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Influenza vaccines

IntroductionInfluenza vaccines, also known as flu shots, are vaccines that protect against influenza. A new version of the vaccine is developed twice a year as the influenza virus rapidly changes.

1918 flu pandemic

The1918 flu pandemic(January 1918 December 1920) was an unusually deadlyinfluenza pandemic, the first of the two pandemics involvingH1N1 influenza virus.It infected 500million people across the world, including remote Pacific islands and the Arctic, and resulted in the deaths of 50 to 100million (three to five percent of the world's population), making it one of the deadliest natural disasters in human history.A considerable spike occurred at the time of the pandemic, specifically the year 1918. Life expectancy dropped by about 12 years.4

In 1931,Robert Shopein the USA managed to recreateswine influenza

In 1931,Robert Shopein the USA managed to recreateswine influenza5

1935-1941FIRST HUMAN INFLUENZA VACCINES TESTED

1942-1943THE FLU DURING WWIIInfluenza vaccine studies occur at Army posts

1946-1947DISCOVERY THAT INFLUENZA STRAINS CHANGE ANNUALLY

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2005CLINICAL DEVELOPMENT BEGINSClinical development of cell culture-based influenza vaccines begins.

September 2009Four major vaccine manufacturers report that their swine flu vaccines work with only one shot.

MANUFACTURING PROCEDURE

How Influenza (Flu) Vaccines Are MadeThere are three different influenza vaccine production technologies approved by the U.S. Food and Drug Administration (FDA):

Egg-based flu vaccine ( Most common method)Cell-based flu vaccine, andRecombinant flu vaccine.

Egg-Based Flu Vaccines

The most common way that flu vaccines are made is using an egg-based manufacturing process that has been used for more than 70 years. Egg-based vaccine manufacturing is used to make both inactivated (killed) vaccine (usually called the flu shot) and live attenuated (weakened) vaccine (usually called the nasal spray).The egg-based production process begins with CDC or another laboratory partner in the WHO Global Influenza Surveillance and Response System providing private sector manufacturers with candidate vaccine viruses (CVVs) grown in eggs per current FDA regulatory requirements. These CVVs are then injected into fertilized hens eggs and incubated for several days to allow the viruses to replicate. The virus-containing fluid is harvested from the eggs. For flu shots, the influenza viruses for the vaccine are then inactivated (killed), and virus antigen is purified. The manufacturing process continues with purification and testing. For the attenuated nasal spray vaccine, the starting CVVs are weakened viruses and go through a different production process. FDA tests and approves vaccines prior to release and shipment. There are many different manufacturers that use this production technology to make flu vaccines for use in the United States. This production method requires large numbers of chicken eggs to produce vaccine and usually takes longer than other methods used to produce vaccine.13

COMPONENTS an A/California/7/2009 (H1N1)pdm09-like virus; an A/Hong Kong/4801/2014 (H3N2)-like virus; a B/Brisbane/60/2008-like virus.It is recommended that quadrivalent vaccines containing two influenza B viruses contain the above three viruses and a B/Phuket/3073/2013-like virus.Thimerosal - antiseptic and antifungal agentFormaldehydeNeomycin http://www.who.int/influenza/vaccines/virus/recommendations/201602_recommendation.pdf

CLINICAL PHARMACOLOGYThe inoculation of antigen prepared from inactivated influenza virus stimulates the production of specific antibodies.Protection is afforded only against those strains of virus from which the vaccine is prepared or closely related strains.Immunity to the surface antigens, especially to the hemagglutinin, reduces the likelihood of infection and lessens the severity of disease if infection occurs.

