The antigens have been selected by CDC for the trivalent
vaccines for the 2013-2014 flu season and the vaccine
contains the following three viruses:
Type A/California/7/2009 (H1N1)pdm09-like virus;
Type A(H3N2) virus antigenically like the cell-propagated
prototype virus known as A/Victoria/361/2011; and,
Type B/Massachusetts/2/2012-like virus.
It has been recommended that quadrivalent vaccines
containing two Type A and two Type B influenza viruses contain the
above three viruses and a Type B/Brisbane/60/2008-like virus.
For those with egg allergies:
The CDC has issued the following media advisory:
The Advisory Committee on Immunization Practices (ACIP) voted
today, 13 to 0, in favor of recommending FluBlok during the
2013-2014 influenza seasons for vaccination of persons 18 through
49 years of age with egg allergy of any severity. FluBlok was
licensed by the Food and Drug Administration (FDA) in January 2013.
Unlike current production methods for other available seasonal
influenza vaccines, FluBlok does not use the influenza virus or
chicken eggs in its manufacturing process.
Vaccines for the 2012-2013 flu season in the US:
This year's trivalent seasonal flu vaccines will protect against
the following three strains of influenza:
Type A/California/7/2009 (H1N1) ~ the "swine flu vaccine",
Type A/Victoria/361/2011 (H3N2), and
There is also a new vaccine in the 2012-2013 flu season that is
FluMist Quadrivalent. This new vaccine includes two Type B strains
of flu instead of one. It contains B strains from both the
B/Yamagata/16/88 and the B/Victoria/2/87 lineages in addition to
the same strains of the Type A viruses (H1N1 and H3N2) that are
included in the trivalent vaccines for this season. See the related
questions below for more info.
For the 2012-2013 Flu season in the US, the following vaccines
for influenza are approved for use:
AFLURIA Trivalent made by CSL/Merck
AGRIFLU made by Novartis
FLUARIX Trivalent made by GlaxoSmithKline Biologicals
FLUMIST made by MedImmune Vaccines, Inc.
FLUMIST QUADRAVALENT made by MedImmune Vaccines, Inc.
FLULAVAL Trivalent made by ID Biomedical Corporation of
FLUVIRIN Trivalent made by Novartis
FLUZONE made by Sanofi Pasteur, Inc.
FLUZONE - High Dose made by Sanofi Pasteur, Inc.
FLUZONE-Intradermal made by Sanofi Pasteur, Inc.
For the 2011-2012 flu season in the US, the Food and Drug
Administration (FDA) announced the approval of six vaccines on July
18, 2011. These approved trivalent vaccines for the seasonal flu
will all contain vaccine for the H1N1/09 "Swine Flu" and two other
viruses suggested by CDC for this season (see more below). These
approved vaccines are:
1. Afluria (CSL Limited)
2. Fluarix (Glaxo Smith Kline Biologicals)
3. FluLaval (ID Biomedical Corporation)
4. FluMist (MedImmune Vaccines, Inc.)
5. Fluvirin (Novartis Vaccines and Diagnostics Limited)
6. Fluzone, Fluzone High-Dose, Fluzone Intradermal (Sanofi
The Fluzone Intradermal is a new formulation for administration
in the layers of the skin (intradermal injection) instead of the
intramuscular (IM) injection. Fluzone Intradermal administration
uses a microinjection system with a very fine needle. Approved for
those aged 18 through 64.
The naming convention for virus strains such as the one used to
produce the pandemic A-H1N1/09 vaccine [ A/California/7/2009
(H1N1)v-like virus ] is explained below:
A/California/7/2009 (H1N1)-like virus
A = Type A influenza. There are three types of influenza: A, B,
CALIFORNIA = The location the strain was first identified.
7 = The strain identification number.
2009 = The year the strain was identified.
H1N1 = The antigenic characterization of the H and N
[Antigenic characterization is a method used to describe
influenza proteins neuraminidase (N) and hemagglutinnin (H) and how
they have changed.]
ADDITIONAL AND HISTORICAL INFORMATION ABOUT H1N1/09 VACCINES
2010-2011 Flu Season:
For the 2010-2011 flu season in the US, it is included in the
regular flu vaccination, so unlike 2009, it will only require a
single vaccination to be protected against swine flu and two other
types of flu that are expected to be circulating this season. There
is no longer any need to prioritize the delivery of the vaccine to
those at highest risk since there is plenty of vaccine available
2009-2010 Flu Season:
Vaccines are available and being administered in the states
using the recommendation of international epidemiologists to
provide the first vaccinations to those who are most vulnerable,
health care workers, to fire and police personnel.
A group of international epidemiologists has met and developed a
roll out plan and suggestions for nations to plan to vaccinate
those critical to the health and welfare of the community first,
such as health care workers, fire and police personnel, and also
the most vulnerable. The very first batch of the vaccine should be
distributed primarily to the following five preferential
Individuals who live with or care for children under 6 months
Healthcare and emergency service workers;
Individuals between 6 months to 24 years old; and then
Adults 25 to 64 with chronic health conditions.
Unlike seasonal flu, the elderly, aged 65 and older, seem to
have a resistance to the H1N1/09 virus (probably from earlier
exposure to some similar virus, perhaps the one in the 1930's) and
will not be among the first to be vaccinated in this plan.
