The recommendations for the influenza season 20192020 were endorsed by ema s human medicines committee chmp at its march meeting. The ema issues advice on the composition of season flu vaccines for the 2019 2020 season for manufacturers. Influenza vaccines quality module european medicines agency. The influenza vaccine for the 20202021 season is composed of the antigens of globally circulating variants of the following viruses. Until 2015, vaccine producers were required by ema committee to perform annual clinical trials in order to evaluate both immunogenicity and safety for the updating of seasonal annual iivs. The vaccines were stressed by temperature and freezethawing.
Ecdc continues to emphasise that all europeans who are recommended to have the influenza vaccine should get vaccinated. In a bad year, the seasonal flu vaccine reduces the risk of flu illness by only 20% to 30% in the overall population. Seasonal influenza vaccines are not expected to provide substantial protection against infection with the recently identified novel influenza a h1n1 318, and guidance for the prevention of infection against this virus will be published separately. The ema chmp has recommended granting marketing authorization for flucelvax tetra seqirus netherlands bv, a quadrivalent cellbased. Niaid supports and conducts research to develop vaccines against newly emerging influenza flu viruses, improve seasonal flu vaccines, and create a universal flu vaccine that would protect people against multiple flu strains, including potential pandemic strains, over multiple flu seasons. The recommendations now also contain a decision on suitable h1n1 and h3n2 viruses for seasonal live attenuated influenza vaccines laiv. Universal flu vaccine shows promise in a challenge study. Seasonal influenza vaccines are used over a relatively short time period, with vaccination campaigns starting prior to peak influenza activity, which generally occurs in january or february in the northern. Regulatory pathways for registration of seasonal and. Ema has issued an update of the eu recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2019. Highlights four seasonal influenza vaccines were characterized before and after stresses. This set out new standards for surveillance that all marketing authorisation holders mahs providing vaccines in the eu must address. Seasonal influenza is a vaccinepreventable disease and annual influenza vaccination is the most effective way to prevent influenza.
Every year, emas ad hoc influenza working group issues eu recommendations for the composition of seasonal influenza vaccines on the basis of observations by the world health organization. Live attenuated influenza vaccine laiv is a type of influenza vaccine in the form of a nasal. Seasonal influenza vaccination coverage rates in older age groups in. The quality modules submitted to the tga as part of registration applications for influenza vaccines category 1 applications, andor variation applications for annual strain updates to seasonal influenza vaccines category 3 applications are expected to meet the ema guidelines. Annual vaccination for disease prevention is crucial. Cellbased quadrivalent flu vaccine recommended by ema panel. Manufacturers of trivalent vaccines for the 20192020 season should include these three virus strains. Immunity following influenza disease and administration of. Regulatory pathways for registration of seasonal and pandemic. Update of eu recommendations for 20202021 seasonal flu. Postauthorisation passive enhanced safety surveillance of. Sponsors wanting to introduce seasonal composition updates for registered influenza vaccines are encouraged to notify the associated changes in two discrete stages. Due to the constant antigenic drift of the influenza virus hemagglutinin ha and neuraminidase na surface.
Although most persons who become infected with influenza viruses. Influenza virus vaccines are unique among currently licensed viral vaccines. Procedural and sampling requirements for annual seasonal update asu submissions for seasonal influenza vaccines for changes that require submission of data under s. Model adjusted for 200910 seasonal and pandemic influenza vaccination, least one chronic disease, sex, at least one hospitalisation in previous 12 months, current smoker, age group practitioner visits in previous 12 months, week of symptom onset. Strains composition of influenza virus vaccines for the 20202021 season. Apr 30, 2015 influenza vaccines centrally authorised use of the vaccine seasonal vaccines pandemic preparedness vaccines authorised in the interpandemic period pandemic vaccines, authorised during a pandemic from the above or via emergency procedure zoonotic influenza vaccines type of vaccine construct. The four seasonal influenza vaccines had different properties. Vaccination remains the principal way to control seasonal infections and is the most effective method of reducing influenza associated morbidity and mortality. Niaid supports and conducts research to develop vaccines against newly emerging influenza flu viruses, improve seasonal flu vaccines, and create a universal flu vaccine that would protect people. Paulehrlichinstitut table of vaccines for influenza flu. Kissling e, valenciano m, imove casecontrol studies team. In an aggressive scenario of producing pandemic influenza vaccines by 20, only 2. Since the 1940s, the main method of producing influenza vaccines has been an eggbased production process. Stability of seasonal influenza vaccines investigated by.
Structural changes and aggregation were investigated without sample dilution. Emas regulatory science strategy to 2025 is highly welcomed by vaccines europe, a trade. The quality modules submitted to the tga as part of registration applications for influenza vaccines category 1 applications, andor variation applications for annual strain updates to seasonal. This document is intended to provide to you, sponsors of seasonal inactivated influenza vaccines, guidance on clinical development approaches to support a biologics license application bla. Effectiveness and safety of seasonal and pandemic influenza. Passive enhanced safety surveillance of gsks quadrivalent. To pilot enhanced safety surveillance of seasonal influenza vaccine meeting the european medicines agency ema requirement to rapidly detect a significant increase in the frequency or severity of adverse events of interest aeis, which may indicate risk from the new seasons vaccine. New fourstrain influenza vaccine, vaxigriptetra, regulatory.
