MASSIVE VACCINE RECALL - 800,000 DOSES

 

STORY HIGHLIGHTS

• Safety, effectiveness of vaccine is not at issue, manufacturer and CDC emphasize
• Sanofi Pasteur is voluntarily recalling about 800,000 doses
• CDC: The four batches were shipped in November, distributed throughout U.S.
• Spokesman: Recalled vaccine was 12 percent below the point where it should have been

Sanofi Pasteur produces these vials of H1N1 vaccine in France.

U.S. version is made in Pennsylvania

 

(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.

...reblog from www.cnn.com

MASSIVE VACCINE RECALL - 800,000 DOSES

NATURAL WAYS TO AVOID FLU

With cold and flu season in full bloom, it is important to discuss the H1N1 vaccine and regular flu vaccine with your doctor. It is also more important than ever to bolster your immune system right now.

Here are some natural, simple solutions that will help you during this season!

Treat your body right - Encourage your body to fight flu and other infections by giving it the care it needs. 

• Get at least seven hours of quality uninterrupted sleep every night. Studies show that the average immune system function drops by an average of 60% after just three nights of poor sleep.
• Keep your stress level low with meditation, tai chi, or yoga. It is well known that stress hormones stress the immune system and make one susceptible to cold, flu, and infections.
• Dry body brushing daily and slough off dead skin, activate surface immunity, promote lymph circulation that is important to clear out toxic debris, and stimulate immune function.

Stimulate your thymus - Your thymus is a golf ball sized gland located behind your sternum in the center of your chest. He plays a critical role in the functioning of the lymphatic and immune systems.

• To Support thymus Health, chinese medicine devised a simple way to stimulate your thymus using acupressure. With your index and middle finger together, gently tap against the sternum (midway between the nipples ) 50 times, in the morning and the evening.

Chestnuts bolsters immunity.

• Chestnuts differ from other nuts with their low-fat content and high fiber. An excellent source of potassium, folate, vitamins B6 and C, chestnut strengthen the kidney-adrenal system and bolster the immune system to fight off the flu and combat infections.  
• This FLU season, introduce more chestnuts into your cooking, they are good oven roasted, cooked with chicken, lamb, or other meats, or in any dish with beans and legumes.

Immune supporting herbs - You can use the following herbs to help strengthen your immune system.

• Ligustrum has been the focus of much research recently, which has revealed the herbs immune boosting functions. It's actions include increasing white blood cell production, phagocytosis, and T-lymphocyte helper cell activities.
• Cherokee Rose is traditionally used to protect the body from external pathogens with its astringent properties.  It is also one of the highest natural sources of vitamin C.
• Honeysuckle is a natural anti-microbial herb that has been used for centuries to increase immune resistance and fight against bacterial, viral, and fungal infections.  
• You can find decent and other herbs in the health food stores, online.

Beta-carotene builds Immunity. 

• Beta carotene is a powerful antioxidant that improves immune function and promotes mucous membrane health.  In fact, a 1997 study conducted by the Institute of food research in the United Kingdom suggested that the dietary intake of beta carotene can enhance cell mediated immune responses.
• Eat more orange colored vegetables, including carrots, winter squash, butternut squash, pumpkins, sweet potatoes, and yams.  Additionally, these are all an excellent source of vitamin C, a famous immune support.

If you feel your immune system has already been compromised and illness is on the way, see your healthcare practitioner immediately. 

Do not underestimate the FLU !

Thousands of patients die of the flu and its complications each year in the US alone. Help yourself and your loved ones by keeping your immune system strong.  

We wish you good health.

NATURAL WAYS TO AVOID FLU

HYGIENE - WASHING HANDS VIDEO

The VIDEO promotes effective hand hygiene for hospital patients and visitors.

Hand hygiene is the best way to prevent infection and illness.

Clean hands prevent infections. Keeping hands clean prevents illness at home, at school, and at work. Hand hygiene practices are key prevention measures in healthcare settings, in daycare facilities, in schools and public institutions, and for the safety of our food.

In healthcare settings, hand hygiene can prevent potentially fatal infections from spreading from patient to patient and from patient to healthcare worker and vice-versa.

To that end, CDC has developed resources for patients and healthcare providers.

CDC partnered with the Association for Professionals in Infection Control and Epidemiology and Safe Care Campaign to develop and launch a hand hygiene video for patients and visitors in hospitals. The video teaches two key points to patients to help prevent infections: the importance of practicing hand hygiene while in the hospital and the appropriateness of asking or reminding their healthcare providers to practice hand hygiene.

Modeled after the video that airline passengers are required to view prior to take-off on a flight, this new video is intended to be shown to patients upon admission to the hospital. The goal is to inform patients at the beginning of their hospital stay about what they can do to help prevent infections throughout the duration of their stay.

The 5-minute video begins with a brief introduction on healthcare-associated infections. It is then narrated by a nurse character named Gayle who stresses the importance of hand hygiene for both patients and healthcare providers. There are two patient room scenes in which patients and visitors model the behavior of asking one another as well as their healthcare providers to perform hand hygiene – with positive results.



