Aug 16, 2007 (CIDRAP News) – The British pharmaceutical company GlaxoSmithKline (GSK) recently announced another major order of prepandemic H5N1 influenza vaccine from the US Department of Health and Human Services (HHS), along with plans to launch a North American clinical trial of the vaccine.HHS ordered enough vaccine in bulk form to provide 22.5 million 15-microgram (mcg) doses, the company announced on Aug 3. The order is in addition to the bulk equivalent of 5 million 15-mcg doses that HHS ordered in November 2006, officials said.The cost of the new vaccine order is $97 million, according to Marc Wolfson, a spokesman for the HHS Office of the Assistant Secretary for Preparedness and Response in Washington, DC.The new order includes 9 million doses produced in the 2006 “manufacturing campaign” and 13.5 million doses to be produced in the 2007 campaign, GSK reported. The vaccine is based on clade 2 strain of the H5N1 virus.GSK will make the bulk vaccine at its facility in Ste. Foy, Quebec, and store it in Marietta, Pa.When HHS announced the plan to buy H5N1 vaccine from GSK in November 2006, the agency said it was ordering 800,000 doses, not the 5 million doses cited in the company’s Aug 3 announcement. Wolfson of HHS and Ken Inchausti, a GSK spokesman in Philadelphia, explained that the two announcements involve the same amount of bulk vaccine, but the HHS statement was based on a dose of 90 mcg, whereas the company announcement assumed a dose of 15 mcg.”The confusion between the 5 million doses that GSK talks about and what we have is that we’re still ordering it at the bulk rate of 90 [mcg] per dose,” Wolfson told CIDRAP News. “They’re doing tests that could possibly take it down to 15 [mcg] per dose, and if you do the math, that’s where the difference comes.”Based on 90 mcg per dose, HHS currently has 2.3 million doses of GSK vaccine in its H5N1 vaccine stockpile, Wolfson reported.The vaccine contract provides that HHS may direct the company to formulate the bulk vaccine into doses in the future, GSK said. In addition, HHS has an option to buy the vaccine in combination with one of the company’s proprietary adjuvants, or immune-boosting chemicals, which could reduce the amount of vaccine antigen needed to induce a protective immune response, the company reported.Funds for the vaccine contract will come through the Biomedical Advanced Research and Development Authority (BARDA) in the HHS Office of the Assistant Secretary for Preparedness and Response, according to GSK.Clinical trial startingGSK also announced the start of the first North American clinical trial of its prepandemic H5N1 vaccine. The trial is described as a phase1/2 study that will compare the safety and immunogenicity of the H5N1 antigen alone and in combination with one of GSK’s adjuvant systems in 675 adult volunteers. Inchausti said the trial will be conducted at sites in Montana, California, Florida, Georgia, Alabama, Kansas, and Nevada and in Halifax and Quebec, Canada.The company said it plans to follow up later this year with a phase 3 trial that will involve about 4,400 volunteers. Results of the phase 1/2 trial are expected in early 2008.Last March, GSK reported that in a clinical trial, one of its adjuvanted H5N1 vaccines triggered a strong immune response with two 3.8-mcg doses, or about half of the 15-mcg dose typically used for each viral strain in seasonal flu vaccines. The company also said tests showed that the vaccine, based on a Vietnam strain of H5N1, generated cross-reactive immunity against an Indonesian strain.GSK, Baxter sign vaccine deals with UKIn other developments, both GSK and US-based Baxter International today announced agreements to sell vaccine to the United Kingdom in the event of a flu pandemic.Under the GSK agreement, the company will make preparations to provide a “tailored” vaccine as soon as possible after a pandemic is declared by the World Health Organization, according to a company news release. GSK said it also has agreements to sell pandemic vaccines to Switzerland, Denmark, and Iceland.Baxter, based in Deerfield, Ill., said its European subsidiary in the UK signed an agreement giving the UK an option to buy Baxter’s vaccine in the event of a pandemic. The company’s candidate pandemic vaccine is produced in vero cell culture rather than in eggs, the conventional medium for flu vaccine production. Baxter said it recently enrolled volunteers for a phase 3 clinical study of its cell-based H5N1 vaccine in Europe.See also: Mar 6 CIDRAP News story “Glaxo H5N1 vaccine may work against multiple strains”Nov 20, 2006, CIDRAP News story “HHS awards 3 contracts for more H5N1 vaccine”
