IAP announces new immunization schedule for 2012
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IAP COI recommendations on the use of Influenza vaccine/s
Novel H1N1 2009 influenza pandemic has created widespread concern across the country. The virus continues to circulate and cause waves of infections leading to hospitalization and complication in different parts of our country even this year. There have been at least 1945 deaths and 37,395 laboratory confirmed cases (testing is done only for severe cases hospitalized) till 15th August 2010; and this is likely to be just the tip of the iceberg 1155 confirmed cases with 84 deaths have occurred in the week ending on 15th August 2010. Since April 2010, Maharashtra, Kerala, Karnataka, Gujarat and some other cities like Kolkata have shown rise in confirmed cases due to novel H1N1 2009 influenza. This means that though WHO has declared that the world is in post-pandemic phase, it does not seem to be the case in India at present. Also now that, novel H1N1 vaccines are available India, pediatricians are interested to know the need, schedule, route of administration and all other relevant information for their day to day practices.
In many parts of world, novel 2009 H1N1 virus transmission peak is over and WHO has declared that we are in post-pandemic phase. In this regard, WHO Statement(1) dated 10th August 2010 on pandemic influenza is relevant and reproduced below.
“The world is now in the post-pandemic period. Based on knowledge about past pandemics, the H1N1 (2009) virus is expected to continue to circulate as a seasonal virus for some years to come. While the level of concern is now greatly diminished, vigilance on the part of national health authorities remains important. Such vigilance is especially critical in the immediate post-pandemic period, when the behaviour of the H1N1 (2009) virus as a seasonal virus cannot be reliably predicted.
For example, it is likely that the virus will continue to disproportionately affect a younger age group, at least in the immediate post-pandemic period. Groups identified during the pandemic as at higher risk of severe or fatal illness will probably remain at heightened risk, though the number of such cases could diminish. In addition, a small proportion of people infected during the pandemic developed a severe form of primary viral pneumonia that is not commonly seen during seasonal epidemics and is especially difficult to treat. It is not known whether this pattern will continue during the post-pandemic period, further emphasizing the need for vigilance.
WHO is today issuing guidance on recommended activities during the post-pandemic period, including advice on epidemiological and virological monitoring, vaccination, and the clinical management of cases. National health authorities are reminded that cases and local outbreaks of H1N1 (2009) infection will continue to occur, and in some locations, such outbreaks could have a substantial impact on communities”
Though there is lot of awareness and anxiety amongst the people about the disease and the vaccine/s available, present situation does not warrant a panic situation. Seasonal influenza, which has in past caused morbidity and mortality all these years and for which vaccine have been available did not create such hype. Case fatality rate in pandemic influenza is not very high and it is estimated to be between 0.05 to 0.2%. Though the virus has high transmissibility it is not highly virulent. Ironically, people in high-income countries used their vaccine stockpiles reluctantly. Around 80% of people in the UK chose not to be vaccinated, many because they doubted they were at serious risk (2). However this is a perception and not a scientific fact.
Now trivalent inactivated influenza vaccines are available in India (and world of course) and one live trivalent vaccine in USA. Before this various monovalent novel H1N1 vaccines were available in the world and these vaccines have been used in the developed world since last 6 months. These vaccines are safe and as such should not be denied to any one demanding it. One can consider the local epidemiology of the H1N12009 and use it on the patient after one to one discussion and informed consent. (3).
Seasonal influenza 2010 and novel H1N1 influenza vaccines available in India:
1.A live monovalent novel H1N1 vaccine (Serum Institute of India ). Immunogenicity, and safety of the vaccine has been established in pre-licensure animal and human studies
2. The inactivated novel H1N1 monovalent vaccine of Zydus is licensed for use only in adults above the age of 18 years.
3. Trivalent inactivated vaccine containing the novel H1N1 strain fare available now (Chiron, Solvay, Lupin, and Sanofi Pasteur) The 2010--11 trivalent vaccines contain A/California/7/2009 (H1N1)-like, A/Perth/16/2009 (H3N2)-like, and B/Brisbane/60/2008-like antigens. The influenza A (H1N1) vaccine virus is derived from a 2009 pandemic influenza A (H1N1) virus.
Who should be administered the H1N1 vaccine?
