October 2009

By Maggie Fox, Health and Science Editor

WASHINGTON (Reuters) – Fear of adverse events such as miscarriages, rare neurological conditions and ordinary heart attacks will discourage some people from participating in mass vaccination efforts to fight swine flu, but public health experts said on Friday they could fight back with statistics.

Vaccination against pandemic H1N1 is underway in the United States, Britain, Canada and China and will start in other countries soon. And many people will associate bad events with the vaccine, said Dr. Steven Black of Cincinnati Children’s Hospital in Ohio and colleagues.

“Highly visible health conditions, such as Guillain-Barre syndrome, spontaneous abortion or even death will occur in coincident temporal association with novel influenza vaccination,” they wrote in the Lancet medical journal.

So they calculated what might be expected anyway, even if there were no vaccination campaign.

“On the basis of the reviewed data, if a cohort of 10 million individuals was vaccinated in the UK, 21.5 cases of Guillain-Barre syndrome and 5.75 cases of sudden death would be expected to occur within 6 weeks of vaccination,” they wrote.

For every 1 million pregnant women vaccinated, 397 will have a miscarriage, known medically as a spontaneous abortion, within a day — all unrelated to the vaccine, they said.

“If millions of people are vaccinated then just by chance we can expect bad things to happen to some of them, whether it’s a diagnosis of autism or a miscarriage,” commented David Spiegelhalter, a specialist in risk understanding at Britain’s University of Cambridge.

“By being ready with the expected numbers of chance cases, perhaps we can avoid over-reaction to sad, but coincidental, events. And why don’t we ever see a headline ‘Man wins lottery after flu jab’?”

Global health officials have set up various systems for monitoring such adverse events to make sure the vaccine is not causing any particular health problems.

But they know many people will blame miscarriages or other health disasters on the vaccine.

“Widespread beliefs that such false associations are true can and do disrupt immunization programs, often to the detriment of public health,” Black’s team noted.

“For example,” they wrote, “when an association between the measles, mumps, and rubella (MMR) vaccine and risk of autism was made, it had a negative effect on public uptake of measles prevention programs in the UK and elsewhere, with a consequent rise in morbidity (sickness) and mortality due to measles.”

Fears about polio vaccines have disrupted efforts to eradicate the paralyzing virus in Nigeria, they added.

People have special fears about Guillain Barre Syndrome (GBS). a rare neurological condition that was linked to a 1976 U.S. swine flu vaccination campaign. Although no case of GBS was ever linked to the vaccine, a belief that the vaccine was worse than the illness remains widespread.

At any given time in the United States, one or two cases of GBS will be seen among any 1 million people in a given month.

If 100 million people are vaccinated, during the six weeks following 200 or more cases of GBS will be seen, completely independent of vaccination they said.

Only if this number goes over 200 should health officials start to be alarmed, they said.

(Editing by Todd Eastham)

© Thomson Reuters 2009 All rights reserved

By Ross Colvin

WASHINGTON (Reuters) – A quarrel between the U.S. government and swine flu vaccine makers reached the highest level on Friday, with President Barack Obama expressing frustration at the slow pace of production.

Federal officials have slashed their initial estimates of how much H1N1 vaccine would be available — from 40 million doses by the end of October to 26 million doses available as of Friday.

Originally the Health and Human Services Department had predicted 20 million doses would roll out every week, but just 10 million have been produced in the past seven days.

HHS secretary Kathleen Sebelius has said she relied on estimates from the five contracted vaccine makers for the U.S. market — MedImmune, a unit of AstraZeneca, Sanofi-Aventis, Australia’s CSL, GlaxoSmithKline and Novartis.

“I think we certainly had hoped that their predictions on this would be correct,” White House spokesman Robert Gibbs said on Friday.

“I think it’s accurate to say the president has been and is frustrated with ensuring that this vaccine is delivered on time and won’t be satisfied until those that want to be vaccinated from H1N1 have the opportunity through the vaccine to do so,” Gibbs told reporters in a briefing.

Two senators — Susan Collins and Joseph Lieberman — have asked Sebelius to explain why the projections were so far off.

