NEWS SCAN: H5N1 deaths in Cambodia, H5N1 poultry outbreaks, flu vaccine for seniors, universal flu vaccine trial, food safety funding, dengue vaccines

Feb 23, 2011

Cambodian mother and son die from H5N1 infections
In a joint statement today, Cambodia's health ministry and the World Health Organization (WHO) announced the H5N1 avian influenza deaths of a mother and her baby son, the Phnom Penh Post reported. The 19-year-old woman and her 11-month-old son were exposed to the virus when they handled poultry during a visit to Prey Veng province. The woman died on Feb 12 after she was admitted to a private clinic, and her son died on Feb 17 while he was being treated at a hospital in Siem Reap province. The joint statement said a response team was sent to the village where the pair was infected to interview people who had close contact with them. Nima Asgari, a WHO public health specialist, aid no similar illnesses in the area have been reported and that over the next 2 weeks health authorities will monitor the condition of several people who submitted respiratory samples. The deaths are Cambodia's second and third from the virus this month and push Cambodia's H5N1 case count to 13, including 11 fatalities. They raise the world's H5N1 total to 522, including 309 deaths.

Vietnam, Indonesia report H5N1 outbreaks
Animal health officials in Vietnam today reported four H5N1 avian influenza outbreaks in poultry between Dec 2, 2010, and Feb 13, according to a report today to the World Organization for Animal Health (OIE). The outbreaks occurred in villages in Ca Mau, Lang Son, and Nam Dinh provinces, as well as on a farm in Kon Tum province. Lang Son and Nam Dinh are in the north, Kon Tum is in the central part of the country, and Ca Mau is in the south. In total, the virus killed 2,874 birds, and 3,657 more were culled to control the spread of the disease. Investigations into the source of the outbreaks suggested the introduction of new live animals into the flocks, illegal movement of birds, and fomites.
Feb 23 OIE report
Elsewhere, Indonesian veterinary officials reported fresh H5N1 outbreaks in Riau and East Java provinces, the Jakarta Post reported today. In Pekanbaru, Riau province, residents have reported several deaths of backyard birds over the past 3 weeks, and health officials sent teams to monitor the poultry outbreaks and to distribute doses of oseltamivir (Tamiflu). The H5N1 virus is considered endemic in both Indonesia and Vietnam.
Feb 23 Jakarta Post story

Canada approves adjuvanted flu vaccine for seniors
Canada yesterday approved the vaccine Fluad for people 65 and older, making it the first adjuvanted seasonal influenza vaccine licensed there, according to Novartis, the manufacturer. Fluad, which contains the adjuvant MF 59, has been used in Europe since 1997, with more than 50 million doses administered so far, Novartis said in a press release. The company said that in trials comparing Fluad with nonadjuvanted vaccines, it enhanced the immune response in older adults, including those with chronic diseases. Also, studies have shown that Fluad provides some protection against flu strains not included in the vaccine. In a statement e-mailed to CIDRAP News, Novartis officials said the company formulated the vaccine for seniors because of their reduced immune response to flu and flu vaccines. The vaccine is egg-based and contains the same amount of antigen as conventional vaccines—15 micrograms per strain, the company said. It will be available in Canada this fall. A monovalent H1N1 flu vaccine, Arepanrix, which contained the adjuvant AS03, was used in Canada during the 2009 flu pandemic. No adjuvanted flu vaccines have been licensed in the United States.
Feb 22 Novartis press release

Dynavax reports promising findings for early universal flu vaccine trials
Dynavax Technologies yesterday said phase 1 studies of its universal flu vaccine candidate suggest that it is safe and immunogenic and that the company will move forward with planning for a phase 2 trial. The company, based in Berkeley, Calif., said in a statement that it presented the findings on Feb 18 at a WHO meeting in Geneva to review progress on pandemic influenza prototype vaccines. The phase 1a and 1b trials tested two vaccines, one alone and one combining two of the company's vaccines that are in development. One is N8295, a fusion protein comprising NP and M2e, two highly conserved influenza antigens covalently linked to Dynavax's proprietary second-generation TLR9 agonist. The company also measured the performance of the vaccine candidate when combined with its investigational H5N1 vaccine. Both forms were safe and well tolerated, with only mild, injection-site reactions reported. The N8295 groups showed antibody response to M2e and NP, when compared to the placebo group and had a cellular response to NP. Adding N8295 to a nonimmunogenic dose of H5N1 vaccine resulted in H1 responses in all N8295 groups. Dr J. Tyler Martin, MD, Dynavax's president and chief medical officer, said in the statement that the trials not only demonstrated safety and immunogenicity attributes, they also demonstrated an adjuvant effect of the hemagglutinin-based vaccine.
Feb 22 Dynavax press release

CIDRAP director calls for full funding of food safety act
Foodborne disease remains a widespread problem in the United States, and although the new Food Safety Modernization Act will help in several concrete ways, the country will take only baby steps unless the act is fully funded, epidemiologist and foodborne disease expert Michael Osterholm, PhD, MPH, wrote today in a New England Journal of Medicine perspective piece. Osterholm, director of the University of Minnesota's Center for Infectious Disease Research and Policy, publisher of CIDRAP News, wrote that the 1990s saw significant reductions in foodborne pathogens but that the last decade has witnessed little improvement. He added that measures in the food safety act should help make our food supply safer, such as increased Food and Drug Administration (FDA) authority to regulate food facilities, including inspection of records and authorization of preventive controls; establishment of minimum food-safety standards; more FDA oversight of food imports; and steps toward better product tracing. However, he concludes, "Recent reports in the media calling this act 'historic legislation' must be tempered by the reality that without the necessary resources, requiring the FDA to carry out the law's required activities will be like trying to get blood out of a rock. And in the end, food safety in the United States cannot be expected to improve in more than an incremental manner."
Feb 23 N Engl J Med perspective

Report recommends broad cooperation to foster dengue vaccines
To spur development and deployment of dengue vaccines in countries that most need them, regulatory agencies need to address issues unique to multivalent vaccines and take steps to speed the approval process, according to a report published yesterday that is based on two international meetings held in 2007. Because an effective dengue vaccine will need to be quadrivalent to counter the four common dengue strains, vaccine safety needs to include such issues as interference between vaccine serotypes, according to the report, in PLoS Medicine. To expedite vaccine approval, manufacturers can submit a dossier to the European Medicines Agency for the Evaluation of Medicinal Products (EMA) for review, a step that was established to aid vaccine assessment by national regulatory authorities in dengue-endemic countries. Manufacturers may also obtain scientific advice and protocol assistance from the EMA, further expediting the process. The meetings were convened by the Developing Countries' Vaccine Regulators Network of the World Health Organization and the Dengue Vaccine Initiative Consortium, which in 2007 was called the Pediatric Dengue Vaccine Initiative. The authors say that no event since the meetings has undermined the report's advice; in fact, they write that vaccine development since then has only magnified the importance of the recommendations.
Feb 22 PLoS Med report

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