The following high risk individuals should be vaccinated against novel H1N1(WHO recommendations)
People who live with or care for infants younger than 6 months of age
Health care and emergency medical personnel
Anyone from 6 months through 24 years of age
Any one from 25 through 64 years of age with certain chronic medical conditions or a weakened immune system
IAPCOI Recommendations on seasonal influenza vaccination (4):
The novel 2009 H1N1 infection, hospitalization and mortality has been disproportionately high in healthy young children and adults(unlike the past seasonal influenza outbreaks).Hence IAPCOI recommends to offer 2010 trivalent vaccine (inactivated or live) to any one who desires to take it, unless contraindicated. IAP COI strongly recommends to continue to use 2010 trivalent vaccine (inactivated only) in high risk children as given below.(Live influenza vaccines are contraindicated in these group of individuals)
At risk individualsinclude:
• Congenital or acquired immunodeficiency
• Chronic cardiac, pulmonary, hematologic, renal, liver disease and diabetes mellitus
• Children on long term aspirin therapy
• Any neurologic disease that might cause respiratory compromise or impair ability to handle secretions
• Asthma requiring oral steroids
• Elderly aged more than 65 years.
Who should not be given the live vaccine ?
2009 H1N1 LAIV should not be given to the following groups.
• children younger than 3 and adults 50 years and older • pregnant women, • anyone with a weakened immune system, • anyone with a long-term health problem such as - heart disease - kidney or liver disease - lung disease - metabolic disease such as diabetes - asthma - anemia and other blood disorders • children younger than 5 years with asthma or one or more episodes of wheezing during the past year, • anyone with certain muscle or nerve disorders (such as cerebral palsy) that can lead to breathing or swallowing problems, • anyone in close contact with a person with a severely weakened immune system (requiring care in a protected environment, such as a bone marrow transplant unit), • children or adolescents on long-term aspirin treatment. Individuals who are moderately or severely ill( might be advised to wait until complete recovery from the illness) • Guillain-Barré syndrome
H1N1 LAIV and seasonal LAIV should not be given together.
Children Who Should Not Be Vaccinated With TIV
Those younger than 6 months;
Those who have a moderate to severe febrile illness;
Those who have a history of hypersensitivity, including anaphylaxis, to eggs, to any previous influenza vaccine dose, or to any of the vaccine components; and
Those who are known to have experienced Guillain-Barre´ syndrome (GBS) within 6 weeks after a previous influenza vaccination (whether influenza vaccination specifically might increase the risk for recurrence of GBS is unknown).
How many doses need to be given ?
In previously unvaccinated persons aged <9 years, 2 doses of seasonal influenza vaccine are required to induce immunity because young children typically have had limited exposure to influenza viruses and are not immunologically primed (i.e., they do not have preexisting antibodies). The lack of preexisting antibody cross-reactive with the novel influenza A (H1N1) virus among children and younger adults raises the possibility that 2 doses of vaccine (typically separated by >21 days) also will be needed to provide protection for persons in these age groups. Ongoing studies will provide additional information about the immune response vaccine, including which groups might need 2 doses.
1. WHO. H1N1 in post endemic period. http://www.who.int/csr/disease/swineflu/notes/briefing_20100810/en/index.php accessed 23rd August 2010.
2. Pandemic influenza-(some) reasons to be cheerful?(Editorial) Lancet 2010; 376: 565
3. Yewale V, Choudhury P. Seasonal flu vaccine (Reply). Indian pediatr 2010; 47: 722
4. IAP Guidebook of Immunization. Individual vaccines. Available from: http://www.iapcoi.com/pdf/chapter04individualvaccines.pdf Accessed on August 24, 2010.
Statement of IAP Committee on Immunization
Rotavirus vaccine (Rotarix) contamination with PCV1
Following the reports of temporary suspension ordered by the US FDA on the use of Rotarix on the issue of contamination of the vaccine with porcine circovirus type-1 (PCV-1), the IAP COI gone through the exact chronology of events (see Annexure 1).
After having thoroughly reviewed the reports of various agencies and institutions, and in view of the recent final statement issued by the Strategic Advisory Group of Experts (SAGE) on immunization of the WHO (see Annexure 2), the IAP COI makes no amendments to its existing recommendations, on the use of Rotavirus vaccine, released and published in 2008. It believes that use of currently available rotavirus vaccine in the country, Rotarix (TM GSK vaccines), poses no immediate health threats to the vaccinees.
Date: April 23, 2010
Chronology of events:
• The presence of DNA material from PCV-1 in RotarixTM (Rotavirus vaccine) was first detected following work done by a research team in the US using a novel technique for looking for viruses and then shared with GSK.
• After being notified, GSK conducted additional tests which confirmed the findings.
• GSK confirmed that the presence of material in the finished Rotarix TM vaccine as well as in the cell bank and seed from which the vaccine is derived.
