Influenza (flu) |
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Seasonal influenza vaccine brands include Fluzone/Fluzone Quadrivalent [1] and Vaxigrip/VaxigripTetra, [2] Influvac and Optaflu.
Fluenz, FluMist and their quadrivalent formulations are nasal attenuated vaccines by AstraZeneca.
Fluarix, Flulaval and their quadrivalent formulations are split virus inactivated vaccines by GlaxoSmithKline. [7]
Influvac and its quadrivalent formulation are surface antigen subunit vaccines marketed by Mylan.
They contain inactivated purified surface fragments (subunits) from the three different strains of the influenza virus (A/H1N1, A/H3N2, and Influenza B virus) that are selected and distributed by the World Health Organization, on the basis of their latest recommendations. Previously, they were produced and marketed by Abbott Laboratories [9]
In February 2010, Abbott acquired the vaccines subunit from Solvay Pharmaceuticals included in its $6.2 billion purchase [10] and the subunit influenza vaccine — Influvac has been commercially available on the market since the early nineteen-eighties. [9] With the acquisition of Solvay, Abbott retained access to the Eastern European, Middle Eastern & Latin American markets. Approximately $850 million of sales revenue from vaccines was reported by Solvay Pharmaceuticals in 2009. [10]
In February 2015, Mylan Laboratories completed the deal with Abbott to purchase Abbott's generic drugs business in developed markets, which includes Influvac. [11] [12]
Optaflu is a trivalent surface antigen inactivated vaccine prepared in cell cultures manufactured by Novartis.
On April 27, 2007, Novartis received a positive opinion supporting European Union approval of Optaflu. It is the first influenza vaccine made in a mammalian cell line, rather than chicken eggs. [13] The plan was to manufacture the vaccine in Holly Springs, North Carolina. The United States government provided $500 million in construction costs and guaranteed vaccine purchases. [14]
Novartis' flu vaccine unit was sold to CSL Limited in 2014, and was placed under CSL subsidiary, bioCSL (Seqirus). [15] bioCSL as marketing authorization holder decided to discontinue the usage of Optaflu brand in 2017 due to commercial reasons [16]
Vaxigrip Tetra and Fluquadri are quadrivalent split virus inactivated vaccines by Sanofi-Aventis.
Sanofi Pasteur produces the following vaccines:
Fluzone and its quadrivalent formulation are split virus inactivated vaccines distributed by Sanofi Pasteur mainly in the United States.
Fluzone is typically administered in a single dose by intramuscular injection; [18] an intradermal injection is also available. [19] It is presented as a 0.25 ml syringe for pediatric use, as a 0.5 ml syringe for adults and children, as a 0.5 ml vial for adults and children, and as a 5 ml vial for adults and children. [18] Fluzone must be refrigerated under temperatures from 2 to 8 °C (36 to 46 °F) and is inactivated by freezing. Fluzone was initially approved in 1980 by the FDA. [18]
The following adverse effects have been reported: [18]
A high-dose vaccine (Fluzone High-Dose) four times the strength of standard flu vaccine was approved by the FDA in 2009. [20] [21] [22] This vaccine is intended for people 65 and over, who typically have weakened immune response due to normal aging. The vaccine produces a greater immune response than standard vaccine. According to the CDC, [1] "a study published in the New England Journal of Medicine [23] [in August, 2014] indicated that the high-dose vaccine was 24.2% more effective in preventing flu in adults 65 years of age and older relative to a standard-dose vaccine." The CDC recommends the high-dose vaccine for people 65 and over but expresses no preference between it and standard vaccine. Further studies were underway as of 2014 [update] .[ citation needed ]
Vaxigrip and its quadrivalent formulation Vaxigrip Tetra are split virus inactivated vaccines made by Sanofi Pasteur in Europe. [2] [24] Vaxigrip provides immune responses to three influenza strains and VaxigripTetra adds another B strain. VaxigripTetra was approved in Europe in 2016 except for infants younger than three years old. [2]
Flublok and its quadrivalent formulation are recombinant subunit vaccines prepared in cell cultures. Recombinant influenza vaccines are produced using recombinant virus technology. This method does not require an egg-grown vaccine virus and does not use chicken eggs in the production process. [25] [26] [17] The DNA for the hemagglutinin antigen of influenza virus is added to a baculovirus. This recombinant virus is then used to infect cultured insect cells (of the moth Spodoptera frugiperda ), which subsequently produce the hemagglutinin protein. The protein is harvested and purified. This is done for four different types of influenza hemagglutinin to create the Flublok Quadrivalent vaccine. [27]
Afluria and its quadrivalent formulation are a split virus inactivated vaccines. Fluad and its quadrivalent formulations are adjuvanted surface antigen inactivated vaccines. Flucelvax and its quadrivalent formulations are surface antigen inactivated vaccines prepared in cell cultures.
