Austin Santaniello on Unsplash