What s the latest on the staff vaccination programme for swine flu?

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H1N1 VACCINATION PROGRAMME Healthcare professional Q&A What s the latest on the staff vaccination programme for swine flu? Scientists have now developed an approved vaccine for the A(H1N1) or Swine Flu virus. The UK has contracts in place with two manufacturers Glaxo Smith Kline (GSK) and Baxter. Both vaccines have now been licensed. This means we will soon be in a position to begin administering them to priority groups, including frontline NHS staff, when supplies arrive from the manufacturers. Who should have the vaccination? The Chief Medical Officer has recommended that all frontline health professionals should get the vaccine as soon as possible to protect themselves, their patients and their colleagues. Staff who will be invited to have the vaccine include everyone who has regular clinical contact with patients, and those who are directly involved in patient care. This includes doctors, dentists, midwives, nurses, paramedics, ambulance drivers, occupational therapists and radiographers, for example. Students and trainees in these disciplines, and volunteers working with patients will also be included. Eligibility is not about a person s job title, but the work they are doing: if a person is providing frontline healthcare, they should have the vaccine. Why do I need the vaccination? There are three reasons why we want as many frontline staff to get the vaccine as possible: First, Swine Flu can lead to serious complications in people with underlying health conditions, so it is important we do everything we can to stop vulnerable patients from catching the virus. Vaccinating front line health professionals is the first line of defence for patients as it reduces the chances of staff transmitting the virus in the course of their duties. Second, vaccination can help us protect frontline health professionals from unnecessary risk. Health professionals are more likely to be exposed to Swine Flu than the rest of the population, and whilst Swine Flu is generally mild, even healthy people can become seriously ill from it or even die.

Third and finally, vaccinating staff is the single most effective way we can prevent disruption to the NHS due to staff absence. This could be a very tough winter for the NHS, as Swine Flu combines with the normal winter pressures we experience (see Fig 1, below: it shows flu consultations are already ahead of 1999/00 levels, which was the worst flu winter for 15 years). Vaccination is crucial for keeping absence rates down and allowing the NHS to continue delivering the best possible care for patients in the months ahead. The latest all Scotland GP consultation rate for those with flu-like symptoms is 106.4 per 100,000. This represents an increase on the previous week s figure of 86.1, but that is comparable to that for the week ending 25 September 2009. [SGoRR Situation Report No.55 16 October 2009] How can you be sure the vaccines are safe if they haven t been used before? While both vaccines are new, they are very similar to existing H5N1 vaccines, that GSK and Baxter have already developed. These vaccines have undergone clinical trials involving many thousands of people, including the elderly and young children, which showed these vaccines are generally safe and effective. Previous studies have also shown that changing the strain of virus in a vaccine does not substantially affect its safety profile. These extensive trials therefore give us confidence that the new Swine Flu vaccines carry a very low risk. We will, of course, continue with clinical trials involving the swine flu vaccine to monitor for any sign of rare side effects. But the evidence we have suggests that the risk of a serious reaction is extremely small, and outweighed by the risk of falling seriously ill from the virus itself. Is there a link with Guillain-Barré Syndrome (GBS)? Guillain-Barré syndrome (GBS), an autoimmune nervous system reaction, can occur after acute viral infections but this is rare. It has also been reported very rarely after immunisation with influenza vaccine (one case per million people vaccinated in one US study). However, a recent study in the UK found that there is no association between GBS and seasonal flu vaccines, although there is a strong association with between GBS and influenza-like illness. Over thirty years ago, GBS was associated with the swine flu vaccines used in the US. The exact reason why the 1976 vaccine increased the risk of GBS

remains unknown. The swine flu vaccines being used in the national immunisation programme are different from the swine flu vaccines used in the US in 1976. I ve heard the vaccine causes flu will I get sick after having the jab? The vaccines contain inactivated flu viruses so they can t cause flu. However, as with most vaccines, some people experience mild side effects, including a slight fever and aches and pains. These reactions usually disappear within one to two days without treatment. Most people will experience nothing worse than a sore arm. Is the vaccination compulsory? No, the vaccine will be optional though we are strongly recommending that all frontline NHS staff take it up. What is the difference between the two vaccines? GSK and Baxter have different methods of producing the vaccine. The main difference is in the way the virus used in the vaccine is produced. The virus for the GSK vaccine (Pandemrix) is prepared in hens eggs, the same way as the seasonal flu vaccine. The Baxter vaccine (Celvapan) is made from virus that is grown in cultured cells. What does the vaccination involve? Following advice from the Joint Committee on Vaccination and Immunisation, the following vaccination schedule is recommended in the UK: Pandemrix (manufactured by GSK) For individuals aged from 10 years to less than 60 years of age: One dose (0.5ml) of Pandemrix For all children aged from 6 months of age to less than 10 years of age: Two half doses (0.25ml) of Pandemrix should be given with a minimum of three weeks between doses. For individuals aged 60 years and over

