What are the ingredients in the Swine Flu vaccine?
In addition to the other ingredients, for the 2013-2014 flu season, the
antigens have been selected by CDC for the US 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 the 2013-2014 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 June 2013:
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.
In the US in the 2012-2013 Flu Season:
The swine flu vaccine is no longer being given as a separate vaccination and has been included in the seasonal flu shots when the data shows it will be likely to be circulating in the next flu season. It has been included in the seasonal flu vaccines for the past several years since it was developed for the pandemic. It is again included in this season's flu vaccines in the US. See the related question section for the question about the ingredients in the seasonal flu vaccines in 2012-2013 and after.
In the US for the 2011 - 2012 Flu Season
The FDA has approved 6 flu vaccines for the 2011-2012 flu season, all of which contain protection against the 2009 H1N1 "Swine Flu". Of these, four are injected inactivated ("dead") vaccines for intramuscular injection (IM), and one is a nasal spray that is made with weakened (attenuated) virus particles that can not cause infection in otherwise healthy individuals. In addition, a new type of vaccine for intradermal injection (within the skin), using a microinjection system with a tiny needle, is also approved this season from Sanofi Pasteur, Inc. This intradermal vaccine is an inactivated vaccine approved for those 18 - 64.
Sanofi Pasteur also makes a third formulation that is for IM administration only for older adults over 65. It is called "High Dose" and is made for those older patients who need a stronger dose to get the same immune response from their immune systems.
The ingredients that are added (in addition to the antigen virus#) in the following six US FDA-approved 2011-2012 influenza vaccines are:
Afluria from CSL Limited:
Beta-Propiolactone, Calcium Chloride, Neomycin, Ovalbumin, Polymyxin B, Potassium Chloride, Potassium Phosphate, Sodium Phosphate, Sodium Taurodeoxychoalate.
Fluvarix from GlaxoSmithKline (GSK) Biologicals:
Egg Albumin (Ovalbumin), Egg Protein, Formaldehyde or Formalin (to inactivate the virus), Gentamicin, Hydrocortisone, Octoxynol-10, á-Tocopheryl Hydrogen Succinate, Polysorbate 80 (an adjuvant), Sodium Deoxycholate, Sodium Phosphate, Thimerosal*
FluLaval from ID Biomedical Corporation:
Egg Albumin (Ovalbumin), Egg Protein, Formaldehyde or Formalin, Sodium Deoxycholate, Phosphate Buffers, Thimerosal
Fluvirin from Novartis Vaccines and Diagnostics Limited:
Beta-Propiolactone , Egg Protein, Neomycin, Polymyxin B, Polyoxyethylene 9-10 Nonyl Phenol (Triton N-101, Octoxynol 9), Thimerosal (in the multidose containers), Thimerosal* (much smaller amounts in the single-dose syringes)
Fluzone, Fluzone High-Dose, Fluzone Intradermal from Sanofi Pasteur, Inc.:
Egg Protein, Formaldehyde or Formalin, Gelatin, Octoxinol-9 (Triton X-100), Thimerosal (only in multidose containers)
FluMist (nasal spray) from MedImmune Vaccines, Inc.:
Chick Kidney Cells, Egg Protein, Gentamicin Sulfate, Monosodium Glutamate,Sucrose Phosphate Glutamate Buffer
*Where "thimerosal" is marked with an asterisk (*) above, it indicates that the product should be considered equivalent to thimerosal-free products. This vaccine may contain trace amounts (<0.3 mcg) of mercury left after post-production thimerosal removal, but these amounts have no biological effect. JAMA 1999;282(18) and JAMA 2000;283(16)
# The virus may be added either in pieces or partial particles that are inactive ("dead"), or it may be active ("alive"), but "attenuated" (weakened) so that it is not able to make an otherwise healthy person ill.
In Europe for the 2011 - 2012 Flu Season:
LONDON (Reuters Health) Jul 21 2011 - European regulators have recommended restricting the use of GlaxoSmithKline's pandemic flu vaccine Pandemrix because of a potential risk of narcolepsy in children or adolescents.
The European Medicines Agency said on Thursday that Pandemrix should only be used in people under 20 years in the absence of seasonal trivalent influenza vaccines, following its link to very rare cases of narcolepsy in young people.
