Nov 2, 2009 (CIDRAP News) – Interim clinical trial findings announced today affirm that children younger than 10 need two pandemic H1N1 vaccine doses, and initial findings in pregnant women reveal no safety concerns and a need for only one dose.Federal officials also detailed the role of an independent panel of experts to review vaccine safety data and released a report outlining the government’s vaccine safety monitoring system.At a media briefing today, Bruce Gellin, MD, director of the National Vaccine Program at the US Department of Health and Human Services (HHS), said federal officials realize that, despite problems with vaccine supply and demand, Americans still have concerns about its safety. He told reporters that an independent expert group charged with reviewing vaccine safety data met for the first time today to become familiar with the data sources they’ll be reviewing.In addition, a federal task force today released a 20-page report that outlines beefed-up systems that officials have put in place to monitor the safety of the vaccine. US health officials are mindful of the 1976 swine flu vaccination campaign, which reached more than 40 million people but was associated with an increase in cases of Guillian-Barre syndrome, a temporary paralytic condition.Though vaccine safety and purifications steps are much more advanced today, officials have added new systems to track the pandemic H1N1 vaccine and are taking extra steps to add transparency to the process, in hopes of reassuring the public.Anne Schuchat, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases, told reporters that a cumulative total of 30 million doses of pandemic H1N1 vaccine have been produced for states to order, which represents an increase of 3.4 million since Friday.Vaccine data for childrenThe latest findings of vaccine efficacy in children come on the heels of a recommendation from World Health Organization (WHO) vaccine experts who on Oct 30 recommended that most people, even young children, receive just one dose of the vaccine.Though the group acknowledged they didn’t have much data to base their guidance on, they said countries that have placed children as a high-priority group to receive the vaccine should administer one dose so they can immunize as many children as possible.Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said the findings today, from National Institutes of Health (NIH) studies, are critical to public health officials who are charged with making policy decisions and to the public for making personal decisions for themselves and their loved ones.He said interim results on vaccine in healthy children ages 6 months to 17 years confirm early results reported on Sep 21. The new findings show that children younger than 10 who receive a second 15-microgram (mcg) dose of pandemic H1N1 vaccine have significant immune response improvement.The new data were obtained 8 to 10 days after the second vaccine dose, compared with the first findings, which were obtained 21 days after the first dose.In the youngest children (6 to 35 months), 100% had a robust immune response after the second dose compared with only 25% after the first dose. In those ages 3 through 9, 94% had a robust immune response after the second dose, compared with 55% after the first dose.Immune responses were comparable in those receiving two 15-mcg doses and in those who got two 30-mcg doses, suggesting that the smaller dose is enough to elicit a strong immune response, according to an NIH press release today.”Our guidelines seem to fit quite nicely with the science,” Fauci said at the news conference. “We would like to get children as fully protected as we can.”Efficacy in pregnant womenIn the initial results on the vaccine in pregnant women, immune response to the pandemic H1N1 shot was similar to that seen in healthy adults.Public health officials have placed pregnant women at the front of the line to receive the vaccine because they have been disproportionately hit by the virus. So far the CDC has received reports of at least 100 pandemic flu infections in pregnant women that required intensive care unit (ICU) treatment, as well as reports of 28 deaths.In a subgroup of 50 pregnant women participating in an NIH clinical trial, a preliminary analysis of blood drawn 21 days after vaccination showed the vaccine was likely protective in 23 of 25 women (92%) who received a single 15-mcg dose and that it was likely protective in 24 of 25 (96%) who received a single 30-mcg dose.The trial began on Sep 9, according to an NIH press release. Participants were between ages 18 and 39 and were in their second or third trimester when they began the study. The ongoing study will also assess the effects of a second dose. Investigators are using Sanofi’s pandemic H1N1 vaccine, which does not contain the preservative thimerosal or an immune-response-boosting adjuvant.Despite the heightened threat of the virus to pregnant women, public health officials worry about the uptake of the pandemic vaccine in this group, because only about 15% of pregnant women typically receive the seasonal vaccine. Safety monitoring of the drug conducted by researchers and an independent expert panel so far suggests that the vaccine is well tolerated, with no safety concerns so far.”For pregnant women, who are among the most vulnerable to serious health problems from 2009 H1N1 infection, these initial results are very reassuring,” Fauci said.Vaccine-safety groupGellin said the independent vaccine safety expert group that met today in its first face-to-face meeting will meet biweekly to review the latest data and will report its findings each month in a publicly accessible conference call with the HHS’s National Vaccine Advisory Committee.The vaccine safety group will be receiving regular briefings from the NIH and the Biomedical Advanced Research and Development Agency (BARDA) and can convene rapidly if needed.See also:Nov 2 NIH press release on vaccine response in childrenNov 2 NIH press release on vaccine response in pregnant womenFederal Immunization Task Force report on plans for monitoring pandemic H1N1 vaccine safetySep 21 CIDRAP News story “Trial predicts 2 H1N1 shots for young kids, 1 for older”
The Spanish world number one was in the throes of wrapping up his second round clash on Rod Laver Arena against Argentine Federico Delbonis when the unfortunate girl found herself in his firing line. Nadal went over to check how she was and gave her a quick peck on the cheek for good measure, leaving the youngster blushing. Loading… Read Also: Aussie Open: Nadal labours past Delbonis to reach third round“For her it was not a good moment, I was so scared for her, the ball was quick and straight on her,” Nadal said after the match, giving her his headband as a momento.“She’s a super brave girl. It has been one of the more scary moments of my career. I’m very happy she is good. She is brave. Well done.”FacebookTwitterWhatsAppEmail分享 Promoted ContentMind-Bending Technology That Was Predicted Before It Appeared11 Most Immersive Game To Play On Your Table TopWhat Happens When You Eat Eggs Every Single Day?9 Iconic Roles That Could Have Been Played By Different Actors10 Risky Jobs Some Women DoWhat Is A Black Hole And Is It Dangerous For Us All?9 Facts You Should Know Before Getting A TattooFantastic-Looking (and Probably Delicious) Bread Art8 Superfoods For Growing Hair Back And Stimulating Its Growth18 Beautiful Cities That Are Tourist Magnets6 Incredibly Strange Facts About HurricanesYou’ve Only Seen Such Colorful Hairdos In A Handful Of Anime Advertisement Rafael Nadal melted hearts at the Australian Open on Thursday, rushing to console a ballgirl and kissing her on the cheek after one of his fearsome shots ricocheted off her.
