Serum Institute of India Ltd. The Nasal-Spray Flu Vaccine (Live Attenuated Influenza Vaccine [LAIV])

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1 Nasovac The Nasal-Spray Flu Vaccine (Live Attenuated Influenza Vaccine [LAIV]) Questions & Answers Who can be vaccinated with the nasal-spray flu vaccine LAIV (Nasovac )? LAIV (Nasovac ) is approved for use in healthy people of the age 3 years and above. How often should the nasal-spray flu vaccine LAIV (Nasovac ) be given? A single dose of 0.5 ml of LAIV should be given intranasally to children of age 3 years and above, adults and elderly. Is the nasal-spray flu vaccine LAIV (Nasovac ) safe? Yes, it is a very safe vaccine. It does not cause any serious reactions or any long-lasting reactions. Such vaccines have been in use in Russia and USA for last many years, where millions of people have received them without any safety concerns. Is the nasal-spray flu vaccine LAIV (Nasovac ) effective? Yes, it is a very effective vaccine. There have been numerous studies on nasalspray flu vaccines which have shown that they give protection to the majority of the people. Their use in Russia and USA for last many years has also shown the same. What are the advantages of the nasal-spray flu vaccine LAIV (Nasovac )? 31 July 2010 Page 1 of 9

2 The vaccines are highly safe and give protection against the virus. Since they mimic the natural route of infection, they also give protection against slightly changed viruses. They also show a phenomenon called herd immunity, which means even the unvaccinated people in contact with vaccinated people may also get protection. This has been seen especially with school children who when got vaccines, their family members were also protected. Since the vaccines induce immunity in the nose, apart from immunity in blood, the protection is by two way defense. Moreover, it is a painless administration. Who should not be vaccinated with the nasal-spray flu vaccine LAIV (Nasovac )? Children less than 3 years of age Children less than 5 years who have a history of recurrent wheezing Children or adolescents receiving aspirin People who have taken influenza vaccine earlier and have a history of Guillain-Barré Syndrome that occurred after receiving influenza vaccine Pregnant women People who have a history of allergy to chicken eggs or who are allergic to any of the nasal spray vaccine components. Are there any precautions and warnings before use of Nasovac? Caution should be exercised in people with a medical condition that places them at high risk for complications from influenza, including those with chronic heart or lung disease, such as asthma or reactive airways disease; people with medical conditions such as diabetes or kidney failure; or people with illnesses that weaken the immune system, or who take medications that can weaken the immune system. If the pandemic situation allows, immunisation should be postponed in patients with severe febrile illness or acute infection. 31 July 2010 Page 2 of 9

3 Nasovac should under no circumstances be injected. Administration of Nasovac, to immunocompromised persons should be based on careful consideration of potential benefits and risks. There is no clinical data available on the use of this vaccine in immunocompromised persons. Antibody response in such patients may be insufficient. The safety of Nasovac in individuals with underlying medical conditions that puts them at risk of complications following wild-type influenza infection has not been established. Nasovac should not be administered unless the potential benefit outweighs the potential risk. Nasovac may not protect all individuals receiving the vaccine. Are there any contraindications to giving breastfeeding mothers LAIV (Nasovac )? It is not known whether Nasovac is passed through human body and into mother s milk. Therefore, as some viruses are excreted in human milk and additionally, because of the possibility of shedding of vaccine virus and the close proximity of a nursing infant and mother, caution should be exercised if Nasovac is administered to nursing mothers. Administration of Nasovac should be based on careful consideration of potential benefits and risks. Can the nasal spray flu vaccine cause Guillain-Barré syndrome (GBS)? No, the nasal-spray flu vaccine LAIV (Nasovac ) does not cause GBS. Can the nasal-spray flu vaccine LAIV (Nasovac ) be given to patients when they are ill? 31 July 2010 Page 3 of 9

4 The nasal-spray flu vaccine LAIV (Nasovac ) can be given to people with minor illnesses (e.g., diarrhea or mild upper respiratory tract infection with or without fever). However, if nasal congestion is present that might limit delivery of the vaccine to the nasal lining, then delaying of vaccination until the nasal congestion is reduced should be considered. Can people receiving the nasal-spray flu vaccine LAIV (Nasovac ) pass the vaccine viruses to others? In clinical studies, transmission of vaccine viruses to close contacts has occurred only rarely. The current estimated risk of getting infected with vaccine virus after close contact with a person vaccinated with the nasal-spray flu vaccine is low (0.6%-2.4%). Because the viruses are weakened, infection does not result in influenza illness symptoms. Can people who are in close contact with patients having weakened immune systems get the nasal-spray flu vaccine LAIV (Nasovac )? People who are in contact with others with severely weakened immune systems when they are being cared for in a protective environment (for example, people with hematopoietic stem cell transplants), should not get LAIV (Nasovac ). People who have contact with others with lesser degrees of immunosuppression (for example, people with diabetes, people with asthma taking corticosteroids, or people infected with HIV) can get LAIV (Nasovac ). What side effects are associated with the nasal-spray flu vaccine LAIV (Nasovac )? Some children and young adults 2-17 years of age have reported experiencing mild reactions after receiving nasal spray flu vaccine, including runny nose, nasal congestion or cough, chills, tiredness/weakness, sore throat and headache. Some adults have reported runny nose or nasal congestion, cough, chills, tiredness/weakness, sore throat and headache. These side effects are mild and 31 July 2010 Page 4 of 9