The vaccine makers say it has been harder than anticipated to make the vaccine using the current 50-year-old technology based on chicken eggs. Despite the difficulties, doses have been rolled out in less than six months — quicker than is usual for seasonal influenza vaccine.

“Not only did we complete our commitment to provide seasonal vaccine ahead of schedule, we are making every effort to make as much H1N1 vaccine available as quickly as possible,” Novartis vaccines chief Andrin Oswald said in a statement on Thursday.

(Editing by Xavier Briand)

© Thomson Reuters 2009 All rights reserved

By Jonathan Lynn

GENEVA (Reuters) – Only one dose of vaccine is needed for protection against pandemic H1N1 flu and the jabs have so far proved to be safe, the World Health Organisation said on Friday, citing immunization experts.

Health experts have been debating whether one or two shots are necessary to protect against H1N1, known as swine flu. The number of doses required is key to estimating how many vaccines are needed in total.

The U.N. health agency has repeatedly sought to reassure people around the world that the H1N1 vaccines being made by 25 different companies — with various formulations — are all safe.

Earlier this week, its Strategic Advisory Group of Experts on Immunisation (SAGE) examined vaccines for H1N1, which tends to affect teenagers and young adults most.

“The experts reviewed early results from the monitoring of people who have received pandemic vaccines and found no indication of unusual adverse reactions,” the Geneva-based WHO said in a statement.

“Some adverse events following vaccination have been notified, but these are well within the range of those seen with seasonal vaccines, which have an excellent safety profile.”

The experts said health officials should continue to monitor H1N1 vaccine programs for adverse events — the technical term for severe complications such as illness or death.

The SAGE committee recommended that a single dose of H1N1 vaccine should be used for adults and adolescents from age 10.

It said more studies were needed on the effectiveness of vaccines in children aged up to 10 years. Where national health authorities have made children a priority for vaccination, they should aim to vaccinate as many children as possible with a single dose, the group concluded.

The recommendation corresponds to WHO’s estimate earlier this month that one dose suffices. Last week Europe’s drug watchdog said two doses would be preferable.

In its statement, the WHO said 1 to 10 percent of patients who developed a serious illness needed hospital treatment. Of those, 10 to 25 percent needed treatment in an intensive care unit and 2 to 9 percent died.

Very young children are most likely to require hospital treatment for the H1N1 virus.

In most cases, the WHO said is safe to administer vaccines for H1N1 and regular seasonal flu together.

(For full WHO statement go to link.reuters.com/buw76f )

(Editing by Erik Kirschbaum)

© Thomson Reuters 2009 All rights reserved

By John Whitesides and Donna Smith

WASHINGTON (Reuters) – Democrats in the U.S. House of Representatives finished work on Wednesday on a healthcare bill that includes a government-run insurance plan, requires individuals to buy health coverage and imposes a surtax on the wealthy to help pay for it.

The measure, the product of weeks of closed-door talks to merge three pending health bills, will be unveiled by party leaders on Thursday and submitted to the full House for debate as early as next week.

The bill includes a government-run “public” insurance option that uses reimbursement rates negotiated with healthcare providers, Democrats said, a setback for House liberals led by Speaker Nancy Pelosi who favored a more “robust” version to compete with private insurers.

Pelosi failed to gain the 218 votes needed to pass a version of the government-run plan using lower rates pegged to Medicare, the health plan for the elderly.

The healthcare measure being prepared for debate in the Senate also includes a public insurance option based on negotiated reimbursement rates but, unlike the House bill, it would allow states to decline to participate.

The House’s version of a sweeping healthcare overhaul, President Barack Obama’s top domestic priority, would require individuals to buy insurance and all but the smallest employers to offer health coverage to workers, Democrats said.

It would offer subsidies to help the uninsured buy insurance through newly created exchanges and would expand eligibility for the Medicaid program to those with incomes up to 150 percent of the poverty level.

The House bill includes a 5.4 percent surtax on individuals making more than $500,000 and couples earning more than $1 million, which an aide said would bring in about $460 billion over 10 years to help pay for covering the uninsured.

