Resolution of the Public Coordination Council on Pneumococcal Infection Investigation and Vaccination in Russia
On December 19, 2015, the regular meeting of the Public Coordination Council on pneumococcal infection investigation and vaccination in Russia was held at the Scientific Centre of Children Health of the Ministry of Health of Russia.
The meeting was attended by the chief specialists of the RF Ministry of Health in Pediatrics (Academician A.A. Baranov), Epidemiology (Academician N.I. Briko), Children Infectious Diseases (Academician Lobzin Y.V.), Pediatric Allergology and Immunology (Corresponding Academician Namazova-Baranova L.S.), Clinical Microbiology and Antimicrobial Resistance (Professor Kozlov R.S.), representatives from the Union of Pediatricians of Russia, Research Institute of Pediatric Infectious Diseases FMBA, Central Research Institute of Epidemiology of Rospotrebnadzor, Institute of Antimicrobial Chemotherapy (IAC), Institute of Vaccines and Serum named upon I.I. Mechnikov.
The meeting was devoted to several key topics:
- Recommendations on the optimal pneumococcal vaccination schedule with the use of polysaccharide and conjugate vaccines in at-risk children of any age;
- Ongoing pneumococcal infection surveillance in Russia;
- Identification of approaches to vaccination uptake optimization and vaccination results evaluation in the short and long-term perspective.
The above-mentioned issues discussion conclusions are the following.
Federal law No. 157-FZ from 17.09.1998 "On the immunoprophylaxis of infectious diseases" (as amended by Federal law No. 368-FZ as of 21.12.2013) approved the right of pneumococcal infection protection and vaccination within the National immunization program (NIP) for all children born from January 1, 2014. From an epidemiological point of view, vaccination uptake, coverage and adherence to schedule are crucial for ensuring immunization program results. Vaccination uptake should be at least 85-95% of the target cohort to create an immune stratum and to achieve the antipneumococcal vaccination program effectiveness (pneumonia, otitis, meningitis and sepsis incidence reduction and creation of herd protection). Qualitative immunization affects the epidemic process, which, in turn, determines the preventive effectiveness of vaccination. Since the pneumococcal infection is today one of the vaccine-preventable diseases, the quality of immunization (timeliness, high uptake and coverage, schedule compliance) is the major factor influencing the disease morbidity and mortality.
The pneumococcal conjugate vaccine was received in the regions at the end of November 2014, which, combined with the season of acute respiratory infections and a relatively busy due to the lack of combined vaccines first half-year of life children vaccination schedule, determined a somewhat time-stretched start of the new vaccination program. Thus, the analysis of the average 6 months of 2015 vaccination uptake in the Russian Federation revealed the low primary immunization in children born in 2014 (14.1% of those subject to immunization) and the suboptimal immunization coverage of children born in 2015 (40.1% of those subject to immunization).
To improve the situation with pneumococcal vaccination uptake and schedule compliance, the Ministry of Health together with the expert community held a number of events, including conference calls with the regional health authorities, information and educational materials for pediatricians and epidemiologists distribution and a big general public pro-vaccination campaign:
- Information letter No. 24-2-2031252 was forwarded on June 05, 2015 to all regions of Russia with explanations and recommendations on pneumococcal vaccination schedule and tactics for children born in 2014 – 2015. The letter emphasized that immunization against pneumococcal infection is required for all children born in 2014 and also proposed various schemes of catch-up vaccination depending on the child age at the start of immunization.
- In August-September 2015, during re-evaluating the progress of immunization campaign, the heads of the executive authorities of the subjects of the Russian Federation in the field of public health were provided with another letter (No. 14-5/10/2-5995 as of 09.10.2015), which recommended to take under special control vaccination of all categories of individuals specified in the NIP.
- From April to September 2015, a wide-range all-Russian pro-vaccination campaign "Vaccination – Healthy Nation!" initiated by the Ministry of Health of Russia was conducted in all Federal Districts with the involvement of federal experts, more than 100 regional health authorities and medical community representatives and more than 230 journalists. According to preliminary estimates the total marathon coverage amounted to more than 60 million people.
- The Union of Pediatricians of Russia and the National Association of Specialists in Control of Infections associated with health care (NP NASKI) released the Federal clinical guidelines, "Pneumococcal Infection Prevention through Vaccination"i , that reflect the main approaches to pneumococcal infection surveillance, diagnosis, treatment and prevention, including immunization of risk group patients and disordered vaccination management.
- Over 20,000 pediatricians received prepared by the Union of Pediatricians of Russia special informational package and educational materials on immunization. A similar action is planned for epidemiologists by the National Association of Specialists in Control of Infections associated with health care (NP NASKI).
All these measures were effective, and in Russia pneumococcal vaccination uptake in the first 10 months of 2015 was on average 79% for children born in 2015.