Overall, the vaccine's benefit-risk balance remains positive, the watchdog added.
More than 31 million doses of Pandemrix have been given to people in 47 countries, and GSK said it had been notified of 335 cases of narcolepsy in those vaccinated as of July 6. Two-thirds of the narcolepsy cases were in Finland and Sweden.
Britain's biggest drugmaker said in a statement it had committed to conduct further research into any potential association between Pandemrix and narcolepsy.
Pandemrix was widely used during the 2009-10 outbreak of H1N1 swine flu, although it was not administered in the United States.
Several other drugmakers, including Novartis , Sanofi , CSL and Baxter also made vaccines against H1N1 flu during the pandemic, which was declared over in August last year.
Finnish and Swedish researchers were the first to raise concerns over a possible narcolepsy link to Pandemrix last August after noting cases in children recently given the GSK shot.
One research team earlier this year suggested children given Pandemrix were nine times more likely to suffer from the condition.
Researchers at Finland's National Institute for Health and Welfare said the increase they found in narcolepsy was "most likely" a joint effect of Pandemrix and some other factor or factors.
In prior flu seasons:
In the US in 2009:
There were four manufacturers' products approved for use: CSL, Novartis, Sanofi Pasteur, and MedImmune are the manufacturers of the vaccines approved so far. GlaxoSmithKline has not yet had approval for their vaccine in the US but it was approved in Europe.
CSL, Novartis and Sanofi Pasteur have produced the vaccines for injection that are made with inactivated viruses, and MedImmune has produced the nasal spray. None of the vaccines approved in the US by FDA contain adjuvants [A substance added to a vaccine to improve the immune response so that less vaccine is needed.]
The purified virus is inactivated with beta-propiolactone, and the virus particles are disrupted using sodium taurodeoxycholate to produce a "split virion". The disrupted virus is further purified and suspended in a phosphate buffered isotonic solution.
Influenza A (H1N1) 2009 Monovalent Vaccine is formulated to contain 15 mcg HA per 0.5 mL dose of influenza A/California/7/2009 (H1N1)v-like virus.
The single-dose formulation is preservative-free; thimerosal, a mercury derivative, is not used in the manufacturing process for this formulation. The multi-dose formulation contains thimerosal, added as a preservative; each 0.5 mL dose contains 24.5 mcg of mercury.
A single 0.5 mL dose of Influenza A (H1N1) 2009 Monovalent Vaccine contains sodium chloride (4.1 mg), monobasic sodium phosphate (80 mcg), dibasic sodium phosphate (300 mcg), monobasic potassium phosphate (20 mcg), potassium chloride (20 mcg), and calcium chloride (1.5 mcg). From the manufacturing process, each dose may also contain residual amounts of sodium
taurodeoxycholate (≤ 10 ppm), ovalbumin (≤ 1 mcg), neomycin sulfate (≤ 0.2 picograms [pg]), polymyxin B (≤ 0.03 pg), and beta-propiolactone (< 25 nanograms).
The rubber tip cap and plunger used for the preservative-free, single-dose syringes and the rubber stoppers used for the multi-dose vial contain no latex.
Grown in eggs with neomycin and polymixin then centrifuged to purify, then inactivated with betapropiolactone Influenza A (H1N1) 2009 Monovalent Vaccine is a homogenized, sterile, slightly opalescent suspension in a phosphate buffered
Influenza A (H1N1) 2009 Monovalent Vaccine is formulated to contain 15 mcg hemagglutinin (HA) per 0.5-mL dose of the following virus strain: A/California/7/2009 (H1N1)v-like virus.
The 0.5-mL prefilled syringe presentation is formulated without preservative. Thimerosal, a mercury derivative used during manufacturing, is removed by subsequent purification steps to a trace amount (≤ 1 mcg mercury per 0.5-mL dose).
The 5-mL multidose vial formulation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5-mL dose from the multidose vial contains 25 mcg mercury.
Each dose from the multidose vial or from the prefilled syringe may also contain residual amounts of egg proteins (≤ 1 mcg ovalbumin), polymyxin (≤ 3.75 mcg), neomycin (≤ 2.5 mcg), betapropiolactone (not more than 0.5 mcg) and nonylphenol ethoxylate (not more than 0.015% w/v).
The multidose vial stopper and the syringe stopper/plunger do not contain latex.