NO CADILLAC TAX

The House bill does not include a tax on high-cost “Cadillac” insurance plans that is included in the Senate bill. House Democrats have strongly opposed that approach, which has drawn criticism from labor unions that fear it will hurt too many middle-income workers.

Obama has sought a health bill that reins in costs, regulates insurers and expands coverage to millions of the uninsured. The House bill includes restrictions to keep insurers from declining to cover those with pre-existing conditions or dropping the sick.

Democrats who attended a meeting with Pelosi said they were told congressional budget analysts had estimated the bill would cost less than Obama’s target of $900 billion.

The House bill includes about $20 billion in fees over 10 years for medical device manufacturers, an aide said.

It will phase in penalties for businesses that fail to provide insurance, starting at 2 percent for firms with a payroll of $500,000 and ending at 8 percent for businesses with a payroll of $750,000 or more, the aide said.

The battle over a government-run insurance plan has become a flashpoint in the debate over the healthcare overhaul. Obama and liberals believe the option would create more choice for consumers.

Critics say the public option, which would compete with private plans on state-based exchanges where individuals could shop for insurance, would lead to a government takeover of the sector.

The House bill still faces a potential uprising by liberals who had pushed hard for a public option tied to Medicare rates. Rural Democrats had opposed that approach, fearing it would hurt small hospitals.

“We think we’ll have the votes,” for the negotiated rates, said George Miller, chairman of the House Education and Labor Committee.

Democratic leaders also face possible opposition from a group of about 40 House Democrats who want to strengthen the bill’s language to ensure no federal funds would be used for abortions.

Democratic Representative Marion Berry of Arkansas said he was undecided if he would support the measure because he was concerned about how it would be paid for and he wanted to see more money taken from the drugmakers and insurance industry.

“If they aren’t squealing to the high heavens, we haven’t hit them hard enough,” he told reporters.

(Editing by Eric Walsh)

© Thomson Reuters 2009 All rights reserved

By Maggie Fox, Health and Science Editor

WASHINGTON (Reuters) – When pregnant women get vaccinated against flu, their babies are bigger, healthier and less likely to be premature, researchers reported on Thursday.

The studies show that influenza vaccines protect not only women, who are extremely vulnerable to flu when pregnant, but also their babies before and after birth, the researchers said.

They hope their findings, presented at a meeting in Philadelphia of the Infectious Diseases Society of America, will encourage women to get vaccinated and encourage their doctors to offer the shots.

“We are talking about one vaccine protecting two individuals,” Dr. Marietta Vazquez of Yale University in Connecticut told a news conference. “Maybe if they are not getting vaccinated for themselves, they will do it for their babies.”

Pregnant women are at special peril from flu in any year. Their immune systems are suppressed to keep the body from rejecting the fetus, and the growing baby presses on their lungs.

The U.S. Centers for Disease Control and Prevention has for years recommended that pregnant women be vaccinated against seasonal flu.

This year, with the H1N1 swine flu pandemic, pregnant women are at the front of the line. The CDC says more than 1,000 Americans have died of swine flu, and figures show that 6 percent of deaths have been among pregnant women.

But only 15 percent to 25 percent are ever vaccinated, and babies under the age of 6 months are too young to get a flu vaccine.

“Obstetricians do not offer influenza vaccine. They should know about this recommendation,” Vazquez said.

‘85 PERCENT EFFECTIVE’

She and colleagues studied some 350 pregnant women starting in 2000 — 157 who got flu and 195 who did not.

“Flu vaccine given to women during pregnancy is 85 percent effective in preventing hospitalization in their infants under 6 months of age,” the team wrote in a statement.

Dr. Mark Steinhoff of Cincinnati Children’s Hospital in Ohio and colleagues studied pregnant women in Bangladesh, who were randomly assigned to get influenza or pneumococcal vaccines.

The newborns of women who got flu vaccine were 63 percent less likely to be infected, Steinhoff told the news conference. And the babies born to vaccinated mothers weighed, on average, half a pound (215 gm) more, he said.

“When you prevent flu in a pregnant woman, you benefit the mother, you benefit the infant, and it is also shown that you benefit the fetus,” Steinhoff said.

The team also found 25 percent of the infants were infected with flu during the first six months of life.

