MedImmune released a letter Dec. 22 to vaccine providers that the potency of 13 lots of 2009 H1N1 nasal spray vaccine had decreased below a pre-specified limit or were at risk of falling below that limit in the next week.
Plumas County Public Health Agency received 200 doses of recalled vaccine, most of which were given during appointments in October and November.
The slight decrease in vaccine potency is not expected to have an impact on the protective response to vaccination. There are no safety concerns with these lots of 2009 H1N1 vaccine.
All lots successfully passed pre-release testing for purity, potency and safety. However, the potency is now or might soon be below the specified lower limit, prompting the voluntary recall.
“The recall does not affect the safety of the vaccine,” said Valeska Armisen, Plumas County health officer. “Tests showed the vaccine in question began to lose some potency this month, rather than the expiration date of Jan. 25, 2010, but people who may have received it don't need to get vaccinated again.
“Parents who have already vaccinated their children should feel confident they are protecting their children’s health. ”
The CDC recommends that all children under 10 years of age should get two doses of H1N1 vaccine, approximately one month apart for the optimal immune response.
While the amount of antigen in these lots may now or soon be slightly decreased, the Centers for Disease Control and Food and Drug Administration agree that those who received the affected vaccine will still have protection from H1N1 flu, and there is no need to re-vaccinate those who received vaccine from these lots.
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