Serum Institute Of India Ltd.

1. 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. There is no upper age limit.

2. How often should the nasal-spray flu vaccine LAIV (NASOVAC) be given ?
A single dose of 0.5 ml of LAIV should be given intra-nasally to children of age 3 years & above, to adults and elderly 0.25 ml is to be sprayed in each nostril.
Under no circumstances NASOVAC should be injected.

3. Is the nasal-spray flu vaccine LAIV (NASOVAC) effective ?
Yes, it is a very effective vaccine as observed in our studies . There have been various other studies on live attenuated nasal-spray flu vaccines in the world which have shown that they give protection to the majority of the people.
Their use in USA and Russia for the last many years has also shown similar results .

4. Can the nasal spray flu vaccine give you the swine flu ?
No, the nasal spray flu vaccine cannot give you swine flu. The nasal spray flu vaccine contains attenuated (weakened) live viruses. The weakened viruses are temperature sensitive and cold-adapted, which means they can grow only at the cooler temperatures found within the nose and will not cause an infection in the lungs .

5. What are the advantages of the nasal-spray flu vaccines LAIV ?
The nasal spray flu vaccines are highly safe and offer protection against influenza viruses. Since they mimic the natural route of infection, they also give protection against slightly changed viruses.
LAIVs have been shown to exhibit a phenomenon called ‘herd immunity’, which means, even the unvaccinated people who come in contact with vaccinated people may also get some protection. This has been seen especially with school children who have received 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.

6. 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 / side effects. 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.

7. What side effects are associated with the nasal-spray flu vaccine LAIV (NASOVAC) ?
Some children & young adults between 3-17 years of age and adults have reported experiencing mild reactions after receiving nasal spray flu vaccine such as sneezing, runny nose, nasal congestion or cough, chills, tiredness/weakness, sore throat and headache.
These side effects are mild and short-lasting (1 to 2 days), especially when compared to symptoms of influenza infection. They usually require no medication. There are no serious side effects.

8. 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 previous 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 ingredients like gelatin.

9. Are there any precautions and warnings before use of NASOVAC ?
Caution should be exercised in people with a medical conditions like -
• chronic heart or lung disease, such as asthma or reactive airways disease
• uncontrolled diabetes or kidney failure
• illnesses that weaken the immune system.
Administration of NASOVAC to such 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 or people who take medications that can weaken the immune system [ for example chronic corticosteroid therapy ] .
Antibody response in such patients may be insufficient.

10. Are there any contraindications to give LAIV (NASOVAC) to breastfeeding mothers ?
It is not known whether vaccine virus is released in mother’s milk. Therefore, administration of NASOVAC should be based on careful consideration of potential benefits and risks. Besides, a close proximity of mother and child also needs consideration.

11. Can the nasal spray flu vaccine cause Guillain-Barré syndrome (GBS) ?
No GBS is reported after immunization with intra nasal LAIV.

12. Can the nasal-spray flu vaccine LAIV (NASOVAC) be given to patients when they are ill ?
The nasal-spray flu vaccine LAIV (NASOVAC) can be given to people with minor illnesses (e.g., diarrhea or mild upper respiratory tract infection without fever). However, if nasal congestion is present that might limit delivery of the vaccine to the nasal lining, in which case delaying of vaccination until the nasal congestion is reduced, should be considered.
If the pandemic situation allows, immunisation should be postponed in patients with severe febrile illness or any acute infection.

13. Can people receiving the nasal-spray flu vaccine LAIV (NASOVAC) pass the vaccine viruses to others ?
In clinical studies, transmission of vaccine virus to close contacts has occurred in extremely rare cases and it was seen to be completely harmless.

14. 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 persons with severely weakened immune systems ( those being cared for in a protective environment for example, people with hematopoietic stem cell transplants ) should not get LAIV (NASOVAC). It is an extreme precaution only.
• People who have contact with persons with low degree of immunosuppression for example, people with diabetes, people with asthma taking corticosteroids, or people infected with HIV can get LAIV (NASOVAC).

15. 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 have taken inactivated influenza vaccine (the flu shot) last year can get the nasal-spray flu vaccine LAIV (NASOVAC) this year.

16. How long does it take for the vaccine to give protection ?
Any vaccine requires approximately 3 weeks to produce antibodies against the disease for which the said vaccine is administered. Similarly nasal spray flu vaccines also require approximately 3 weeks to offer optimum protection.

17. Can a person get swine flu infection within 3 weeks after being vaccinated with nasal spray LAIV ?
Like any other vaccine, during 3 weeks after vaccination, you remain vulnerable to swine flu infection.

18. If a person gets severe flu-like symptoms within 3 weeks of vaccination, is it a vaccine reaction or swine flu/seasonal flu infection? What should we do ?
The vaccine does not cause severe flu-like symptoms. If you get severe flu like symptoms immediately or within three weeks from vaccination , it could be either because of already acquired natural infection before vaccination or natural infection occurring during the three week period after vaccination.
Please consult your doctor Immediately because it could be influenza (either swine or seasonal infection). Don’t ignore it thinking that it is a reaction to the vaccine taken. As you know, swine flu can be fatal.

19. Can a person use antiviral drugs like Tamiflu / Fluvir if he is 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, such person should get revaccinated.
( Please note that the antiviral drugs will kill the vaccine viruses that were administered to give protection against the real swine flu virus.)

20. Can a person take the nasal-spray flu vaccine LAIV (NASOVAC) if he is already taking influenza antiviral medications ?
If a person is taking an influenza antiviral drug (including Tamiflu , Fluvir, Relenza etc. ), then the nasal spray flu vaccine should not be given until 48 hours after the last dose of the influenza antiviral medication was given.

21. 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.
There is no data on co-administration of NASOVAC with other vaccines or intra nasal medicines. However, if co-administration with another vaccine is necessary, vaccination may be carried out. The immunological response to the vaccine may be lower if the patient is undergoing immunosuppressant treatment.

22. If adults and elderly are taking aspirin therapy, can they take the vaccine ?
The restriction of aspirin use is only for children and adolescents.

23. How long does the nasal-spray flu vaccine LAIV give protection ?
This vaccine gives protection at least for a year.

24. 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).

25. What personal protective equipment is recommended for those who are administering LAIV (NASOVAC) ?
Personal protective equipment like gloves and masks are not required.

26. 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, including Mercury based preservatives.

Issued in the public interest by:
Serum Institute of India Ltd,
212/2, Hadapsar,
Pune-411028, INDIA