I think that this problem is going to get much worse before it gets better. I hope I'm wrong

http://www.foxnews.com/story/0,2933,579033,00.html?test=latestnews

BALTIMORE — Maryland health officials are reporting the state's first two known cases of swine flu resistant to Tamiflu.

Johns Hopkins Hospital in Baltimore announced Wednesday that the two patients were treated there and have been discharged.

The hospital says the federal Centers for Disease Control and Prevention and Maryland health officials confirmed the patients had a drug-resistant form of the virus.

Last month, health officials in North Carolina announced four patients at a one hospital tested positive for Tamiflu-resistant swine flu, the biggest cluster seen in the U.S.

Tamiflu is one of two common swine flu treatments, and health officials have been watching for signs of resistance to the drugs. More than 50 resistant cases have been reported since April, including 21 in the U.S.

H1N1 Evolution Outpacing Vaccine and Host Defenses

Recombinomics Commentary 13:32
November 30, 2009

The designation of one of the Ukraine D225G isolates as a "low reactor" raises concerns that the H1N1 evolution is outpacing the vaccine as well as immune responses from unvaccinated hosts. This concern was present ealry when changes began to appear at position 225, a known antigenic site.

One of the highest profile isolates was the San Francisco traveler to Hong Kong, who was reported (in July) to have Tamiflu resistant H1N1, even though she had not taken Tamiflu. Her case was mild and she recovered without antiviral treatment, but the virus had a receptor binding domain change, D225E. A survey of D225E at the time demonstrated that it was first reported in the US in New Jersey, but not subsequently. However, it had spread to many other countries, raising concerns that the US surveillance was missing this widespread sub-clade.

Moreover, there were soon examples of D225G and D225N in other early samples supporting the use of position 225 to escape host defenses. The concern of multiple changes at the same position increased when sequences from fatal cases in Sao Paulo were releasd recently. The July/August collections had D225G in two of two fatal cases, and D225N in two of two other fatal cases, with 3 of 4 samples coming from lung.

These concerns increased when sequence data from Ukraine was released and 4 of 4 fatal cases had D225G.

The above data reinforced concerns that the changes at position 225 were becoming more prevalent, especially in samples collected from affected organs of fatal cases.

The concerns ratcheted up another notch when one of the four cases was characterized antigenically, and was reported to be a "low reactor". Since the low reactor had only one amino acid change in HA, the role of D225G in the reduced titers raised the level of concern higher.

However, WHO has yet to address this result. The "low reactor" status was quietly added to the characterization sheet at GISAID and there has been little comment in the mainstream media, other than a sentence in the New York Times on Friday.

Comment form WHO and other agencies, including Mill Hill and the CDC, who were conducting testing of the Ukrainian samples, is long overdue.

http://www.recombinomics.com/News/11300901/225_Evolution.html

800,000 H1N1 vaccine doses for young children recalled

http://www.cnn.com/2009/HEALTH/12/15/flu.vaccine.recall/index.html

(CNN) -- One of the five manufacturers supplying H1N1 vaccine to the United States is recalling hundreds of thousands of flu shots because they aren't as potent as they should be.

The French manufacturer Sanofi Pasteur is voluntarily recalling about 800,000 doses of vaccine meant for children between the ages of 6 months and 35 months.

The company and the Centers for Disease Control and Prevention emphasized that the recall was not prompted by safety concerns, and that even though the vaccine isn't quite as potent as it's supposed to be, children who received it don't have to be immunized again against H1N1.

The CDC emphasized that there is no danger for any child who received this type of vaccine.

When asked what parents should do, CDC spokesman Tom Skinner said, "absolutely nothing." He said if children receive this vaccine, they will be fine.

Sanofi Pasteur spokesman Len Lavenda said that the company's test results found the recalled vaccine's potency was 12 percent below the point where it should have been. He added that the company has done studies in the past that showed "vaccine containing as little as half of the recommended dosage" still created the necessary immune response in children.

Lavenda said Sanofi Pasteur has never had this happen with a flu vaccine before, and the company is having all of its experts investigate the cause of this loss in potency.

Lavenda told CNN that it takes about three to four months to produce flu vaccine. He said 85 percent of that time is spent on testing.

"In order for vaccine to move to next phase of production it [the vaccine] has to pass all tests and at the end, it has to pass another battery of tests before it can be shipped out," Lavenda said. The company also keeps samples of each batch of vaccine "to periodically test them to see if they stay within specification until expiration date."

Four batches -- or lots -- of H1N1 vaccine in question were shipped in early November. Lavenda said all four lots passed every test before they left the factory. However, on December 7, the company learned that all "four lots we tested failed," according to the spokesman.

That's when the company notified the CDC and the Food and Drug Administration, which asked them to retest the samples. Results from the subsequent sample came in on Monday, according to Lavenda, who said it takes about a week to complete these tests.

