Moderna gets BARDA funding for mRNA flu vaccine

Moderna has received $176 million from the Biomedical Advanced Research and Development Authority to accelerate the development of messenger RNA-based pandemic flu 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 it has been in discussions with mRNA vaccine manufacturers with the aim of diversifying 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 scalability and reliability of production in addressing infectious disease outbreaks, as demonstrated during the Covid-19 pandemic,” Stéphane Bancel, CEO of Moderna, said in the explanation. “We are pleased to continue our collaboration with BARDA to accelerate our development efforts for mRNA-based pandemic influenza vaccines and support the global public health community in preparing for potential outbreaks.”

The company has already been working on mRNA-based pandemic vaccines specifically targeting the H5 and H7 avian flu viruses. Last year, Moderna conducted one Phase 1/2 clinical trial of its candidate mRNA-1018, testing the H5 and H7 versions at different doses in a two-shot regimen separated by three weeks. Previous research has shown that H5 viruses are poorly immunogenic in humans and that vaccination requires two doses to elicit a putative protective response.

Moderna would not disclose the volume of doses tested, saying it is keeping that information secret for “competitive reasons.” Results from the Phase 1/2 study have not yet been released but will be released sometime in 2024, the company said. Adding the results will inform the design of a Phase 3 study.

The H5 virus targeted by the Moderna vaccine used in the Phase 1/2 trial was an H5N8, a cousin of H5N1, the virus spreading among dairy cattle in the United States. Both the Centers for Disease Control and Prevention and the World Health Organization have said that the hemagglutinin in the H5N8 virus — hemagglutinin is the protein on the virus’s surface that attaches to cells it tries to invade — is genetically similar enough to that of the circulating H5N1 virus. virus that it must provide protection against. The Seqirus H5 vaccine in the National pre-pandemic stockpile of influenza vaccines also targets that H5N8 virus.

BARDA wanted to expand the nation’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, about 140 herds in a dozen states have tested positive for the virus. Many more herds are believed to be infected, but farmers refuse to test because they see no benefit in making the problem public.

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