Storage and Handling for Dengue Vaccine

Sanofi-Pasteur will stop manufacturing its dengue vaccine for children. The manufacturer is discontinuing the vaccine citing a lack of demand in the global market to continue production of this vaccine. CDC, in collaboration with the Puerto Rico Department of Health, will continue alerting health professionals about the discontinuation of Dengvaxia and the use of this vaccine as recommended by the Advisory Committee on Immunization Practices (ACIP). Dengvaxia is safe and effective when administered as recommended. There are two other dengue vaccines either approved or in late stages of development. However, they are not currently available in the United States. People can continue to protect themselves and their families from dengue by preventing mosquito bites and controlling mosquitoes in and around their homes.

Proper vaccine storage and handling practices play an important role in protecting people and communities from vaccine-preventable diseases. For general recommendations and guidance, see Vaccine Storage and Handling. Provided below is guidance specific to the dengue vaccine.

Storage and Handling

Store lyophilized vaccine antigen and saline diluent in a refrigerator at 2°C to 8°C (36°F to 46°F).
Do not freeze.
Protect from light.
Do not use after the expiration date shown on the vial labels of the lyophilized vaccine antigen and saline diluent.
After reconstitution, administer Dengvaxia immediately or store refrigerated at 2°C to 8°C (36°F to 46°F) and use within 30 minutes.
Discard reconstituted vaccine if not used within 30 minutes.

Preparation

The package contains a vial of lyophilized vaccine antigen and a vial of saline diluent (0.4% NaCl).

After removing the “flip-off” caps, cleanse the lyophilized vaccine antigen and diluent vial stoppers with a sterile alcohol swab. Do not remove the vial stoppers or metal seals holding them in place.
To reconstitute Dengvaxia, use a sterile needle and syringe to withdraw 0.6 mL from the diluent vial and inject it into the vial of lyophilized vaccine antigen. Swirl the vial gently.
Changing needles between withdrawing the vaccine from the vial and injecting it into a recipient is not necessary unless the needle has been damaged or contaminated.
After reconstitution, the suspension is colorless and may develop trace amounts of white to translucent endogenous proteinaceous particles.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard the vial if the solution is cloudy or contains particles other than trace amounts of white to translucent particles.
Dengvaxia should not be mixed in the same syringe with other parenteral products.

Resources

See the Dengvaxia Package Insert for additional information and ingredient list.
Vaccine Storage and Handling Toolkit – This toolkit is a comprehensive resource for providers on vaccine storage and handling recommendations and best practice strategies. It includes considerations for equipment, both storage units and temperature monitoring devices, strategies for maintaining the cold chain, routine storage and handling practices, inventory management and emergency procedures for protecting vaccine inventories.