FDA to review Emergent's adjuvanted anthrax vaccine for adults
Emergent BioSolutions said in a news release late last week that the US Food and Drug Administration (FDA) has accepted for review an adjuvanted version of its anthrax vaccine for post-exposure prophylaxis (prevention) of anthrax.
The product, called AV7909—or Anthrax Vaccine Adsorbed, Adjuvanted—is designed to prevent disease caused by exposure to Bacillus anthracis, the bacterium that causes anthrax, in adults 18 to 65 years old. An adjuvant is a substance in a vaccine that boosts the body's immune response, and the US government stockpiles anthrax vaccine in the event of a bioterrorism event. The FDA will review Emergent's Biologics License Application (BLA) in the coming months.
Kelly Warfield, PhD, senior vice president of research and development at Emergent, said, "As we progress toward licensure of AV7909, which is designed to follow a two-dose immunization schedule and to elicit a faster immune response, we redouble our efforts to support the government's overall preparedness and response strategy for large-scale emergencies involving anthrax and other threats to public health."
The BLA submission, completed in April 2022, includes data from a phase 3 clinical study of AV7909 that evaluated vaccine lot consistency, immunogenicity, and safety following two shots in healthy adults. It also included data from a phase 2 study that evaluated non-interference between AV7909 and antibiotics approved for post-exposure prophylaxis of anthrax.
Advanced development and delivery of AV7909 is funded by the Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the Department of Health and Human Services. Three years ago BARDA bought 50 million doses of AV7909 for the Strategic National Stockpile.
Jun 24 Emergent BioSolutions news release
Jul 3, 2019, CIDRAP News scan
H5N6 avian flu hospitalizes another person in China
China has reported another H5N6 avian flu infection in a human, this time involving a 58-year-old man from the Jiangxi province city of Ganzhou, home to more than 2.5 million people.
In a statement today, Hong Kong's Centre for Health Protection (CHP) said the man had been exposed to market poultry and is hospitalized in critical condition. Jiangxi province is in southeastern China.
The infection marks the country's 15th case of the year and its 79th since the virus was first detected in people in 2014. H5N6 cases are often severe or fatal in humans. The virus is known to circulate in poultry in a handful of Asian countries, but so far, China and Laos are the only nations to report illnesses in people.
Jun 27 CHP statement
More avian flu in US poultry and wild birds
Though the pace of highly pathogenic avian flu outbreaks in poultry has slowed in the United States, federal officials continue to report sporadic events, including five involving backyard birds, all in Washington state.
According to the latest update from the US Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS), the virus hit five flocks in four counties: Pierce, King, Snohomish, and Yakima. Flocks ranged in size from 3 to 200 birds.
US outbreaks in poultry began in February, spreading roughly from east to west, with commercial poultry in the Midwest experiencing the biggest impact. So far, the outbreaks have led to the loss of more than 40 million birds across 36 states.
In related developments, APHIS reported 24 more H5N1 avian flu detections in wild birds, raising the national total since January to 1,635. Most were from Minnesota and Wisconsin, though Pennsylvania and Oregon also reported detections. Most of the new detections, which involved birds found dead, were in waterfowl such as pelicans, gulls, and terns.
USDA APHIS poultry avian flu updates
USDA APHIS wild bird avian flu updates