Some influenza-vaccine makers have delayed shipments to U.S.
doctors and pharmacies because of production problems, forcing some
health-care providers to put off vaccinations as flu season gets
under way.
The U.S. Centers for Disease Control and Prevention says there
have been delays in shipments--from big manufacturers including
GlaxoSmithKline PLC and Sanofi SA--that were originally anticipated
for August and September. The delayed flu vaccines included some
that were approved specifically for children.
The CDC still expects that there will be a sufficient supply of
flu vaccine for the season and that a majority of the doses will be
shipped by the end of October, a spokeswoman said. Flu-vaccine
makers have projected shipping up to 156 million doses in total for
the 2014-15 flu season, above the 134.5 million doses distributed
last season, according to the agency.
As of Oct. 17, nearly 118 million doses of the projected 156
million were distributed, CDC said; the figure doesn't represent
the number of people already vaccinated. The agency recommends all
people 6 months and older get flu shots, with rare exceptions.
About 59% of children and 42% of adults were vaccinated for the
2013-14 flu season, according to the CDC.
The delays come as some public-health experts have renewed calls
for people to get flu vaccines this season, in the wake of concerns
about two other viruses that don't have vaccines: the Ebola virus,
which has primarily affected West Africa but also a handful of U.S.
patients; and a U.S. outbreak of enterovirus D68, which causes
respiratory illness.
The CDC says it's difficult to count flu deaths, but has
estimated they range from 3,000 to 49,000 deaths annually in the
U.S. And because Ebola causes flu-like symptoms, experts say flu
vaccinations could reduce chances for a flu case to create a false
alarm over Ebola.
Recent supply disruptions have forced some health-care providers
to delay vaccinations or send people elsewhere for shots. Western
Washington University in Bellingham, Wash., received about 150 of
the 600 doses it ordered from Sanofi, said Emily Gibson, director
of the university's student health center. The university allocated
the limited supply to certain staff and at-risk students.
"This is our prime vaccination time for our population, so we
are now having to refer our students to local pharmacies who offer
vaccinations, " Dr. Gibson said.
The Arkansas Department of Health has postponed its community
flu-vaccine clinics throughout the state and delayed providing
vaccines to nursing homes because it didn't receive shipments in
time, a spokeswoman said. The department also delayed vaccinating
staffers who don't have direct patient contact, but has allocated
an available supply of vaccines for school clinics.
The department is encouraging people at high risk, such as
pregnant women, to get vaccinated at private providers.
Some pediatric practices in the U.S. have been receiving vaccine
supplies later than in the past two seasons, according to the
American Academy of Pediatrics. Henry Bernstein, professor of
pediatrics at Hofstra Northshore-LIJ School of Medicine in
Hempstead, N.Y., said after an initial delay in shipments, his
practice now has "a good supply."
A CDC spokeswoman said flu shots should continue to be offered
throughout the flu season, which usually peaks between December and
February. It takes about two weeks after vaccination for antibodies
to develop to protect against infection.
Sanofi, whose Sanofi Pasteur division is the largest supplier of
flu vaccine in the U.S., says it delayed shipments of certain forms
of the flu vaccine Fluzone because one of the flu strains used to
produce the shot grew more slowly than expected. Shipments of three
versions of Fluzone are expected to continue into November,
including adult and pediatric versions of a vaccine targeting four
flu strains, as well as a shot that targets three flu strains.
The company still plans to produce all of the 65 million doses
it has projected for the U.S. market this season, a spokesman
said.
GlaxoSmithKline has reduced its production target for the U.S.
market to a range of 26 million to 27 million doses, from a prior
forecast of 28 million to 33 million doses, a spokesman said. The
company delayed shipments of a portion of its vaccine supply
because batches made at a plant in Ste-Foy, Quebec, didn't meet
Glaxo's quality-assurance standards and were discarded, a spokesman
said.
In June, the U.S. Food and Drug Administration sent a warning
letter to GlaxoSmithKline, saying the Quebec plant had deviated
from manufacturing rules in its production of the flu vaccine
Flulaval. FDA inspectors cited microbial contamination in the
plant, among other findings. The FDA urged GlaxoSmithKline to work
closely with the agency to correct the problems, "given the
potential contributions of Flulaval to the public health."
GlaxoSmithKline has shipped the majority of its flu-vaccine
supply and expects to complete all shipments before the end of
November, the spokesman said.
AstraZeneca PLC's MedImmune unit delayed the start of shipments
of its nasal-spray vaccine FluMist to mid-August from late July.
The company cited longer-than-expected internal quality testing
before the vaccine could be released. MedImmune has delivered
nearly 13 million doses to national distributors to date, and
expects to deliver 14 million to 15 million doses by the end of
October, a spokeswoman said.
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