5 short-lasting, especially when compared to symptoms of influenza infection. There are no serious side effects. Can people who received inactivated influenza vaccine (the flu shot) last year get the nasal-spray flu vaccine LAIV (Nasovac ) this year? Yes, people who got inactivated influenza vaccine (the flu shot) last year can get the nasal-spray flu vaccine LAIV (Nasovac ) this year. How long does it take for the vaccine to give protection? It takes at least 3 weeks for the vaccine to induce protective response in your body. In that case, can you catch swine flu infection within 3 weeks after vaccination? Yes, like any other vaccine, during 3 weeks after vaccination, you remain vulnerable to swine flu infection. Ok. If I get severe flu-like symptoms within 3 weeks of vaccination, is it a vaccine reaction or swine flu/seasonal flu infection? The vaccine may cause flu-like symptoms which are very mild. If you get severe symptoms, please consult your doctor because it could be influenza (either swine or seasonal infection). Don t ignore it thinking that it is a reaction. As you know, swine flu can actually kill patients. What if I get severe flu-like symptoms within 5-6 days of vaccination, isn t it vaccine reaction? As said above, the vaccine generally causes flu-like symptoms which are very mild. If you get severe symptoms, please consult your doctor because it could be influenza (either swine or seasonal infection). 31 July 2010 Page 5 of 9

6 In case of swine or seasonal flu, even if people catch infection, they show symptoms after 1-5 days. This period is called incubation period during which the virus is growing in your body. But in this period, they will look perfectly healthy and may receive the H1N1 vaccine. After receiving the vaccine, they may show symptoms of influenza. Since the symptoms will start after receiving the vaccine, people may think it as a vaccine reaction. Please don t ignore severe flu-like symptoms thinking that it is a reaction. As you know, swine flu can actually kill patients. But can I use antiviral drugs like Tamiflu/Fluvir if I am confirmed to have swine flu? You must take antiviral drugs if you are diagnosed with swine flu, as prescribed by your doctor. If the antiviral drugs are used within two weeks of getting the nasal spray flu vaccine, that person should get revaccinated. (The antiviral drugs will have killed the vaccine viruses that are supposed to cause the immune response against those viruses.) Can I take the nasal-spray flu vaccine LAIV (Nasovac ) if I am already taking influenza antiviral medications? If a person is taking an influenza antiviral drug (including Tamiflu or Relenza ), then the nasal spray flu vaccine should not be given until 48 hours after the last dose of the influenza antiviral medication was given. Can other medicines and vaccines be used together with the nasal-spray flu vaccine LAIV (Nasovac )? As said above, children and adolescents taking aspirin therapy should not get the vaccine. 31 July 2010 Page 6 of 9

7 There are no data on co-administration of Nasovac with other vaccines. However, if co-administration with another vaccine is necessary, vaccination may be carried. The side effects may be intensified. There are no data regarding co-administration of Nasovac with other intranasal medicines. The immunological response to the vaccine may be lower if the patient is undergoing immunosuppressant treatment. If adults and elderly are taking aspirin therapy, can they take the vaccine? 31 July 2010 Page 7 of 9

8 The restriction of aspirin use is only for children and adolescents. Can the nasal spray flu vaccine give you the swine flu? Unlike the flu shot, the nasal spray flu vaccine does contain live viruses. However, the viruses are attenuated (weakened) and cannot cause flu illness. The weakened viruses are cold-adapted, which means they can grow only at the cooler temperatures found within the nose. The viruses cannot infect the lungs or other areas where warmer temperatures exist. How long does the nasal-spray flu vaccine LAIV give protection? This vaccine gives protection at least for a year. How is the nasal-spray flu vaccine LAIV (Nasovac ) stored? The nasal-spray flu vaccine LAIV (Nasovac ) must be stored in a refrigerator at 2-8 C (35-46 F). What personal protective equipment is recommended for health-care workers who are giving LAIV (Nasovac )? Personal protective equipment (gloves and masks) are not needed. Does the nasal-spray flu vaccine LAIV (Nasovac ) contain thimerosal? No, the nasal-spray flu vaccine LAIV (Nasovac ) does not contain thimerosal or any other preservative. Issued in the public interest by: Serum Institute of India Ltd, 212/2, Hadapsar, 31 July 2010 Page 8 of 9

9 Pune , INDIA 31 July 2010 Page 9 of 9