May 17, 2007 (CIDRAP News) – A US Food and Drug Administration (FDA) advisory panel unanimously agreed Wednesday that FluMist, a nasal spray vaccine against seasonal flu, is safe and effective in children 2 years of age and older.The live-virus vaccine, which is manufactured by Gaithersburg, Maryland–based MedImmune, is already FDA-approved for 5- to 49-year-olds. The company has filed a supplemental biologics licensing application (sBLA) to expand its use to children younger than 5.In a 15-0 decision, the panel of outside experts supported the vaccine’s use for children 2 and older who do not have a history of wheezing. The FDA, which is expected to make a decision by the end of May, is not required to follow the panel’s recommendations.”The question remaining is how the FDA ultimately will rule on children under 2,” said MedImmune’s Chief Medical Officer Dr. Edward Connor, according to an Associated Press report.The panel voted 9-6 for the vaccine’s safety and benefits for children between 12 to 59 months without wheezing history and 12-3 against using the nasal spray in children between 6 to 23 months, according to a MedImmune press release.”The vote did demonstrate that there is a safety concern among a significant minority of the advisory committee,” Florence Houn, FDA deputy director of the office handling MedImmune’s application, told the Washington Post. “We do have to be careful about this respiratory adverse event profile and make sure we understand it.”A recent international study published in the New England Journal of Medicine showed children between 6 and 11 months who received FluMist had more hospitalizations and slightly more wheezing than those who got the standard vaccine, CIDRAP News reported in February. However, the same study, which was conducted in the 2004-2005 flu season, revealed 55% fewer cases of flu in the children who received the FluMist.CIDRAP Medical Director Kristine Moore, MD, MPH, said the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices recommends vaccination for children between 6 and 59 months because they have an increased risk for influenza-related hospitalizations and emergency room visits. Having a vaccine that is not a shot could enhance vaccination rates, Moore said.”It’s more tolerable to younger children,” she noted. “If FluMist is approved for this age-group, it would probably improve compliance to the CDC recommendation.”Currently only injectable inactivated vaccines are available for this group.FluMist vaccine has been on the market since 2003. It is effective against influenza A and B viruses; side-effects of the vaccine based on results from placebo-controlled clinical trials have included runny nose, sore throat, cough, headache, and chills.In January, the FDA also approved a refrigerated formulation of FluMist (previous formulations had to be frozen), which will be available for the 2007-2008 flu season, according to MedImmune.British company AstraZeneca is scheduled to acquire MedImmune in June in a $15.6 billion sale.See also:MedImmune Press ReleaseFeb 16, 2007, CIDRAP News story “Large study supports FluMist use in toddlers”2007 New England Journal of Medicine article [Abstract]
Former Asante Kotoko midfielder Emmanuel Agyemang has debunked rumors in the media claiming he had belittled Hearts fine start to the season by saying they are enjoying ‘cheap’ matches as compared to Kotoko.In a chat with Asempa FM, the box to box midfielder categorically denied all claims stating he only felt Hearts had not met title contenders.“I said Hearts are playing teams that are not contenders of the league not ‘cheap’ teams”.“Apart from Medeama, which side will you say is difficult opponent for Hearts? All the teams that have played Hearts are not title contenders,” Badu said.“Even when you take into consideration the fact that Medeama have been a strong opponent for Kotoko in Kumasi of late, then you will know that Kotoko’s opponents have been stronger than Hearts.”Hearts and Kotoko clash in matchday of the Ghana Premier League. –Follow Joy Sports on Twitter: @JoySportsGH. Our hashtag is #JoySports
– Fire Chief advises safe use of electricityWith a 17 per cent rise in electrical fires documented, the Guyana Fire Service (GFS) is advising safer use ofFire Chief Marlon Gentleelectricity, according to the Government Information Agency (GINA).GINA quoted Chief Fire Officer Marlon Gentle as saying that 135 external electrical fires have been reported this year compared to 115 for the same period last year.He asserted that most of these fires are observed to be stirring within the newly established villages, including Diamond (East Bank Demerara), Parfait Harmonie (West Bank Demerara) and Cummings Lodge (East Coast Demerara).“We’re still at the stage where persons are using drop cords or two or three households sharing the same power which is somewhat illegal also,” Gentle highlighted.The Fire Chief noted that electrical fires not only cause destruction to buildings but can result in the loss of lives through electrocution, thus emphasis is being placed on the need to use electricity safely.“If you need to use electricity, use it correctly, use it properly. Have a hired certified electrician to do your electrical installations,” Gentle advised.Though there has been an increase in electrical fires, the GFS reported a six per cent reduction in malevolent locations of fires and a 10 per cent decline in buildings being affected by fires.However, documentation shows an increase of “fire calls” totalling 1405 for the year but according to the Fire Service, this was due to the “dry spell” period endured by Guyana recently, where grass fires and bush fires erupted at various locations in the country.Additionally, there has also been an increase in “crank calls” to the Fire Service where Gentle explained the difficulty in detaining these callers because of the use of mobile phones. Nevertheless, it was stressed that falsely reporting a fire is a criminal offence.
WASHINGTON — President Donald Trump questioned Thursday why the U.S. should permit more immigrants from “shithole countries” after senators discussed revamping rules affecting entrants from Africa and Haiti, according to three people briefed on the conversation.Trump made the remark in the Oval Office as two lawmakers described details to him of a bipartisan compromise among six senators that would extend protections against deportation for hundreds of thousands of young immigrants and strengthen border protections.The senators had hoped Trump would back their accord, ending a months-long, bitter dispute over protecting “Dreamers.” But the White House later rejected their proposed agreement, plunging the issue back into uncertainty just eight days before a deadline that threatens a government shutdown.During their conversation, Dick Durbin of Illinois, the chamber’s No. 2 Senate Democratic leader, was explaining that as part of that deal, a lottery for visas that has benefited people from Africa and other nations would be ended, the sources said, though there could be some other way for them to apply. Durbin said people would be allowed to stay in the U.S. who fled here after disasters hit their homes in places including El Salvador, Guatemala and Haiti.Trump specifically questioned why the U.S. would want to admit more people from Haiti. He also mentioned Africa and asked why more people from “shithole countries” should be allowed into the U.S., the sources said.