Scottish Vaccine Update

Transcription

1 Scottish Vaccine Update Health Protection Scotland - Issue 7 - August 2009 HPS Welcome to the first edition of Scottish Vaccine Update in its new and improved format. Scottish Vaccine Update will now be issued by Health Protection Scotland and will replace the previously issued immunisation newsletters. Although the appearance has changed Scottish Vaccine Update will still be the place for front line health professionals to receive current information and practical advice about immunisation policy, practice and vaccine supply in Scotland. This is a special influenza A H1N1v edition. Look out for future issues covering seasonal flu, HPV and other regular topics. The mechanism of distribution will also be changing shortly to allow readers to request that an electronic copy of Scottish Vaccine Update is delivered automatically to their in box as soon as it is published. Please look out for further detail in a future edition. Influenza A H1N1v Immunisation Programme General introduction to H1N1v infection Influenza A H1N1v is a new influenza virus of swine origin that first caused illness in Mexico in March and April In mid April the new virus was identified in two specimens in California (USA), since then the virus has spread globally. The first cases of Influenza A H1N1v were identified in Scotland on 27 April Influenza A H1N1v is continuing to circulate in Scotland. Scotland, along with the rest of the UK has moved from the containment phase to the treatment phase of the pandemic flu response. Further information on the current situation in Scotland is available at swineinfluenza.aspx On 11 June 2009 the World Health Organisation (WHO) signalled that a global pandemic of Influenza A H1N1v was underway by raising the worldwide pandemic alert level to Phase 6. This action was a reflection of the spread of the new H1N1v virus and not the severity of illness caused by the virus, with human-to-human spread of the virus into a least two countries in one WHO region, with community level outbreaks in at least one other country in a different WHO region. There were three influenza pandemics in the 20th Century. Compared to seasonal flu all have shown: A shift in the pattern of disease with younger age groups mainly affected. Excess mortality from the pandemic virus for up to 5 years after its first emergence. The behaviour of the present pandemic virus so far is consistent with this: while so far the mortality rate is no higher than for seasonal flu deaths in individuals who have confirmed Influenza A H1N1v are occurring at younger ages. General introduction to H1N1v immunisation programme The Cabinet Secretary for Health and Wellbeing has publicly committed to delivering an immunisation programme that will offer immunisation against Influenza A H1N1v to 100% of the population in Scotland.

2 Advance purchase agreements that were in place should the WHO declare a pandemic have now been activated and contracts signed with two vaccine manufacturers (Baxter and GlaxoSmithKline) on behalf of the UK administrations. Scotland will receive a proportionate share of all vaccine as it arrives in the UK. The overall aim of the programme is to protect those who are at most risk of serious illness or death should they develop influenza. In addition immunisation is provided to reduce the transmission of the H1N1v virus within health and social care premises; to indirectly protect those who may have a suboptimal response or are too young to be immunised and to avoid disruption to essential care services. Programme management and governance The H1N1 National Immunisation Programme will be overseen by the Scottish Government. A Steering Group for the Programme has been established chaired by George Brechin, Chief Executive of Fife and includes senior representation from across the and other public agencies. As with the introduction of other new vaccines, the programme management role will be led by Health Protection Scotland (HPS). A coordination group and working groups have been established by HPS with representation including from the Scottish Government, territorial boards, Health Scotland, National Services Scotland (NSS), Education Scotland (NES), Scottish General Practitioners Committee (BMA), Primary and Community Services, Occupational Health, Directors of Nursing, 24, Scottish Social Services Council, Scottish Care, Community Care Providers Scotland, School Nurses and Practice Mangers. These groups are considering Service Delivery, Data Management, Information and Resources and Monitoring and Evaluation requirements for the programme. The National Programme is responsible for: Assuring local delivery matches key principles defined by working groups. Co-ordinating local implementation with vaccine logistics and national communications. Liaising with operational leads in boards identifying and remedying risks and issues. Consulting on key national developments. Supporting and sharing good practice. H1N1 Governance Structure Policy as recommended by JCVI- SGHD-SAGE Pandemic Flu Group - SG Chair Frances Wood H1N1 Steering Group Chair - Mr George Brechin, CEO Fife (1.0) Coordination Group- Chair; Martin Donaghy, Medical Director, Health Protection Scotland (2.0) Immunisation Epidemiology & Surveillance /Guidance/ Expert Advice Group Joint Chair: Claire Cameron/ Katy Sinka (3.0) Data Management Group Chair: Adam Bryson (4.0) Service Delivery Group Chair: Professor Lewis Ritchie (5.0) Procurement & Logistics Group Chair: Billy Malcolm (6.0) Information & Resources Group Chair: Wendy Peacock 4.1 Occupational Health- Eugene Waclawski 4.2 Education Transferred to NES 4.3 School- Aged: Scott Hanley/Rina Duff 4.4 Primary Care: Sheena MacDonald Professionals 14 Boards (H1N1 Operational Lead) Ayrshire & Arran Borders Dumfries & Galloway Fife Forth Valley Grampian Greater Glasgow & Clyde Highland Lanarkshire Lothian Orkney Shetland Tayside Western Isles 8 Special Boards 24 Golden Jubilee National Hospital Health Scotland State Hospital Education for Scotland Scottish Ambulance Service National Services Scotland Quality Improvement Scotland 2