Dr. Saad Omer of Emory University in Atlanta and colleagues looked at 6,410 births between June of 2004 and September of 2006, checking to see how many babies were premature or small for gestational age.

When flu was the most widespread, vaccinated moms had an 80 percent lower risk than unvaccinated mothers of having a premature baby, Omer said. The risk of having a baby that was small for gestational age was 70 percent lower for vaccinated mothers.

There was little effect outside flu season, he said.

It is likely that many of the pregnant women had flu infections that they did not report or notice, but this would have affected the baby, Omer said.

“A mild flu infection probably reduces the amount of nutrition that goes through the placenta,” Steinhoff said.

(Editing by Xavier Briand)

© Thomson Reuters 2009 All rights reserved

By Kate Kelland

LONDON (Reuters) – More than 5,500 children across Africa have been given an experimental new malaria vaccine and the British drugmaker behind it, GlaxoSmithKline, promised on Wednesday that price would be no hurdle if it works.

The vaccine, called Mosquirix and the first malaria shot to make it to final-stage trials, is creating a buzz ahead of a conference of 1,500 malaria experts in Nairobi next week.

And while the world will have to wait a little longer for the trial’s results, Glaxo Chief Executive Andrew Witty said his company was committed to being reasonable on price.

“We are not going to let price get in the way of access for malaria vaccines,” he told reporters on Wednesday. “We will be extremely responsible about the way we price this vaccine.”

Christian Loucq, president of the non-profit PATH Malaria Vaccine Initiative, said international and African health experts hope Mosquirix, also known as RTS,S, would prove a winner in bringing the elusive goal of eradicating the killer disease within sight.

“Malaria is such a huge problem in Africa, and a vaccine is perceived as such a strong intervention, that when we talk about a potential vaccine candidate the cry is always ‘when will it come?’” he said in an interview in London before the Nairobi conference, which runs from November 1 to November 6.

“Among public health specialists and vaccinologists in Africa, this is seen as the major upcoming intervention — and that is creating great excitement.”

Malaria kills almost a million people each year and around 40 percent of the world’s population is at risk of the disease, mainly in world’s poorest countries. Health experts stress that there are no “magic bullets” against the disease.

They also estimate that $4.2 billion will be needed each year to fully fund the fight against it.

The large-scale efficacy and safety trials of Mosquirix began in May [ID:nL053242] and it has now been given to between 5,000 and 6,000 children in seven African countries including Tanzania, Kenya, Malawi, Mozambique and Gabon.

The trial, the largest ever on the African continent, will eventually involve 16,000 children and yield initial data after 12 months and final results after 30 months.

Data from earlier trials of Mosquirix suggest it is 50 to 55 percent effective — but since it is likely to be another three to five years before it is licensed and put into use if it does prove to work, malaria experts stress that eradicating the disease will mean fighting on many fronts.

Insecticides to spray bednets and houses to deter mosquitoes, and finding new and funding existing drugs to treat infected people are essential elements of the battle, as are keeping up funding for research into possible vaccines and newer, more effective drugs.

“We must not repeat the mistakes of previous elimination and eradication campaigns, when people forgot about investing in continuous research,” Loucq said.

“If we are really serious about this goal, the investment in the tools of today is critical. But we need to have the tools of today and the tools of tomorrow — which we will need when today’s tools lose their efficacy.”

Glaxo’s Witty said he favoured structures like the Advance Market Commitment programme devised by international donors, which creates a financial incentive with a guaranteed price for drugmakers to deliver vaccines to poorer countries.

© Thomson Reuters 2009 All rights reserved

By Brendan Borrell

NEW YORK (Reuters Health) – These are heady days for the medical tourism industry. With U.S. healthcare prices spiraling upward, more and more insurers and individuals are looking abroad for treatment. By some estimates, 650,000 Americans will check into foreign hospitals from Mexico to Thailand this year.

The boom has created rich opportunities for entrepreneurs catering to first-time medical travelers, start-up businesses and eager hospital managers in developing countries.

Enter lawyer couple Jonathan Edelheit and Renée-Marie Stephano.