• GSK notified regulatory authorities worldwide of the presence of DNA material from PCV-1 in RotarixTM (Rotavirus vaccine) including Indian Drug Authorities (Office of DCGI).
• Statements were issued on March 22, 2010 by FDA, EMA, WHO along with GSK explaining the situation (1-4).
• GSK issued a press release at a global level confirming that it has notified regulatory authorities worldwide of the presence of material from PCV-1 in Rotarix™.4
• This was followed by TGA statement on 24 March 2010 in support of continuing use of Rotarix(5) .
• The European Medicines Agency (EMA) issued a press release on 26th March 2010 and concluded that the unexpected presence of DNA of a non-disease causing viral strain in batches of the oral vaccine Rotarix does not present a risk to public health. At an extraordinary meeting held on 25 March 2010, the Committee for Medicinal Products for Human Use (CHMP) endorsed the recommendations from its Vaccines Working Party and agreed that there was no need to restrict the use of Rotarix. 6
• WHO Global Advisory Committee on Vaccine Safety (GACVS) on Rotarix was released on 26th Mar 2010. It states that “Given the extensive clinical data supporting the safety of Rotarix and the benefits of rotavirus vaccination for children, GACVS considers that the benefits of vaccination far outweigh any currently known risk associated with use of Rotarix”(7).
• GSK issued a second press release on 26March 2010 confirming the position statements of EMA and CHMP which is in line with previous communications by WHO, FDA, other national regulatory agencies as well as GSK that the presence of the material does not present a safety risk(8).
• PCV-1 does not multiply in humans and is not known to cause any illness in humans(9,10). 10 It is found in everyday meat products and is eaten with no resulting disease.
1. FDA News Release.Components of Extraneous Virus Detected in Rotarix Vaccine; No Known Safety Risk [Online].2010 Mar 22[cited 2010 Apr 23].Available from:URL: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm205625.htm
2. European Medicines Agency statement on new information on Rotarix oral vaccine[Online].2010 Mar 22 [cited 2010 Apr 23].Available from:URL:http://www.ema.europa.eu/humandocs/PDFs/EPAR/rotarix/18935010en.pdf
3. WHO does not recommend any change to use of Rotarix vaccine[Online].2010 Mar 22 [cited 2010 Apr 23]. Available from:URL: http://www.who.int/immunization/newsroom/news_rotavirus_vaccine_use/en/index.php
4. GlaxoSmithKline statement on new information relating to manufacture of Rotarix (rotavirus vaccine)[Online]. 2010 Mar 22 [cited 2010 Apr 23]. Availablefrom:URL:http://www.gsk.com/media/pressreleases/2010/2010_pressrelease_10029.htm
5. TGA .Statement on Rotarix® (Rotavirus vaccine)[Online].2010 Mar 24[cited 2010 Apr 23].Available from:URL: http://www.tga.gov.au/alerts/medicines/rotarix.htm
6. European Medicines Agency sees no safety concerns with the Rotarix oral vaccine.[Online].2010 Mar 24 [cited 2010 Apr 23]. Available from:URL: http://www.ema.europa.eu/humandocs/PDFs/EPAR/rotarix/20192310en.pdf
7. Statement of the Global Advisory Committee on Vaccine safety on Rotarix.[Online].2010 Mar 26 [cited 2010 Apr 23].Available from:URL: http://www.who.int/vaccine_safety/topics/rotavirus/rotarix_statement_march_2010/en/index.php
8. Updated GlaxoSmithKline statement on European regulatory guidance relating to manufacture of Rotarix (rotavirus vaccine)[Online].2010 Mar 26.Available from: URL:http://www.gsk.com/media/pressreleases/2010/2010_pressrelease_10032.htm
