Moderna receives $176 million from BARDA for mRNA influenza vaccines

Moderna has been awarded $176 million by the Biomedical Advanced Research and Development Authority to accelerate development of messenger RNA-based pandemic influenza vaccines, the company announced in a statement Tuesday.

BARDA, a strategic preparedness arm of the Department of Health and Human Services, has said for weeks that it has been in talks with mRNA vaccine manufacturers with an aim to diversify the government’s pandemic flu vaccine response capacity. The U.S. government already has vaccine contracts with and stockpiles of H5 vaccines made using other platforms by other manufacturers, including CSL Seqirus and Sanofi.

“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,” Moderna CEO Stéphane Bancel said in the statement. “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.”

The company has already been working on mRNA-based pandemic vaccines, specifically targeting H5 and H7 avian influenza viruses. Last year Moderna conducted a Phase 1/2 clinical trial of its candidate mRNA-1018, testing H5 and H7 versions at several dosages in a regimen of two shots separated by three weeks. Previous research has shown that H5 viruses are poorly immunogenic in people and vaccination requires two doses to induce what is thought to be a protective response.

Moderna will not disclose the size of the doses it has tested, saying it is keeping that information secret for “competitive reasons.” Results of the Phase 1/2 trial haven’t yet been released but will be at some point in 2024, the company said, adding the results will inform the design of a Phase 3 trial.

The H5 virus targeted in the Moderna vaccine used in the Phase 1/2 trial was an H5N8, a cousin of H5N1, the virus spreading in dairy cattle in the United States. Both the Centers for Disease Control and Prevention and the World Health Organization have said the hemagglutinin in that H5N8 virus — hemagglutinin is the protein on the virus surface that attaches to cells it is attempting to invade — is genetically similar enough to that of the circulating H5N1 virus that it should provide protection against it. The Seqirus H5 vaccine in the National Pre-Pandemic Influenza Vaccine Stockpile also targets that H5N8 virus.

BARDA was looking to expand the country’s pandemic vaccine production arsenal even before the U.S. Department of Agriculture announced in late March that H5N1 was sickening lactating dairy cattle in Texas, Kansas and New Mexico. Since that announcement, approximately 140 herds in a dozen states have tested positive for the virus. It’s believed that many more herds have been infected but farmers refuse to test because they see no upside to disclosing the problem.

Since the outbreak was recognized, three farmworkers — one in Texas and two in Michigan — tested positive for the virus. Two had very minor symptoms, effectively only conjunctivitis or pink eye. The third had more traditional flu-like respiratory symptoms; all three recovered.