The immediate nationwide recall on October 20 of all stocks of oral polio vaccine
manufactured by Medeva after it was discovered that the company had misled the
Medicines Control Agency about adherence to European guidelines on the use of
bovine materials.
Guidelines issued in 1999 said that bovine materials from countries in which
there were known cases of BSE should not be used in the manufacture of oral
medicines. Prior to that, similar guidance had been issued by the MCA in 1989
with reference to injectable medicines, eye preparations and materials applied
to open wounds.
Since 1989 the MCA had sought, and received, assurances from manufacturers that
the guidance was being implemented.
“The MCA has now advised Ministers that in the case of the Medeva oral
polio vaccine the assurances by the company have proven inaccurate,” the
statement said. Medeva’s vaccine had been produced using a growth medium
containing material of British bovine origin. “This specifically breaches
the 1999 guidance, which, in March, 2001, is expected to have the full force
of law.”
The vaccine concerned was manufactured by Medeva from 1991 until production
ceased in September this year. Between 1989 and 1991 it was produced by Wellcome.
The recall of the vaccine was ordered despite an MCA assessment which said that
the risk associated with the vaccine was incalculably small.
The Department’s chief medical officer (Professor Liam Donaldson) said:
“Public confidence in medicines safety is paramount. We have to approach
this from a precautionary principle, knowing that these important guidelines
have been breached.”
Medeva’s polio vaccine was made by blending three previously manufactured
polio virus strains. Two of these had been produced by Medeva before 1996, while
seven batches of the third had been in stock when Medeva bought the business
from Wellcome. Six of these batches had been produced using foetal bovine serum
obtained from BSE-free herds in New Zealand, the seventh was UK derived.
The company said : “Records relating to the seventh batch do not fully
clarify the BSE status of this veterinary-controlled UK herd, although there
is no evidence to suggest that the herd was infected.”