Seasonal influenza causes numerous deaths worldwide each year. Manufacturers of eggbased or live attenuated trivalent vaccines for the 20202021 season should include these three virus strains. Ppd postauthorisation passive enhanced safety surveillance. Model adjusted for 200910 seasonal and pandemic influenza vaccination, least one chronic disease, sex, at least one hospitalisation in previous 12 months, current smoker, age group practitioner visits in. The key objective of the ema enhanced safety surveillance is to rapidly detect a significant increase in the frequency andor. Priming with mf59 adjuvanted versus nonadjuvanted seasonal. Ema revised guidelines applicable to pandemic vaccines. Every year, emas ad hoc influenza working group issues eu recommendations for the composition of seasonal influenza vaccines on the. Quality requirements, influenza vaccines, inactivated, laiv, seasonal, zoonotic, pandemic preparedness, pandemic, annual strain update, pandemic. However, current seasonal influenza vaccines are only protective against closely matched circulating strains. Seasonal influenza vaccines are not expected to provide substantial protection against infection with the recently identified novel influenza a h1n1 318, and guidance for the prevention of infection against. Seasonal influenza is a common, highly contagious infectious disease that can cause severe illness and lifethreatening complications in many people. Annual updates centralised procedural advice on the submission of variations for annual update of human influenza inactivated vaccines applications in the centralised. Seasonal vaccines are updated each year to closely match circulating.
Vaccines for pandemic influenza european medicines agency. Ema offers a specific type of marketing authorisation to allow a vaccine to be developed and authorised before an influenza pandemic such vaccines normally contain a strain of bird flu virus for example ah5n1 that few people in the world have already been exposed to and that could potentially cause a pandemic. They are one of the most effective means for preventing people from becoming ill and for controlling the spread of infection. Centre for infectious disease research and policy, influenza vaccines area. Food and drug administration 10903 new hampshire avenue silver spring, md 20993 1888infofda 18884636332 contact fda. The ema has defined a regulatory procedure for approval of prepandemic vaccine manufacture based on substrains of avian influenza known to be infective for humans. Brandspecific enhanced safety surveillance of gsks. Vaccines europe response to the ema regulatory science. Vaccines free fulltext immunogenicity and safety of the new. Fluorescence, light scatter and microscopy methods were used. Enhanced safety surveillance of seasonal quadrivalent influenza. The compelling need for gamechanging influenza vaccines an analysis of the influenza vaccine enterprise and recommendations for the future michael t. While efforts have been made to prepare stockpile vaccine against zoonotic animal strains, the following descriptions relate primarily to seasonal human vaccines, unless otherwise.
Ema offers a specific type of marketing authorisation to allow a vaccine to be developed and authorised before an influenza pandemic such vaccines normally contain a strain of bird flu virus for example. In response to a recent expansion of national vaccination programmes in european union eu member states, the european medicines agency ema has released interim. Vaccination is the most effective measure at preventing influenza virus infections. Influenza vaccines centrally authorised use of the vaccine seasonal vaccines pandemic preparedness vaccines authorised in the interpandemic period pandemic vaccines, authorised. Oilinwater emulsion adjuvants for pediatric influenza. Current adjuvants, new perspectives in vaccine formulation. Even with extensive monitoring and annual reformulation our efforts remain one step behind the rapidly evolving virus, often resulting in mismatches and low vaccine effectiveness.
Fluarix and flulaval are flu vaccines brand of glaxosmithkline. Vaccination remains the principal way to control seasonal infections and is the most effective method of reducing influenzaassociated morbidity and mortality. Sponsors should refer to the most uptodate version of the european medicines agency ema guideline on influenza vaccines quality module for guidance on the quality data requirements for seasonal. Influenza vaccination in humans, the seasonal influenza vaccine is supposed to protect against endemic h1n1, h3n2, and b strains that circulate in humans globally. Pdf enhanced safety surveillance of seasonal quadrivalent.
It contains inactivated purified surface fragments subunits from the three different strains of the influenza virus ah1n1, ah3n2, and influenza b virus that are selected and. Early estimates of seasonal influenza vaccine effectiveness in europe, 201011. Every year, ema s ad hoc influenza working group issues eu recommendations for the composition of seasonal influenza vaccines on the basis of observations by the world health organization. All the abovementioned vaccine types have a common feature. Until 1978, seasonal influenza vaccines included only two strains one of type a influenza. Recently, the european medicines agency ema released interim guidance for vaccine. Tiv and laiv can be used to reduce the risk for influenza virus infection and its complications. In 2014, the european committee for medicinal products for human use chmp published a draft regulatory guideline for the evaluation of influenza vaccines.
