H5N1 mRNA Vaccines Frequently Asked Questions

Researchers have been studying and working with mRNA vaccines for decades, and mRNA was one of the technologies used to rapidly develop and manufacture safe and effective COVID-19 vaccines. As with all licensed vaccines, mRNA vaccines undergo multiple clinical trials to generate safety data for FDA review prior to licensure.

Currently, H5N1 is circulating in birds and in some dairy cows, and at this time, risk to human health is low and vaccination is not recommended for any segment of the population. If successfully developed, a licensed mRNA-based pandemic influenza vaccine would further improve U.S. government response capabilities.

ASPR recently announced that we are labeling and filling H5 vaccine manufactured from a well-matched candidate vaccine virus as part of preparedness efforts. This is a cell-based vaccine, another technology licensed for seasonal and pre-pandemic vaccines supported by ASPR. An mRNA-based licensed pandemic influenza vaccine could further improve response timelines. This capability would establish a fourth platform option to the already licensed egg-, cell-, and recombinant protein-based approaches for influenza vaccine production.

The base award will support advanced development towards FDA approval of a vaccine for H5; however, this agreement was structured such that it could readily support the development and procurement of a vaccine targeting novel strains of influenza or other emerging infectious viruses.

As with all vaccine development, timelines will be data driven. This vaccine is early in clinical development, with ongoing Phase I clinical trial data expected later this year. Phase three trials are projected to start in 2025.

Under Federal Acquisition Regulations, federal agencies are prohibited from disclosing any information on potential future contracts.

mRNA is a proven platform for accelerated development, and this partnership will help enable access to this capability. ​