Yearly Steps to Influenza Vaccine

Identification and Distribution

1.
6. Using reagents developed

7.
and calibrated by FDA,
manufacturers and the
FDA test their vaccine Vaccine is formulated into
Worldwide influenza

2.

for potency and safety.

standard dosages, and is filled
disease surveillance and finished by the manufacturers
by the World Health FDA and WHO review data

into final containers such as

Organization (WHO) to recommend the composition

vials, syringes, and sprayers.

of influenza virus vaccines for

8.
next winter’s influenza season.

Each vaccine set (“lot”) must meet

FDA’s rigorous standards for
safety and efficacy as it rolls off
the manufacturer’s production line.

5. U.S. licensed vaccine manufacturers

obtain reference influenza viruses from
WHO Collaborating Centers to generate

3.
the “seed virus” for further vaccine
Each February, FDA convenes its manufacturing.
Vaccine and Related Biological

9.
Products Advisory Committee and

recommends the three strains

FDA releases lots and the

of influenza virus to include in

manufacturers begin shipping

the U.S. vaccine.

vaccine throughout the U.S.

4.
for use by the public.

The viruses are adapted

for use in manufacturing.