News Scan for Jun 17, 2014

News brief

Companies seek approval for meningococcal serogroup B vaccines

Novartis and Pfizer today announced that they have submitted applications to the US Food and Drug Administration (FDA) for marketing approval of their vaccines against Neisseria meningitidis serogroup B infection.

The FDA had granted each company breakthrough therapy designations for their vaccines, Pfizer in March and Novartis in April. Both companies are seeking indications for use in those aged 10 to 25.

Currently, there is no vaccine in the United States approved for use against serogroup B, which accounted for about 40% of N meningitidis infections in the country in 2012. Though antibiotics can be used to treat infections, the disease is fatal for about 10% to 15% of patients, and 11% to 19% of survivors have complications that cause long-term disability, according to the statement from Pfizer.

Outbreaks involving serogroup B occurred on some college campuses in 2013, and nearly 30,000 doses of the Novartis vaccine (Bexsero) were provided to students and staff at Princeton University and the University of California at Santa Barbara under an FDA investigational new drug designation in response to the events, according to the Novartis statement.

The company said the US Centers for Disease Control and Prevention (CDC) has recommended that incoming freshmen at Princeton receive Bexsero, which is already approved in the European Union, Australia, and Canada.
Jun 17 Novartis press release
Jun 17 Pfizer press release

USDA licenses first vaccine for porcine epidemic diarrhea virus

The US Department of Agriculture has issued a conditional license for the country's first licensed vaccine for controlling porcine epidemic diarrhea virus (PEDv) in swine, the agency's Animal and Plant Health Inspection Service (APHIS) said in a news release yesterday.

The vaccine, made by Harrisvaccines, Inc., of Ames, Iowa, will be used to vaccinate sows so they transmit antibodies through their milk to protect newborn piglets, the APHIS said in the release. PEDv has decimated US swine populations and has been up to 100% fatal in piglets, Bloomberg News reported.

"Preliminary studies have been promising, and they've shown sufficient data that we think the vaccine will be effective," the APHIS said. "The company will continue working toward completing the requirements for a full license. In the meantime, there are no restrictions on vaccine use under the conditional license."

Harrisvaccines has sold nearly 2 million doses of its PEDv vaccine through veterinary prescriptions, the company said in a release.
Jun 16 APHIS news release
Jun 16 Bloomberg story
Jun 16 Harrisvaccines news release

Flu Scan for Jun 17, 2014

News brief

China reports fatal H7N9 case

Health officials in China's Guangdong province today reported a fatal H7N9 avian influenza infection in a 42-year-old man, according to a health department statement translated and posted by FluTrackers, an infectious disease news message board.

The man's illness was confirmed on Jun 9, and he had been hospitalized in critical condition. His case pushes China's overall H7N9 outbreak total to 450, according to an ongoing tally kept by FluTrackers. Based on the most recent numbers from China's health ministry, recently cited by Hong Kong health officials, the man's death raises the fatality toll from the disease to at least 158.

Although the second wave of infections has tapered off, experts have said sporadic H7N9 cases are likely to be reported over the summer, since the virus appears to still be present in poultry and their environments.
Jun 17 FluTrackers thread
FluTrackers human H7N9 case list

Global flu activity inches along at low levels

Global flu activity continues at very low levels, with some increases in temperate South America, the World Health Organization (WHO) reported yesterday.

Influenza was at interseasonal levels in North America and Europe, approaching such levels in eastern Asia, declining in southern and southeastern Asia, and at low levels in northern and western Africa, the agency said in its weekly update.

Flu activity remained low in the Southern Hemisphere, "although some countries in the temperate zone of South America showed increases in [flulike illness] activity with slight increase in influenza detections," the WHO said.

Of 30,179 specimens tested, 1,919 (6.3%) were positive for flu. Of those, 62% were influenza A and 38% influenza B. Of subtyped influenza A viruses, 188 (21%) were 2009 H1N1 and 694 (79%) were H3N2.
Jun 16 WHO update

BARDA extends contract for recombinant flu vaccine development

Protein Sciences announced today that the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services, has extended its contract to support the development and production of recombinant influenza vaccines through the end of 2015.

The extension is worth $50.6 million and pushes the overall total of Protein Sciences' BARDA contract to $146.9 million. The firm said the extension will support the licensing of its newly acquired, larger manufacturing facility in Pearl River, N.Y., which makes Flublok, its recombinant seasonal flu vaccine.

The facility is designed to be able to produce 50 million doses of the company's a pandemic vaccine (Panblok) within 6 months of a pandemic declaration, as a stipulation of the BARDA contract. The contract extension will also cover clinical studies to support the licensing of Panblok and a quadrivalent version of Flublok.

The vaccine is produced with cell culture technology, and because no steps involve eggs, federal vaccine advisors last year recommended Flublok for adults who have egg allergies, no matter how severe. Protein Sciences said it has filed for approval of Flublok for people age 50 and older and anticipates clearance in time for the 2014-15 flu season.
Jun 17 Protein Sciences press release