MORE: 10 best Packers-Cowboys games of all timeThis season, Green Bay (3-1) and Dallas (3-1) meet Sunday in a key NFC showdown between teams trying to get an early leg up on the playoff race. Both suffered their first loss of the season in Week 4.Will Rodgers deal the Cowboys another losing hand? Here is a look at the stats, the moments and the significance of Rodgers’ success against Dallas.Aaron Rodgers vs. Cowboys stats— Rodgers is 6-2 as a starter against the Cowboys. His first start doubled as Dallas’ first victory at Lambeau Field on Sept. 21, 2008. Rodgers has won six of seven starts since.— Rodgers has led two game-winning drives in the playoffs in his career, and both came at the expense of Dallas in the divisional playoffs. The first came in a 26-21 victory against the Cowboys in the 2015-16 postseason. The second came two years later in a 34-31 victory in the 2016-17 playoffs.— In nine career games against Dallas (including postseason), Rodgers has 2,371 yards with 16 TDs and just 2 interceptions. He has added 2 rushing TDs, as well. Rodgers has a 101.7 passer rating against the Cowboys in the regular season and a 109.5 rating against them in the playoffs.— In three games at Dallas, Rodgers is 65-of-95 passing for 876 passing yard, 6 TDs and 1 interception. Sunday will mark his third start at AT&T Stadium.PACKERS vs. COWBOYS PICKS:Pick against the spread | Straight-up predictionAaron Rodgers vs. Cowboys momentsNov. 29, 2007: Rodgers replaces FavreA “Thursday Night Football” matchup between 10-1 teams took a turn when Favre was injured, but Rodgers impressed with 201 yards and a TD in a 37-27 loss that influenced the franchise’s quarterback decision the next season.Green Bay knew Rodgers could play.Jan. 11, 2015: Rodgers wins on one legThe 2014-15 NFC divisional playoff matchup is remembered for the Dez Bryant catch ruling. It overshadowed Rodgers, who despite a leg injury led two TD drives in the second half of the Packers’ 26-21 victory.Jan. 15, 2017: Rodgers delivers on third-and-20 Rodgers led Green Bay to a quick 21-3 lead in the NFC divisional playoffs, but the Cowboys tied the game at 28. The teams traded field goals, and Dallas tied it again with a 52-yarder by Dan Bailey with 35 seconds left.That was too much time for Rodgers, who hit Jared Cook for 35 yards on third-and-20 to set up a game-winning, 51-yard field goal by Mason Crosby.Rodgers passed for 355 yards, 2 TDs and an interception in the 34-31 victory.Oct. 28, 2017: Rodgers leads a comebackGreen Bay trailed 21-12 at one point, but Rodgers heated up in the second half with 20 fourth-quarter points in a 35-31 regular-season victory at AT&T Stadium.Rodgers threw the game-winning touchdown pass to Davante Adams with 11 seconds left and finished with 221 yards and 3 TDs.Why Aaron Rodgers’ success vs. Cowboys mattersRodgers’ success against the Cowboys has flipped the script on the rivalry after the days of Favre, who was 2-9 as a starter against the Cowboys. That includes an 0-8 record in Dallas and 0-3 against the Cowboys in the postseason. While Favre was struggling, Troy Aikman led Dallas to three Super Bowl appearances during the 1990s. Will Packers quarterback Aaron Rodgers be the star of the rivalry with the Cowboys again Sunday?Perhaps “star” is a poor word choice given how Rodgers has tormented Dallas since 2007. Of the 10 greatest games between the Cowboys and Packers, Rodgers has been the headliner in three. That includes the 2007 matchup when he nearly led Green Bay to a victory after replacing an injured Brett Favre. With Rodgers, Green Bay’s two playoff victories over Dallas knocked out Cowboys teams that finished with 12-4 and 13-3 records, respectively. It can be argued that Rodgers has been the biggest hurdle for the Cowboys to clear in this decade.Rodgers’ success has tilted the all-time series back in the favor of Green Bay, too. The Packers now lead the all-time series 19-17, and the 38th meeting should add another interesting chapter.Rodgers will play a huge role in that outcome. The only question is whether he will be the “star” again.