3 Delivery models It is the intention of National Programme to provide boards with a framework for models of delivery of the vaccination to ensure a cohesive and equitable framework for delivering the immunisation across the country. Models are currently being defined which cover health and social care workforce, current priority groups and other sectors of the population. Eligible frontline health and social care workers will also be offered immunisation as a separate priority group. Because of the diversity of health service provision throughout Scotland, models of immunisation delivery are best defined locally including the social and voluntary sectors. Local boards, in concert with their partners, are responsible for oversight and delivery to all eligible staff in health, social and voluntary settings. Planning the H1N1v immunisation programme locally boards are developing local plans for the implementation of the immunisation programme, which is supported by information derived from appraisal of models at national level, and which follow the Key Principles defined for the programme. Key decisions and planning assumptions Although there are still some uncertainties and points for which a final decision is awaited, for planning purposes it is currently being assumed, based on advice from the Scottish Government that: The vaccines will be supplied by two manufacturers (GlaxoSmithKline and Baxter). The programme will start at the same time across the UK. The programme will only start when the vaccines have been licensed by the European Medicines Agency and licensed stock has been distributed across the country. The earliest date for the progarmme to start in mid October Each person will need two doses of H1N1v vaccine. The doses need to given at least three weeks apart. The different brands of vaccine are not interchangeable. Meaning that each person should receive two doses of either the GSK or the Baxter brand vaccine. The HPV immunisation programme, routine childhood immunisation and seasonal influenza immunisation programmes will proceed as planned. H1N1v vaccine will be suitable for co-administration with HPV, seasonal influenza and childhood immunisations. Deliveries of vaccine will be made into Board Vaccine Holding Centres on a weekly basis, staged over several months. Priority groups The latest scientific advice on priority groups has been considered by the Joint Committee on Vaccination and Immunisation (JVCI) and Scientific Advisory Group on Emergencies (SAGE) and both groups have provided advice on priority groups for vaccination. On 13 August the Scottish Government announced details of the clinical priority groups. The following groups will be given first priority once the vaccine is licenced: i. Individuals aged six months and up to 65 years in the current seasonal flu vaccine clinical at-risk groups. ii. Pregnant women, subject to licensing considerations. iii. Household contacts of immunocompromised individuals. iv. People aged 65 and over in the current seasonal flu vaccine clinical at-risk groups. Ministers have also agreed that frontline health and social care workers will be vaccinated alongside the first priority groups as they are at increased risk of infection and of transmitting that infection to susceptible patients. Frontline health workers eligible for this vaccination programme are those also eligible for seasonal influenza vaccine, as detailed in the Green Book.

