Drugmakers report U.S. shortages of flu vaccine, Tamiflu
By Ransdell Pierson and Caroline Humer
Thu Jan 10, 2013 4:14pm EST
(Reuters) - This year's U.S. flu season has created shortages of the Tamiflu treatment for children and of the most widely used flu vaccine, their manufacturers said.
Roche Holding AG told Reuters late on Wednesday that it had a shortage of the liquid form of Tamiflu, given to children who already have the flu to slow or stop symptoms. A spokeswoman for the U.S. Food and Drug Administration confirmed that there have been supply interruptions in some locations.
Roche said it told wholesalers and distributors in recent weeks that temporary delays in shipments were imminent. In the meantime, pharmacists can make a substitute by dissolving Tamiflu capsules in a sweet liquid, according to Tara Iannuccillo, spokeswoman for Roche's Genentech unit, which makes Tamiflu.
Sanofi SA, the largest flu vaccine provider in the United States, said on Thursday it had sold out of four of the six different dosages of Fluzone seasonal flu vaccine due to unanticipated late-season demand. The vaccine is made in different sized vials and pre-filled syringes.
"At this point we are not able to make any more vaccine because we are gearing up for next year's vaccine," said Michael Szumera, a spokesman for Sanofi.
Most of the United States is nearing peak levels seen during moderately severe flu seasons, according to the Centers for Disease Control in Atlanta. As of last Friday, the percentage of people seeing health care providers for influenza had increased for the previous four consecutive weeks to 5.6 percent. That compares with 2.2 percent the previous year, when flu was mild.
"We are hearing of spot shortages. Given the time in our flu season, it isn't surprising. People who haven't been vaccinated and want to get the vaccine may have to look in several places for it," CDC spokesman Tom Skinner said on Thursday.
It is not unusual to run out mid-season during a moderate to severe season, which is what this year looks like, he said.
It is definitely not too late to receive the seasonal flu vaccine, said epidemiologist Craig Roberts, a physician assistant at University Health Services at the University of Wisconsin, Madison. The 42,000-student campus gave 10,000 flu shots before the holiday break in December and has 5,000 more in stock. "We'll be offering walk-in shots" once the students return around January 22, he said, "which we haven't done in January before. We also sent out a mass e-mail asking students to get the shot at home if they can."
The vaccines that are available this year are a fairly good match to the strains of the flu that are circulating, Skinner said. It takes about two weeks for the vaccines to provide protection.
Manufacturers planned to produce 137 million doses of the vaccine and as of late last year, 112 million people had been vaccinated, the CDC said.
Sanofi produced 60 million of those doses and GlaxoSmithKline PLC had planned to make 25 million doses.
A spokesman for GlaxoSmithKline said on Thursday it expected to have the vaccine available until mid-February.
Novartis, AstraZeneca Plc, ID Biomedical Corp of Quebec and CSL Biotherapies are also authorized to sell flu vaccines in the United States. ID Biomedical's product is distributed by Glaxo, while Merck & Co distributes the CSL Biotherapies vaccine.
AstraZeneca's MedImmune unit sells FluMist, an intranasal spray approved for people aged 2 to 49. Tara Mullins, an outside spokesperson for MedImmune, declined to provide details about demand for and available supply of FluMist.
Karen Andersen, an analyst with Morningstar, said Tamiflu sales would likely more than double to about $750 million this year from about $350 million in the 2011-2012 flu season. Tamiflu demand could boost overall Roche revenue this year by about 1 percent, but she said that would be a "small positive impact" for the company.
Tamiflu sales peaked at $3 billion in 2009, when governments stockpiled the product in case of a global epidemic of avian flu that never materialized.
WALGREENS FLU SHOTS UP
Walgreen Co, which provides flu shots in some of its pharmacy locations, said on Wednesday it had given 5.7 million doses so far this flu season, up from 5.3 million a year ago.
"We've kept our reimbursement rates the same, so we are making a consistent level of profitability on flu shots," Walgreens President of Pharmacy, Health and Wellness Kermit Crawford said after the company's annual shareholder meeting in Chicago. Walgreens is the largest distributor of flu vaccines in the United States other than the government
Walgreens is reimbursed by health insurers such as UnitedHealth Group, Wellpoint Inc and Aetna Inc, whose profitability can be hurt by the flu because of reimbursements to pharmacies, doctors and other providers for vaccines and treatments.
One small insurer, Centene Corp, in December cut back on its earnings estimates for 2012 because its managed care business in Texas and Kentucky, where the flu was active early in the season, had increased its medical costs.
Aetna said this week it has seen a spike in flu cases this year but it is not resulting in more inpatient admissions and it is budgeting about $40 million to $50 million for a normal flu season. That compares with $100 million it spent during the flu season in 2009.
"We don't see this flu season, even at its worst, getting close to that number," Aetna CEO Mark Bertolini said during Tuesday's J.P. Morgan Healthcare conference in San Francisco.
Jason Gurda, an analyst at Leerink-Swann in healthcare equity research, said in a research report this week that 2,255 flu-related hospitalizations have been reported since October 1, 2012, up 735 from the previous week but below the 6,896 hospitalizations in the 2009-2010 season.
He said that could have a "modestly positive impact" on first-quarter volumes for hospitals and said that many companies, including HCA Holdings and Tenet Healthcare, had hospitals in the states most affected so far.
