GSK said it is working to rectify the problems and does not expect a
delay in distributing the vaccine for the 2014-2015 flu season. The
company typically starts shipping the product at the end of July.
In a warning letter dated June 12 to GSK's flu vaccine manufacturing
facility in Ste-Foy, Quebec, the FDA said the company failed to take
appropriate steps to prevent microbiological contamination of
products, among other violations.
GSK said on Tuesday no contaminated products had been released to
"Every batch of GSK vaccines is subject to extensive review before
it is released," the company said. "Vaccines that do not pass this
rigorous review are discarded."
The FDA said controls for the purified water system at the plant
were inadequate and that some Gram-negative bacteria identified in
water used for equipment washing had been implicated in product
contamination issues at the facility as far back as 2011.
In 2011, 24 vaccine lots were rejected due to the excessive presence
of endotoxins. These are found in the cell walls of Gram-negative
pathogens such as salmonella. When bacteria die the endotoxins are
released, possibly contaminating laboratory equipment and causing
health problems in people and animals.
Other lots were rejected in March and July 2012, and certain test
lots were contaminated last year. These were manufactured on the
same equipment as commercial lots for release to the United States,
the FDA said in its warning letter.
This year, 20 of the lots manufactured, or 21 percent, showed
bacterial growth and endotoxin levels. These lots were also
rejected. GSK said the lots were rejected as part of the company's
quality review process.
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The FDA said there was no set schedule for disinfection of the water
system and that manufacturing controls in place were inadequate to
control bacteria on unsterilized surfaces. The agency said the
company's investigation into the repeated accumulations of bacteria
had been inadequate.
The deficiencies, the FDA said in its letter, "are an indication of
your quality control unit not fulfilling its responsibility to
assure the identity, strength, quality, and purity of your licensed
biological drug product and intermediates."
GSK said it anticipates providing between 28 and 33 million doses of
flu vaccine to the United States for the upcoming season and said it
is working with health agencies in Canada and the United States to
"support their efforts in managing supply of influenza vaccines for
the 2014-15 flu season."
(Reporting by Toni Clarke in Washington and Esha Dey in Bangalore;
Editing by Sriraj Kalluvila, Marguerita Choy and Paul Simao)
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