The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. The virus is then chemically disrupted using a non-ionic surfactant, polyethylene glycol p-isooctylphenyl ether (Triton® X-100), producing a "split virus". The split virus is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution.
Influenza A (H1N1) 2009 Monovalent Vaccine is formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009 (H1N1) v-like virus per 0.5 mL dose. Gelatin 0.05% is added as a stabilizer. Each 0.5 mL dose may contain residual amounts of formaldehyde (not more than 100 mcg), polyethylene glycol p-isooctylphenyl ether (not more than 0.02%), and sucrose (not more than 2.0%).
There is no thimerosal used in the manufacturing process of the single-dose presentations of Influenza A (H1N1) 2009 Monovalent Vaccine. The multi-dose presentation of Influenza A (H1N1) 2009 Monovalent Vaccine contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose of the multidose presentation contains 25 mcg mercury.
Antibiotics are not used in the manufacture of Influenza A (H1N1) 2009 Monovalent Vaccine.
All presentations of Influenza A (H1N1) 2009 Monovalent Vaccine do not contain latex.
Each 0.2 mL dose contains 106.5-7.5 FFU of the live attenuated influenza virus reassortant of the pandemic (H1N1) 2009 virus:
["attenuated" means weakened to be non-infective]
A/California/7/2009 (H1N1)v. Each 0.2 mL dose also contains 0.188 mg/dose monosodium glutamate, 2.00 mg/dose hydrolyzed porcine gelatin, 2.42 mg/dose arginine, 13.68 mg/dose sucrose, 2.26 mg/dose dibasic potassium phosphate, 0.96 mg/dose monobasic potassium phosphate, and <0.015 mcg/mL gentamicin sulfate. The vaccine contains no preservatives.
In Europe in the 2009- 2010 flu season:
European Medicines Agency (EMEA) recommended two new drugs which were manufactured by GlaxoSmithKline and Novartis. The vaccines are called Pandermix and Focetria. A third vaccine by Baxter did not pass the committee's approval process but it is still being considered.
The ingredient list from the EMEA specifies:
Squalene 10.68 mg
Alpha-tocopherol 11.86 mg
Polysorbate 80 4.86 mg
Potassium dihydrogen phosphate
Water for injections
The manufacturing process includes:
Propagation of the working seed in fertilised hen's eggs, harvesting and pooling of infected allantoic fluids
• Purification of the whole virus bulk
• Splitting of the monovalent with sodium deoxycholate [derived from bovine bile].
• Inactivation of the monovalent split virus using sodium deoxycholate and formaldehyde, followed by ultrafiltration and sterile filtration
Ingredients per 0.5 ml dose adjuvanted by AS03. AS03 consists of the oil-in-water emulsion containing DL-α-tocopherol, squalene and tween 80. Thiomersal, 10 μg/ml (5 μg per dose), is added because of the
"The pandemic vaccine has been developed using traditional influenza manufacturing processes in an egg-based formulation. Focetria contains MF59®, Novartis proprietary adjuvant, which has been added to boost the immune response in individuals receiving the vaccine. . .
. . . Novartis proprietary MF59 adjuvant has an established safety profile, supported by more than 12 years of clinical safety data and more than 40 million doses of commercial use in Europe."
The following information is from the EMEA package leaflet:
Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain:
A/California/7/2009 (H1N1)v like strain (X-179A) 7.5 micrograms** per 0.5 ml dose
* propagated in eggs
** expressed in microgram haemagglutinin.
This vaccine complies with the WHO recommendation and EU decision for the pandemic.
The vaccine contains an 'adjuvant' (MF59C.1) to stimulate a better response. MF59C.1 is an oil/water emulsion containing 9.75 mg squalene, 1.175 mg polysorbate 80 and 1.175 mg sorbitan trioleate in a citrate buffer.
- Other Ingredients:
The other ingredients are: thiomersal (multidose vial only), sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid and water for injections.
Note of Interest: The U.S. is in "very active discussions" about donating some of its supply to countries that need it. CSL plans to donate vaccine to developing nations in Asia and the South Pacific. They are working on this with the World Health Organization to start by providing as many as 100,000 doses. According to the WHO, an initial distribution of the more than 300 million doses, which were donated by other countries to over 90 countries in need, will begin sometime in November.