This season, consider a cell-based flu vaccine produced using modern biotechnology. It is not produced in chicken eggs and contains no antibiotics or preservatives.1,2
- An advanced scientific process that uses mammalian cells instead of fertilized chicken eggs to produce the flu vaccine3
- Technology that is also used to produce the polio, smallpox, rubella, and chickenpox vaccines3
Benefits of Cell-Culture Technology
- Flu vaccine production is not limited by the supply of eggs because it is not manufactured in eggs1
- Cell culture production has the potential to yield large quantities of vaccine quickly. This is beneficial in the event of a pandemic3
- Modern cell-culture technology allows rapid initiation of influenza vaccine production within sterile, closed system bioreactors without using antibiotics. No antibiotics need to be added to
The FLUCELVAX® production facility, based in Holly Springs, North Carolina, is the first of its kind in the United States.4 FLUCELVAX® is made in the US.
FLUCELVAX® is manufactured differently, but it contains the same seasonal flu strains as a conventional trivalent flu vaccine.1
Presentation, Storage and Handling
FLUCELVAX® is supplied in a carton containing ten 0.5 mL single-dose syringes without needles:
- Carton NDC number: 62577-614-01
- Pre-filled syringe NDC number: 62577-614-11
The tip caps of the pre-filled syringes may contain natural rubber latex. The syringe and syringe plunger stopper are manufactured without natural rubber latex.
Store this product refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. Do not use after the expiration date.
Important Safety Information
- Do not administer FLUCELVAX® to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine.
Warnings & Precautions
- Guillain-Barré Syndrome (GBS): 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.
- Latex: The tip caps of the pre-filled syringes may contain natural rubber latex which may cause allergic reactions in latex-sensitive individuals.
- Preventing and Managing Allergic Reactions: Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
- Syncope: Syncope (fainting) can occur in association with administration of injectable vaccines, including Flucelvax. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope by maintaining a supine or Trendelenburg position.
- Altered Immunocompetence: After vaccination with FLUCELVAX®, immunocompromised individuals, including those receiving immunosuppressive therapy, may have a reduced immune response.
- Limitations of Vaccine Effectiveness: Vaccination with FLUCELVAX® may not protect all vaccine recipients against influenza disease.
Most Common Adverse Reactions
- The most common (≥10%) solicited adverse reactions occurring in adults 18-64 years of age within 7 days of vaccination with FLUCELVAX® were pain at the injection site, erythema at the injection site, headache, fatigue, myalgia and malaise. The most common (≥10%) solicited adverse reactions occurring in adults ≥65 years of age within 7 days of vaccination were erythema at the injection site, fatigue, headache and malaise.
- FLUCELVAX® (package insert). Cambridge, MA.
- FDA approves first seasonal influenza vaccine manufactured using cell culture technology (news release). Silver Spring, MD: U.S. Food and Drug Administration; November 20, 2012.
- Centers for Disease Control and Prevention. Cell-based flu vaccines. www.cdc.gov/flu/protect/vaccine/cell-based.htm. Accessed June 18, 2014.
- Seqirus Holly Springs cell culture influenza vaccine manufacturing facility first to be declared pandemic ready by US government [news release]. Cambridge, MA: Seqirus.; December 12, 2011
- Gregersen JP, Schmitt HJ, Trusheim H, Broker M. Safety of MDCK cell culture-based influenza vaccines. Future Microbiol 2011;6(2):143–152.