FDA approves first US adjuvanted flu vaccine
The US Food and Drug Administration (FDA) yesterday approved the nation's first seasonal flu vaccine containing an adjuvant—an immune-boosting substance—although European and other countries have used adjuvanted vaccines for years.
The agency approved Novartis's Fluad, a trivalent (three-strain) vaccine for preventing seasonal flu in people age 65 and older, it said in a press release. The egg-based vaccine contains MF59, an oil-in-water emulsion of squalene oil, which is a naturally occurring substance that is highly purified for use in vaccines.
"Fluad provides another alternative for a safe and effective influenza vaccine in people 65 years of age and older," said Karen Midthun, MD, director of the FDA's Center for Biologics Evaluation and Research. "Immunizing individuals in this age group is especially important because they bear the greatest burden of severe influenza disease and account for the majority of influenza-related hospitalizations and deaths."
In a multicenter clinical trial of 7,082 seniors, Fluad showed comparable immune-boosting capabilities as Agriflu, a trivalent flu vaccine also made by Novartis. Studies of about 27,000 other people 65 and older demonstrated the safety of Fluad, the FDA said.
Nov 24 FDA press release
UK sees 151% rise in excess winter deaths, many caused by flu
Excess winter deaths were up 151% in Britain last season compared with the year before, partly attributed to deaths from influenza, UK officials reported today.
The UK Office for National Statistics (ONS), in its annual report, estimated that England and Wales had 43,900 excess winter deaths 2014-15, the highest number since 1999-2000. It said respiratory diseases were the underlying cause of death in a third of cases.
The ONS noted that the 2014-15 flu season was dominated by the H3N2 strain. "This strain of flu had a particularly noticeable effect on the elderly, resulting in numerous care-home outbreaks and far higher levels of excess mortality than the last notable H3N2 season of 2008/09," the report said.
The agency added that the weeks beginning Dec 29 and Jan 5 saw 14,428 and 14,632 deaths caused by flulike illness, respectively—35% and 39% higher than the same weeks in 2013-14.
The ONS also noted the low effectiveness of the flu vaccine last season. Claudia Wells, head of mortality analysis at ONS, told the UK's The Guardian newspaper, "It [flu] was associated with more deaths than we expected. As it wasn't a particularly cold winter, we do think it was probably down to ineffectiveness of the flu vaccine."
Nov 25 ONS news release
Nov 25 ONS report
Nov 25 Guardian story
France, Vietnam report H5N1 outbreaks in poultry
France has detected highly pathogenic H5N1 avian flu for the first time in 8 years, while Vietnam has again detected the virus in poultry, officials said today in separate reports.
H5N1 killed 22 of 32 chickens in a backyard flock in Biras in the Perigord, a southwestern region in France known for poultry and foie gras (poultry liver) production, Reuters reported. The outbreak comes as foie gras demand rises for the holidays, but French officials were quick to reassure the public about its safety.
"This virus has no effect as far as consuming poultry meat or anything that comes from poultry products is concerned—I am thinking particularly about foie gras since we are approaching times of high consumption," said French Agriculture Minister Stephane Le Foll.
After previous H5N1 outbreaks in France, however, several countries, including Japan, Egypt, and Hong Kong, had banned French poultry, Reuters noted. Japan is the largest importer of French foie gras.
Nov 25 Reuters story
In Vietnam, meanwhile, 100 birds in a backyard flock of 649 poultry died in an H5N1 outbreak in Ha Tinh province in the north-central part of the country, Vietnamese officials said in a World Organization for Animal Health (OIE) report posted today.
The outbreak began on Nov 7 and was confirmed on Nov 12. All surviving birds were euthanized to contain disease spread, and other measures such as disinfection were taken. The country has had several H5N1 and H5N6 outbreaks in recent weeks.
Nov 25 OIE report