Edelheit and Stephano, both 37, are the founders of the Medical Tourism Association (MTA), a non-profit association they created to further “quality of care, transparency, communication and education” in the industry. They are also the organizers of the industry’s annual top conference, under way this week in Los Angeles.

In many ways, Edelheit and Stephano have become the face of medical tourism. That has caused admiration, envy and unhappiness in the tight-knit industry.

Former MTA board members and industry colleagues have stories of how their collaborations with the couple have become marred by a sense of disillusionment and legal threats since the organization was founded in 2007. Their concerns center on three issues:

- Edelheit has been accused of selling unauthorized insurance in Washington and Montana. The first probe has been settled. Edelheit dismisses the allegations and says the second investigation will be settled in his favor.

- Edelheit and Stephano have threatened several critics with legal action and have filed one lawsuit against a competing non-profit. Edelheit calls it legal diligence to protect themselves and the MTA’s members.

- The couple set up a thriving annual conference, but critics say the profits go into their private corporation rather than the industry association. Edelheit says the arrangement benefits the MTA.

Rudy Rupak of medical tourism facilitator Planet Hospital captured the feelings of many industry players in December when one slide of his Powerpoint presentation said: “The biggest threat to our industry is the MTA.”

ALLEGATIONS OF “BOGUS HEALTH PLANS”

Edelheit’s foray into health insurance started in 2001 after he left the Villanova University School of Law and moved to Florida to join his father’s company, United Group Programs.

As vice president of sales for the company’s OptiMed Health Plans, Edelheit says he became the first to sell self-funded employee health plans that included medical travel in 2005. OptiMed’s Web site lists companies like Dunkin’ Donuts and Chrysler as clients.

The Washington State Insurance Commissioner alleged in 2007 that Edelheit and others had sold or managed “bogus health plans” to 4,000 residents and made “false, deceptive, and misleading representations” to customers between 2003 and 2007. Edelheit, United Group and OptiMed Health were also named in a Montana investigation.

“I have never been so screwed over in my life,” one consumer, Judy Bergin, told an investigator with the Washington State Insurance Commissioner. Bergin had found a plan on the Internet later linked to the United Group, made an initial payment of $275 and paid $228 a month thereafter. She said her doctor never got paid, leaving her to foot about $3,000 in medical bills.

Edelheit and his father bought insurance from underwriters, and were responsible for paying claims filed by customers, according to the investigator’s report obtained by Reuters Health. The policies were not authorized in Washington and the Edelheits did not always pay the underwriters’ premiums on time, the report said.

The Edelheits have since settled with Washington, agreeing to no longer sell insurance there. Edelheit brushes off suggestions that he was doing anything wrong, and says he is confident that a pending cease-and-desist order in Montana will be dismissed. Stephano calls the Washington investigation a “witch hunt.”

FROM INSURANCE TO MEDICAL TOURISM

The couple set up the non-profit Medical Tourism Association in May 2007, persuading the industry’s big names to join their advisory board. But former board members say they had little power, and were just part of what one calls “the Jonathan and Renée show.”

By the end of 2008, Karen Timmons of Joint Commission International, Laura Carabello of CPR Communications, John Bridges of Johns Hopkins University and Ruben Toral of Medeguide had all resigned. Uwe Klein of Germany’s Health Care Strategy International resigned this year, saying that the organization sought to dominate the conversation on medical tourism.

“The world has more countries than Florida,” Klein says. At least a few were upset after the couple announced an accreditation program for foreign hospitals and agents who book medical trips. They complained the program was not transparent and did not link its stamp of approval to an operator’s quality of care.

Edelheit and Stephano have since backpedaled. A facilitator “certification” program is in pilot phase. Applicants pay $2,500 and answer an extensive questionnaire.

Bethany Van Boxtel of Guam-based Veiovis, who is undergoing the process, says the MTA is filling a gap: “We were looking for some kind of accreditation or certification to give validity to travel facilitators.”

Experts agree patients need to check out operators.

“Most facilitators are operating from a basement and a BlackBerry,” says Maria Todd of the Council on the Global Integration of Healthcare.

But the industry’s biggest names have expressed little interest in MTA’s certification program.

