Influenza A(H1N1)v virus vaccination programme

January 2010

Monica MaguireHealth Protection Nurse Specialist

Influenza A(H1N1)v Programme

• Background information about flu virus• Emergence of A(H1N1)v virus• Epidemiology of Flu A(H1N1)v virus• Vaccines against Flu A(H1N1)v virus• Indications, contraindications and safety

of vaccines

Influenza A viruses

• 1918 pandemic by H1N1• 1957 pandemic by H2N2• 1968 pandemic by H3N2• 1977 outbreaks by H1N1 (Red Flu)• Until 2009, a combination of H3N2 and H1N1

(seasonal)• 2009 pandemic by Flu A (H1N1)v, otherwise

known as “swine flu”• From 2010 which Flu A?

Flu A(H1N1)v virus

• Mid-February 2009 – outbreak of respiratory disease in La Gloria, Mexico

• Mid-April – new virus identified in two specimens in California – reported to WHO

• Contains segments of bird (avian), swine and human viruses – new unique combination and has similarities to current pig-type viruses

• First case in UK – 27th April 2009• June 2009 – WHO went to pandemic phase 6

“Swine Flu”• Not really a “swine flu” as “swine flu” mainly

infects pigs• Occasionally transmitted to humans in close

contact with pigs• Last outbreak of swine flu in 1976 in America• First analysis of the Flu A(H1N1)v genetic

materials showed genetic similarities with existing pig-type viruses

• WHO name: Influenza A (H1N1)v and also known as Influenza A(H1N1)2009

Age distribution lab confirmed new A/H1N1 cases & deaths: Mexico – a disease of children and working age adults

Epidemiology/Surveillance Pandemic H1N1 cases rate per 100,000 population by age group as of 16 July 2009 (n=33,112*) in the USA

Epidemiology/Surveillance Pandemic H1N1 case fatality ratio by age group

16 July 2009 (n=262) in the USA

Epidemiology/Surveillance Distribution by age group of influenza hospitalised cases

Emerging Infections Programme Pandemic H1N1 - 14 July 2009 in the USA

UK age distribution: initial cases

0

50

100

150

200

250

300

350

<=5 6 - 14 15 - 24 25 - 34 35 - 44 45 - 54 55 - 64 65 + N/K

Age Groups

Num

ber

of C

ases

Confirmed Cases of H1N1 by Age Group(Total number of cases 1092 in GGCNHSB

since outbreak began)

Flu A(H1N1)v epidemiology: international situation

• Spread to every continent• CFR ~ around 0.1%• Most cases and deaths are in people

aged <50 years• H1N1 is the dominant Flu A virus in

most parts of the world• Most viruses still sensitive to oseltamivir

(H1N1)v epidemiology - Scotland

• 1482 patients ever hospitalised by 06 January 2010

• About 50% have underlying medical conditions

• 62 deaths in Scotland, not all with underlying medical conditions

Influenza A(H1N1)v: risk factors for severe outcome

• Underlying chronic conditions• Pregnancy (6 deaths in UK by 15th Oct)• Immunocompromised individuals• Metabolic abnormality, eg obesity• But a significant proportion of severe

cases have no underlying risk factors

Flu A (H1N1)v: best guess

• Number will continue to increase over the next few weeks/months

• Peak uncertain but experience in Southern Hemisphere encouraging

• Prepare for the worst case scenario but hope for the best

• Vaccination will change the epidemiology

Those who have been immunised in Phase 1

Clinical Priority Groups(c. 240,000 in GG&C)

Clinical Priority Groups(c. 240,000 in GG&C)

Health & Social Care Workers(c. 56,000 in GG&C)

Health & Social Care Workers(c. 56,000 in GG&C)

• Individuals aged between six months and up to 65 years in the current seasonal flu vaccine clinical at-risk groups.

• All pregnant women.

• Household contacts of immunocompromised individuals.

• People aged 65 and over in the current seasonal flu vaccine clinical at- risk groups.

• Individuals aged between six months and up to 65 years in the current seasonal flu vaccine clinical at-risk groups.

• All pregnant women.

• Household contacts of immunocompromised individuals.

• People aged 65 and over in the current seasonal flu vaccine clinical at- risk groups.