4 The following definitions for these staff have been agreed: Healthcare workers with direct patient contact Social care staff who are employed to provide personal care to children and adults, both in care homes and in the community. Data management Reporting on vaccine uptake will be enabled for each setting, it is expected that uptake reporting will be required more frequently than for seasonal flu initially on a weekly basis. This will rely on timely data recording by vaccine providers. For the GP service delivery, it is envisaged that software developments will enable automatic and secure data extraction of anonymised, aggregated data from practice clinical systems most likely via elinks as for the surveillance of consultations for flu like illness currently being developed. The Read codes to support the uptake data reporting from GP IT systems will reflect those used across the UK for seasonal flu vaccination. When finalised, practices will be given detailed information about the data requested and the timescale for the software development. Children under 5 will be invited via SIRS and data captured both on the GP IT systems and within the SIRS database. Workforce immunisation data collection through occupational health will be more diverse and solutions are being sought to obtain consistent data on uptake. There is necessarily some overlap between the different settings for vaccine delivery for example, some individuals may be in a targeted occupational group while also being in a clinical at-risk group. To avoid individuals receiving unnecessary duplicated vaccinations, a personally held record card is being developed. Further safeguards for school age children who may have been vaccinated by their GP prior to any possible schools programme are also being considered. The two vaccine products The vaccine will be supplied by two companies (GSK and Baxter). Baxter product The Baxter H1N1v vaccine is a whole virion, inactivated vaccine. It does not contain an adjuvant and is grown in vero cells (laboratory cell culture). Will be presented in a pack of multidose vials. Each vial will contain 5ml suspension for injection. Each 5ml vial should provide 10 doses. Each pack will contain 20 multidose vials. Each pack should provide 200 doses. Pack size is 206mm x 166mm x 55mm. GSK product The GSK H1N1v vaccine is a split virion, inactivated vaccine. It is grown in hen s eggs and contains the AS03 adjuvant. Will be presented in a pack of multidose vials. Each pack will contain. 1 box (50 vials) containing 2.5ml antigen suspension. 2 boxes (25 vials) each containing 2.5ml adjuvant. Antigen and adjuvant must be mixed before administration. Each 5ml vial for administration should provide 10 doses. Each pack should provide 500 doses. Pack size 260mm x 113mm x 97mm. 4

5 Needles and syringes Needles and syringes have been procured on a UK wide basis. The arrangements for ordering needles and syringes will communicated to health professionals in Scotland as more information becomes available. Information for professionals Information for professionals is currently been prepared and is expected to be available ahead of the immunisation programme commencing, this is likely to include: UK wide public information leaflet. Q&A sheet. Technical factsheet. DVD outlining administration issues. Green book chapter. Training materials for professionals Materials to support the training of health professionals, including a detailed set of slides are also available at These will be updated as needed. A regular e-newsletter outlining the current position on training and education issues is also available from this site. Information for the public Scottish Government is working with the Department of Health and the other devolved administrations to develop UK wide communications campaign to educate the public and raise awareness about the immunisation programme. This campaign will build on the existing campaigns that are currently running under the swine flu banner in relation to respiratory hand hygiene messages. This campaign will include a UK wide door drop leaflet which will cover flu and immunisation. Further information is available on the Scottish Government website. Frequently asked questions The immunisation programme When is the vaccine likely to be available for the programme to start? The vaccination programme will only commence once vaccines are licensed and stock has been distributed around the county. The earliest a vaccination programme could begin is mid-october. As more information becomes available this will be communicated to health professionals in Scotland. When is the programme expected to finish? The exact delivery schedule of the vaccines has not yet been confirmed. It is not possible at present to say when this will be achieved. Vaccine supplies and the opportunity for immunisation will continue into

