HHS funds work on dose-sparing H5N1 vaccines

first_img See also: The $14.4 million award to Iomai is intended to support completion of phase 1 clinical trials of a candidate vaccine with adjuvant, according to HHS. The company “may receive an additional $114 million in funding upon successful completion of the phase 1 trials.” The Novartis contract will help the company bring its MF59 adjuvant, used in seasonal flu vaccines for elderly people in Europe, to the United States, the company said. Iomai will use the funds to develop an adjuvant skin patch to be used with flu vaccines, while a GSK news release said only that the money would be used for an “innovative adjuvant technology.” GSK will use the HHS contract to conduct “research and development leading towards licensure of antigen-sparing prepandemic and pandemic vaccines with adjuvant” to protect more people, according to a company statement. The contract gives HHS the option to provide another $44 million for “future clinical development programs” for antigen-sparing vaccines, the company said. Hall said the company’s H5N1 vaccine is egg-based. In July 2006 GSK reported that in a clinical trial, an H5N1 vaccine coupled with the company’s adjuvant triggered a good immune response with only 3.8 micrograms (mcg) of antigen, as compared with 15 mcg of antigen in a typical dose of seasonal flu vaccine (for one flu strain). As noted in today’s HHS statement, early trials of the (unadjuvanted) H5N1 vaccine in the current stockpile showed that it took two 90-mcg doses to induce what was considered a protective immune response. The patch is applied to the skin over the site of vaccination, the company said. “Once the patch is applied, the adjuvant passes into the skin, targeting cells called Langerhans cells. Those specialized skin cells carry the adjuvant to the lymph nodes, where it works to boost an individual’s immune response to the vaccine.” The Department of Health and Human Services (HHS) awarded a 5-year, $63.3 million contract to British-based GlaxoSmithKline (GSK) and a 5-year, $54.8 million contract to Swiss-based Novartis. In addition, Iomai Corp., Gaithersburg, Md., received a $14.4 million, 15-month contract, which could lead to an additional $114 million award, HHS announced in a news release. The aim of the contracts, HHS said, is to put each company in a position to produce, within 6 months after the emergence of a flu pandemic, either 150 million doses of an adjuvant-based pandemic vaccine or enough adjuvant for 150 million doses of such a vaccine. “The contracts also require each company to provide its proprietary adjuvant for U.S. Government–sponsored, independent evaluation with influenza vaccines from other manufacturers,” HHS said. “If we actually had licensed cell-based vaccines with an immunogenic adjuvant, it would put us in a much better position in the US to respond to pandemic influenza,” Osterholm said. The Novartis vaccine Fluad, which contains MF59, is licensed in Europe for preventing seasonal flu in people aged 65 and older, the company said. It said many studies have shown that the vaccine induced stronger antibody responses in elderly people than were seen with an unadjuvanted vaccine. In a news release, Novartis officials said their contract will be used to test the safety and effectiveness of the MF59 adjuvant in a pandemic flu vaccine and to support work on an MF59 production facility in Holly Springs, N.C. The vaccine will be grown in cell culture rather than in eggs. In May 2006 the company received an HHS contract to develop a cell-culture-based flu vaccine and a manufacturing facility for it. Jan 17 HHS news releasehttp://www.hhs.gov/news/press/2007pres/01/20070117b.html Jan 17 Novartis news releasehttp://cws.huginonline.com/N/134323/PR/200701/1098644_5.html With current technology, it would take about 6 months to start producing a vaccine well matched to the pandemic strain, HHS spokesman Bill Hall noted. “By having an adjuvant you can rapidly extend the number of people you can cover early on with vaccine,” he told CIDRAP News. Jan 17, 2007 (CIDRAP News) – In an effort to stretch the nation’s supply of vaccines for a potential influenza pandemic, federal health officials today announced contracts totaling $132.5 million to help three companies develop dose-sparing substances, or adjuvants, to be used with H5N1 flu vaccines. He also expressed gratification that the Novartis contract will support development of a cell-based vaccine. Cell-based production “will definitely shave time off the production of the [pandemic] vaccine,” although the pandemic strain will have to be identified first, he said. Nov 20, 2006, CIDRAP News story “HHS awards 3 contracts for more H5N1 vaccine” Michael T. Osterholm, PhD, MPH, director of the University of Minnesota Center for Infectious Disease Research and Policy, publisher of the CIDRAP Web site, praised HHS for awarding the contracts. “Adjuvants likely will play an important role in extending the number of doses that will be available once a pandemic strain is identified and vaccine production begins,” he said. Novartis said several published studies have indicated that MF59 may reduce the amount of antigen needed in H5N1 vaccines and may help such vaccines provide cross-protection against slightly different, or “drifted,” strains of the virus. An Iomai news release said the additional funding is the estimated amount needed to bring the combination of vaccine and dose-sparing patch to licensure. If the H5N1 avian flu virus evolves into a pandemic strain, vaccines are expected to be in extremely short supply. HHS is stockpiling H5N1 vaccines, but in November the stockpile amounted to enough for only about 3 million people. And no one knows how effective the vaccines will be against an emerging pandemic strain. Hence HHS is funding efforts to make vaccine supplies stretch further and to produce vaccines faster than with the conventional method of growing them in chicken eggs. Jul 26, 2006, CIDRAP News story “Glaxo says its H5N1 vaccine works at low dose”last_img read more