Based on the experience obtained, the main aspects affecting immunization quality and timeliness are defined:
- the correct definition of targeted cohort (who is to be vaccinated– age group, health status);
- the compliance to immunization schedule according to the Ministry of Health Order 125-n and vaccines’ instructions;
- the appropriate targeted cohort planning with 3-month carry-over vaccine stock creation. The quantity of doses calculation should be done in accordance to the following formula:
K – the newborns cohort size in the region according to the year statistics (fixed on January 1st)
Kp – the previous year newborns cohort size according to the statistics (doses for the booster (revaccination))
2 – the number of doses in the primary immunization scheme and in the catch-up immunization scheme for children of the second year of life
1 – the number of booster doses
95% – the recommended vaccination coverage
25% – the carry-over vaccine stock to secure immunization consistency
The schedule of preventive vaccinations according to the epidemiologic situation (Annex No. 2 to the Order No. 125-N of the Ministry of Health of the Russian Federation from March 21, 2014) approves pneumococcal infection risk groups vaccination including children 2 to 5 years old and adults, embodying recruitsii. Vaccination programs for children older than 2 years financing is entrusted to the regions, that need to make the choice in favor of a proper use of the budget combined with the maximum vaccination effect.
For pneumococcal infection prevention in children 2-18 years old two qualitatively different types of non-interchangeable vaccines are registered: 13-valent pneumococcal conjugate vaccine (PCV13) iii and 23-valent pneumococcal polysaccharide vaccine (PPV23)iv. 10-valent pneumococcal conjugate vaccine (PCV10)v is used for children up to 5 years of age.
Different pneumococcal immunization schedules for high-risk patients were reviewed, analyzing clinical trials, international recommendations and accumulated regional experience. In order to achieve the optimal vaccination effect recognizing immunity building patterns, children 2 – 18 years old from high-risk groups (patients with immunodeficiency, HIV infection, any oncological diseases; those receiving immunosuppressive therapy, including corticosteroids; those with anatomic/functional asplenia; those with an installed cochlear implant or planned for such operation; patients with cerebrospinal fluid leakage; those with chronic lung diseases including asthma and COPD; chronic diseases of cardiovascular system, liver (HBV, HCV), kidney (including nephrotic syndrome, ESRD, hemodialysis); patients with diabetes; persons subject to transplantation or received transplantation of organs, tissues and/or bone marrow) must start pneumococcal vaccination with PCV13, then, not earlier than in 12 months, it is recommended to administer one dose of PPV23. In special cases (preparation for transplantation and/or immunosuppressive therapy, surgical interventions) the minimum interval between administrations of PCV and PPV23 may be ≥8 weeks.
These recommendations are based on evidences of high level and soundness (1А-1В). In addition, the Expert Board emphasizes that there are other recommendations supported by up to date evidences of lesser strength (2B – 2C), according to which antipneumococcal vaccination is indicated for two additional risk groups:
- children 2-18 years old – convalescents of acute otitis media, meningitis and/or pneumonia, for which a one-time administration of PCV13 is recommended in 1 month after recovery (for children 2-5 year old PCV10 in a 2-dose scheme, when 2 vaccine doses are administered at least 8 weeks apart, can be used), and
- children 2 – 18 years old often suffering from respiratory infections and also those infected with Mycobacterium tuberculosis, for which a one-time administration of PCV13 or PPV23 is recommended (for children 2-5 year old PCV10 in a 2-dose scheme, when 2 vaccine doses are administered at least 8 weeks apart, can be used).
According to the recommendations of the World Health Organization, S.pneumoniae serotypes distribution epidemiological data in the Russian Federation had been obtained more than 2 years before the implementation of the mass immunization against pneumococcal infection. In 2010 – 2014, the retrospective and prospective studies of pneumococcal infections seroepidemiology in children and adults were conducted in research centers in St. Petersburg, Moscow, Smolensk, Yekaterinburg, Barnaul and Murmansk, as well as in 14 other cities of Russia. According to the Reference Centre for bacterial meningitis monitoring, in 2014 (before PCV mass immunization implementation in Russia) 25% of purulent meningitis were caused by S.pneumoniae. Moreover, in 2015 the results of typing showed that 76% of pneumococcal isolates are covered by the PCV13 serotypes, and 46% – by PCV10.
Thus, it is important to continue epidemiological monitoring after the introduction of vaccination for at least 5 years (WHO, 2012). One should also consider the possibility of a relative increase in the incidence rate due to the improvement of pneumococcal infection cases detection and reporting through newly available diagnostic approaches, as it already had been observed in Germany.
To evaluate PCV13 vaccination influence on serotype distribution and in the children health dynamics in 2015-2018, by using Russian research centers experience (Research Institute of Pediatric Infectious Diseases FMBA (St. Petersburg), Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing (Rospotrebnadzor) Central Research Institute of Epidemiology (Moscow), Scientific Center of Children’s Health (Moscow), and IAC (Smolensk)) with extending the network of the sentinel centers in the regions (Yekaterinburg, Chelyabinsk, Perm, Khanty-Mansiysk, Krasnoyarsk, Khabarovsk), and with the support of the Rostropovich-Vishnevskaya Charitable Foundation "In the Name of Health and Future of Children", it has been proposed to carry out the multicenter international prospective non-interventional observational pneumococcal infection epidemiological study (SAPIENS). The development of microbiological laboratories network operating according to the uniform methodology of pneumococci identification, verification, typing and antibiotic resistance evaluation will help to improve the quality of the results to upgrade their reliability and confidence in results. The objectives of the study include:
- The determination of a serotype landscape of pneumococci:
- for the carriage in healthy children aged ≤ 5 years.