CLICK HERE TO START VIDEO - ENGLISH VERSION




CLICK HERE TO START VIDEO - SPANISH VERSION

...sourced from the CDC website

HYGIENE - WASHING HANDS VIDEO

BEWARE FRAUDULENT PRODUCTS

Purpose of the Fraudulent Products List

This list is intended to alert consumers about Web sites that are or were illegally marketing unapproved, uncleared, or unauthorized products in relation to the 2009 H1N1 Flu Virus (sometimes referred to as the “swine flu” virus). Note that until evidence to the contrary is presented to FDA, the owner of the listed Web site is considered responsible for promoting the unapproved, uncleared, or unauthorized products. The uses related to the 2009 H1N1 Flu Virus are not necessarily being promoted by the manufacturers of the products.

Consumer Considerations about the Products List

• This list does not include every Web site that is marketing products related to the 2009 H1N1 Flu Virus without FDA approval, clearance, or authorization, only those Web sites to which FDA has issued a warning letter.
• Even if a Web site is not included in this list, consumers should exercise caution before purchasing over the Internet any product purporting to diagnose, mitigate, prevent, treat, or cure the 2009 H1N1 Flu Virus.
• Please note that some of these products may be approved or cleared by FDA for other medical uses. The fact that a product is listed on this page indicates ONLY that the products are not cleared, approved, or authorized for the diagnosis, mitigation, prevention, treatment, or cure of the 2009 H1N1 flu virus.

Once included, all Web sites and products will remain listed. After FDA has verified that the products or the objectionable claims related to the 2009 H1N1 Flu Virus have been removed from the Web site, this information will be added to the list.
The information is current as of the date indicated. If we learn that any information is not accurate, we will revise the list as soon as possible.

View Products List
Important note: Consumers are advised that FDA has not determined whether these Web sites include products promoted for uses not related to the 2009 H1N1 Flu Virus that are also illegally marketed because they are not approved, cleared, or authorized by FDA for those other uses.

( CLICK ON THE BELOW CATEGORIES / PRODUCTS TO EXPAND )

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BEWARE FRAUDULENT PRODUCTS

SURGICAL MASK vs. RESPIRATOR

 THIS IS THE N95 RESPIRATOR

A preliminary report suggesting that N95 respirators -- filtering devices worn over the mouth and nose -- protect against swine FLU better than surgical face masks seems to be incorrect, researchers revealed during a meeting of the Infectious Diseases Society of America (IDSA).

In fact, surgical face masks, which are cheaper and easier to wear, may be just as good as N95 respirators. At the very least, researchers can't prove that one is better than the other. It's the latest wrinkle in a continuing debate over how to protect health-care workers from the H1N1 virus, also known as swine flu.

THESE ARE SURGICAL MASKS

Raina MacIntyre, Ph.D., a professor of infectious diseases epidemiology and the head of the University of New South Wales School of Public Health and Community Medicine, in Sydney, Australia, says the research team didn't exactly retract the findings.

"I would certainly wear an N95 respirator if I were exposed to infectious patients". --Raina MacIntyre, Ph.D.

For the new analysis, the researchers removed a control group of nearly 500 health-care workers and made other statistical adjustments. Ultimately, the difference in infection rates between mask and respirator users was not statistically significant.

"[The study] still shows a likely superiority of N95s, with half the rate of infection compared to surgical [masks]," MacIntyre says. "But the study was probably underpowered to pick up statistical significance when we removed the control group."

The N95 respirator is a tightly fitted facial mask designed to filter out even very fine airborne particles, according to the U.S. Food and Drug Administration. Looser-fitting surgical masks protect against large-particle droplets, splashes, sprays, or splatter, the FDA says, but they don't completely block the germs from coughs and sneezes.

To figure out which protective device is best, MacIntyre and her colleagues tracked hospital workers in Beijing, China, who wore surgical masks or N95 respirators, and compared rates of influenza and respiratory illness. Preliminary findings were presented at a meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy in September 2009. Final results have yet to be published.

.......sourced from health.com

SURGICAL MASK vs. RESPIRATOR

NEW VACCINE AND UPDATE

STORY HIGHLIGHTS

The U.S. Food and Drug Administration said Friday it has approved a new vaccine to prevent seasonal influenza.Agriflu, made by Novartis Vaccines and Diagnostics, is not intended to protect against the H1N1 virus, commonly known as swine flu.

The vaccine was approved using an accelerated approval process, the FDA said. Novartis demonstrated that the vaccine induces levels of antibodies in the blood that are effective in preventing seasonal influenza, but it still needs to conduct further studies.

Agriflu, for ages 18 and older, is administered as a single injection in the upper arm and is available in single-dose, prefilled syringes, according to the FDA.  Novartis produces another licensed vaccine for seasonal influenza, Fluvirin, approved for ages 4 and older. Although no vaccine is 100 percent effective in preventing disease, vaccination is the key to flu prevention, according to the FDA. Novartis spokesman Eric Althoff said Agriflu is made in Siena, Italy, with eggs, and it has been available in Europe under the brand name Aggripal. This approval, he said, will add to future seasonal vaccine supplies.

