WHO experts favor single-dose H1N1 vaccine regimen

first_imgOct 30, 2009 (CIDRAP News) – An expert committee that advises the World Health Organization (WHO) today updated its guidance on pandemic H1N1 vaccines, recommending a single dose for most age-groups and advising that any of the forms are safe for pregnant women.At a media briefing today, Dr Marie-Paule Kieny, director of the agency’s Initiative for Vaccine Research, said this week’s 3-day meeting of the Strategic Advisory Group of Experts (SAGE) on immunizations marked the group’s first discussion of the pandemic H1N1 vaccine since mid July, when it took up the vaccine priority question and addressed concerns about low yields with the first vaccine seed strains.”The level of evidence in October is much higher than July, and the recommendations are much more precise than July,” she said.After examining clinical trial data for all versions of the vaccine, the group recommended a single dose for everyone aged 10 and older, as long as such use in line with national regulatory authorities. Though the group said immunogenicity data are more limited for young children, it also recommended that countries that have children as a high-priority group administer one dose so that as many children can be vaccinated as possible.The United States has prioritized children to receive the pandemic vaccine has recommended that those under age 10 receive two doses. Also, Europe’s drug regulatory agency on Sep 23 announced it would stick to its initial recommendation that the three vaccines it approved be given in two doses, because data were insufficient to merit a one-dose recommendation. However, it added that one dose may be enough in adults.At a separate press briefing today, reporters asked Thomas Frieden, MD, director of the US Centers for Disease Control and Prevention (CDC), about the difference between the SAGE recommendation and the CDC’s guidance. He said preliminary vaccine data on children have not shown the desired immune response in children that would warrant a single-dose recommendation. Though the CDC is anticipating new data soon from the National Institutes of Health, “for the time being, we’re sticking with what the ACIP [Advisory Committee on Immunization Practices] has recommended,” Frieden said.Kieny said the WHO group advised that more studies are needed to guide a recommended vaccine dose for immunocompromised patients.Fourteen countries have now launched pandemic H1N1 vaccination programs, she said. In its review of early vaccine monitoring data for the pandemic, SAGE found no indication of unusual reactions, and it found that the events reported so far are well within the range of those seen with seasonal flu vaccines.Given concerns about vaccinating pregnant women, the WHO panel looked at animal studies of all forms of the vaccine and found no evidence of direct or indirect harm to fertility, pregnancy, embryonic or fetal development, birthing, or postnatal development. Given the high risk of flu complications in pregnant women, the group said any licensed vaccine can be used in pregnant women, unless specific contraindications have been outlined by national regulatory bodies.The United States is among countries where authorities have recommended that pregnant women not receive the intranasal, live attenuated H1N1 vaccine (LAIV). Public health officials were in a difficult position when the first pandemic vaccine doses were delivered, because nearly all of them were the LAIV version, though pregnant women are at the front of the line to be vaccinated. However, US officials have recently said the injectable version that pregnant women and other high-risk groups can receive makes up half of the increasing supply.The group also took up the issue of whether seasonal and pandemic H1N1 vaccines can be given at the same time. In a statement today, the WHO panel said clinical trials on coadministration of the vaccines are ongoing, but it endorsed the CDC recommendation that the intranasal versions of the seasonal and pandemic vaccines should not be given together. The group said the seasonal and pandemic vaccines can be given at the same time provided both are inactivated (injectable) or one is inactivated and the other is LAIV.Regarding options for the Southern Hemisphere’s 2009-2010 seasonal flu vaccine, SAGE weighed whether a trivalent vaccine (pandemic H1N1 plus seasonal H3N2 and B) or a bivalent vaccine (seasonal H3N2 and B) plus a separate pandemic H1N1 vaccine would be best. They concluded that both formulation options should be available, depending on national needs.See also:Oct 30 WHO statement on SAGE recommendationshttp://www.who.int/csr/disease/swineflu/notes/briefing_20091030/en/index.htmllast_img read more

Tribunal throws out Thika’s play/off petition

first_img0Shares0000Thika United head coach Nicholas Muyoti watches on the touchline during his side’s Kenyan Premier League clash against Gor Mahia at the Thika Sub-County Stadium on September 17, 2017. PHOTO/Raymond MakhayaNAIROBI, Kenya, Dec 20- Thika United will after all take part in the promotion and relegation play/off against National Super League side Ushuru FC after the Sports Disputes Tribunal threw out their petition challenging the game.The ruling, delivered on Tuesday evening by chair John Ohaga further directed Thika United to bear all the costs for the petition, punching a huge financial blow to the Kenyan Premier League side and its ambition to avoid the play-off. “In view of the conduct of the petitioner, we direct that it meets the costs of the respondents and the interested party on a full indemnity basis. It shall also be responsible for any wasted costs occasioned by the postponement of the play-offs,” Ohaga’s ruling read.Thika had earlier obtained temporary orders stopping the play off initially det for December 10 and 13, but the same have since been vacated.The tribunal was visibly irked with Thika’s lack of legal backing when they argued that the play-off was illegitimate as they were informed of it after the season had ended, but the tribunal dismissed this claim as Football Kenya Federation had written a letter to KPL in March, before the season started.“We remind not only the petitioners but all parties who approach this tribunal that the duty of a litigant is to make a full and fair disclosure of the material facts. In the present case it is our view that the non-disclosure was not innocent at all but deliberate and such conduct cannot be countenanced by this tribunal,” Ohaga’s ruling further noted.The tribunal was displeased with the fact that Thika did not support their claims that the promotion and relegation rules were changed at the end of the season.“The tribunal during the inter-parte hearing ceded to the fact that they were aware of the letters dated 20th March and 6th June 2017 that communicated the changes. As a matter of fact, they had a representative during the pre-match meetings and had been a party to the whole process,” the tribunal further said.Thika United players hurdle together to celebrate a goal scored against Mathare United at the Thika Sub County Stadium on March 12, 2017. PHOTO/Timothy OlobuluOhaga’s team admitted that they might have been misled in issuing the temporary orders barring the play-off by concealment of material facts.Also, the tribunal was astounded by the fact that Thika United sent a representative, George Maina to a play-off meeting at FKF’s Goal Porject offices on November 29 where there was a coin toss to determine who starts home and who starts away.Further, Maina wrote a letter to the league managers involving them of the results of the coin toss and further asked whether they could act on their behalf to petition FKF to move the play-ff dates due to the closure of their Thika Stadium home ground.The tribunal was hence astounded as to why, days later, Thika would go on and file a petition seeking to stop the play-off.Also, the tribunal further noted that the communication on the play off was done to all parties and in time and argued that if anyone was against it, then they would have taken immediate action and not wait for almost a month to make their move.KPL’s Governing Council early last month said they would be okay with Thika taking part in the play-off, with a source at the league body intimating to Capital Sport they would have no legal ground to object to it.FKF is now set to pick out a new date.0Shares0000(Visited 1 times, 1 visits today)last_img read more