Is there a vaccine to prevent Swine Flu?

Answer 1

Yes.

The antigens have been selected by CDC for the trivalentvaccines 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 vaccinescontaining 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

• Type B/Wisconsin/1/2010.

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 Quebec

• 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 Pasteur, Inc.)

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.

Nomenclature

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, and C.

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 proteins.

[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 now.

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 groups:

• Pregnant women;
• Individuals who live with or care for children under 6 months old;
• 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 vaccine.

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 administration services.

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 year (2009).

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 swine flu.)

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 very low.

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 fish.

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.