FDA Approves Flu Vaccine Nasal Spray(for kids, too)

If you’re between the ages of 5 and 49, you have a less painful option for the influenza virus this season: Instead of getting an injection, you can choose to have the vaccine sprayed in your nose. The Food and Drug Administration recently gave final product approval for Flumist, an intranasal flu vaccine that will appeal to many who detest the needle that, until now, was the only mode of delivery. Developed by Med Immune, a Maryland-based biotechnology company, Flumist has been shown to be comparable to the current injectable vaccine in its ability to guard against the flu. Thus, the major benefit for the new form is the ease of administration. MedImmune, along with its marketing partner Wyeth, hopes that this benefit is incentive enough to make Flumist a popular choice. The company will be producing four to five million doses of the vaccine this year, according to Jamie Lacey, associate director of public relations at MedImmune. While many emerging diseases like the West Nile Virus and Severe Acute Respiratory Syndrome (SARS) get a lot more media attention, the annual flu quietly claims far more lives. During an average influenza season, approximately 20,000 deaths and approximately 114,000 hospitalizations result from influenza-related complications, according to the American Social Health Association, which runs the National Immunization Information Hotline. In an average year, the flu causes Americans to miss 70 million work days and 38 million school days. While Flumist is an option for the 160 million healthy people in the U.S. between the ages of 5 and 49, it has not been approved for the age groups most at risk — infants and the elderly, whose immune systems may not be strong enough to ward off the virus. MedImmune is developing clinical trials to test the vaccine for children under 5 and adults ages 50-64, Lacey says. “Flumist is designed for healthy people who otherwise don’t want their lives interrupted by the flu,” she says. The traditional flu shot is approved for people over the age of 6 months. Besides the approved age groups, the major difference between Flumist and the injectable vaccine is that unlike the injectable form, Flumist contains a live but weakened form of the influenza virus. The injectable vaccine contains an inactive, or non-replicating, form of the virus. Typically, oral — or in this case intranasal — vaccines have to be live, or they “won’t take,” says Dr. Monica Shah, a specialist in infectious diseases at Harlem Hospital. (The oral polio vaccine which is no longer routinely used, for example, contains the weakened live virus. The injectable form of the polio vaccine, on the other hand, contains the inactive virus). “With some major exceptions, injectable vaccines can get away with the inactive form,” Dr. Shah says. “When you give a vaccine, you’re trying to induce an immunological response from the patient’s own body,” Dr. Shah explains. Local antibodies are made in the respiratory tract and also systemically, in the blood. A vaccine that is sprayed into the nose can illicit a local and a systemic immunologic response. Because it is an actual live virus, albeit a severely weakened one, it is not recommended for use on people with compromised immune systems, Dr. Shah says. A dose of Flumist will cost $46. Flu shots typically cost $5-$10. Children ages 5-8, who have not been vaccinated in the past, will require two doses of the vaccine, 60 days apart. MedImmune is working with insurance companies to negotiate product coverage, Lacey says. Currently, only healthcare providers can administer Flumist. But to increase availability, she says, “We are looking to have pharmacists administer it.” The National Immunization Information Hotline is operated by the American Social Health Administration for the Centers for Disease Control. Information services are offered 8am-11pm in English 1-800-232-2522, Spanish 1-800-232-0233, and TTY 1-800-243-7889 for the deaf and hard of hearing. NIIH’s website also contains flu shot locations and information at www.vaccines.ashastd.org.

TRUE or FALSE: FLU FACTS: The Centers for Disease Control has a wealth of flu-related information on its website (www.vaccines.ashastd.org), including the following “myths debunked”:

• “Even if I get flu vaccine, I can still get a mild case of the flu.” TRUE. Flu vaccine protects most people from the flu. A person who receives flu vaccine can get the flu but will be far less sick than someone who has flu and has not received flu vaccine. Flu vaccine does not protect you from other viruses that sometimes feel like the flu.

• “The side-effects are worse than the flu.” FALSE. The worst side-effect you’re likely to get with injectable vaccine is a sore arm. The nasal-spray flu vaccine might cause nasal congestion, runny nose, sore throat, or cough. The risk of allergic reaction to flu vaccine is far less than the risk of severe complications from flu itself.

• “Not everyone can take flu vaccine.” TRUE. You might not be able to get this protection if you are allergic to eggs (used in making the injectable vaccine), are very sick with a high fever, or have had a severe reaction to the flu vaccine in the past.

• “Only older people need flu vaccine.” FALSE. Adults and children with conditions like asthma, diabetes, heart disease, and kidney disease need to get flu vaccine. And people who are active and healthy can also benefit from the protection the flu vaccine offers.

• “You must get a flu vaccine before December.” FALSE. Flu vaccine can be given before or during the flu season. While the best time to get flu vaccine is October or November, getting vaccinated in December or later can still protect you against the flu.


REACTIONS: SHOTS or SPRAY? From the CDC’s website (www.vaccines.ashastd.org): The flu shot uses an inactivated or “killed” vaccine. This vaccine can’t give you the flu. However, flu vaccine, like other vaccines, can occasionally cause a reaction. Feeling some response to the shot is not unusual. The vaccine acts to stimulate your immune system and prepare you to resist infection. You may feel your body's protective activity through mild symptoms. Also, some people may experience symptoms of mild sickness after getting a flu shot, but these symptoms are not necessarily connected to the shot. If you do experience a reaction to the flu shot, it is usually local and mild — redness, soreness, and swelling at the site of the injection. Usually if you have this kind of reaction you find that it doesn't interfere with normal daily activity and does not make you feel sick. Fever and more generalized aches and pains can occur but are even less likely; those who are receiving the vaccine for the first time ever are most likely to have this type of reaction. You feel the symptoms, if any, within a few hours of the injection. The symptoms typically cause discomfort, not sickness, and last for a day or two.

The nasal-spray flu vaccine may cause nasal congestion, runny nose, sore throat, and cough — symptoms of a cold. Mild reactions to the nasal mist vaccine are not unexpected and should be brief.

Treating a Mild Reaction To treat either of these mild reactions to a flu shot, use over-the-counter medication only for the symptoms you have (fever, swelling, nasal congestion, cough, and aches and pains). Do not give aspirin to children; use another medication to relieve their fever or aches and pains. If fever is high or symptoms persist or are severe, talk to your doctor or healthcare professional.