“I don’t know that they are qualified to certify,” says Victor Lazzaro, CEO of BridgeHealth. “No one has asked us if we are certified, and we have a million lives under contract.”

SEE YOU IN COURT

Edelheit has threatened critics with legal action.

Keith Pollard, whose company runs medical tourism web sites, says Edelheit told him he was on the verge of “defamation, slander and libel” and that he reserved “the right to proceed with a legal action” in an e-mail late last year.

Edelheit also put Dana Taormina at CPR Communications and Planet Hospital’s Rupak on notice — but did not always get the desired results.

“So I get one of those famous Cease and Desist mails from our BFFs (best friends forever) at the MTA,” Rupak wrote in an email to colleagues in August. “The first thing I did was fax them a letter that read: F**K YOU!”

Edelheit says that he sent the emails to protect the reputation of the MTA, after Pollard and Rupak “distributed false statements about the MTA in writing and in person to advisory board members and (regular MTA) members.”

Edelheit also filed suit against the International Medical Travel Association for trade name infringement and unfair business practices in September.

“MTA has the right and is indeed required to protect the interest in its brand against intentional confusion which has been developed through the efforts of its membership,” Edelheit says.

The suit was triggered when the Singapore-based non-profit registered its U.S. arm in Florida in January. Toral, who heads the group, says the lawsuit is baseless but that he may not have money to fight it.

A spoof press release now circulating in medical travel circles says that the MTA has sued New York City’s Metropolitan Transportation Authority, also known as the MTA.

“There are so many people to sue in the world,” reads a quote attributed to “Edelheit-Stephano” in the phony press release. “Sometimes when I wake up in the morning, I just don’t know where to begin.”

LUCRATIVE CONFERENCES

Annual industry conferences are the couple’s biggest coup.

“Don’t be fooled by the other medical tourism conferences in the industry,” their advertising materials say.

The MTA conference website says it does not “promote the interests of any private corporate or governmental interests.”

Less than a year after the MTA was formed, Stephano set up a for-profit business, WMT & GHC, which runs the “Official Conference of the Medical Tourism Association.” The company operates from the same address as the MTA and collects all registration and sponsorship fees.

The fees are substantial: The first conference in San Francisco in September 2008 had 850 attendees paying between $500 and $2500 each, or between $425,000 and $2.1 million.

Sponsors and exhibitors add to the tally. This year, the Council for Korea Medicine Overseas Promotion paid $100,000 to be the diamond sponsor, according to rate sheets. Malaysia Healthcare paid $75,000 to be a platinum sponsor, and three other organizations paid $40,000 each as gold sponsors. USAID was one of 13 silver sponsors, who paid $15,000 each.

While it is not unusual for a non-profit organization to have agreements with for-profit corporations, the WMT & GHC is not directly paying the MTA for rights to run the conference nor for advertisements on its website.

Edelheit says WMT & GHC provides benefits to the MTA by paying for shipping the organization’s magazine, for DVDs, for promotional materials and for staff travel. It also provides a mailing list and fronts $600,000 to run the conference, Edelheit says.

The MTA received outside bids for the annual conference but “none (could) provide MTA all content and speakers, and cover the costs,” Edelheit says, declining to name bidders. He did not respond to a request for an estimate of WMT & GHC’s revenues.

“It sounds like the non-profit is acting like the marketing arm of the for-profit companies,” says Lloyd Mayer, an expert in non-profit tax law at Notre Dame University. “If that’s true, then it exists primarily to generate a profit for the companies and not primarily to promote the industry.”

If they are getting rich, the couple is not showing it: They bought a single family home on 5 acres of land in West Palm Beach, Florida, for about $445,000 in 2004, property records show.

Edelheit and Stephano also own Free Health, which runs the conferences of two other healthcare non-profit associations they lead. Those conferences are taking place this week alongside the MTA at the Los Angeles Hyatt Regency Century Plaza.

Organizers expected 2,000 attendees for the MTA conference alone. Rupak is boycotting the event — but says he rented three suites at the hotel.

“I’ve told everyone if they happen to be in Los Angeles, come to my party,” he says.

