FDA requires reports on species-specific animal-antimicrobial sales
As part of the effort to preserve medically important antimicrobials, pharmaceutical companies will henceforward be required to report sales of antimicrobial drugs for food animals by species, not just overall totals, the US Food and Drug Administration (FDA) announced yesterday.
The FDA said it has finalized a rule that was first proposed in May 2015, after considering hundreds of comments from stakeholders, including consumers. The rule says companies must report the amounts of antimicrobials sold for use in cattle, swine, chickens, and turkeys. It will apply to reports of sales this year, which must be filed by the end of next year.
"The new sales data will improve the agency's understanding of how antimicrobials are sold and distributed for use in major food-producing species and help further target efforts to ensure judicious use of medically important antimicrobials," the agency announcement said.
Until now, drug makers have been required under a 2008 law to report the total amount of all antimicrobial drugs they sell and distribute for use in food-producing animals, but they haven't had to report the amounts by animal species, the FDA said. Under the same law, the agency prepares summary reports of sales information received from the drug sponsors each year and provides them to the public.
The requirement for species-specific sales estimates will complement a data collection plan the FDA is developing with the US Department of Agriculture and the Centers for Disease Control and Prevention to obtain additional on-farm use and resistance data, the FDA said.
"This information will further enhance FDA's ongoing activities related to slowing the development of antimicrobial resistance to help ensure that safe and effective antimicrobial new animal drugs will remain available for use in human and animal medicine," William T. Flynn, DVM, MS, deputy director for science policy in the FDA's Center for Veterinary Medicine, said in the agency announcement.
The agency said the requirement to file calendar-year sales reports by the end of the following year is new and will improve the timeliness of the information. It didn't say what the previous reporting deadline was.
May 10 FDA announcement
Related Dec 11, 2015, CIDRAP News item
Two Chinese provinces report 7 more H7N9 cases
China's Jiangsu province yesterday reported six H7N9 avian flu infections that occurred in April, five of hem fatal, according to a monthly health department surveillance report translated and posted by FluTrackers, an infectious disease news message board.
Jiangu's new cases and a case reported on May 6 in Zhejiang province's monthly report for April lifts the global H7N9 total to 788 infections from H7N9 since the virus was first detected in humans in 2013, according to a case list maintained by FluTrackers.
The reports didn't list any details about the cases, but a statement today from Hong Kong's Centre for Health Protection (CHP) seems to add some clarifications. The patients from Jiangsu are from Wuxi (3), Nantong (2), and Changzhou (1), and all are adults who were exposed to poultry or poultry markets. The patient from Zhejiang province is a 49-year-old woman from Wenzhou who had poultry market exposure.
May 10 FluTrackers thread
May 6 FluTrackers thread
FluTrackers H7N9 case list
May 11 CHP statement
In other avian flu developments, the World Health Organization (WHO) yesterday posted more details about an H5N6 case recently reported in China's Anhui province. Hong Kong's CHP first noted the case on May 3.
The patient is a 65-year-old woman from Xuancheng City whose symptoms began on Apr 24. She was hospitalized 3 days later, where she remains in critical condition. An investigation revealed that she had exposure to live poultry before she got sick.
Nigeria reports first vaccine-derived polio case in 2 years
Nigeria has reported its first case of type 2 circulating vaccine-derived poliovirus (cVDPV2) since July 2014, in the Maiduguri district of Nigeria's northeastern Borno state, according to a story today in Nigeria's The Guardian newspaper. The report did not disclose any details about the patient.
An environmental sample collected on Mar 23 in the Maiduguri district tested positive for cVDPV2. The strain is closely related to a vaccine-derived poliovirus that was last detected in May 2014, suggesting that it has been circulating for 2 years, the story said.
Nigeria, along with 154 other countries, switched in April to a bivalent (two-strain) oral polio vaccine from which type 2 poliovirus has been withdrawn. In response to the cVDPV2 case, the country will conduct its first vaccination campaign using monovalent oral polio vaccine type 2, which the World Health Organization (WHO) will release from its global stockpile, the story said
In addition to planned monovalent vaccination, Nigeria will hold immunization days in the northern part of the country using bivalent oral polio vaccine. Despite the newly reported cVDPV2 case, Nigeria is still on track to being certified polio-free by the WHO after July 2017.
May 11 The Guardian story
Delays in 3-dose DTaP schedule may heighten pertussis burden in infants
Delays in each scheduled dose of the diphtheria-tetanus-pertussis (DTaP) vaccine may cause more than 250 pertussis cases and more than 100 hospitalizations in infants each year, according to a study in the May issue of the Pediatric Infectious Disease Journal.
Researchers affiliated with GlaxoSmithKline Vaccines evaluated the effects of DTaP vaccine delays in a sample of 17,000 US infants 12 months or younger represented in the 2010 National Immunization Survey. The Advisory Committee on Immunization Practices recommends that the DTaP regimen adhere to a strict schedule of vaccination at 60, 120, and 180 days.
On average, infants received their first, second, and third DTaP doses at 76 days, 147 days, and 224 days, respectively, representing delays of 16, 27, and 44 days for the three doses. When the effects were modeled, dose delays contributed to 278 pertussis cases, 103 hospitalizations, and 1 death. Timely vaccination resulted in a gain of 38 quality-adjusted life years and a reduction of $1.03 million in healthcare costs.
Factors associated with delaying infant DTaP doses included maternal demographics (women who were younger than 30, unmarried, and/or without a college degree); non-Hispanic black or multiracial infants; poverty; eligibility for the Vaccines for Children program; and residence in California, New Jersey, or Oklahoma.
Given that timely administration of DTaP doses could prevent 9.1% of cases, 7.2% of hospitalizations, and 3.1% of deaths in the first year of life, the authors recommend adhering to the strict immunization schedule when possible.
May Pediatr Infect Dis J study