AS03

Last updated

AS03 (for "Adjuvant System 03") is the trade name for a squalene-based immunologic adjuvant used in various vaccine products by GlaxoSmithKline (GSK). It is used, for example, in GSK's A/H1N1 pandemic flu vaccine Pandemrix. It is also in Arepanrix and the Q-pan for H5N1 influenza. [1] A dose of AS03 adjuvant contains [2]

In the 2009 influenza pandemic, vaccines containing AS03 delivered a stronger immunogene response against pandemic H1N1 influenza than non-adjuvanted vaccines, despite their containing lower levels of viral antigen. [3]

Small observational studies reported from Finland and Sweden in 2012, and larger studies from Ireland reported in 2012, and reported in each of England, Norway and France in 2013, found an association between narcolepsy and an A(H1N1)pdm09 vaccine that used AS03 adjuvant; the rates ranged from one in 16,000 doses to one in 50,000 doses. [4] As of 2016 it was unclear whether or not the adjuvant was responsible; other suspected causes include genetic susceptibility, exposure to A(H1N1)pdm09, manufacturing impurities, or combinations of these factors. [4]

See also

Related Research Articles

<span class="mw-page-title-main">Squalene</span> Chemical compound

Squalene is an organic compound. It is a triterpenoid with the formula C30H50. It is a colourless oil, although impure samples appear yellow. It was originally obtained from shark liver oil (hence its name, as Squalus is a genus of sharks). An estimated 12% of bodily squalene in humans is found in sebum. Squalene has a role in topical skin lubrication and protection.

<span class="mw-page-title-main">Influenza vaccine</span> Vaccine against influenza

Influenza vaccines, also known as flu shots, are vaccines that protect against infection by influenza viruses. New versions of the vaccines are developed twice a year, as the influenza virus rapidly changes. While their effectiveness varies from year to year, most provide modest to high protection against influenza. The United States Centers for Disease Control and Prevention (CDC) estimates that vaccination against influenza reduces sickness, medical visits, hospitalizations, and deaths. Immunized workers who do catch the flu return to work half a day sooner on average. Vaccine effectiveness in those over 65 years old remains uncertain due to a lack of high-quality research.

<span class="mw-page-title-main">Live attenuated influenza vaccine</span> Flu vaccine that is sprayed into the nose

Live attenuated influenza vaccine (LAIV) is a type of influenza vaccine in the form of a nasal spray that is recommended for the prevention of influenza.

<span class="mw-page-title-main">Influenza pandemic</span> Pandemic involving influenza

An influenza pandemic is an epidemic of an influenza virus that spreads across a large region and infects a large proportion of the population. There have been six major influenza epidemics in the last 140 years, with the 1918 flu pandemic being the most severe; this is estimated to have been responsible for the deaths of 50–100 million people. The most recent, the 2009 swine flu pandemic, resulted in under 300,000 deaths and is considered relatively mild. These pandemics occur irregularly.

<span class="mw-page-title-main">H5N1 vaccine clinical trials</span>

H5N1 clinical trials are clinical trials concerning H5N1 vaccines, which are intended to provide immunization to influenza A virus subtype H5N1. They are intended to discover pharmacological effects and identify any adverse reactions the vaccines may achieve in humans.

In immunology, an adjuvant is a substance that increases or modulates the immune response to a vaccine. The word "adjuvant" comes from the Latin word adiuvare, meaning to help or aid. "An immunologic adjuvant is defined as any substance that acts to accelerate, prolong, or enhance antigen-specific immune responses when used in combination with specific vaccine antigens."

<span class="mw-page-title-main">Pandemrix</span> Flu vaccine

Pandemrix is an influenza vaccine for influenza pandemics, such as the 2009 flu pandemic. The vaccine was developed by GlaxoSmithKline (GSK) and patented in September 2006.

A subunit vaccine is a vaccine that contains purified parts of the pathogen that are antigenic, or necessary to elicit a protective immune response. Subunit vaccine can be made from dissembled viral particles in cell culture or recombinant DNA expression, in which case it is a recombinant subunit vaccine.

<span class="mw-page-title-main">2009 swine flu pandemic</span> 2009–2010 pandemic of swine influenza caused by H1N1 influenza virus

The 2009 swine flu pandemic, caused by the H1N1/swine flu/influenza virus and declared by the World Health Organization (WHO) from June 2009 to August 2010, is the third recent flu pandemic involving the H1N1 virus. The first two cases were discovered independently in the United States in April 2009. The virus appeared to be a new strain of H1N1 that resulted from a previous triple reassortment of bird, swine, and human flu viruses which further combined with a Eurasian pig flu virus, leading to the term "swine flu".

<span class="mw-page-title-main">2009 swine flu pandemic vaccine</span> Protection against the H1N1/09 virus

The 2009 swine flu pandemic vaccines were influenza vaccines developed to protect against the pandemic H1N1/09 virus. These vaccines either contained inactivated (killed) influenza virus, or weakened live virus that could not cause influenza. The killed virus was injected, while the live virus was given as a nasal spray. Both these types of vaccine were produced by growing the virus in chicken eggs. Around three billion doses were produced, with delivery in November 2009.

