Pathfinder
Editor, Senior Moderator
FDA chief defends H1N1 vaccine supply
Thu Nov 12, 2009 6:11pm EST
<SCRIPT language=javascript>addImpression("3098077_Article Tools");</SCRIPT><SCRIPT type=text/javascript>var showComments = false;var allowSLCall = false; function singlePageView() { document.location.href = ReplaceQueryStringParam(document.location.href, "sp", "true"); } function replaceString(oldS, newS, fullS) { // Replaces oldS with newS in the string fullS for (var i = 0; i < fullS.length; i++) { if (fullS.substring(i, i + oldS.length) == oldS) { fullS = fullS.substring(0, i) + newS + fullS.substring(i + oldS.length, fullS.length); } } return fullS; } </SCRIPT>
By Susan Heavey
NEW YORK (Reuters) - The head of the U.S. Food and Drug Administration defended the agency's decision not to use an additive that could have stretched swine flu vaccine supplies, adding that doses should be coming more regularly.
The vaccine to prevent the H1N1 strain of influenza has been in short supply following production issues but more doses are becoming available, FDA Commissioner Margaret Hamburg said on Thursday at the Reuters Health Summit in New York.
"The gap between need and availability is narrowing. I think we are going to see doses coming off the lines and into people's arms or noses on a regular basis now," Hamburg said.
U.S. health officials have been scrambling to get the swine flu vaccine to market after the virus emerged too late to be included in this year's regular seasonal flu version. Initially, officials said there would be enough for everyone, but the public quickly grew frustrated when supplies ran short.
The FDA has approved H1N1 vaccine from five makers who already produce seasonal flu vaccine -- GlaxoSmithKline Plc, AstraZeneca Plc's MedImmune unit, Novartis, Sanofi-Aventis, and CSL Limited.
Both products use an egg-based technology to produce the vaccine, but the H1N1 virus grew slower than expected in the eggs, Hamburg said. She added the agency is working with manufacturers to move toward other, more efficient technology such as cell-based cultures that could spur production.
Hamburg said it was not too late for people to benefit from immunization.
Some experts have suggested the government could have increased supplies by embracing adjuvant vaccine technology that is widely used in Europe.
Adjuvanted vaccines contain an additive to boost the immune system response and need less of the active ingredient than the unadjuvanted types approved by the FDA.
But Hamburg said they have not been widely tested and that the agency did not want to risk using them when standard vaccines worked well with a single dose.
"Had the shape of epidemic or the characteristics of the virus and the disease required it, we would have moved toward an adjuvanted approach," she said.
"Europe took a little bit more of a risk. Yes, there was experience with an adjuvanted vaccine but it was really only used in the elderly and there wasn't experience with that vaccine in other populations, including pregnant women and children."
Still, people remain wary of vaccine supplies and the public outcry has prompted the White House to look into the issue. It is still somewhat unclear when enough vaccine will become available to patients to meet demand.
Earlier on Thursday, Centers for Disease Control and Prevention officials said they had expected 8 million H1N1 vaccine doses this week but that they are unsure how many they will get.
Hamburg, who took office in May, said that while the government may have over-promised on the availability of the vaccine earlier this year, lessons had been learned.
"We are also going to be better-prepared the next time around," she said.
As for her own family, Hamburg said it was surprisingly easy to get her own children vaccinated.
"I just called my pediatrician's office ... and they said 'We have it. just come in,'" she said. "I just walked in on a Saturday morning with my kids, and they got it. No wait. No complications."
(Reporting by Susan Heavey with additional reporting by Ben Hirschler; editing by Tim Dobbyn and Matthew Lewis)
http://www.reuters.com/article/domesticNews/idUSTRE5AB57420091112?sp=true
Thu Nov 12, 2009 6:11pm EST
<SCRIPT language=javascript>addImpression("3098077_Article Tools");</SCRIPT><SCRIPT type=text/javascript>var showComments = false;var allowSLCall = false; function singlePageView() { document.location.href = ReplaceQueryStringParam(document.location.href, "sp", "true"); } function replaceString(oldS, newS, fullS) { // Replaces oldS with newS in the string fullS for (var i = 0; i < fullS.length; i++) { if (fullS.substring(i, i + oldS.length) == oldS) { fullS = fullS.substring(0, i) + newS + fullS.substring(i + oldS.length, fullS.length); } } return fullS; } </SCRIPT>
By Susan Heavey
NEW YORK (Reuters) - The head of the U.S. Food and Drug Administration defended the agency's decision not to use an additive that could have stretched swine flu vaccine supplies, adding that doses should be coming more regularly.
The vaccine to prevent the H1N1 strain of influenza has been in short supply following production issues but more doses are becoming available, FDA Commissioner Margaret Hamburg said on Thursday at the Reuters Health Summit in New York.
"The gap between need and availability is narrowing. I think we are going to see doses coming off the lines and into people's arms or noses on a regular basis now," Hamburg said.
U.S. health officials have been scrambling to get the swine flu vaccine to market after the virus emerged too late to be included in this year's regular seasonal flu version. Initially, officials said there would be enough for everyone, but the public quickly grew frustrated when supplies ran short.
The FDA has approved H1N1 vaccine from five makers who already produce seasonal flu vaccine -- GlaxoSmithKline Plc, AstraZeneca Plc's MedImmune unit, Novartis, Sanofi-Aventis, and CSL Limited.
Both products use an egg-based technology to produce the vaccine, but the H1N1 virus grew slower than expected in the eggs, Hamburg said. She added the agency is working with manufacturers to move toward other, more efficient technology such as cell-based cultures that could spur production.
Hamburg said it was not too late for people to benefit from immunization.
Some experts have suggested the government could have increased supplies by embracing adjuvant vaccine technology that is widely used in Europe.
Adjuvanted vaccines contain an additive to boost the immune system response and need less of the active ingredient than the unadjuvanted types approved by the FDA.
But Hamburg said they have not been widely tested and that the agency did not want to risk using them when standard vaccines worked well with a single dose.
"Had the shape of epidemic or the characteristics of the virus and the disease required it, we would have moved toward an adjuvanted approach," she said.
"Europe took a little bit more of a risk. Yes, there was experience with an adjuvanted vaccine but it was really only used in the elderly and there wasn't experience with that vaccine in other populations, including pregnant women and children."
Still, people remain wary of vaccine supplies and the public outcry has prompted the White House to look into the issue. It is still somewhat unclear when enough vaccine will become available to patients to meet demand.
Earlier on Thursday, Centers for Disease Control and Prevention officials said they had expected 8 million H1N1 vaccine doses this week but that they are unsure how many they will get.
Hamburg, who took office in May, said that while the government may have over-promised on the availability of the vaccine earlier this year, lessons had been learned.
"We are also going to be better-prepared the next time around," she said.
As for her own family, Hamburg said it was surprisingly easy to get her own children vaccinated.
"I just called my pediatrician's office ... and they said 'We have it. just come in,'" she said. "I just walked in on a Saturday morning with my kids, and they got it. No wait. No complications."
(Reporting by Susan Heavey with additional reporting by Ben Hirschler; editing by Tim Dobbyn and Matthew Lewis)
http://www.reuters.com/article/domesticNews/idUSTRE5AB57420091112?sp=true