Sanofi says H5N1 vaccine with adjuvant may go further

first_imgEditor’s note: The title and first two paragraphs of this story were revised Dec 16 to correct a statement in the original that gave a more positive reflection of the trial results described below than may be warranted. The original version said that Sanofi Pasteur had described the trial results as “promising,” but the company actually said only that the results were “a sign of progress.”Dec 15, 2005 (CIDRAP News) – Sanofi Pasteur today announced preliminary trial results suggesting that using an additive to boost the immune response may help to stretch the supply of a vaccine for H5N1 avian influenza by a modest amount.Previous results had indicated that an H5N1 vaccine without an immune-boosting adjuvant would have to contain 12 times as much antigen (active ingredient) as seasonal flu vaccines do. In the results announced today, it took four times as much antigen as in a seasonal flu vaccine to induce an adequate immune response—an improvement, but far from what is needed to remedy the global shortage of vaccine production capacity.Sanofi tested an H5N1 vaccine it is making for the French government on 300 volunteers, using three different doses: 7.5, 15, and 30 micrograms. The volunteers were divided into six groups, and each group received two doses of vaccine with or without alum, an adjuvant used in many vaccines, according to Len Lavenda, US spokesman for Sanofi. The shots were given 3 weeks apart.”A 30-microgram dose with an adjuvant in a two-dose regimen demonstrated an immune response at levels consistent with requirements of regulatory agencies for licensure of seasonal influenza vaccine,” the company said in a news release.The two 30-microgram doses of vaccine containing alum induced an immune response in line with what the European Agency for Evaluation of Medicinal Products (EMEA) requires for flu vaccines, Lavenda told CIDRAP News.”We saw responses in all six groups, but the two-30-microgram-dose adjuvant group was the only one within the range of EMEA approval,” he said.”The 7.5- and 15-microgram studies provided results that were not as high as the 30, but we are continuing to study that data and we expect to publish the full set within a few months,” Lavenda said.Seasonal flu vaccines typically contain 15 micrograms of antigen, the active ingredient, for each viral strain covered. The amount that proved adequate in the Sanofi trial was 60 micrograms (two 30-microgram doses), four times as much.However, 60 micrograms is a much smaller amount than what was found to be adequate in a trial of an H5N1 vaccine that Sanofi is producing for the US government, according to results announced in August. In that trial, which didn’t involve an adjuvant, the regimen that looked most promising was two 90-microgram doses, a total of 180 micrograms.H5N1 vaccines are being developed in the hope that they will be protective if the H5N1 virus evolves into a pandemic strain. But even if the current experimental vaccines turn out be effective, the world’s current production capacity is far too small to provide enough vaccine for more than a small fraction of the population, according to disease experts. Researchers hope that dose-sparing tools such as adjuvants will help stretch the supply.Sanofi called the new trial results “a sign of progress” that will help guide further development of a pandemic flu vaccine. “Subsequent trials will explore different dosages, which may be helpful in answering questions about dose-sparing strategies,” the company said.The vaccine used in the latest trial is being developed to provide a stockpile for the French government, the company said. It comes from a different human isolate of H5N1 virus than the one used in the vaccine Sanofi is making for the United States, according to Lavenda.See also:Aug 8, 2005, CIDRAP News story “Hopeful news on human H5N1 vaccine, but production concerns considerable”last_img read more

MWB in no rush to follow Regus float

first_imgTo access this article REGISTER NOWWould you like print copies, app and digital replica access too? SUBSCRIBE for as little as £5 per week. Would you like to read more?Register for free to finish this article.Sign up now for the following benefits:Four FREE articles of your choice per monthBreaking news, comment and analysis from industry experts as it happensChoose from our portfolio of email newsletterslast_img

What’s the magic number to clinch a playoff berth in a 60-game MLB season?

first_imgMORE: Why the Padres, A’s and Mets could surprise in a 60-game season Vegas odds Odds Shark released its win totals for the 60-game season, and the Yankees and Dodgers have the highest number at 37.5 each. Those two — which will be heavy World Series favorites even in the new format — are the only teams picked to win more than 35 games.  Houston is next at 35, followed by Minnesota at 34.5. Atlanta, Tampa Bay and Washington are at 34. That list provides five of the six division winners from last season — with the Cardinals the other team. St. Louis is at 32.5.  By these numbers, any team that gets to 35-38 victories should be good for a playoff berth.  That might not be enough to win the division, however.  2019 division winners  We totaled the winning percentage for the six division winners from 2019, and that number is .622. If you are targeting that winning percentage over a 60-game season, then the closest record would be 37-23 — a .616 winning percentage.  Teams that win 38 games would have a .633 winning percentage. The Astros (.660), Dodgers (.654) and Yankees (.636) were the only teams that did better than that over a 162-game season last year.  Of course, a 60-game season is much different.  A 60-game sample  We looked at the division leaders after 60 games last season. The Dodgers were the best of the bunch at 41-19. Here’s a look at the division leaders’ records after 60 games last season:  TeamWLDodgers4119Yankees3822Astros4020Twins4020Brewers3426Braves3327The average record among those teams? Again, we’re looking at 38-22.   Room for variation  Vegas, the full-season numbers and the 60-game sample all seem to agree. A team that wins 38 games should be able to claim its division in a 60-game season.  So, we’ll call 38 the magic number to essentially assure a postseason berth.  You can go a few games up or down to allow for variation, and that’s why that 40-20 vision is important in a 60-game season. Wild card teams can probably get in with 34 wins or fewer, but there are no guarantees in a 60-game format.   Win totals via Odds Shark Team2019 WINS2020 WINSLos Angeles Dodgers10637.5New York Yankees10337.5Houston Astros10735Minnesota Twins10134.5Atlanta Braves9734Tampa Bay Rays9634Washington Nationals9334Oakland Athletics9733.5St. Louis Cardinals9132.5Chicago Cubs8432Cleveland Indians9332Los Angeles Angels7232New York Mets8632Boston Red Sox8431.5Chicago White Sox7231.5Cincinnati Reds7531.5Philadelphia Phillies8131.5Arizona Diamondbacks8531Milwaukee Brewers8931San Diego Padres7031Texas Rangers7829.5Toronto Blue Jays6728Colorado Rockies7127.5Pittsburgh Pirates6925.5San Francisco Giants7725.5Seattle Mariners6825Kansas City Royals5924.5Miami Marlins5724.5Baltimore Orioles5421.5Detroit Tigers4721.5 MLB’s 60-game season should create some wild playoff races within the six divisions. But what’s the magic number to claim a division title? That will be interesting to find out, but teams should have 40-20 vision heading into the season. That is, 40 wins should be more than enough to win a division, while a wild card berth should fall at least several wins below that.Let’s take a closer look at what should be the goal for major league teams in 2020.last_img read more