• 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.

• 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.

Health & Social Care Workers Example RolesHealth & Social Care Workers Example Roles

Those who have been immunised in Phase 1

Healthcare workers with Direct Patient Contact.

Healthcare workers with Direct Patient Contact.

Social Care Staff who provide Personal Care Social Care Staff who provide Personal Care

• Community Pharmacists • Doctors (including GPs + Practice staff) • Dentists (hospital & GDPs)• Midwives• Nurses • Occupational Therapists• Physiotherapists• other AHPs• Radiographers• Students and trainees in these disciplines • Local risk assessment of non-clinical staff with Direct Patient Contact e.g. ward clerks

• Community Pharmacists • Doctors (including GPs + Practice staff)• Dentists (hospital & GDPs)• Midwives• Nurses • Occupational Therapists• Physiotherapists• other AHPs• Radiographers• Students and trainees in these disciplines• Local risk assessment of non-clinical staff with Direct Patient Contact e.g. ward clerks

• Care home staff in residential/nursing homes who provide personal care to residents • Domiciliary care workers employed by agencies who provide personal care to service users in their own homes • Personal assistants – staff employed to provide personal care to a single service user • Students and trainees

• Care home staff in residential/nursing homes who provide personal care to residents• Domiciliary care workers employed by agencies who provide personal care to service users in their own homes• Personal assistants – staff employed to provide personal care to a single service user • Students and trainees

Immunosuppressed individuals

• As detailed in the “Green Book”– Due to disease or treatment– Patients undergoing chemotherapy– Asplenia or splenic dysfunction– HIV patients– Individuals on systemic steroids for more than a

month at a dose equivalent to Prednisolone at 20mg or more per day, or children under 20kgs at a dose of 1mg or more/kg/day

Phase 1

Delivery of the H1N1 vaccination programme should have been completed by 31st December 2009

Phase 2

• The cohort group is children aged from 6 months up to 5 years i.e. children born up to 31st July 2009

• Vaccination should be completed by 31st March 2010• Screening Services Dept will produce a schedule list

of all eligible children along with a blank invite letter from the SIRS system

• Lists and letters for practices that are not participating will be sent to their local CH(C)P so that alternative arrangements can be made.

• Practices should check that the child has not already been vaccinated as part of Phase 1

Phase 2 – ordering sundries

• 21 gauge, 1.5 inch, green needles (100 per box) and/or

• The 3 ml Braun syringes (100 per box) for mixing the adjuvant with the antigen

• 25 gauge, 1 inch, integrated/fixed orange needle/syringes for drawing the vaccine dose and administering it to the patient

• 1 litre and 5 litre sharps/clinical waste bins• Orders should be placed via email to:

scott.hanley@ggc.scot.nhs.uk

Phase 2 – Ordering Vaccine

• You can obtain vaccine supplies of Pandermix and Celvapan, by placing an order with your local Vaccine Distribution Centre:

Clyde Sector: RAH Pharmacy – Tel No: 0141 314 6148

Glasgow Sector: Leverndale Pharmacy – Tel No: 0141 211 6675

Flu A(H1N1)v vaccine

• Which products • Schedule• Licensing process and time scale• Adjuvants• Other composition• Safety data and side effects

Two (H1N1)v specific vaccines in the UK

• GSK- Pandemrix®

• Baxter- Celvapan®

• Approximately 50:50 split but initially more of GSK than Baxter product

• Both vaccines licensed by EU countries

Flu A(H1N1)v vaccination

• Both vaccines initially developed and tested as a pandemic vaccine by using antigen from H5N1 influenza (bird flu)

• Used exactly the same methods and ingredients as above but using Flu A (H1N1)v antigen

• Very similar process as seasonal flu vaccines

GSK vaccine - Pandemrix®

• Inactivated split virion vaccine, so no live viruses

• Virus grown in hens’ eggs• Contains an adjuvant (ASO3) to boost

immune response• Contains thiomersal as preservative and

has longer shelf life once opened

Baxter vaccine - Celvapan®

• Inactivated whole virion vaccine, so no live viruses

• Virus grown in cell culture, so no egg allergy issue

• No adjuvant• No thiomersal as preservative, so

shorter shelf life once opened

Adjuvants

• Added to vaccine to increase immune response

• Most adjuvants used in vaccines in the UK are aluminium salts. They have been in use over 70 years and are safe