In the united kingdom uk, groups eligible for influenza vaccination are based on the advice of the joint committee on vaccination. Update of eu recommendations for 20192020 seasonal flu. Seasonal vaccines are updated each year to closely match circulating strains. Seasonal influenza vaccines are used over a relatively short time period, with vaccination campaigns starting prior to peak influenza activity, which generally occurs in january or february in the northern hemisphere. In the context of pharmacovigilance and continuous monitoring, the european medicines agency ema released guidance on enhanced safety surveillance ess for seasonal influenza. Until the 20142015 influenza season the immune responses to updated seasonal influenza vaccine were evaluated each year through serological tests in a limited number of healthy individuals n200 according to set criteria established by the european medicines agency committee for medicinal products for human use ema chmp committee in 1997. Ecdc continues to emphasise that all europeans who are. The purpose of this 201617 pilot study is to improve the combination of a cardbased adverse drug reaction adr system and the use of routine data to collect adverse events following. To pilot enhanced safety surveillance of seasonal influenza vaccine meeting the european medicines agency ema. Ema has issued the eu recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2019. However, in the event of a pandemic, this method has a significant limitation, as the time lag from strain isolation to final. Eu recommendations for 20202021 seasonal flu vaccine. Until 2015, vaccine producers were required by ema committee to. The live attenuated vaccine is based on a flu strain that does not cause disease, that.
Ema has issued the recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2020. Interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the eu, 2014. Every year flu is different, so every year you need an updated vaccine. Criteria established by ema for the licensing of influenza vaccines. Clinical data to support licensure of seasonal inactivated.
Although most persons who become infected with influenza viruses will recover without sequelae, influenza can cause serious illness and death, particularly among older adults, very young children, pregnant women, and those with chronic medical conditions. Ema guidelines on influenza vaccines european commission. Influvac is a subunit vaccine produced and marketed by mylan laboratories. The european medicines agency ema requires vaccine manufacturers. Sep 09, 2016 the purpose of this 201617 pilot study is to improve the combination of a cardbased adverse drug reaction adr system and the use of routine data to collect adverse events following vaccination with seasonal influenza vaccines, as per european medicines agency ema guidance and pharmacovigilance risk assessment committee of ema prac requirements, and to identify additional data which may. The european medicines agency ema requires vaccine manufacturers to conduct enhanced safety surveillance ess of seasonal influenza vaccines including a near realtime evaluation. Quadrivalent influenza vaccines will contain ha derived from these three viruses and from an additional influenza b vaccine virus, a bphuket307320 like virus yamagata lineage. Dec 28, 2019 seasonal influenza causes numerous deaths worldwide each year. Influenza viruses typically circulate widely in the united states annually, from the late fall through early spring. Influenza vaccines are used to immunise people against a flu virus that is in circulation among the population. Seasonal influenza vaccines european centre for disease.
Eu recommendations for 20192020 seasonal flu vaccine. Prevention and control of seasonal influenza with vaccines. Vaccination is especially important for people at higher risk of serious influenza complications. Seasonal vaccine 201011 effectiveness by influenza subtype, imputed dataset, pooled analysis 8 study sites overall sample size n 4410.
Ema backs fluad tetra for influenza prophylaxis in the elderly. Prevention and control of seasonal influenza with vaccines mmwr. Eu recommendations for 20192020 seasonal flu vaccine composition. An overview of the regulation of influenza vaccines in the. Usually, a flu vaccination reduces the risk by 60%. Eggindependent influenza vaccines and vaccine candidates. May 17, 2017 2glaxosmithkline vaccines, rixensart, belgium. Brandspecific enhanced safety surveillance of gsks fluarix. Set criteria established by the european medicines agency committee for medicinal products for human use ema chmp ema. Traditionally, influenza vaccines both iiv and laiv have been produced to protect against 3 different seasonal influenza viruses also called trivalent vaccines. In response to a recent expansion of national vaccination programmes in european union eu member states, the european medicines agency ema has released interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the eu. The vaccine will be available as an injectable suspension in prefilled syringes. Ema has issued an update of the eu recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2020 the recommendations now also contain a decision on a suitable h1n1 virus for seasonal live attenuated influenza vaccines.
Adjuvanted seasonal influenza vaccines were designed to promote a better immune response among young vaccinenaive children. Procedural and sampling requirements for annual seasonal update asu submissions for seasonal influenza vaccines for changes that require submission of data under s 9d3, the quality updates to the module 3 included in the submission should meet the requirements of tgas minor variations to prescription medicines biological. Apr 29, 2015 ema guideline on influenza revision of the regulatory framework and scientific requirements for influenza vaccines include the lessons learnt exercise post2009 exercise 3 integrated modules regulatory and procedural requirements quality requirements nonclinical clinical requirements 2. In most countries this is still the case and the current trivalent vaccines contain influenza ah3n2, pandemic ah1n1 and 1 of 2 influenza b lineage viruses. Guideline on influenza vaccines nonclinical and clinical module, 2016. The list of reagents for vaccine standardisation has also been updated. Dear colleagues, the last decade has seen much innovation in the field of influenza vaccines research, but, despite the continued threat of a.
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