(Reporting by Ransdell Pierson, Julie Steenhuysen, Susan Kelly and Jessica Wohl, Writing by Caroline Humer; Editing by Jilian Mincer, Lisa Von Ahn, James Dalgleish and Dan Grebler)
Flu reaches epidemic level in U.S., says CDC
By Sharon Begley
Fri Jan 11, 2013 5:57pm EST
(Reuters) - Influenza has officially reached epidemic proportions in the United States, with 7.3 percent of deaths last week caused by pneumonia and the flu, the U.S. Centers for Disease Control and Prevention said on Friday.
The early start and fast spread of flu this season - especially after 2011-2012's very mild outbreak - has overwhelmed doctors' offices and hospitals, forcing some patients to wait through the night to be seen in emergency departments.
Nine of the 10 U.S. regions had "elevated" flu activity last week, confirming that seasonal flu has spread across the country and reached high levels several weeks before the usual late January or February, CDC reported.
Only one region - the Southwest and California - had "normal" flu activity last week.
Tens of thousands of Americans die every year from flu, even in non-epidemic years. The threshold for an epidemic is that it causes more than 7.2 percent of deaths, but as yet there is no definitive count of the total caused by flu this year.
In Boston, flu cases are 10 times higher than they were last year, causing Mayor Thomas Menino to declare a public health emergency on Wednesday.
In Illinois, 24 hospitals struggling to cope with the flood of flu cases had to turn away people arriving in the emergency department, while in Pennsylvania, the Lehigh Valley Hospital outside Allentown has set up a tent for people who arrive with less-severe flu.
A total of 20 children have now died from this season's flu, up two from the previous week, the CDC said. That compares to 34 during the full 2011-2012 flu season and 282 during the severe 2009-2010 season.
The outbreak has led to attempts at prevention that go beyond the standard advice of getting vaccinated, avoiding contact with sick people and frequently washing hands with soap.
In Boston, the Catholic Archdiocese has told priests they could suspend the offering of communion wine using a shared chalice and bow rather than shake hands while exchanging the Sign of Peace, a Christian greeting.
Auxiliary Bishop Robert P. Deeley urged priests to use hand sanitizer before and after communion and to avoid touching congregants' tongues or hands. He said parishioners who were ill "should remain at home and return to church when they are well."
'MODERATELY EFFECTIVE' VACCINE
While flu vaccines offer protection, they are not failsafe.
This year's flu vaccine is 62 percent effective, scientists reported on Friday in the CDC's weekly publication, meaning that almost four in 10 people who receive the vaccine and are exposed to the virus will nevertheless become infected.
This is considered "moderate" effectiveness and is in line with previous years' flu vaccines, which range from 50 percent to 70 percent effective, Dr. Joseph Bresee, chief of the CDC's influenza division, told reporters.
Experts recommend the vaccine for everyone over 6 months of age. Even if it does not prevent flu, immunization can reduce the severity of the illness, preventing pneumonia and other life-threatening results of flu.
Public health authorities were correct in their forecast of which flu strains would emerge this season and therefore what vaccine to make: one that contains two strains of influenza A and one strain of influenza B. An A strain, called H3N2, predominates this season, though the B strain has caused about 20 percent of cases.
About 10 percent of cases have been caused by a B strain that is not in the vaccine, which "has space for only three strains," CDC Director Dr. Tom Frieden said.
Dr. Arnold Monto of the University of Michigan, a co-author of the vaccine-effectiveness study told Reuters this year's vaccine was "a good vaccine, but not a great vaccine."
It is less effective for the frail elderly, for people receiving chemotherapy for cancer, and for people taking oral steroids, as their immune systems have been weakened and are often unable to produce an effective number of antibodies in response to the vaccine.
One reason flu vaccines are far from perfect, said Monto, is where in the body the viruses find a home - congregating on the surface of small airways in the respiratory tract, while virus-fighting antibodies that are stimulated by vaccines mostly stay in the bloodstream.
According to the most recent CDC data, 37 percent of Americans - 112 million people - had received the flu vaccine as of mid-November.
Of the 135 million doses produced this year, 128 million have been distributed to doctors' offices, drug stores, clinics and other facilities.
Although public health officials believe enough doses were produced, some spot shortages have developed. "You may have to call a few places," before finding one with vaccine, said the CDC's Bresee, "but it should be available."
MAY HAVE PEAKED
In its weekly flu update on Friday, the CDC reported that 24 of the 50 U.S. states as well as New York City had experienced "high activity" in flu-like illnesses last week. In 16 states, activity was moderate, while in 10 it was low or minimal.
The 24 states reporting high activity was down from 29 the previous week, raising hopes that the disease may have peaked in some regions, particularly the Southeast, and that a flu season that began early may also end early. It typically starts in December, peaks in January or February and peters out by late March or early April.
The percentage of visits to healthcare providers last week for flu-like illness - 4.3 percent - is comparable to that during the 2007-2008 flu season, which was characterized as "moderately severe" but which peaked some two months later. By comparison, in the 2009 H1N1 "swine" flu pandemic, 7.7 percent of visits were for flu-like illness.
(Reporting by Sharon Begley in New York and Daniel Lovering in Boston; Editing by Vicki Allen, Eric Beech and David Brunnstrom)
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