• GSK vaccine has ASO3 as adjuvant• Adjuvant drive immune response

Other Composition: Thiomersal

• Mercury based substance that has been used widely in vaccines for over 60 years

• Most new vaccines do not use thiomersal as a precaution

• Added to some multi-dose vaccines to prevent them from being contaminated by bacteria and fungi

• Added to the GSK products

Mercury• Heavy metal naturally found in the

environment• Main source of exposure is the diet mainly

organic form methylmercury, found in fish such as tuna

• Methylmercury can accumulate in the body if individuals eat large quantities of predatory fish or seafood

• Mercury in thiomersal is ethylmercury in a very small amount and is rapidly broken down in the body.

Guillain-Barré Syndrome (GBS)

• Reversible neurological condition• Usually following infections• Thought to be due to auto-immune

process• Recent study showed risk of GBS about

17 times higher following infection with a flu like illness compared to background risk

Flu vaccines and GBS

• A cluster of GBS cases reported following swine flu vaccines used in America in 1976. Estimated one case for every 100,000 vaccine used but reason not known.

• Surveillance since 1976 found no link between seasonal flu vaccine and GBS

• Flu vaccine found to be protective against GBS

Summary so far…

• New flu virus has caused a pandemic• Mild self-limiting illness for most people• If older people catch the virus they are

more likely to become seriously ill• 2 vaccines• Both safe and licensed

Dosage and Schedule: Pandemrix®

Age Dose

Children aged 6 months Single injection of to 10 years 0.25ml

Immunocompromised Two injections of 0.25ml atchildren least 3 weeks apart

Dosage and schedule: Celvapan®

• Two doses of 0.5ml at least 3 weeks apart for all individuals aged 6 months and above

Flu A (H1N1)v vaccine: contraindications

• Pandemrix® – if severe life threatening allergic reaction to egg and egg products

• Previous life threatening allergic reaction to flu vaccines

• Life threatening reaction to any components of the vaccines

• Confirmed case of (H1N1)v infection • Skin rash following flu vaccines not a

contraindication

Flu A (H1N1)v vaccine

• Side effects similar to seasonal flu vaccines– Headache, fatigue, fever, arthralgia,

myalgia and pain and redness at injection site

• Other rare side effects detailed in the SPC

• If second dose delayed, do not need to restart course but protection delayed.

H1N1 Immunisation Programme

Site and Route• Route – intramuscular• Site:-deltoid for children over 1 year and adults-anterolateral aspect of thigh for infants under 1 year oldSite and route can affect both the immunogenicity and

reactogenicity of the vaccine

Presenter

Presentation Notes

k

H1N1 Immunisation Programme

MethodTo give a vaccine by IM injection: • gently stretch the skin flat between your thumb and

forefinger• Insert the needle at a 90º angle• Quickly push the needle straight down into the

muscle (it is not necessary to aspirate first)• Inject slowly to reduce pain

Phase 2 - Recording

• H1N1 immunisation should be recorded as per the current childhood immunisation method i.e. practices should complete the SIRS-generated schedule lists and return to the Screening Department for input into the SIRS system, as well as recording on their own GP systems.

• Opt out practices send schedule lists and recording sheets to SIRS

H1N1 Immunisation Programme

Document the following• Product name of the vaccine• Batch number – this is necessary in case problems

associated with a particular batch are identified at a later date

• Expiry date – recording this provides evidence that it was checked prior to administration

• The date given• The site of injection• Name and signature of immuniser

Flu A (H1N1)v vaccine

• Vaccines are not interchangeable• Co-administration with other vaccines• Side effects monitored by

– Yellow card scheme– “swine flu” ADR Portal atwww.mhra.gov.uk/swine flu

Flu A (H1N1)v vaccine: communications

• Public – TV/radio– Leaflets/posters– Vaccination record card

• Professional– Fact sheets/Q&As/DVD– Template letter for GPs to invite patients– “Green Book” chapter– Websites

Resources

• Green Book chapter – available online• HPS website• NES website• Department of Health website• PHPU – 0141 2014917

Any questions?