The WHO supports the use of vaccines against the H1N1 flu.


The H1N1 virus has now become the dominant influenza virus around the globe, with high levels and an increase of activity in many regions, the World Health Organization said Thursday.

In a weekly update, the WHO's point person on the H1N1 virus, Dr. Keiji Fukuda, also warned the public not to treat the virus like just another flu.  Like seasonal flu, H1N1 is more active in the winter than in the summer, and a majority of infected people get better on their own, Fukuda said. H1N1 also is as transmissible and infectious as seasonal flu, he said.

But unusually for influenza, Fukuda said, H1N1 continues at high levels over the summer months, and many of the serious illnesses and deaths are concentrated in people younger than 65.  Seven months into the pandemic, the virus commonly known as swine flu remains at high levels and continues to increase in North America, Fukuda said. Mexico, for example, has seen more cases from September to November than they saw in the preceding months from April, when the virus emerged, he said.

The virus is also becoming more active in Europe and Central and Western Asia, Fukuda said.   Health officials this week reported an outbreak of cases in Ukraine, which now has more than 250,000 cases of influenza-like illness, with 235 patients requiring intensive care, the WHO said.   Activity is picking up in East Asia, Fukuda said. Mongolia reported "a number" of cases over the past week, he said.




"East Asia is one of the parts of the world where seasonal influenza viruses have remained in reasonably high circulation," Fukuda said. "But even in that part of the world, the pandemic virus is becoming dominant."

More cases are being reported from a number of Caribbean countries such as Cuba and Haiti, he said.   In Central America and the Southern Hemisphere, however, activity levels have dropped as those regions enter the summer season, Fukuda said.   "There are several regions in the world -- North America, Europe, Northern and Central Asia -- where we are clearly seeing pandemic influenza activity increase," he said, but "there is no one single place in the world where we are focused on."
Disease activity has been difficult to predict, Fukuda said.

"We really are not going to know what the future is going to bring, and so the main focus of our effort here is ... what steps are needed to make sure countries are as prepared as possible to deal with disease levels," he said. H1N1poses different challenges in different countries, but it does seem to be affecting indigenous groups more heavily than nonindigenous groups, he said. In Australia, for example, "aboriginal groups are disproportionately represented in people who end up in hospitals from diseases related to the pandemic," Fukuda said. The WHO still doesn't know whether the effect on indigenous groups is because of the pandemic itself or because of underlying factors.

Because most people infected with swine flu tend to recover on their own and don't suffer major problems afterwards, some people are tempted to dismiss the infection and think it's not serious. But Fukuda said that's a dangerous mind-set. "At WHO, we remain quite concerned about the patterns we are seeing, particularly because a sizable number of people develop complications [that lead to death]," he said. "We do see that the serious complications are concentrated in the younger age groups rather than the older age groups."

While the complications are most often seen in people who have chronic, underlying health conditions and in pregnant women, they also can develop in people "who are currently healthy and young."

But contrary to some reports, Fukuda said, the WHO has not seen big mutations in the virus since it first emerged. He said viruses being isolated now are "generally similar" to those isolated over the past several months, indicating they haven't changed much. The WHO also has no evidence of widespread resistance to antiviral medication, Fukuda said. There have been sporadic instances of resistance to oseltamivir -- the generic name for Tamiflu, one of the main drugs used against influenza -- but such cases are still "isolated and infrequent," he said.
 
Antivirals are quite useful against these infections.

Fukuda praised as "innovative" the decision by Norway to distribute antiviral medication over the counter for a limited period of time. The move can help take stress off the primary health system and allow patients to get the medicine more quickly, he said. Other useful protections against H1N1 are vaccines, which the WHO recommends against pandemic infections, Fukuda said.   "These vaccines now have been used in a significant number of countries ... and based on this experience, in which millions of people have now received vaccine, we in fact see that these vaccines are very safe," he said.

The only side effects are swelling and pain at the injection site, but "these are occurring at rates that are expected and usually seen with seasonal influenza vaccine," Fukuda said.   "WHO, along with other public health authorities, believes that these vaccines are very useful against pandemic infections and [we] do support their use," he said.

..............sourced from CNN

NEW VACCINE AND UPDATE

CURRENT FLU FORECAST AND TRENDS

United States

National 2009-2010 ▼ Intense High Moderate Low Minimal Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun

Canada

National 2009-2010 ▼ Intense High Moderate Low Minimal Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun

Mexico

National 2009-2010 ▼ Intense High Moderate Low Minimal Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun

Explore FLU trends around the world

 Click this link to Learn more »

U.S. Confirmed Influenza Cases

Influenza Cases	Hospitalizations	Deaths
	26,315	1,049

Estimates made on Data current through November 18, 2009.

CURRENT FLU FORECAST AND TRENDS