News Scan for Dec 09, 2013

Mideast polio vaccination
Chikungunya on St. Martin
Meningitis B vaccine
Quadrivalent flu vaccine
Leafy-greens standards
Saudi MERS patients

Massive polio vaccine campaign under way in Middle East

The biggest push to vaccinate children in seven Middle Eastern countries against polio starts this week, with a goal of reaching 23 million kids in Syria and neighboring nations, the World Health Organization (WHO) said today. The campaign aims to reach all children under age 5 over the next few months, whether they live at home or in displaced populations.

Hostilities in Syria have disrupted the country's immunization activities, and the resurgence of polio poses a threat to children there as well as a risk of spread to other countries in the region, where the virus has been detected in sewage samples. So far 17 polio cases have been confirmed in Syria.

The vaccination program in Syria will try to reach 2.2 million children who were missed in an earlier effort, including those in difficult-to-reach contested areas. In coming months the United Nations Children's Fund (UNICEF) will deliver 10 million doses of polio vaccine to Syria, the WHO said.

The first shipment of 2 million doses arrived in Damascus on Nov 29. The WHO put the cost of the polio vaccination campaign, scheduled to run through April, at $39 million.
Dec 9 WHO statement


Chikungunya cases confirmed on St. Martin in Caribbean

Two cases of the mosquito-borne disease chikungunya have been confirmed on the Caribbean island of St. Martin, apparently marking the disease's first appearance in the region, according to a Dec 6 story in the Daily Herald, a newspaper on the island.

The two cases were found on the French side of the island, the story said. The island is divided between France and the Netherlands and is located about 190 miles east of Puerto Rico.

Patrice Richard, regional health director on the French side, said doctors have been reporting suspected chikungunya cases for about 2 weeks. In addition to the two confirmed cases, there are 30 suspected cases and 4 probable cases, according to the story.

"Chikungunya is in the Pacific islands, in Asia, in India, but never until now in the Caribbean islands," epidemiologist Marion Petit-Sinturel told the Herald. "It's the first time we have had a located transmission here in St. Martin."

French and Dutch officials promised to cooperate to stop the outbreak and urged people to eliminate mosquito breeding sites, the story said.

Chikungunya is spread by Aedes aegypti, the same mosquito species that spreads dengue fever, a somewhat similar disease. St. Martin has also been experiencing a dengue epidemic, with 1,074 probable or confirmed cases on the French side so far this year, the story said.

Chikungunya is found mainly in Africa and Asia. A US Centers for Disease Control and Prevention map shows no chikungunya-affected countries in the Americas as of last month.
Dec 6 Daily Herald story
Related Dec 9 ProMED-mail post
CDC information on the distribution of chikungunya


EU approves AstraZeneca's 4-strain intranasal flu vaccine

The European Union has approved AstraZeneca's quadrivalent intranasal influenza vaccine for children from the ages of 24 months to 18 years, the company announced on Dec. 6. The action makes Fluenz Tetra the first four-strain intranasal vaccine to gain European approval.

Fluenz Tetra is the European version of FluMist Quadrivalent—made by MedImmune, a divison of AstraZeneca—which was approved by the FDA in February 2012, the company announcement said.

Over the past several decades flu vaccines have usually contained three flu strains: two influenza A and one influenza B. In recent years manufacturers have developed vaccines containing two type B strains in an effort to provide broader protection against type B viruses, because of the difficulty of predicting which B lineage (Victoria or Yamagata) would predominate in any given year.

The European Commission's marketing authorization for Fluenz Tetra is based on a pediatric study that showed the vaccine has a safety and immunogenicity profile similar to that of Fluenz, a trivalent intranasal vaccine already available in Europe, AstraZeneca said.

The EU decision authorizes marketing of the vaccine in all 28 member states and the three European Economic Area states.
Dec 6 AstraZeneca press release
Aug 5 CIDRAP News story on quadrivalent flu vaccines on US market


Canada clears meningitis serogroup B vaccine

Novartis announced today that Health Canada has approved Bexsero, its vaccine against meningococcal serogroup B disease, according to a statement from the company's Canadian division in Dorval, Quebec. The vaccine is indicated for children ages 2 months through 17 years.

