Shortened shelf life of 13 lots of MedImmune H1N1 influenza nasal
spray vaccine
Company announces limited, voluntary, non–safety-related
recall of remaining unused product
According to reports received by CDC and FDA from MedImmune, the potency
of 13 lots of H1N1 nasal spray vaccine has dropped or will shortly drop
below a prespecified limit. Although this decline in potency is not
expected to affect the protective response to vaccination, safety
concerns do exist with these lots of vaccine. According to MedImmune,
because the protective response is considered adequate, revaccinating
patients who have received vaccine from these lots is not necessary.
All 13 lots successfully passed prerelease testing for purity,
potency, and safety. However, because their potency has or may soon drop
below the specified lower limit, MedImmune is issuing guidance to
providers on returning any unused vaccine from these lots. The following
lots are affected:
- 500754P
- 500751P
- 500756P
- 500757P
- 500758P
- 500759P
- 500760P
- 500761P
- 500762P
- 500763P
- 500764P
- 500765P
- 500776P
No action is needed on the part of patients vaccinated from the
recalled lots. Patients aged 10 years or older who received the vaccine
will not require further doses of vaccine. However, consistent with
recommendations for all 2009 H1N1 vaccines, children younger than 10
years should get the recommended two doses of 2009 H1N1 vaccine
approximately 1 month apart. Therefore, children younger than 10 years
of age who have only received one dose of vaccine thus far should
receive a second dose of 2009 H1N1 vaccine. The same type of vaccine for
the first and second doses is recommended.
A total of 4.7 million doses are included in the 13-lot recall. The
doses were shipped to CDC’s contract distributor in October and
early November. Most of the doses are thought to have already been
administered while fully potent and within specifications. However, it
is highly likely that some doses have not been used.
Additional information
Posted by Joe Sheffer (jsheffer@aphanet.org)
December 29, 2009
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