Bird flu vaccine trials
The U.S. government has awarded Moderna nearly $600 million to accelerate its efforts in developing vaccines for various strains of bird flu, as well as mRNA vaccines for other influenza strains with pandemic potential. This substantial funding comes through the Department of Health and Human Services’ (HHS) Biomedical Advanced Research and Development Authority (BARDA), which has been collaborating with Moderna since 2023 to bolster vaccine development against potential flu pandemics, including the avian influenza strain H5N1.
This recent allocation significantly boosts the initiative, following a previous $176 million given to Moderna as part of the same effort last year. The partnership aims to prepare mRNA vaccines to combat not only current flu threats but also potential future outbreaks that could pose significant public health risks.
Moderna is gearing up to launch a phase 3 study for its mRNA-1018 vaccine, which targets H5 and H7 avian influenza viruses. The company has reported “positive preliminary data” from a phase 1/2 study of this vaccine and plans to present these findings at an upcoming medical conference, highlighting the progress made so far in the vaccine’s development.
The HHS, in its announcement on January 17, emphasized that the new funding will allow Moderna to expedite the development of an H5N1 mRNA influenza vaccine that aligns closely with strains currently affecting birds and cows. The goal is to broaden the clinical data supporting mRNA vaccines’ use against various influenza strains, especially those that could emerge with pandemic potential.
This investment is part of a broader effort by BARDA to ensure the U.S. remains prepared for flu pandemics. Moderna will also conduct a phase 3 trial for a vaccine targeting the H7N9 strain of avian influenza. Additionally, the company is expected to design up to four new flu vaccines, which will be tested in phase 1 studies. The intent behind these efforts is to generate the necessary background data to speed up the development of mRNA vaccines tailored to different influenza virus subtypes that might present a pandemic threat.
The funding comes from BARDA’s Rapid Response Partnership Vehicle Consortium and was announced in the final days of the Biden administration. This financial support is likely a relief for Moderna, which recently announced a revision in its financial guidance and a commitment to reduce costs by $1 billion due to lower-than-expected sales of its COVID-19 and respiratory syncytial virus vaccines.
Outgoing HHS Secretary Xavier Becerra, in a statement, stressed the urgency of the response to avian flu variants, which have historically been unpredictable and hazardous to human health. “That is why this response has been a top priority for the Biden-Harris Administration and HHS,” Becerra noted. “Accelerating the development of new vaccines will allow us to stay ahead and ensure that Americans have the tools they need to stay safe.”
As of now, the Centers for Disease Control and Prevention (CDC) has reported 67 confirmed cases of avian influenza in humans in the U.S., with one death attributed to the virus. While the current public health risk is considered “low,” the CDC remains vigilant, closely monitoring the situation and working with states to track individuals who have had exposure to infected animals.
This proactive approach reflects the government’s commitment to preventing another widespread health crisis by investing in cutting-edge vaccine technology and ensuring readiness for future influenza threats. Moderna’s work on these vaccines is seen as a crucial step in fortifying the nation’s defenses against potential flu pandemics, emphasizing the role of innovation in public health preparedness.