Ducky and Oregon fans have had plenty of reasons to smile this season, as a high-powered offense once again rules in Eugene.[/media-credit]With a No. 4 BCS ranking, the Oregon Ducks should feel slighted. Winning the past two games by a total of 78 points should not equate to a drop.But that is exactly what has unfolded. After dominating Arizona State on the road last Saturday, the Ducks (8-0, 5-0 Pac-12) dropped one spot from No. 3 in Week 9. Then, after destroying Colorado Saturday and then-No. 2 Florida falling at the hands of Georgia, Oregon was again discredited, as Notre Dame jumped ahead to the No. 3 spot behind new No. 2 Kansas State and No. 1 Alabama.Both the USA Today Coaches Poll and the AP Top 25 put the Ducks where they belong – at the second spot – most likely because they have actually watched this team pick apart every opponent.But a soft schedule plagues the team, as Oregon has played just a single currently ranked team, No. 22 Arizona. This is why the Ducks are fifth in the computer-generated ranking that accounts for one-third of the BCS ranking.The problem is there is nothing more Oregon could do to increase its appeal.The offense, led by freshman quarterback Marcus Mariota, has scored at least 42 points in each of its first eight games. Sophomore De’Anthony Thomas has rushed for seven touchdowns, tallying three more receiving. Averaging 53.4 points per game should be enough for a higher spot than fourth, right?Perhaps what makes this offense the most impressive is its ability to get things done early, and there is no better example than what happened Saturday in Eugene, Ore. The Ducks outscored the Buffaloes 56-0 — in just the first half. Yes, you read that right, 56 points in two quarters. Colorado is by no means a serious competitor against Oregon, but four touchdowns in each quarter puts a whole new meaning to the word offense.The Ducks’ defensive play makes these early scores look that much better. While the defensive unit is not on the same level as the powerhouse offense, scoring at least 40 points every game means it’s OK to give up a few touchdowns. The team is 24th in the nation in points allowed, averaging 19.4. If you look at each win, Oregon has never truly faced a serious challenge yet this season. The closest game for the Ducks was back in Week 2, when they won by 17 points. The other seven games have been victories of at least 20 points.And against the tougher competition, Oregon looked even better. The Ducks completely shut out Arizona, and against the other then-ranked team, No. 23 Washington, they gave up just three touchdowns after taking a 21-0 lead in the first quarter, going on to win 52-21.However, the marshmallow-like schedule is about to change, and quickly. Heading into Week 10, the Ducks will travel to southern California to play No. 17 USC. And after a trip to Memorial Coliseum, Oregon will take on two more ranked teams in the month of November.It’s a rare situation for a team to want success for conference opponents, but for Oregon that ironically is exactly what they need. Remaining ranked opponents USC, No. 14 Stanford and No. 11 Oregon State will be doing the Ducks a service by winning, as the higher these teams are ranked, the more impressive it will look when Oregon plays, and likely defeats, each of them.Another advantage for the Ducks heading into November is the unimpressive lot Kansas State and Notre Dame will play. The Fighting Irish have a single opponent remaining that is above .500, and it happens to be USC. Not only will this be the team’s 12th game, it will provide a common opponent to the Ducks.Kansas State has two opponents, Oklahoma State and Texas, remaining on its regular season docket, but both are barely clinging onto their spots as the No. 24 and No. 23 ranked teams, respectively. While this means the Wildcats will likely go 12-0, the competition Oregon faces in November should bump it ahead if the team remains successful.It should also not be overlooked that Oregon, unlike Kansas State and Notre Dame, will play in a conference championship game, and if the Ducks win, it will be another quality opponent to add to Ducky’s long list of victims.So for now, the Ducks should feel a bit snubbed, but the prospect of success down the road in this last stretch should not cause the computer rankings any doubts that Oregon is the real No. 2 team in the nation.Caroline is a junior majoring in journalism and political science. What do you think about the current BCS rankings? Let her know by emailing firstname.lastname@example.org.