(Editing by Ivan Oransky, Jack Reerink and Martin Langfield)

© Thomson Reuters 2009 All rights reserved

By Maggie Fox, Health and Science Editor

WASHINGTON (Reuters) – The U.S. government may end up throwing away unused doses of swine flu vaccine if people cannot get it soon enough, the director of the U.S. Centers for Disease Control and Prevention said on Tuesday.

Members of Congress questioned whether federal officials were too rosy in their estimates of how much vaccine would be available and when, and companies said they were still struggling to produce immunizations against H1N1.

CDC director Dr. Thomas Frieden said 22.4 million doses were now available to states, which can get them a day after they order them.

“It’s quite likely that too little vaccine is one of the things that’s making people more interested in getting vaccinated, frankly,” Frieden told reporters.

“We think it will get easier to find vaccine in the weeks that come.”

President Barack Obama’s daughters found it. “Malia and Sasha were both vaccinated for H1N1 last week, after the vaccine became available to Washington, D.C. schoolchildren,” a White House blog reads.

“President and Mrs. Obama have not yet been vaccinated for H1N1, and they will wait until the needs of the priority groups identified by the CDC — including young people under the age of 24, pregnant women, and people with underlying conditions — have been met.”

Many states and cities say they have received about one-tenth as much vaccine as they originally had expected by this time. Frieden said the delays may discourage people who are lining up for vaccine.

“It is likely also as we produce more vaccine and as both people are given the opportunity to get vaccinated, and as disease maybe wanes in the future, we will have significant amounts of vaccine that can’t be used,” Frieden said.

“One of the messages for states, localities and health providers is not to reserve vaccine that they have available, to give it out as soon as it comes in, because more is on the way.”

In September, U.S. officials said 40 million vaccine doses would be available by the end of October and they estimated 20 million doses a week would be delivered, with a goal of 250 million doses by the end of flu season in March or April.

UNRELIABLE ESTIMATES

Maine Republican Senator Susan Collins asked why the estimates were so far off.

“It now appears that much of the vaccine could arrive only after many people have already been infected with H1N1,” she said in a letter to Health and Human Services Secretary Kathleen Sebelius, released late on Monday.

“It seems that HHS gave its assurance of sufficient supply in August without adequate information to make such a commitment.”

Connecticut independent Senator Joseph Lieberman weighed in

on Tuesday.

“Unfortunately, these missteps in estimating available doses of H1N1 vaccine have effects beyond just growing public frustration; they have the potential to critically undermine our vaccine distribution efforts, which depend on accurate estimates of vaccine availability,” he said.

But HHS spokeswoman Jenny Backus said the agency was simply passing on information as it became available.

“We have been very clear and open and told the American people what we know when we know it,” she said in a telephone interview.

“We have passed on the manufacturing estimates, and as they have changed, we have conveyed the information to the American people, too.”

(Editing by Mohammad Zargham)

© Thomson Reuters 2009 All rights reserved

WASHINGTON (Reuters) – U.S. President Barack Obama has signed a proclamation declaring 2009 H1N1 swine flu a national emergency, the White House said Saturday.

The proclamation, which Obama signed Friday night, will make it easier for U.S. medical facilities to handle a surge in flu patients by allowing the waiver of some requirements of Medicare, Medicaid and other federal health insurance programs as needed, the White House said in a statement.

The U.S. Centers for Disease Control and Prevention said on Friday that H1N1 swine flu has become widespread in 46 of the 50 U.S. states, a level comparable to the peak of ordinary flu seasons but far earlier and with more waves of infection expected.

The White House statement said the declaration was intended to prepare the country in case of “a rapid increase in illness that may overburden health care resources” and was similar to disaster declarations issued before hurricanes hit coastal areas.

Seasonal flu normally peaks sometime between late November and early March.

Swine flu has hit young adults and children the hardest, while seasonal flu normally is more dangerous for people over age 65. H1N1 has killed more than 1,000 Americans and put more than 20,000 in the hospital in the United States since it emerged earlier this year, the CDC said. But health officials are quick to note that the actual number of cases cannot be measured.

(Reporting by Patricia Zengerle, editing by Eric Beech)

© Thomson Reuters 2009 All rights reserved