1.

Vaccines are made using the disease-causing virus or bacteria, but in a form
that will not harm your child. Instead, the weakened, killed, or partial virus or bacteria
prompts your baby's immune system to develop antibodies, or defenders, against the
disease.

How Vaccines are Made

You already know that vaccines protect kids against severe and life-threatening disease, but
you may not know exactly how vaccines are made to give your child a healthy defense.
Vaccines are made using the disease-causing virus or bacteria, but in a form that will not
harm your child. Instead, the weakened, killed, or partial virus or bacteria prompts your
babys immune system to develop antibodies, or defenders, against the disease.
Once it is determined how the virus and bacteria will be modified, vaccines are created
through a general three-step process:
1. Antigen is generated. Viruses are grown in primary cells (i.e. chicken eggs for the
influenza vaccine), or on continuous cell lines (i.e. human cultured cells for hepatitis b
vaccine); bacteria is grown in bioreactors (i.e. Hib vaccine).
2. Antigen is isolated from the cells used to create it.
3. Vaccine is made by adding adjuvant, stabilizers and preservatives. Adjuvants
increase immune response of the antigen; stabilizers increase the vaccines storage life; and
preservatives allow for the use of multi-dose vials.
It is important to remember that vaccines undergo rigorous safety testing prior to FDA
approval and are continually monitored for safety. The vaccine production process involves
several vaccine manufacturer-funded testing phases over many years to ensure that it is
safe to administer. The vaccines are also studied to be administered in groups, to work
together to protect your child.
View this infographic from the Centers for Disease Control and Prevention (CDC) to learn
more about the journey of your child's vaccine.

Production

Two workers make openings in chicken eggs in preparation for production of measles vaccine.

Vaccine production has several stages. First, the antigen itself is generated. Viruses are grown either
on primary cells such as chicken eggs (e.g., for influenza) or on continuous cell lines such as
cultured human cells (e.g., for hepatitis A).[48] Bacteria are grown inbioreactors (e.g., Haemophilus
influenzae type b). Likewise, a recombinant protein derived from the viruses or bacteria can be
generated in yeast, bacteria, or cell cultures. After the antigen is generated, it is isolated from the
cells used to generate it. A virus may need to be inactivated, possibly with no further purification
required. Recombinant proteins need many operations involving ultrafiltration and column
chromatography. Finally, the vaccine is formulated by adding adjuvant, stabilizers, and preservatives
as needed. The adjuvant enhances the immune response of the antigen, stabilizers increase the
storage life, and preservatives allow the use of multidose vials.[49]Combination vaccines are harder to
develop and produce, because of potential incompatibilities and interactions among the antigens and
other ingredients involved.[50]
Vaccine production techniques are evolving. Cultured mammalian cells are expected to become
increasingly important, compared to conventional options such as chicken eggs, due to greater
productivity and low incidence of problems with contamination. Recombination technology that
produces genetically detoxified vaccine is expected to grow in popularity for the production of
bacterial vaccines that use toxoids. Combination vaccines are expected to reduce the quantities of
antigens they contain, and thereby decrease undesirable interactions, by using pathogen-associated
molecular patterns.[50]
In 2010, India produced 60 percent of the world's vaccine worth about $900 million(670 million). [51]

Excipients
Beside the active vaccine itself, the following excipients are commonly present in vaccine
preparations:[52]

Aluminum salts or gels are added as adjuvants. Adjuvants are added to promote an earlier,
more potent response, and more persistent immune response to the vaccine; they allow for a
lower vaccine dosage.

Antibiotics are added to some vaccines to prevent the growth of bacteria during production
and storage of the vaccine.

Egg protein is present in influenza and yellow fever vaccines as they are prepared using
chicken eggs. Other proteins may be present.

Formaldehyde is used to inactivate bacterial products for toxoid vaccines. Formaldehyde is

also used to inactivate unwanted viruses and kill bacteria that might contaminate the vaccine
during production.

Monosodium glutamate (MSG) and 2-phenoxyethanol are used as stabilizers in a few

vaccines to help the vaccine remain unchanged when the vaccine is exposed to heat, light,
acidity, or humidity.

Thimerosal is a mercury-containing preservative that is added to vials of vaccine that contain

more than one dose to prevent contamination and growth of potentially harmful bacteria. Due to
the controversy surrounding thimerosal it has been removed from most vaccines.

Role of preservatives
Many vaccines need preservatives to prevent serious adverse effects such
as Staphylococcus infection, which in one 1928 incident killed 12 of 21 children inoculated with
adiphtheria vaccine that lacked a preservative.[53] Several preservatives are available,
including thiomersal, phenoxyethanol, and formaldehyde. Thiomersal is more effective against
bacteria, has a better shelf-life, and improves vaccine stability, potency, and safety; but, in the U.S.,
the European Union, and a few other affluent countries, it is no longer used as a preservative in
childhood vaccines, as a precautionary measure due to its mercury content.[54] Although controversial
claims have been made that thiomersal contributes to autism, no convincing scientific evidence
supports these claims.[55]

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