Shiloh
Editor, Senior Moderator
Source: http://www.cidrap.umn.edu/news-perspective/2014/08/flu-scan-aug-18-2014
Flu Scan for Aug 18, 2014
FDA clears flu vaccine for jet injection; H7N9 in Chinese poultry
Filed Under:
Influenza Vaccines; H7N9 Avian Influenza
FDA approves first flu vaccine for jet-injector use
The US Food and Drug Administration (FDA) announced on Aug 15 that it had approved the administration of bioCSL's Afluria inactivated influenza vaccine for use with ajet-injector device, the PharmaJet Stratis. The approval applies to intramuscular injection only in adults ages 18 through 64 years, the FDA said in its statement.
The action marks the first flu vaccine to be approved for use in a jet injector. The FDA said over the past few years it has received several questions about the use of jet injectors for giving inactivated flu vaccines. In October 2011, some pharmacy chains and other health providers said they had plans to use needle-free injectors to administer flu vaccines, but the FDA advised them to stop because it had not approved any flu vaccines for use in the devices.
At the time, the Centers for Disease Control and Prevention (CDC) weighed in and said people who had been immunized through the off-label practice didn't need to be revaccinated with a standard needle syringe.
In May, a study involving Afluria given with a jet injector found that the immune response was similar to that resulting from administration by syringe and that the vaccine?jet injector combination met non-inferiority criteria for all six endpoints. Researchers found that the device had an acceptable safety profile, though the frequency of injection-site reactions was higher than for needle and syringe administration.
The FDA said Afluria is the only inactivated flu vaccine approved for use in a jet injector and that jet injectors approved by the FDA should only be used to deliver medications and vaccines that have been approved and labeled for use in the devices.
Aug 15 FDA statement
May 30 CIDRAP news scan "Needle-free vaccine produces 'non-inferior' immune response"
More H7N9 detected in bird market, farm samples in China
In its ongoing surveillance for H7N9 avian influenza in poultry, China's agriculture ministry recently detected the virus in 14 samples from two provinces, according to an Aug 15 update from the World Health Organization's (WHO's) Western Pacific Region.
The monitoring results cover much of July and the first third of August and included 23,516 serum samples and 12,755 virologic samples from Guangdong and Shandong provinces.
Nine samples from Guangdong were positive, all from live bird markets, and five from Shandong, two from breeder farms and three from layer farms. All of the positive tests were in serum samples.
H7N9 avian flu has been circulating in Chinese poultry and began spreading in humans in the spring of 2013. Although human cases have slowed, over 450 have occurred.
Aug 15 WHO update
Jul 8 CIDRAP News scan on previous poultry testing
Flu Scan for Aug 18, 2014
FDA clears flu vaccine for jet injection; H7N9 in Chinese poultry
Filed Under:
Influenza Vaccines; H7N9 Avian Influenza
FDA approves first flu vaccine for jet-injector use
The US Food and Drug Administration (FDA) announced on Aug 15 that it had approved the administration of bioCSL's Afluria inactivated influenza vaccine for use with ajet-injector device, the PharmaJet Stratis. The approval applies to intramuscular injection only in adults ages 18 through 64 years, the FDA said in its statement.
The action marks the first flu vaccine to be approved for use in a jet injector. The FDA said over the past few years it has received several questions about the use of jet injectors for giving inactivated flu vaccines. In October 2011, some pharmacy chains and other health providers said they had plans to use needle-free injectors to administer flu vaccines, but the FDA advised them to stop because it had not approved any flu vaccines for use in the devices.
At the time, the Centers for Disease Control and Prevention (CDC) weighed in and said people who had been immunized through the off-label practice didn't need to be revaccinated with a standard needle syringe.
In May, a study involving Afluria given with a jet injector found that the immune response was similar to that resulting from administration by syringe and that the vaccine?jet injector combination met non-inferiority criteria for all six endpoints. Researchers found that the device had an acceptable safety profile, though the frequency of injection-site reactions was higher than for needle and syringe administration.
The FDA said Afluria is the only inactivated flu vaccine approved for use in a jet injector and that jet injectors approved by the FDA should only be used to deliver medications and vaccines that have been approved and labeled for use in the devices.
Aug 15 FDA statement
May 30 CIDRAP news scan "Needle-free vaccine produces 'non-inferior' immune response"
More H7N9 detected in bird market, farm samples in China
In its ongoing surveillance for H7N9 avian influenza in poultry, China's agriculture ministry recently detected the virus in 14 samples from two provinces, according to an Aug 15 update from the World Health Organization's (WHO's) Western Pacific Region.
The monitoring results cover much of July and the first third of August and included 23,516 serum samples and 12,755 virologic samples from Guangdong and Shandong provinces.
Nine samples from Guangdong were positive, all from live bird markets, and five from Shandong, two from breeder farms and three from layer farms. All of the positive tests were in serum samples.
H7N9 avian flu has been circulating in Chinese poultry and began spreading in humans in the spring of 2013. Although human cases have slowed, over 450 have occurred.
Aug 15 WHO update
Jul 8 CIDRAP News scan on previous poultry testing