One dose (0.5ml) of Pandemrix (this advice will be reviewed when more data become available). For immunocompromised individuals aged 10 years and over Two doses (0.5ml) of Pandemrix should be given with a minimum of three weeks between doses Celvepan (manufactured by Baxter) For children from 6 months of age and adults Two doses (0.5ml) of Celvepan should be given with a minimum of three weeks between doses. The two vaccine products are not interchangeable and the same brand of vaccine must be used for both doses if two doses are needed. This dosage advice may change in the light of new clinical data and any such changes will be made public if and when they are made. The swine flu vaccine can be taken at the same time as the seasonal vaccine. Can the swine flu vaccine be given to women who are pregnant? Yes, pregnant women are recommended to receive swine flu vaccination because they are at an increased risk from the complications of swine flu and are more likely to be hospitalised. Both Pandemrix and Celvapan are licensed for use in pregnant women. The Joint Committee on Vaccination and Immunisation have advised that pregnant women should be given Pandemrix since a one-dose schedule with this vaccine appears to give adequate levels of antibodies and thereby confer more rapid protection that would be afforded by a two-dose schedule. There is no evidence that thiomersal-containing vaccines present a risk to pregnant women or their offspring. There is no evidence of risk from vaccinating pregnant women, or those who are breast-feeding, with inactivated virus vaccines 6. Can I work immediately after vaccination or will I be infectious? It is safe for NHS staff to carry on with normal duties after or in between doses of vaccine if two are needed..the vaccines contain inactivated forms of the virus, so they do not make the person infectious.

How long will the immunity last will I need to be vaccinated every year? It is anticipated that this vaccine will provide protection against swine flu for the duration of the pandemic. The vaccine may also provide some protection should the virus change. However, it is important to stress, the Swine Flu vaccine will only protect against the pandemic flu strain. Staff must continue to have their annual seasonal flu jab if they want to be protected from the normal winter flu strains every year. Does the vaccine contain mercury? Pandemrix from GSK contains very small quantities of thiomersal, a preservative that contains mercury. Thiomersal has been used in vaccines for over 60 years to prevent bacterial contamination. Studies by the World Health Organisation and the UK Commission on Human Medicine have found no evidence of health risks linked to thiomersal. Can the vaccine be given to people with an egg allergy? Because of the way the GSK (Pandemrix) vaccine is made (see above), people with a confirmed anaphylactic reaction to egg products should not have this vaccine. However, the Baxter vaccine (Celvapan) is not manufactured using eggs and can be given to those with confirmed anaphylactic reaction to eggs and egg products. I m allergic to latex are the vaccines safe for me? Yes, both vaccines are manufactured and packaged without latex. Does the vaccine contain pork products? Some porcine products are used in the manufacturing process of the Baxter vaccine. However there are no detectable traces of these products in the vaccine itself. The GSK vaccine (Pandemrix) does not contain porcine products. For more advice on vaccines and faith groups, please see: www.immunisation.nhs.uk/library/search?stags=&terms=porcine.

Do I need the vaccine if I ve already had Swine Flu? Unless the diagnosis was confirmed by a laboratory test, it is impossible to say whether the illness actually was Swine Flu. As a result, staff should still be offered the vaccine. Is it safe to have my seasonal flu jab and the swine flu vaccine at the same time? Yes, the swine flu vaccine can be given at the same time as other vaccines, including the seasonal flu vaccine. I ve never had the seasonal flu vaccine before and haven t had any problems with flu why should the Swine Flu be any different? We know that Swine Flu can lead to serious complications. The most severe cases tend to involve people with underlying health conditions but even among healthy people; Swine Flu has the potential to be a dangerous disease. How will I be vaccinated? NHS Boards and occupational health services have made arrangements for the vaccination of frontline health and social care staff. This will be either through open clinics or by invitation starting from the 21 st October, building up over a period of a few weeks. Version 1.0 19 October 2009