EFFICACY DATAPopulationType of OutcomeLevel of protection(95% confidence intervals)Infants under 6-months whosemothers received influenza vaccineduring pregnancyEfficacy against laboratoryconfirmed influenza41% - 48%Healthy children under 2 years of ageEffectiveness against laboratoryconfirmed influenza66% (9% - 88%)Healthy children aged 6-35 monthsEffectiveness against laboratoryconfirmed influenza66% (29% - 84%)Healthy children under 16 yearsof ageTIV vaccine efficacy inprevention of laboratoryconfirmed influenza inRandomised Controlled Trials59% (41% - 71%)Healthy adults (18-65 years)Effectiveness against influenzalike-illness30% (17% - 41%)Elderly aged 65 years and over (Cochrane review 2010)Effectiveness in preventing influenza, influenza-like-illness, hospitalisations, complications and mortalityInconclusive due to poor quality of studies

http://www.influenza.org.nz/effectiveness-inactivated-influenza-vaccines

INDICATIONS AND USAGE Indicated for active immunization against influenza caused by influenza virus in adults and children 6 months of age and older.Influenza vaccine may be administered to any child 6 months of age, adolescent, or adult in whom contraindications are not present.Annual vaccination using the current vaccine is necessary because immunity declines in the year following vaccination.

Annual influenza vaccination is particularly recommended for persons in the following categories

Persons at high risk of influenza-related complications Adults and children with selected chronic health conditions - cardiac or pulmonary disorders, diabetes mellitus and other metabolic diseases, cancer, immunodeficiency, immunosuppression, renal disease, anaemia or hemoglobinopathy, and conditions that compromise the management of respiratory secretions and are associated with an increased risk of aspiration Persons of any age who are residents of nursing homes and other chronic care facilities. Persons 65 years of age and over. Aged 6 months to 18 years with conditions treated for long periods with acetylsalicylic acid. Pregnant women with any of these co-morbidities Healthy children aged 6 to 23 monthsNational Advisory Committee on Immunization (NACI). , CDC. Prevention and control of influenza

Persons capable of transmitting influenza to those at high risk Health care and other care providers in facilities and community Those who provide services within closed or relatively closed settings to persons at high risk Household contacts (adults and children) of persons at high risk of influenza complications. Those providing regular child care to children < 24 months of age. Persons in direct contact with poultry. National Advisory Committee on Immunization (NACI). , CDC. Prevention and control of influenza

Immunization of healthy persons Immunization of healthy persons aged 2 to 64 years. Persons in this group should beencouraged to receive the vaccine. Employers and their employees should consider yearly influenza immunization for healthy working adults. Students or other persons in institutional settings should be encouraged to receive vaccine during epidemics. TravellersNational Advisory Committee on Immunization (NACI). , CDC. Prevention and control of influenza

DOSAGE

http://novaccine.com/wp-content/uploads/2014/02/vaxigrip_package_insert.pdf

ADMINISTRATIONInspect for extraneous particulate matter and/or discolouration before use. If these conditions exist, the product should not be administered.Administer the vaccine intramuscularly.The preferred site is into the deltoid muscle, in adults and children >1 year of age.The preferred site for infants and young children (38C)RigorsMalaise Headache ArthralgiaMyalgia Sweating increased

DRUG INTERACTIONSClinical studies show that influenza vaccine may be administered with pneumococcal vaccine using separate syringes at different sites. Inactivated vaccines usually do not interfere with the immune response to other inactivated or live vaccines and influenza vaccine may be given at the same time as other vaccines, provided different sites and administration sets (needle and syringe) are used.National Advisory Committee on Immunization: Canadian Immunization Guide, Sixth ed. Her Majesty the Queen in Right of Canada represented by the Minister of Public Works and Government Services Canada; 2002. p. 4,7,14-8,20-6,31-2,120-1,125.

TOXICOLOGYData in animals revealed no unexpected findings and no target organ toxicity.Sanofi Pasteur. Data on file. CIT/STudy AA17119. Repeated dose toxicity and local tolerance in rabbits by intramuscular route. 2004.

Toxicologyis the scientific study of adverse effects that occur in living organisms due to chemicals. It involves observing and reporting symptoms, mechanisms, detection and treatments of toxic substances, in particular relation to the poisoning of humans.30

BrandsInactivated influenza vaccine (quadrivalent)-Fluarix,FluLaval,FluzoneInactivated influenza vaccine (trivalent)-Afluria,Fluvirin,FluzoneInactivated influenza vaccine (cell culture based)-Flucelvax Recombinant influenza vaccine (trivalent)-Flublok Live attenuated influenza vaccine (quadrivalent)-FluMist