9. Linlin Li, Kapoor A, Sikas B, Bamidele OS, Wang C, Shaukat S et al. J Virology 2010; 84: 1674–1682.
10. Hattermann K, Roedner C, Schmitt C, Finsterbusch T, Steinfeldt T, Mankertz A. Xenotransplantation. Infection studies on human cell lines with porcine circovirus type 1 and porcine circovirus type 2. Xenotransplantation 2004; 11: 284–294
Statement issued by the Strategic Advisory Group of Experts (SAGE) on immunization of the WHO:
April 2010 meeting of the Strategic Advisory Group of Experts (SAGE) - SAGE noted that PCV1 is not known to cause disease in animals or humans. PCV1 DNA is often found in food products and has been detected in human stool specimens from healthy children who have not received Rotarix vaccine. The safety of Rotarix is supported by both large prelicensure clinical trials (more than 50,000 subjects) and an extensive postlicensure safety experience (over 60 million doses of vaccine administered). SAGE noted the conclusions of GACVS indicating that the extensive clinical data support the safety of Rotarix and that GACVS was of the view that the benefits of rotavirus vaccination for children far outweigh any known risk associated with use of Rotarix. Rotavirus gastroenteritis is the most common cause of severe diarrheal disease in young children throughout the world and rotavirus immunization is recommended by WHO (1, 2). Given the absence of any known risk, SAGE strongly recommends the continued use of Rotarix for immunization programs, in particular in those parts of the world with elevated under-5 mortality associated with rotaviruses. SAGE requested to be regularly updated by GACVS as new information becomes available (3).
1. TGA .Statement on Rotarix® (Rotavirus vaccine)[Online].2010 Mar 24[cited 2010 Apr 23].Available from:URL: http://www.tga.gov.au/alerts/medicines/rotarix.htm
2. European Medicines Agency sees no safety concerns with the Rotarix oral vaccine.[Online].2010 Mar 24 [cited 2010 Apr 23]. Available from:URL: http://www.ema.europa.eu/humandocs/PDFs/EPAR/rotarix/20192310en.pdf
3. April 2010 meeting of the Strategic Advisory Group of Experts on Immunization: preliminary statements on H1N1 and Rotarix vaccines[Online].[2010 Apr 23] Available from :URL:http://www.who.int/immunization/interim_report_Flu_Rotarix_16_April_draft_v1.pdf
Measles on the Upswing
(From Medscape Infectious Diseases > Expert Reviews and Commentary )
Measles is on the upswing in the United States. This Viewpoint examines the trend in the context of a recent update from the Centers for Disease Control and Prevention on the first 7 months of 2008.
Update: Measles -- United States, January-July 2008
MMWR Morb Mortal Wkly Rep. 2008;57:893-896
This CDC report reviews 131 cases of measles occurring in January-July 2008. The following points should be noted:
• This is the highest year-to-date number of measles cases in the United States since 1996.
• Of the 131 cases, 91% were persons who were unvaccinated or who had an unknown vaccination status.
• 123 were US residents, including 80% under age 20; 112 were unvaccinated or had unknown vaccination status; 95 of these 112 (85%) were eligible for vaccination, and 63 of these 95 (66%) were unvaccinated because of philosophical or religious beliefs.
• During this time, 2 outbreaks were reported. The first outbreak, in Washington State, included 7 children in 1 household and 19 additional cases linked epidemiologically. The possible source of the outbreak was a church conference. The second outbreak was in Illinois and involved 4 unvaccinated girls followed by 26 additional measles cases that were epidemiologically linked to these 4, making a total of 30 cases. Of these, 29 of the children were home-schooled, not subject to school-entry vaccination requirements, and had parents who rejected vaccinations.
The authors note that the United States had an average of 450 reported deaths from measles and 4000 cases of measles encephalitis annually before the availability of measles vaccine in the mid-1960s. Public health experts claim that sustaining the elimination of measles requires that more than 90% of children in preschool and 95% of school-age children be vaccinated. The measles vaccine coverage in the United States is adequate to sustain this goal; a problem surfaces when susceptible children travel abroad and import cases from Europe and other regions of the world. When these children return to the United States, they transmit measles to other vulnerable, unvaccinated children by passing the herd-immunity threshold. Those who are susceptible also include children under age12 months, who are too young to be vaccinated. The obvious recommendation is for parents to ensure childhood vaccination according to current guidelines; adults without evidence of measles immunity should receive a single dose of MMR vaccine, and travelers should be up-to-date on measles vaccination.
3-Update on recommendations from the Advisory Committee on Immunization Practices
4-Space PCV7 doses at least eight weeks apart
5-More than a pinprick
link : http://www.tehelka.com/story_main45.asp?filename=Ne190610coverstory.asp#
Dr. T. U. Sukumaran
Dr. Rohit C. Agrawal
Dr. Vipin M. Vashishtha
Dr. Amarjeet Chitkara
Dr. Manjori Mitra
Dr. S. Sanjay
Dr. S. G. Kasi
Dr. Suhas V. Prabhu
Dr. Nitin K. Shah
Dr. Raju C. Shah
Dr. Naveen Thacker
Dr. A. Parthasarathy
Dr. Panna Choudhury (Chairman, IAPCOI, 2009-11)
Dr. Vijay N. Yewale (Convener, IAPCOI, 2009-11)
Dr Sailesh Gupta (Hon Secretary General, IAP)