Meningococcal B is the most common type of meningitis in Canada and is responsible for 80% of cases in infants younger than 1 year, 67% in young children, and 62% in adolescents ages 15 to 19, the company said.

In contrast, US health officials have said the serogroup B is responsible for about a third of meningococcal disease cases in the US, and the vaccine used in the United States doesn't include the strain. However, it was recently linked to outbreaks at two college campuses—one at Princeton University and the other at University of California at Santa Barbara (UCSB).

Ron Gold, MD, senior medical advisor at the Meningitis Research Foundation of Canada, said in the Novartis statement that until now, Canada hasn't had a vaccine against meningitis B to routinely protect children.

In other developments, Princeton University today launched an immunization campaign in the wake of its meningococcal B outbreak, which has so far sickened eight students. The vaccine was approved for the response under an Investigational New Drug application, and the US CDC recently approved a plan for its use at Princeton.

Novartis said in a press statement today that it has been working closely with the CDC and Princeton on outbreak response plans. It said it is talking with the Food and Drug Administration (FDA) to find a licensing pathway for the vaccine to fill unmet public health needs. So far the vaccine is approved only in Europe, Australia, and Canada.

The company said it has completed phase 1 and 2 clinical studies for Bexsero in the United States and is continuing to work with the FDA to advance a single vaccine to protect against the five most common meningitis serogroups (A, B, C, Y, and W).
Dec 9 Novartis Pharmaceuticals Canada press release
Dec 9 Novartis press release


USDA halts plan for voluntary national standards for leafy greens

The US Department of Agriculture (USDA) announced last week it was pulling the plug on a plan for a national marketing agreement on the handling of leafy greens, citing pending produce-safety rules proposed under the Food Safety Modernization Act (FSMA) as the reason.

The National Leafy Greens Marketing Agreement (LGMA), proposed by the produce industry in 2009, would have set national safety standards for growing and handling leafy greens. The agreement was modeled after similar pacts in California and Arizona, where signers promise to meet the standards.

In a Dec 5 Federal Register notice, the USDA noted that the Food and Drug Administration (FDA) in January of this year proposed its produce safety and preventive-controls rules under the FSMA.

"This ongoing rulemaking may affect fundamental aspects of the proposed leafy green vegetable marketing agreement program," the USDA notice said. "As a result, it is appropriate to terminate the leafy green vegetable marketing agreement rulemaking proceeding at this time.

"Termination of this proceeding will remove ex parte communication prohibitions and allow USDA to engage fully with all interested parties to discuss and consider the evolving needs of the industry and consumers going forward. Based on the above, USDA is terminating this rulemaking proceeding," the agency said.

The timing of the USDA announcement surprised Scott Horsfall, head of the California LGMA, as growers have been waiting for the final version of the FDA's produce safety rule, according to a Food Safety News (FSN) story today. "Personally, it made sense to let the NLGMA sit until the FSMA rules had been finalized," he said.

The LGMA previously asked the FDA to consider its certified growers to be compliant with FSMA rules, the story said.
Dec 5 USDA Federal Register notice
Dec 9 FSN story


Saudi Arabia says two latest MERS patients are women

The two latest cases of Middle East respiratory syndrome coronavirus (MERS-CoV), which were announced last week, both involve women, according to Saudi Arabia's first English-language statement on the illnesses.

One case involves a 26-year-old citizen who is a healthcare worker in Riyadh and had contact with another case-patient, the Saudi Ministry of Health (MOH) said in a statement dated Dec 6. She was reported to have had no symptoms.

The other case is in a 51-year-old citizen in the Jawf region who has chronic diseases. She is being treated in a hospital intensive care unit in the Riyadh area, the MOH said. The statement did not suggest how the woman might have been exposed to the virus.

The ministry first reported the two cases Dec 5 in a statement in Arabic, which did not list the patients' genders.

Including these two cases, the MOH's MERS count is 132 cases with 55 deaths.
Dec 6 MOH statement

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