(Adds details from FDA warning letter, GSK comment)
By Toni Clarke
WASHINGTON, June 24 A GlaxoSmithKline Plc
plant in Canada that makes the flu vaccine Flulaval has been
cited by the U.S. Food and Drug Administration for failing to
meet quality control standards.
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
GSK said on Tuesday no contaminated products had been
released to the public.
"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. (1.usa.gov/1jL3UUS).
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.
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
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