# 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This is the second time this month that H1N1 vaccines have been withdrawn due to a drop in antigenic potency over time.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.”
Related Post:
- Anticipating The Flu Season Down Under
- ACP Calls For Health Care Worker Immunizations
- Branswell On Flu Vaccine Matches
- Flu Vaccine Still Available, But Spot Shortages Exist
- Study: Self-Administered Vaccines In Adults
- Egypt: A Paltry Poultry Vaccine
- Lancet: Low Flu Vaccine Effectiveness
- Hong Kong: H5N1 Vaccine Recommended For Certain Lab Workers
- AAP Endorses SAGE Recommendations Keeping Thimerosal In Vaccines
- NIVW 2012
- Study Supports Safety Of Tdap Vaccine In Older Patients
- JAMA: Waning Pertussis Vaccine Effectiveness Over Time
- Revisiting The Numbers Racket
- Of Pregnancy, Flu & Autism
- Canada & Switzerland Clear Novartis Flu Vaccine For Use
- CMAJ On Mandatory Flu Shot For HCWs
- Novartis Fluad And Agriflu Vaccines Suspended In Canada
- The UK’s Whooping Cough Outbreak
- Peter Sandman On the CCIVI Vaccine Report
- CIDRAP: The Need For `Game Changing’ Flu Vaccines
- Rhode Island Adopts New Flu Vaccination Requirements For HCPs
- Vietnam Reports Progress On New Bird Flu Vaccine
- WHO: Southern Hemisphere 2013 Flu Vaccine Composition
- NPM12: Giving Preparedness A Shot In The Arm
- Yes, We Have No Pandemic . . .
Widget by [ Iptek-4u ]