Generic Name: influenza virus vaccine
Date of Approval: November 20, 2012
Company: Novartis Vaccines and Diagnostics, Inc.
Treatment for: Prevention of Influenza
FDA Approves Flucelvax
The U.S. Food and Drug Administration (FDA) approved the use of Flucelvax (Influenza Virus Vaccine), the first cell-culture-derived vaccine, for individuals 18 years of age and older.
Flucelvax utilizes full-scale cell-culture manufacturing technology, an alternative production method to traditional egg-based production. Cell-culture technology utilizes a well-characterized mammalian cell line rather than chicken eggs to grow virus strains.
The production occurs in a closed, sterile, controlled environment, which significantly reduces the risk of potential impurities. Flucelvax does not contain any preservatives, such as thimerosal, or antibiotics.
Cell-culture technology enables rapid response to urgent public health needs such as a pandemic within weeks. Traditional influenza vaccine production depends on a large number of fertilized chicken eggs to grow virus strains and requires many months for organization of egg supplies, virus incubation and actual production before the vaccine is delivered to physicians or pharmacies. Cell-culture technology is successfully used to manufacture other vaccines, including those distributed during the H1N1 pandemic, as well as vaccines for polio, rubella and hepatitis A.
Indication and Important Safety Information
Flucelvax is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. Flucelvax is approved for use in persons 18 years of age and older.
Do not administer Flucelvax to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine.
If GBS has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give Flucelvax should be based on careful consideration of the potential benefits and risks.
The tip caps of the pre-filled syringes may contain natural rubber latex which may cause allergic reactions in latex-sensitive individuals.
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
After vaccination with Flucelvax,immunocompromised individuals, including those receiving immunosuppressive therapy, may have a reduced immune response.
Vaccination with Flucelvax may not protect all vaccine recipients against influenza disease.
What is Flucelvax?
Flucelvax is a vaccine that helps protect against influenza. Flucelvax is for people aged 18 and older. Vaccination with Flucelvax may not protect all people who receive the vaccine.
How does Flucelvax work?
Flucelvax contains viruses that are inactive (“dead”). It will not cause influenza. However, Flucelvax, like other flu vaccines, can help the body mount a defense with antibodies against similar viruses. If you come in contact with these influenza viruses, these antibodies can help defend against the flu. Because viruses are constantly changing, the Food and Drug Administration (FDA) determines the three viruses most likely to cause illness in the coming season. Flucelvax contains those three viruses. Flucelvax is for people aged 18 and older.
Who should not get Flucelvax?
- You should not get Flucelvax if you have had a severe allergic reaction to any of the ingredients in the vaccine
Who may not be able to get Flucelvax?
Tell your health care provider if you:
- have ever had Guillain-Barré Syndrome (severe muscle weakness) after getting a flu shot
- have an allergy to rubber latex
What if I have a weakened immune system?
Tell your health care provider if you have problems with your immune system, as your immune response to the vaccine may be less.
Flucelvax side effects
The most common side effects of Flucelvax are:
- pain or redness where you got the shot
- muscle aches
- feeling unwell (malaise)
These are not all of the possible side effects of Flucelvax. You can ask your health care provider for a complete list of possible side effects.
Ask your health care provider for advice about any side effects that concern you. You may report side effects to the Vaccine Adverse Event Reporting System (VAERS) by calling 1-800-822-7967 or by going to http://vaers.hhs.gov.
See also: Side effects (in more detail)