4.7 Million Doses of Flu Vaccine Recalled by AstraZeneca

Even though there are no safety issues related to AstraZeneca’s recall of 4.7 million doses of swine flu vaccine, other issues remain.  In particular, the nasal spray version loses an unacceptable amount of potency while in storage.  As a general rule of thumb, drugs and vaccines all lose potency over time.  This is one of many reasons why vaccine potency is monitored even after doses become available for sale.  There are also federal guidelines that stipulate a minimum level of potency that must be maintained.

Fortunately, individuals that have already received vaccination for the swine flu will not need to get a new inoculation.   Current estimates indicate that approximately 3,000 doses remain in warehouses.  It is not known how many doses remain in clinics and private practices.

Needless to say, clinics and doctors that still have swine flu vaccine in the office will be scrambling for replacements.  In fact, medical providers may have a difficult time locating replacement vaccines, as Sanofi-Aventis SA had to recall swine flu vials on December 15th.  They also recalled 800,000 doses because of decreased potency.  Both recalls were voluntary.

At the beginning of the flu season, many people were concerned about the safety of the swine flu vaccine.  Manufactures uncategorically state that these doses were not withdrawn because of safety issues.  Unfortunately, speculations may arise about whether or not doses were manufactured as close to potency tolerances as possible.  This, in turn, may create more uneasy questions as the world looks to future flu seasons and the potential for larger swine flu outbreaks.  Without a question, people will most certainly be wondering if a vaccine with fewer declining potency issues will translate into one with more serious side effects.

See Related Report: Influenza Vaccines and Anti-virals – The Pandemic’s Long-Term Impact – A Commercial Insight