GAA NEWS: RED HUGHS CLUB NOTES

first_imgLotto & 100+ ClubThere was no winning sequence in this weeks Lotto but the winner of the lucky dip was Geraldine Gallinagh, Railway Avenue who wins €30. Next weeks Lotto jackpot is €1,650. Thanks to all for their continued support of the weekly Lotto. The Lotto sellers in the coming weeks are: 9th February – Liam Kelly, 16th February – Paul Bradley, 23rd February – Kieran Bradley and 2nd March – Joe Sweeney. The winners of the players draw in the last two weeks were Michael Sweeney and Ryan Kelly. €4 to be paid every week at training for entry to the draw.MembershipThanks to all who helped out at the registration night on Wednesday night last. All those who have not registered should do so as soon as possible. Adult membership costs €30 per person with a concession rate of €50 for couples (an adult and their partner/husband/wife). Underage registration costs €10 per child or a maximum of €20 for a family. New members are very welcome to join the club. Sam Maguire VisitA big thank you to county star Eamon McGee and all the Red Hughs players and club officials for all their help last week with the visit of Sam Maguire and The Anglo Celt to the parish. Thanks for the fantastic welcomes in Gleneely, Killygordon and Dromore schools, at the Cake Wednesday Club and the Playschools.Senior Ladies Team ManagerCongratulations to Michael Shiels who has been appointed as the new senior ladies manager for 2013. Best of luck to him in the year ahead. Thanks from the club to outgoing manager Gerard McColgan for all his work with this team in the last few years.Minor BoardThere is still a coaching vacancy remaining for the U16 Girls team. Anyone interested in coaching this team should contact Stephen Gallagher on (087) 2054484.The special coaching workshop will now go ahead on Tuesday 12th February from 8.00pm to 9.30pm at the clubhouse. This is on the topic ‘Getting Fit For Sport’. This years minor panel are asked to attend along with all underage coaches. Anyone else who wishes to attend contact Stephen Gallagher on (087) 2054484. Spaces are limited to 40 persons. All parents and guardians should be aware that a new rule came has come into force from GAA headquarters making it mandatory to use a mouth guard in all matches and training sessions from the beginning of 2013. This is for all underage grades up to and including minor. It should be noted that players will not be allowed to play without mouth guards so it is now an essential part of a players kit.Night at the RacesThe club will be holding a ‘Night at the Races’ on Saturday the 23rd February in Brownes.Zumba Zumba classes now take place at the clubhouse on Monday mornings at 10.00am and Wednesdays at 7.00pm. Price of class is €5 per person. All are welcome.Clubhouse Open for ActivitiesThe upstairs room in the clubhouse is currently available for use for classes/activities. Times are flexible and reasonable rates apply. Anyone interested in using these facilities should contact Andy Doherty on (087) 6843311 for more details.SympathySincere sympathy is extended to the McConnell family, Monellan on the recent sad passing of Vincent McConnell. Vincent was a great supporter of the club down through the years.GAA NEWS: RED HUGHS CLUB NOTES was last modified: February 4th, 2013 by StephenShare this:Click to share on Facebook (Opens in new window)Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Reddit (Opens in new window)Click to share on Pocket (Opens in new window)Click to share on Telegram (Opens in new window)Click to share on WhatsApp (Opens in new window)Click to share on Skype (Opens in new window)Click to print (Opens in new window)Tags:RED HUGHS CLUB NOTESlast_img read more