Novartis developed the first influenza vaccine, which did not need to be grown in chicken eggs, a cell-based vaccine. [28] In 2014, CSL Limited obtained Novartis' flu vaccine unit, and transferred it to CSL Subsidiary, bioCSL, named Seqirus. [15]
The following are list of bioCSL flu vaccine brands: [29]
The DPT vaccine or DTP vaccine is a class of combination vaccines against three infectious diseases in humans: diphtheria, pertussis, and tetanus. The vaccine components include diphtheria and tetanus toxoids and either killed whole cells of the bacterium that causes pertussis or pertussis antigens. The term toxoid refers to vaccines which use an inactivated toxin produced by the pathogen which they are targeted against to generate an immune response. In this way, the toxoid vaccine generates an immune response which is targeted against the toxin which is produced by the pathogen and causes disease, rather than a vaccine which is targeted against the pathogen itself. The whole cells or antigens will be depicted as either "DTwP" or "DTaP", where the lower-case "w" indicates whole-cell inactivated pertussis and the lower-case "a" stands for "acellular". In comparison to alternative vaccine types, such as live attenuated vaccines, the DTP vaccine does not contain any live pathogen, but rather uses inactivated toxoid to generate an immune response; therefore, there is not a risk of use in populations that are immune compromised since there is not any known risk of causing the disease itself. As a result, the DTP vaccine is considered a safe vaccine to use in anyone and it generates a much more targeted immune response specific for the pathogen of interest.
Influenza vaccines, colloquially 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. Vaccination against influenza began in the 1930s, with large-scale availability in the United States beginning in 1945.
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.
CSL Limited is an Australian multinational specialty biotechnology company that researches, develops, manufactures, and markets products to treat and prevent serious human medical conditions. CSL's product areas include blood plasma derivatives, vaccines, antivenom, and cell culture reagents used in various medical and genetic research and manufacturing applications. The company was established in 1916 as Commonwealth Serum Laboratories and was wholly owned by the Australian federal government until its privatisation in 1994.
Influenza A virus subtype H3N2 (A/H3N2) is a subtype of viruses that causes influenza (flu). H3N2 viruses can infect birds and mammals. In birds, humans, and pigs, the virus has mutated into many strains. In years in which H3N2 is the predominant strain, there are more hospitalizations.
Influenza B virus is the only species in the genus Betainfluenzavirus in the virus family Orthomyxoviridae.
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.
A zoster vaccine is a vaccine that reduces the incidence of herpes zoster (shingles), a disease caused by reactivation of the varicella zoster virus, which is also responsible for chickenpox. Shingles provokes a painful rash with blisters, and can be followed by chronic pain, as well as other complications. Older people are more often affected, as are people with weakened immune systems (immunosuppression). Both shingles and postherpetic neuralgia can be prevented by vaccination.
Ofatumumab is a fully human monoclonal antibody to CD20, which appears to provide rapid B-cell depletion. Under the brand name Kesimpta, it is approved for the treatment of multiple sclerosis in the United States as well as in the European Union and other regions. Under the brand name Arzerra, it is approved for the treatment of certain types of chronic lymphocytic leukemia (CLL) in the United States. It is sold by Novartis under license from Genmab.
Hepatitis B vaccine is a vaccine that prevents hepatitis B. The first dose is recommended within 24 hours of birth with either two or three more doses given after that. This includes those with poor immune function such as from HIV/AIDS and those born premature. It is also recommended that health-care workers be vaccinated. In healthy people, routine immunization results in more than 95% of people being protected.
Hepatitis A vaccine is a vaccine that prevents hepatitis A. It is effective in around 95% of cases and lasts for at least twenty years and possibly a person's entire life. If given, two doses are recommended beginning after the age of one. It is given by injection into a muscle. The first hepatitis A vaccine was approved in Europe in 1991, and the United States in 1995. It is on the World Health Organization's List of Essential Medicines.
Meningococcal vaccine refers to any vaccine used to prevent infection by Neisseria meningitidis. Different versions are effective against some or all of the following types of meningococcus: A, B, C, W-135, and Y. The vaccines are between 85 and 100% effective for at least two years. They result in a decrease in meningitis and sepsis among populations where they are widely used. They are given either by injection into a muscle or just under the skin.
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.
A H5N1 vaccine is an influenza vaccine intended to provide immunization to influenza A virus subtype H5N1.
Cell-based vaccines are developed from mammalian or more rarely avian or insect cell lines rather than the more common method which uses the cells in embryonic chicken eggs to develop the antigens. The potential use of cell culture techniques in developing viral vaccines has been widely investigated in the 2000s as a complementary and alternative platform to the current egg-based strategies.
DTaP-IPV-HepB vaccine is a combination vaccine whose generic name is diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B (recombinant) and inactivated polio vaccine or DTaP-IPV-Hep B. It protects against the infectious diseases diphtheria, tetanus, pertussis, poliomyelitis, and hepatitis B.
A hexavalent vaccine, or 6-in-1 vaccine, is a combination vaccine with six individual vaccines conjugated into one, intended to protect people from multiple diseases. The term usually refers to the children's vaccine that protects against diphtheria, tetanus, pertussis, poliomyelitis, haemophilus B, and hepatitis B, which is used in more than 90 countries around the world including in Europe, Canada, Australia, Jordan, and New Zealand.
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.
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.
Live recombinant vaccines are biological preparations that improve immunity through the use of live bacteria or viruses that are genetically modified. These live pathogens are biologically engineered to express exogenous antigens in the cytoplasm of target cells, triggering immune responses as a result. This form of vaccine combines the beneficial features of attenuated and recombinant vaccines, providing the preparation with attenuated vaccines’ long-lasting immunity and recombinant vaccines’ genetically engineered precision and safety.
But Novartis is building a cell culture flu vaccine factory in Holly Springs, N.C., which might be ready for use in 2010 or 2011. The federal government is providing nearly $500 million in construction costs and guaranteed vaccine purchases.