6 Licensing and safety Is the product licensed? The vaccine manufacturers are seeking approval to their pandemic flu vaccines from the European Medicines Agency (EMEA). Subject to satisfactory review of the data, the manufacturers anticipate that licences to their vaccines may be granted in late September or early October. More detail is available at: Once more information on the licensing of either vaccine becomes available this will be communicated to health professionals in Scotland. What about pharmaco-vigilance? As with all vaccines and medicines used in the UK, the Medicine and Healthcare Products Regulatory Agency (MHRA) has statutory responsibility to monitor the safety of pandemic influenza vaccines ( Reporting of adverse events can be done using web-based reporting assessed from the MHRA website. This is similar to the existing web-based yellow card scheme. On a European level once the vaccines have been authorised the Committee for Medicinal Products for Human Use (CHMP) will continue to evaluate all the future data that will be generated from the clinical trials the companies are carrying out. While the final H1N1v vaccines are expected to have the same safety profile as previously developed pandemic vaccines, it is only with the widespread use of a vaccine in the general population that any rare side effects or benefits can be detected. The CHMP is therefore requiring that vaccine manufacturers carry out further safety studies and put special pandemic risk management plans in place. These will ensure that the safety of the vaccines can be monitored very closely, by the companies and regulatory authorities. When is the National Patient Group Direction (PGD) likely to be published? HPS is currently working on a draft of the PGD. A final PGD will be produced once information on the licensing of the vaccines is available. Once more information on the PGD is available this will be communicated to health professionals in Scotland. Use of the H1N1v vaccines Is one of the vaccines better than the other, or should one be use for particular priority groups? At present there is no information on this. The Scottish Government has asked that this is considered by the JCVI, as more information becomes available this will be communicated to health professionals in Scotland. As pregnant women at any stage in their pregnancy are a priority group, is there an optimum time at which they should be offered immunisation? At present there is no information on this. The Scottish Government has asked that this is considered by the JCVI, as more information becomes available this will be communicated to health professionals in Scotland. Is there any flexibility on the interval between doses? Both vaccines should be given as two doses with a minimum interval of three weeks. All vaccines should be administered according to the recommended schedule. The schedule will have been designed in order to make sure an individual gets the best protection possible from the immunisation course. The general advice if any course of immunisation is interrupted is to resume and complete the course as soon as possible. There is no need to re-start a course of immunisation. Why two doses of the H1N1v vaccine? The Influenza A H1N1v is a new virus to which most people have not previously been exposed, therefore two doses of the vaccine are required to stimulate a sufficient immune response to provide protection. 6

7 What about other immunisation programmes? It is the intention that the seasonal flu programme and childhood immunisations (including the HPV programme) will continue alongside the H1N1v programme What about the co-administration of the H1N1v vaccine with other vaccines? The current planning assumption is that the vaccines will be suitable for co-administration with childhood immunisations, HPV and seasonal flu vaccines. If more than one vaccine is given they should be given in different limbs. Is there anyone who should not receive the vaccine? Infants under 6 months should not be immunised. There is no information on influenza vaccination in children this age. Consideration may be given to immunising the household contacts of children this age. Anyone with a confirmed anaphylactic reaction to the vaccine or any of its ingredients. For the GSK vaccine this will include a confirmed anaphylactic reaction to eggs. What if an individual has already had H1N1v influenza do they still need the vaccine? Yes, many organisms can cause symptoms similar to influenza. Laboratory testing of suspected swine flu cases in Scotland found that only about 10% of these flu like illness were confirmed as infections with H1N1v virus. Individuals who suspect they may have had swine flu should still be offered immunisation, particularly those at-risk of complications. Priority groups Who are the front line staff that will be included the priority group? Ministers have agreed that frontline health and social care workers will be immunised alongside the first priority groups. These have been defined as healthcare workers with direct patient contact and social care staff who are employed to provide personal care to children and adults, both in care homes and in the community. Information resources When will professional information available? Information for professionals is currently been prepared and is expected to be available ahead of the immunisation programme commencing. Will there be a national training programme for immunisers? Materials to support the training of health professionals, including a detailed set of powerpoint slides are available at These will be updated as needed. 7