December 20, 2014
Many of the projected 135-139 million doses of influenza vaccines being produced for this flu season for use in the U.S. are now available to consumers from six manufacturers licensed by the Food and Drug Administration (FDA).
A variety of flu vaccines, including some that were not available during past influenza seasons, are available this year. In addition to the availability of vaccines that protect against three strains of influenza virus (trivalent), vaccines that protect against four strains of the virus (quadrivalent) will also be available this year.
In addition, a vaccine that is produced by growing the virus in cells rather than in eggs will be available for use in people 18 years of age and older.
Unlike eggs, cells can be frozen for later use to grow large volumes of cells for the production of vaccine. This could provide a faster start-up time of the manufacturing process for any unexpected need.
“New technologies are providing additional and diverse influenza vaccines, which helps to ensure an adequate supply in the Unites States,” said Karen Midthun, M.D., director of FDA’s Center for Biologics Evaluation and Research.
“Influenza seasons are unpredictable and can be severe, even deadly,” she added. “Last year’s influenza season brought an increase in reported hospitalizations and deaths compared to recent years, and vaccination is the best defense to prevent influenza.”
All of the vaccines have been determined by FDA to be safe and effective. Getting vaccinated early, before flu season is in full swing, is key to prevention.
Manufacturing flu vaccines is an exacting and complex process. New vaccines must be produced each year because the viruses change from year to year and because the protection received the previous year diminishes over time.
Each February, before one flu season ends, the FDA, World Health Organization, the Centers for Disease Control and Prevention (CDC) and other public health experts collaborate on collecting and reviewing data to identify the virus strains likely to cause the most illnesses in the next flu season. Based on that information and the recommendations of an FDA advisory committee, FDA selects the strains for manufacturers to include in their vaccines for use in the United States.
Both egg-based flu vaccines and vaccines made with newer technologies work the same way; they trigger the immune system of the person receiving the vaccine to produce antibodies capable of attacking the virus.
Vaccines are available in a variety of delivery methods, as a needle into muscle, as a needle injected into skin (approved for ages 18 through 64), and as a nasal spray (approved for people ages 2 through 49). In addition, one vaccine made in a high dose formulation is approved for people 65 years of age and older.
Under traditional egg-based production methods, once the influenza viruses have been selected, they are adapted for use in manufacturing and provided to companies licensed by FDA. The manufacturers inject each virus strain into eggs, which are incubated for several days to allow the virus to multiply.
The virus-loaded fluid from the eggs is then harvested and purified.
Manufacturers grow each strain separately then test it, including for potency. Then the strains are mixed and tested again. Once divided into standard dosages, the vaccines are put into containers such as vials, syringes or sprayers.
Test results are submitted to FDA, along with samples from each batch, or lot. FDA reviews the test results and the samples before releasing the vaccine for distribution in the United States. Each lot, or batch, undergoes testing before release by FDA.
FDA also inspects the manufacturing facilities on a regular basis and continues to monitor the safety of the vaccines once they are in use by the public.
The level of effectiveness can depend on the health and immune system of individuals and how well a particular season’s vaccine strains match circulating flu strains.
There is a possibility of a less than optimal match between the virus strains predicted to circulate and the virus strains that end up causing the most illness. However, even if the vaccine and the circulating strains are not an exact match, the vaccine may reduce the severity of the illness and help prevent influenza-related complications.
CDC recommends that everyone six months of age and older get vaccinated soon after vaccine becomes available. Those people for whom vaccination is particularly important include young children, the elderly, pregnant women, and those who suffer from a variety of chronic illnesses, including asthma, diabetes and heart disease.
Although the winter months are usually the peak month for flu activity, influenza disease in people typically begins appearing in October.
FDA’s website has specific information about each flu vaccine, including the FDA-approved age range of use. The website also provides the names of the influenza viruses included in this season’s vaccines and an up-to-date list of the number of vaccine lots that have been released for each manufacturer.
September 26, 2013
As the flu continues to make people sick—and even cause deaths—scammers are alive and well, promoting their fraudulent products to the unsuspecting public.
These scammers sell their products with claims to prevent, treat or cure the flu, even though they have not been tested and the Food and Drug Administration (FDA) has not approved them.
FDA warns consumers to steer clear of fraudulent flu products, which can be found online and in retail stores and may include products marketed as dietary supplements or conventional foods, drugs, nasal sprays and devices.