Adjuvant System 04 or AS04 is a trade name for a combination of adjuvants used in various vaccine products by GlaxoSmithKline, in particular the Fendrix hepatitis B vaccine and Cervarix human papillomavirus (HPV) vaccine. It consists of aluminium hydroxide and monophosphoryl lipid A (MPL). It is the successor of AS03, a squalene based adjuvant used in H1N1/09 and H5N1 influenza vaccines.

Zoltan Vajo is a Hungarian/American scientist, best known for his contributions to the Human Genome Project, including cloning the COQ7 gene, characterizing the human CLK-1 timing protein cDNA and its potential effect on aging, and research on the molecular and genetic background of skeletal dysplasias and fibroblast growth factor receptor 3 disorders, including Achondroplasia, SADDAN, Thanatophoric dysplasia, Muenke coronal craniosynostosis and Crouzon syndrome as well as more recently on genetically engineered insulin analog molecules, including their structure, metabolic effects and cellular processing and the role of recombinant DNA technology in the treatment of diabetes.

<span class="mw-page-title-main">H5N1 vaccine</span> Vaccine designed to provide immunity against H5N1 influenza

A H5N1 vaccine is an influenza vaccine intended to provide immunization to influenza A virus subtype H5N1.

Respiratory syncytial virus vaccine, or RSV vaccine, is a vaccine which prevents infection by respiratory syncytial virus. The RSV vaccines Arexvy (GSK), and Abrysvo (Pfizer), were both approved for medical use in the United States in May 2023.

<span class="mw-page-title-main">Vaccine ingredients</span> Ingredients used in a vaccine dose

A vaccine dose contains many ingredients, very little of which is the active ingredient, the immunogen. A single dose may have merely nanograms of virus particles, or micrograms of bacterial polysaccharides. A vaccine injection, oral drops or nasal spray is mostly water. Other ingredients are added to boost the immune response, to ensure safety or help with storage, and a tiny amount of material is left-over from the manufacturing process. Very rarely, these materials can cause an allergic reaction in people who are very sensitive to them.

<span class="mw-page-title-main">CoVLP</span> COVID-19 vaccine candidate produced in a plant

CoVLP was a COVID-19 vaccine developed by Medicago in Canada and GlaxoSmithKline (GSK). The product and Medicago, Inc. were owned by Mitsubishi who terminated the company and program in February 2023 due to high international market competition for COVID-19 vaccines.

<span class="mw-page-title-main">SCB-2019</span> Vaccine candidate against COVID-19

SCB-2019 is a protein subunit COVID-19 vaccine developed by Clover Biopharmaceuticals using an adjuvant from Dynavax technologies. Positive results of Phase I trials for the vaccine were published in The Lancet and the vaccine completed enrollment of 29,000 participants in Phase II/III trials in July 2021. In September 2021, SCB-2019 announced Phase III results showing 67% efficacy against all cases of COVID-19 and 79% efficacy against all cases of the Delta variant. Additionally, the vaccine was 84% effective against moderate cases and 100% effective against hospitalization.

<span class="mw-page-title-main">Sanofi–GSK COVID-19 vaccine</span> Vaccine candidate against COVID-19

The Sanofi–GSK COVID-19 vaccine sold under the brand name VidPrevtyn Beta, is a COVID-19 vaccine developed by Sanofi Pasteur and GSK.

Type A influenza vaccine is for the prevention of infection of influenza A virus and also the influenza-related complications. Different monovalent type A influenza vaccines have been developed for different subtypes of influenza A virus including H1N1 and H5N1. Both intramuscular injection or intranasal spray are available on market. Unlike the seasonal influenza vaccines which are used annually, they are usually used during the outbreak of certain strand of subtypes of influenza A. Common adverse effects includes injection site reaction and local tenderness. Incidences of headache and myalgia were also reported with H1N1 whereas cases of fever has also been demonstrated with H5N1 vaccines. It is stated that immunosuppressant therapies would reduce the therapeutic effects of vaccines and that people with egg allergy should go for the egg-free preparations.

References

  1. "FDA panel endorses H5N1 vaccine with adjuvant". 15 Nov 2012.
  2. Pandemrix – Summary of product characteristics Archived October 7, 2009, at the Wayback Machine , European Medicines Agency websiteEuropean Medicines Agency website Archived 2013-07-15 at the Wayback Machine
  3. Yin JK, Khandaker G, Rashid H, Heron L, Ridda I, Booy R (September 2011). "Immunogenicity and safety of pandemic influenza A (H1N1) 2009 vaccine: systematic review and meta-analysis". Influenza and Other Respiratory Viruses. 5 (5): 299–305. doi:10.1111/j.1750-2659.2011.00229.x. PMC   4986623 . PMID   21668694.
  4. 1 2 Ahmed, SS; Montomoli, E; Pasini, FL; Steinman, L (2016). "The Safety of Adjuvanted Vaccines Revisited: Vaccine-Induced Narcolepsy" (PDF). The Israel Medical Association Journal. 18 (3–4): 216–20. PMID   27228647.