According to Sanofi Pasteur, it is unclear how many doses of this particular vaccine are still in circulation. This particular vaccine was targeted for infants and toddlers between the ages of 6 months and 35 months -- children who need to get two shots several weeks apart, but only get half of a regular dose each time.

The vaccine was shipped in 0.25-milliliter pre-filled syringes, which contain half a dose of vaccine in each shot. Children 3 years old and older would have been given a shot with a full dose.

According to the CDC's vaccine recommendations, children younger than 9 years need to have two flu shots to be fully protected against the H1N1 virus.

The CDC's Skinner said there is scientific evidence that when there's a slight drop in vaccine potency, the immune response is still sufficient.

"We're very confident that children who received this vaccine are properly protected, provided that they get the second dose that is recommended," Skinner said.

According to the CDC, this vaccine was distributed throughout the United States. Doctors and providers are urged to check their vaccines and return any to Sanofi Pasteur if they come from the following lots:

• 0.25 mL pre-filled syringes, 10-packs (NDC . 49281-650-25, sometimes coded as 49281-0650-25): UT023DA, UT028DA, UT028CB.

• 0.25 mL pre-filled syringes, 25-packs (NDC . 49281-650-70, sometimes coded as 49281-0650-70): UT030CA.

The vaccine was manufactured in Sanofi Pasteur's Swiftwater, Pennsylvania, factory.

Nasal swine flu vaccine recalled over potency

Drugmaker MedImmune is recalling nearly 5 million doses of swine flu vaccine because the nasal spray appears to lose strength over time, federal health officials announced Tuesday.

The vaccine recall is the second this month caused by declining potency and comes as public health officials urge millions of Americans to get vaccinated against swine flu.

The action affects more than 4.6 million doses, but the vast majority have already been used, according to the Food and Drug Administration. Agency officials said the vaccine was strong enough when it was distributed in October and November.

"The slight decrease in potency is not expected to have any effect on the protective effect of the vaccine," said Norman Baylor, director of the FDA's vaccine research office. "We are not recommending revaccination."

The agency is looking into the problem but said it's not uncommon for vaccines to lose strength over time. MedImmune's vaccine has a recommended shelf life of about four months. The company has about 3,000 doses in its warehouses but does not know how many remain in the field, according to the FDA.

Last week, vaccine maker Sanofi Pasteur recalled hundreds of thousands of swine flu shots for children because tests indicated those doses lost some strength. Most of those doses had already been used, too.

Maryland-based MedImmune, a subsidiary of London-based AstraZeneca PLC, voluntarily recalled 13 lots of its vaccine, "due to a slight decrease in potency" discovered through routine quality control testing, said spokesman Tor Constantino.

"It's not a safety concern. People who have received doses from the affected lots do not need to be revaccinated. The doses were well within potency specification," he said.

Swine flu vaccine has been available since early October, and since then manufacturers have released over 111 million doses for distribution in the U.S. MedImmune makes the only nasal spray version, which can be used by healthy people ages 2 to 49.

Only in recent weeks have state authorities lifted restrictions on who can get vaccinated. Previously the vaccines were reserved for high-risk patients, including pregnant women and schoolchildren.

In a telephone news conference on Tuesday, Dr. Anne Schuchat of the federal Centers for Disease Control and Prevention estimated that 60 million Americans have received swine flu vaccine, and said intense monitoring for side effects has not turned up any safety concerns.

"We are not seeing any worrisome signs," she said.

The vaccine supply has increased so much in recent weeks that she urged parents of children 10 and younger to get them a second dose, because studies show this age group needs two for optimal protection.

Flu activity has slowed, but "it's not gone," Schuchat said. "None of us know what the weeks and months ahead will bring in terms of influenza activity, and it's very important not to become complacent."

The first wave of the swine flu pandemic began in April, when the strain was discovered. A larger wave started in the late summer and is declining. Infections are now widespread in 11 states, down from 48 in late October.

A new Harvard poll released Tuesday finds that concern about swine flu has waned along with the number of new cases being reported.

Only 40 percent of people now say they are concerned that they or a family member will get sick from swine flu during the next year. That's down from an earlier poll in September, when 52 percent said they were worried about swine flu.

The new poll found that most parents who sought vaccine for their children were able to get it. However, more than one-third of respondents said they did not plan to seek it for their kids.

The Harvard School of Public Health polled more than 1,600 adults on Dec. 16 and 17.

Also on Tuesday, a 13-year-old dog in suburban New York was confirmed as the first known case of swine flu in a dog. The pet apparently caught the virus from his owner. The CDC's Schuchat said that animals can carry and spread flu viruses, but such cases are rare and people should not be afraid to enjoy their pets. A few cats and ferrets have also been diagnosed with swine flu.

http://www.comcast.net/articles/news-health/20091222/US.MED.Swine.Flu/