“As any health threat emerges, fraudulent products appear almost overnight,” says Gary Coody, R.Ph., FDA’s national health fraud coordinator. “Right now, so-called ‘alternatives’ to the flu vaccine are big with scammers.”
“These unproven products give consumers a false sense of security,” says Mary Malarkey, director of FDA’s Office of Compliance and Biologics Quality. “There is no need to buy a product that claims to be an alternative to the vaccine. Flu vaccine is still available and it’s not too late to get vaccinated.”
The best way to prevent the flu is by getting vaccinated every year, and the Centers for Disease Control and Prevention (CDC) recommends the vaccine for adults and children over six months of age. To find a list of clinics, supermarkets, pharmacies and other vaccine providers in your neighborhood, visit www.flu.gov, click on “Flu Vaccine Finder” and enter your zip code.
If you get the flu, two FDA-approved antiviral drugs—Tamiflu (oseltamivir) and Relenza (zanamivir)—are treatment options recommended by CDC. These prescription drugs can help fight the virus in your body and shorten the time you’re sick. They can also be used to help prevent the flu.
Types of Fraudulent Flu Products
There are no legally marketed over-the-counter (OTC) drugs to prevent or cure the flu. However, there are legal OTC products to reduce fever and to relieve muscle aches, congestion, and other symptoms typically associated with the flu.
But unapproved drugs (which sometimes are marketed as dietary supplements), conventional foods (such as herbal teas) or devices (such as air filters and light therapies) are fraudulent if they make flu prevention, treatment or cure claims, says Coody, “because they haven’t been evaluated by FDA for these uses.”
On Jan. 25, 2013, FDA and the Federal Trade Commission jointly sent a warning letter to the company that markets “GermBullet,” a nasal inhaler that makes flu prevention and treatment claims. The firm is required to remove the language in its labeling and advertising that violates federal law.
“If the company continues to sell the product without removing the deceptive and illegal language, the firm may be subject to enforcement action, which could include seizure of the products or other legal sanctions,” says FDA Regulatory Counsel Brad Pace, J.D., of FDA’s Health Fraud and Consumer Outreach Branch.
September 7, 2013
There is still time to protect your children and yourself from the flu in what remains of a severe influenza season.
“Everyone seems to know that the elderly are particularly vulnerable, but so too are children,” says William Rodriguez, M.D., Ph.D., a pediatrician at the Food and Drug Administration (FDA). “Severe complications are most common in children under age 2, and all children ages 6 months and older should be immunized.”
Rodriguez notes that in each of the last 10 flu seasons, between 43 and 153 children died from influenza in the U.S. An average 20,000 children a year under age 5 are hospitalized. So far this year, 16 deaths of children under age 18 have been reported to the Centers for Disease Control and Prevention (CDC).
Currently, 43 states are reporting widespread flu outbreaks, with the District of Columbia and remaining states—Washington, Oregon, California, Arizona, Montana, South Dakota and Missouri—reporting localized outbreaks.
People are generally immunized in the fall, but they can still get protection from the flu for what remains of the flu season—even though immunization takes several weeks to take effect. The season usually peaks in January or February, with some cases continuing into the spring and even beyond.
“This is particularly late in the flu season for very young children, because to optimize immune response, children between the ages of 6 and 35 months need two shots, four weeks apart, during their first season of vaccination,” said Rodriguez. “However, even one shot provides some protection, so even now there is time to get some benefit.”
March 14, 2013
When shopping for food, consumers can read food labels and choose foods that are lower in sodium.
The Nutrition Facts Label on food and beverage packages lists the “Percent Daily Value (%DV)” of sodium in one serving of a food, based on 2,400 mg per day. The %DV tells you whether a food contributes a little or a lot to your total daily diet. Foods providing 5%DV or less of sodium per serving are considered low in sodium and foods providing 20%DV or more of sodium per serving are considered high. But remember, all of the nutrition information on the label is based upon one serving of the food and many packaged foods have more than one serving.
It is recommended that consumers not exceed 100% of the daily value for sodium and those advised to limit intake to 1,500 mg per day should aim for about 65% of the daily value.
Consumers can also be aware of the sources of sodium in their diet. In a report issued in February 2012, CDC identified these 10 foods as the greatest sources of sodium:
- breads and rolls
- luncheon meat, such as deli ham or turkey
- poultry, fresh and processed—(Much of the raw chicken bought from a store has been injected with a sodium solution.)
