China approves its first H5N1 vaccine

first_imgApr 3, 2008 (CIDRAP News) – China’s State Food and Drug Administration (SFDA) yesterday approved the country’s first prepandemic H5N1 influenza vaccine, an inactivated whole-virus product made by Sinovac, a Beijing-based biotechnology company.China’s approval of Sinovac’s Panflu vaccine marks the third H5N1 vaccine to win approval from national or international regulatory bodies. In April 2007, the US Food and Drug Administration approved a Sanofi Pasteur H5N1 vaccine. A month later, the European Union approved a mock-up pandemic flu vaccine made by Novartis (it is designed to speed vaccine production when a pandemic emerges and will not be manufactured until then).Sinovac said its vaccine is approved only to supply China’s national vaccine stockpile and will not be available for commercial sale, according to a company press release yesterday. In 2006 the company said it planned to produce 20 million doses of the vaccine over the next few years, according to a previous report. The latest information gave no production estimate.”This vaccine is reserved for emergencies in the country and we have to get instructions on how much to produce,” Liu Peicheng, Sinovac’s publicity supervisor, told Reuters today.Vaccine experts say there is no guarantee that vaccines based on current H5N1 strains will be effective if a pandemic H5N1 virus emerges, but they hope such vaccines will provide some protection and buy time while a vaccine specifically matched to the pandemic strain is developed.The Sinovac vaccine contains an inactivated Vietnam strain of H5N1 virus and an aluminum hydroxide (alum) adjuvant. A phase 1 study of the vaccine, published in a 2006 issue of The Lancet, induced potentially protective immune responses in 78% of volunteers after two 10-microgram (mcg) doses.In late December 2007, Sinovac in a press release reported preliminary phase 2 results for the vaccine. The trial included 402 adults (aged 18 to 60). Groups received two doses of 5, 10, or 15 mcg of the vaccine.Each dosage induced varying degrees of immune response, but the 10- and 15-mcg dosages reached standards set by the EMEA to indicate good results for seasonal flu vaccines. Sinovac said the trial did not show any serious adverse reactions among the volunteers.The researchers who conducted the phase 1 trial said a whole-virus vaccine offers a dose-sparing advantage, because 20% to 23% of the vaccine antigen is lost during the preparation of split-virus vaccines. However, Iain Stephenson, MD, of the Infectious Disease Unit at Leicester Royal Infirmary in Leicester, England, had said in a Lancet editorial that though whole-virus vaccines usually produce a better response than split or subunit counterparts, it is difficult for manufacturers to switch production methods. Also, he said whole-virus vaccines are linked to febrile reactions in children.Sinovac has also completed a phase 1 trial of a split-virus H5N1 vaccine, which was found to be safe for children, adults, and elderly people, according to its December 2007 press release.Peicheng said Sinovac is also conducting trials to see if its H5N1 vaccine yields cross-protection against other strains, including those from Indonesia, Turkey, and Anhui province in China, Reuters reported.China has reported three H5N1 cases so far this year, all of them fatal.Vietnam starts H5N1 vaccine trialIn other vaccine developments, Vietnamese researchers said today that clinical trials have begun for an H5N1 vaccine that the country is developing, according to a report from Reuters. The vaccine is based on a Vietnam strain of H5N1 virus.The vaccine is being tested in 11 volunteers, all of whom are researchers, the report said. They received their second dose of the vaccine today at the National Institute of Hygiene and Epidemiology in Hanoi.Nguyen Tuyet Nga, an epidemiologist and virologist who is leading the trial, told Reuters that the US Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) have helped with the project, though no foreign pharmaceutical firms are involved in the study.Subjects in the trial are receiving two injections 28 days apart, with doses ranging from 3.75 to 45 mcg, Nga said. She also told Reuters that researchers would test the vaccine at a later date to see if it offers cross-protection against other H5N1 strains. The report did not say if the Vietnamese vaccine is a split- or whole-virus product or if it contains an adjuvant.Vietnam has reported five H5N1 cases this year, all of them fatal.See also:Sep 7, 2006, CIDRAP News story “Chinese report results for whole-virus H5N1 vaccine”Apr 2 Sinovac press releasehttp://www.sinovac.com/?optionid=754&auto_id=569Dec 24, 2007, Sinovac press releasehttp://www.sinovac.com/?optionid=754&auto_id=496Oct25 to Nov 2, 2007, CIDRAP News report “The pandemic vaccine puzzle: A seven-part series on the chances for immunizing the world against pandemic flu”last_img read more

Hoegh rethinks turning around, turns in IMCA Modified win at Bagby Memorial

first_imgThat’s when things turned around. Instead, he got back on the road, got to HO’T in time and won the Jack Bagby Memorial main event for IMCA Modifieds, earning both $1,000 and a berth of the Fast Shafts All-Star Invitational ballot.  It was also one of those nights that didn’t start out that way. Hoegh finished fourth and starting last in a heat race that ran caution-free, then drew the pole for the 20-lap feature. He led every time around the oval, taking the checkers ahead of two-time defending track champion Eric Tomlinson and Chris Morris. Jeffrey Abbey scored the IMCA Sunoco Stock Car victory and Sid Kiphen was the Smiley’s Racing Products Southern SportMod winner Friday at Heart O’ Texas. Brian Schoenbaum Jr. was first across the stripe in the Mach-1 Sport Compact feature. David Goode Jr. and former track champ Kevin Green completed the top five. Feature results – 1. Jeff Hoegh; 2. Eric Tomlinson; 3. Chris Morris; 4. David Goode Jr.; 5. Kevin Green; 6. Justin Radcliff; 7. Cody Daniel; 8. Mark Carrell; 9. David Goode Sr.; 10. Mike McCarthy; 11. Jerry Frydrych; 12. Brent Gilliam; 13. Evan Pardo; 14. Donald Banker; 15. Rob Slott; 16. Jason Kingrey. ELM MOTT, Texas (March 1) – Just 30 minutes into the 3-1/2 hour tow to Heart O’ Texas Speedway and already running late, Jeff Hoegh thought about turning around and starting his season another night.center_img Hoegh had to stop for fuel half an hour into the trip, then needed another half hour to fill up. He had already missed the draw when he pulled up to the pit gate and learned the wristbands were his unlucky red. Hoegh also won his first race last season, then went 27 starts and two days shy of a year before his next checkers Friday night.  “Being in front is the loneliest place. I gave the car what I had to and was able to drive away when I needed to,” Hoegh said. “We won two track championships in 2017, then traveled more last year. We did a lot of learning and experimenting,” said Hoegh, who ventured to Iowa for the IMCA Speedway Motors Super Nationals fueled by Casey’s and later in September to Arkansas for Race For Hope 74. “I’ve got a new car this year (a 2019 CAM Chassis) and have run practice laps a couple times. The car is comfortable and was working right.” Jeff Hoegh started his season with the $1,000 IMCA Modified feature win at Heart O’ Texas Speedway’s Jack Bagby Memorial lidlifter. The victory put Hoegh on the ballot for the Fast Shafts All-Star Invitational. (Photo by Stacy Kolar, Southern Sass Photography) “Getting on the ballot is a pretty big deal for me. I’m glad we started off the year the way we have,” said Hoegh. “It was one of those nights when everything turned out good.” last_img read more