- for the carriage in children with ARI aged ≤ 5 years.
- for the carriage in healthy children aged 3-5 years in organized groups (kindergartens)
- for otitis media in children aged 0 – 5 years
- for community-acquired pneumonia in children and adults
- for meningitis in children and adults.
- The determination of the profile of antibiotic resistance in pneumococci.
- The retrospective and prospective epidemiological analysis of the incidence of community-acquired pneumonia, otitis media and meningitis
- The serotype landscape in vaccinated and unvaccinated children (a prospective study in similar age groups and in comparison with historical data)
- The development of standard operating procedures of an etiologic diagnosis of pneumococcal infection for microbiological and PCR laboratories.
Based on the data obtained, the economic outcomes of vaccination will be assessed in 2 and 3 years after the start of mass immunization as compared with the simulated effect and with the analysis of influence factors and the forecast.
In the course of the activities of the medical community to increase population commitment to vaccination the all-Russian pro-vaccination campaign "Vaccination – Healthy Nation!" – the experts discussed the scientific and practical project "HUMAN" of the Rostropovich-Vishnevskaya Charitable Foundation "In the Name of Health and Future of Children", that provided the polling of medical professionals (pediatricians, nurses, health care providers) and parents with a subsequent analysis of results, round table discussions and focus groups on optimal communications for a mass media campaign aimed both at health professionals and general population. In addition, the Union of Pediatricians of Russia prepared the book for physicians "Vaccination: Simple Answers to Difficult Questions".
Thus, based on the results of the discussion, the Public Coordination Council considered it essential to recommend:
- Catch-up immunization (in accordance with Prevenar®13 instruction) covering all children born in 2014 and 2015 to improve immunization effectiveness and the realization of the right of children to protection against pneumococcal infection.
- Vaccination of children born in 2016 should be implemented in a planned manner with observance of the start of vaccination from 2 months of life. The calculation of the targeted cohort of children to be vaccinated should be carried out on the newborns cohort basis considering the need of 100% uptake.
- The public health authorities of the Russian Federation subjects should control applications for immunobiological medicinal products, as well as the report on the use of immunobiological medicinal products purchased within the framework of the National schedule of preventive inoculations.
- To develop strategic NIP development plan, including step-wise implementation of pneumococcal vaccination in at risk individuals.
- To include pneumococcal vaccination into clinical guidelines and standards related to high-tech medical care for categories of individuals at risk.
- To initiate the improvement of sanitary rules and norms of the Rospotrebnadzor for the vaccination against pneumococcal infection (indicating the immunization schedules and the groups subject to vaccination).
- To submit proposals to the Ministry of Health of the Russian Federation on the Order No. 125-n "On the national schedule of preventive inoculations and the schedule of preventive vaccination on epidemic indications" as of March 21, 2014, amendments related to the vaccination intervals in case of disrupted schedules and risk groups.
- To introduce the obligatory component of vaccinology into undergraduate and postgraduate medical education programs. To amend the Federal State Educational Standard of medical education for nurses and physicians with a unified executable code on immunization issues prevailing in all courses.
- The qualification testing of the teaching staff of secondary and higher medical schools and the physicians of any specialties should be carried out with the mandatory inclusion of immunization.
- To inform the Rospotrebnadzor and the Ministry of Health of the Russian Federation on the project of the multicenter international prospective non-interventional observational pneumococcal infection epidemiology study (SAPIENS). In the cities involved in the SAPIENS, the electronic system of immunization monitoring should enter columns for recording pneumonia, meningitis, otitis media (acute, recurrent and chronic) incidence of vaccinated and unvaccinated children.
- To continue the educational pro-vaccination campaign for the public with tracking the content of mass media publications and, in case of an inaccurate presentation of information, to provide medical experts comments. Improvement of the legal framework in terms of the introduction of liability for false or defamatory information about vaccines.
- To initiate the improvement of the legal base and to introduce a measure of responsibility for, first of all, health care workers for providing false or defamatory information about vaccination and vaccines.
- To establish an advisory body on immunization issues – the National Committee on Immunization – with participation of expert medical community, Ministry of Health of the Russian Federation, Rospotrebnadzor, organizations and Federal agencies responsible for the treatment of medicines (including vaccines) representatives to optimize organizational and consultative activities on immunization issues and to assign their special significance in the Public Health matters.
iiOrder of the Ministry of Health of the Russian Federation as of March 21, 2014/ No. 125n "On the national schedule of preventive inoculations and the schedule of preventive vaccination on epidemic indications"
iiiPrevenar13 Instruction (13-valent adsorbed conjugate polysaccharide pneumococcal vaccine) LP 000798-140915
ivInstructions for use of Pnevmo23 (polyvalent polysaccharide pneumococcal vaccine), 18.02.2014, No. 011092
vInstructions for use of Synflorix, medicinal product for medical use, LP 001412-110112