# 4185
Although some headlines are screaming `5 million doses of flu vaccine being recalled’, the reality is a bit less dramatic than these banners might suggest.
Maryland based MedImmune, makers of FluMist, has voluntarily recalled the remaining doses from 13 lots of vaccine sent out in October and November. While the original lots consisted of 4.7 million doses . . . the `vast majority’ of those have already been dispensed.
Once again, the concern is a reduction in potency over time, not over any safety concerns.
Vaccine manufacturers retain a small portion of each lot of vaccine produced and perform ongoing potency tests. In this case, the potency of the FluMist dropped over time.
The FDA states that those who took the nasal spray vaccine received a sufficient dose of antigen to afford protection, and need not get another dose.
This is the second time this month that H1N1 vaccines have been withdrawn due to a drop in antigenic potency over time. Just over a week ago I reported on Sanofi: Non-Safety Related Recall Of 800K Doses Of Vaccine.
Tom Randall of Bloomberg News has more details.
AstraZeneca’s Swine Flu Nasal Spray Recalled for Lower Potency
December 23, 2009, 02:53 AM ESTDec. 23 (Bloomberg) -- AstraZeneca Plc recalled 4.7 million doses of its nasal spray version of the swine flu vaccine after routine tests showed a decline in potency, U.S. regulators said.
The doses remain safe, and people who have already been inoculated don’t need to get vaccinated again, said Norman Baylor, director of vaccines research and review for the U.S. Food and Drug Administration. About 3,000 of the affected doses remain in warehouses, and AstraZeneca will send recall notices to clinics that may have unused vials of the vaccine.
The recall follows a similar move on Dec. 15 by Paris-based Sanofi-Aventis SA, which recalled 800,000 swine flu shots. Manufacturers maintain samples for testing from each vaccine lot that is shipped, and they continue to test them for waning potency, Baylor said. Both recalls were made voluntarily after the strength dropped below pre-specified thresholds.
“There are no safety concerns with these lots,” Baylor said in a conference call with reporters yesterday. “We do see a decline in potency every now and then.”