The vaccines for the US approved so far by the Food and Drug
Administration (FDA) are those produced by Novartis, Sanofi, and
CSL who have produced the injection inactivated vaccines and
MedImmune who has produced an attenuated (weakened) vaccine for
administration in nasal spray for ages 2-49.
The vaccines for Europe approved by EMEA, are two vaccines that
are inactivated ("dead") and adjuvanted ("strengthened" so smaller
doses can produce the same immunization to enable more doses). They
are Focetria by Novartis and Pandemrix by GlaxoSmithKline and both
are for administration by injection. Approval awaits for a third
Up to 60 human trials of the vaccines that were produced by the
various drug Manufacturers were undertaken and monitored by the
FDA, the US Centers for Disease Control and Prevention (CDC) and
the World Health Organization (WHO).
The manufacturers who were contracted and licensed by Health and
Human Services (HHS) to produce the H1N1/09 Vaccine are the same
ones used for seasonal flu since 2004. Novartis, GlaxoSmithKline,
Sanofi Pasteur, CSL Biotherapies, and MedImmune.
The first vaccines were released 10/6/09 in the US. The demand
is great and therefore the above distribution recommendations are
being followed. The latest information available from the CDC is
that about 45 million doses will be available in the first round of
released vaccine over several weeks in mid to late October. After
that the vaccine will be produced at a rate of approximately 20
million doses per week.
On September 21, 2009, The U.S. Department of Health and Human
Services (HHS) ordered an additional 56 million doses of vaccine
for the 2009 H1N1 flu from MedImmune and Sanofi Pasteur.
The drug manufacturers who had been given seed stock from the
CDC and WHO, are continuing to grow virus to produce vaccines from
the seed stock. Since the growth of the seed stock was not as
prolific as was hoped, the release date has now been pushed back,
however the first rounds of vaccinations will be made available to
those at most risk of complications first to assure the best use of
the early doses that are available.
A second seed stock was selected that is a more prolific
producer and it is expected that the speed of production will
increase by use of these more robust strains.
The vaccine will be provided to a central distribution point in
each state in the US and providers who want to give vaccine
directly to their patients can request vaccine from the local
government public health contacts. Other vaccination centers will
be eventually also set up in schools, hospitals, clinics, and other
locations for public vaccination programs.
The vaccine will be provided free of cost, however private
providers who administer the vaccinations may charge for their
Distribution will be made on a priority basis to those at
highest risk first, such as children and pregnant women, those who
care for infants under 6 months old who can not take the
vaccinations themselves, those who are immunocompromised, people
who have underlying health problems such as asthma and diabetes,
and healthcare workers, etc.
Two injections will not be required for adults or children over
10 as was originally believed, since the trials are showing very
good immune responses to the good seed stock that is being used. It
is more likely now, that these immunizations will be very similar
to the seasonal flu vaccinations. Immunization should be complete
approximately 8 to 10 days after the flu shot in adults. However,
children under 10 will still need two vaccinations to cause the
proper immune response in their immature immune systems, just as
with other vaccinations these are given 28 to 30 days apart and
within approximately two weeks of the last injection in the series
of two, they should have developed an appropriate level of immunity
for protection against this strain of flu.
The CDC and WHO recommend that people get the seasonal flu shot
as usual. It will have no protection against A-H1N1/09, and the
swine flu shot will have no protection against the seasonal flu
strains that are expected to be in the Northern Hemisphere this
fall and winter as usual. Two vaccinations (one for seasonal flu
strains and one for H1N1/09) will be required for full protection
against the seasonal flu strains and against H1N1/09 Swine Flu this
Both types of vaccines could be given at the same time (still in
separate vaccinations, they can not be combined in one shot,
though), however, you should not wait to get the seasonal flu shot
until the swine flu shot is available to your risk group. As soon
as you have an opportunity to get the seasonal flu shot, you should
go ahead and get that done as soon as possible, especially if you
are among those at high risk for influenza (for seasonal flu this
does include those 65 and older, while for H1N1/09, that older
group is actually at less risk than younger healthy people for the
The H1N1/09 vaccine is will contain the new 2009 strain of swine
flu, but otherwise it is being made the same way and with the same
preservatives, and other ingredients for injection as has been used
for decades now for seasonal flu shots. So there is no expectation
of new side effects or problems with getting the vaccination than
that which would be normal for the seasonal flu injections. Over
the long period of use of this type of vaccine, problems have been
There have been very few reactions or problems with this method
of vaccine development (unlike the problems that were had with the
swine flu shots in the 1970's) and there is no scientific data to
support the concerns that some have voiced about the preservative
thimerosal. There is no data from the scientific studies that have
been done that link autism or other problems to the thimerosal. The
minuscule amount of mercury in the preservative's compound
ingredients is no more than would be obtained through a meal of
There are some manufacturers who have developed single doses of
vaccine that will not contain the thimerosal. These will be
available in some locations to those who have this concern. The
larger 10cc vials will have to have the preservative added, but
single dose vials and single dose pre-loaded syringes may be an
option for some. Discuss this with your health care professional in
advance of presenting for the vaccination if you have concerns and
you may need to reserve this type of single dose vaccine from your
pharmacy in advance.