- cheeseburgers and other sandwiches
- cheese, natural and processed
- pasta dishes
- meat dishes, such as meat loaf with gravy
- savory snack foods, such as potato chips, pretzels and popcorn
And how do you know how much sodium is in the food served at your favorite restaurant? Fasano notes that many chain restaurants are putting the nutritional content of their foods—including calories, fats, sodium and sugars—on their websites, or it’s available by asking for it.
FDA has also created a number of online resources to help consumers reduce their sodium intake. They include:
- A Sodium Reduction website provides links to resources on how to reduce the amount of sodium in your diet.
- A Sodium Education website offers consumer advice on how to use the Nutrition Facts Label to reduce sodium intake.
- The Spot the Block campaign challenges tweens from 9 to 13 to use the Nutrition Facts Label (the “block”) to make healthy food choices.
March 1, 2013
Most Americans consume way too much sodium, with salt (sodium chloride) being the most common form. That can be a serious health hazard, because excess sodium consumption contributes to the development and escalation of high blood pressure, a leading cause of heart disease, kidney disease, and stroke.
Research shows that Americans consume on average about 3,300 milligrams (mg) of sodium every day. The 2010 Dietary Guidelines for Americans recommends a reduction of sodium intake to less than 2,300 mg daily.
And those age 51 and older, and people of any age who are African-American or have high blood pressure, diabetes or chronic kidney disease should further reduce sodium intake to 1,500 mg daily. This amount meets your essential need for sodium. These populations comprise about half the U.S. population.
The Centers for Disease Control and Prevention (CDC) recently reported that children and adolescents consume about the same amount of sodium as adults and also risk developing high blood pressure. The researchers found that kids who consumed the most sodium faced double the risk of having high blood pressure, compared to those who took in less sodium. For overweight or obese children, the risk was more than triple.
“There has been a common misconception that sodium intake is just a concern for people with high blood pressure,” says Jessica Leighton, Ph.D., MPH, senior advisor for science in the Food and Drug Administration’s Office of Foods and Veterinary Medicine. “But it’s a health risk for all people, including children, as the CDC report shows.”
FDA is working on a number of fronts to help consumers manage their sodium intake.
February 21, 2013
About 10% of couples in the United States are affected by infertility. Both men and women can be infertile. According to the Centers for Disease Control, 1/3 of the time the diagnosis is due to female infertility, 1/3 of the time it is linked to male infertility, and the remaining cases of infertility are due to a combination of factors from both partners. For approximately 20% of couples, the cause cannot be determined.
February 19, 2013
When public health agencies recognized the signs of an emerging Salmonella outbreak in early September 2012, they could tell that the bacterium was contaminating a food popular with children.
And there aren’t many foods more loved by kids than peanut butter.
The outbreak of Salmonella Bredeney in peanut butter produced by one company has infected 41 people in 20 states, according to the Centers for Disease Control and Prevention (CDC). The majority of those who have fallen ill with diarrhea, fever and abdominal cramps are children under age 10.
More people would have fallen ill if not for fast action by federal and state public health agencies.
Those actions culminated on Nov. 26, 2012 with the Food and Drug Administration’s suspension of the food facility registration for Sunland Inc., of Portales, N.M. Sunland produced the peanut butter product linked to the outbreak—Trader Joe’s Creamy Salted Valencia Peanut Butter made with Sea Salt.
This is FDA’s first use of the suspension-of-registration authority since the authority became effective in July 2011. Provided by the FDA Food Safety Modernization Act, this authority enables FDA to suspend a facility’s registration when the agency has determined, in part, that a food that is manufactured, processed, packed, or held by a facility is likely to cause serious illness or even death.
Sunland will not be able to distribute food from this facility until the suspension is lifted.
Donald Zink, Ph.D., a senior science advisor at FDA, says that peanut butter is particularly vulnerable to Salmonella contamination. “Salmonella is in the soil and peanuts come right out of the ground,” he says.
Great care has to be taken to produce peanut butter in a “highly sanitized” environment, he says. Special protections have to be in place to make sure the finished product isn’t contaminated after the nuts are roasted, the only “kill step” for the Salmonella.
However, FDA inspectors report finding insanitary conditions at Sunland, including conditions that likely resulted in cross-contamination between raw and roasted peanuts, such as unclean equipment that comes into contact with food, employees who didn’t wash their hands or wear clean gloves, and the use of totes to transport both raw and roasted peanuts without any cleaning or sanitizing process.