Vaxelis painless hexavalent vaccine

Vaxelis painless hexavalent vaccine

Vaxelis vaccine as its name implies is a hexavalent vaccine. It protects against diseases diphtheria, pertussis, tetanus, hepatitis B, IPV and Haemophilus influenzae type b. It contains purified pertussis toxin and cell components so it is a relatively painless vaccine. 

As indicated in above table it contains diphtheria toxoid 15 LF, 

tetanus toxoid 5 Lf, 

pertussis toxoid 20 mcg and filamentous haemaggutinin 20 mcg, Pertactin RRN 3 mcg, FIM type 2 and 3 5 mcg, 

Poliovirus inactivated type 1 29 DU, poliovirus inactivated type 2 7 DU, poliovirus inactivated type 3 26 DU, 

Haemophilus influenzae type b polysaccharide 3 mcg in conjugated form to 50 mcg Neisseria meningitidis outer membrane protein, 

other inactive ingredients include aluminium salt as adjuvant 0.319 mcg, 

Other ingredients per 0.5 mL dose include <0.0056% polysorbate 80 and the following residuals from the manufacturing process: ≤14 mcg formaldehyde, ≤50 ng glutaraldehyde, ≤50 ng bovine serum albumin, <5 ng of neomycin, <200 ng streptomycin sulfate, <25 ng polymyxin B sulfate, ≤0.125 μg ammonium thiocyanate and ≤0.1 mcg yeast protein

 It contains water to make a total volume of 0.5 ml. Effectively it is DTaP-IPV-HiB-Hepatitis B vaccine.

ComponentsQuantity per 0.5 ml
Active ingredients
Diphtheria Toxoid15 Lf
Tetanus toxoid5 Lf
Bordetella pertussis antigens Pertussis toxoid Filamentous haemagglutininPertussis toxoid PRNFIM 2 and 3   20 mcg20 mcg3 mcg5 mcg
Poliovirus inactivated Type 1 (Mahoney) Type 2 (MEF-1) Type 3 (Saukett)  29 DU 7 DU 26 DU
Hepatitis B surface antigens10 mcg
Haemophilus influenzae type b polysaccharide (PRP) Conjugated3 mcg
Inactive ingredients:
Aluminium salts0.319 mcg
NeomycinFormaldehydeGlutaraldehydeBovine serum albumin < 5 nanograms< 14 mcg< 50 ng< 50 ng
Water for injectionUp to 0.5 ml

Contents of Vaxelis  vaccine

How is this Vaxelis available?

Vaxelis Vaccine is available as an injection liquid form. It is a single dose packet. It comes in a single dose vial form with 10 vials in a packet. Generally a needle for intramuscular injection is not included in the packet. The liquid for injection looks hazy and colourless normally.

How is Vaxelis vaccine stored?

Vaxelis vaccine is stored at 2-8 degree Celsius. The temperature range should be strictly maintained with the help of cold chains at all stages of transport and storage. The vaccine should not be accidentally frozen. If accidentally frozen, the vaccine should be discarded and not used.

How is Vaxelis vaccine given?

Vaxelis vaccine is given by injection. The dose of this vaccine is  0.5 ml liquid. The injection is given with a syringe attached to a needle. It is generally given on an anterolateral aspect of the thigh. It should be given with all safety injection precaution protocols. The disposable are discarded as per bio-medical waste management protocols.

At what age is the Vaxelis vaccine given?

Vaxelis vaccine is given at age 6-10-14 weeks or at 2, 4,6 months followed by a booster of DTaP-HiB-IPV at 18 months. If penta valent booster DTaP-HiB-IPV is not available for 18 months then Vaxelis can be safely used for a booster too.

Otherwise booster at 18 months is done with pentaxim vaccine and at 5 years Tetraxim can be used.

Safety with other vaccine:

Vaxelis vaccine can be safely given with BCG, MMR, Measles, yellow fever, pneumococcal vaccine, rotavirus vaccine and most other vaccines.

This vaccine should not be mixed with other medicines or vaccines while injecting.

Separate syringes should be used to inject and separate the location of the body preferably a separate limb.

How does Vaxelis vaccine work?

Vaxelis vaccine when given as indicated doses and schedule, it protects from diphtheria, tetanus, pertussis, polio, hepatitis B and Haemophilus influenzae type b. It contains inactivated killed components of all these bacteria or viruses. It is active method immunization. When injected to the child the immune system of the child recognizes the antigens as foreign antigens and immune response is induced against the antigens. It contains conjugated Hamophilus polysaccharide antigens. Conjugated forms help to boost the immune response and also the long term immunity is induced. The pertussis components help to enhance the immune response against diphtheria and tetanus. Additionally aluminium salt in it helps the immune system to recognize the antigens more efficiently. This vaccine is safe below age 7 years. This vaccine contains all 3 poliovirus strains in inactivated form which when injected are very efficient in inducing the immunity.

What are the side effects of Vaxelis vaccine?

Vaxelis vaccine contains acellular pertussis components in purified form so the side effects are relatively less with the Vaxelis vaccine when compared to DPT whole cell killed pertussis containing vaccine.

· Very common side effects are:

1. Loss of appetite may occur after vaccination but usually improves by its own.

2. Crying may last for a few hours and usually subsides by itself.

3. Sleepiness may occur after vaccination in some children may subside with time on its own.

4. Vomiting may occur after vaccination. Mostly subsides on its own. It can be managed with increasing the frequency of the feeding and if needed oral medication like ondansetron.

5. Pain, redness and swelling at the injection site can occur may last for 1-3 days, usually less severe than whole cell pertussis containing vaccines. It can be easily managed at home with oral medicine like paracetamol and local cold fomentation.

6. Irritability.

7. Fever: May last for 1-3 days. Usually mild to moderate grade. It can be easily managed at home with oral medication like paracetamol.

· Common side effects are:

1. Abnormal crying.

2. Diarrhea can be easily managed with increasing frequency of feeding and oral rehydration solution. It usually subsides on its own.

3. Injection site hardness (induration).

· Rare side effects are:

1. Allergic/anaphylactic reaction.

2. Lump at injection site.

3. High fever.

Though side effects are there they are usually mild and manageable at home. Fever and pain can be easily managed by oral medicine like paracetamol and local cold fomentation at injection sites. Side effects are much lesser when compared to whole cell pertussis vaccines and the actual diseases which the vaccine prevents.

Like all other vaccines this vaccine can very rarely cause anaphylaxis reaction which can be life threatening if not managed swiftly. It is suggested to give all the vaccines at the center which is anaphylaxis management ready. Necessary drugs and equipment and a skilled person is available to manage the reaction.

To whom this vaccine should not be given?

This vaccine should not be given to those who are allergic to any of its components.

This vaccine should not be given to those who have got anaphylactic or severe allergic reaction to the previous dose of the vaccine.

This vaccine is safe for use in age below 6 years.

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