Approval for a UK swine flu vaccine is expected shortly, it has been announced. The vaccine is being recommended to be authorised for use in adults, including pregnant women, and in children from six months of age.
The recommendation has been made by the European Medicines Agency after carrying out an extensive review. The final decision will be made by the European Commission and is expected soon.
The Department of Health said: “This is a positive step towards getting full licences for vaccine to protect the public. The European Commission must now consider the recommendations and we hope for their decision as quickly as possible.”
The vaccine, Pandemrix, made by GlaxoSmithKline, is one of two vaccines being produced for the UK. The other vaccine being produced by Baxter is still under review. The two together will provide enough vaccine for the entire UK population.
The European Medicines Agency is currently recommending that the vaccine be delivered in two doses, three weeks apart. However, it has acknowledged that there is initial data suggesting that one dose may be sufficient in adults. This will be reviewed using findings from ongoing clinical studies that are expected to be available from October or November 2009. Further safety studies will go on after the vaccine is approved, and the European Medicines Agency will make more recommendations if necessary.
Weekly update
The number of new swine flu cases has almost doubled in the past week, with an estimated 9,000 new cases. The Chief Medical Officer, Sir Liam Donaldson said,
“Everything suggests that we’re starting to see a second wave to follow on from the July peak. We don’t know how big that wave is going to be, but we’re reaching the starting line.”
Other news from the weekly update:
- There are 218 people in hospital with swine flu, 25 of whom are in critical condition.
- To date, 82 people with swine flu have died in the UK. There have been 70 deaths in England, nine in Scotland, two in Northern Ireland, and one in Wales.
- There have been outbreaks in schools in 8 out of 10 regions in England.
Revised planning assumptions
It was announced on September 3 that estimates of deaths in the worst-case scenario for swine flu have been lowered. The government’s expert advisers on swine flu, the Scientific Advisory Group for Emergencies (SAGE), said that new data from the UK, north America, Australia and elsewhere give a better picture of how the virus might spread in the autumn.
The revised planning assumptions have cut the estimated death toll in a worst-case scenario from 65,000 people in the UK to 19,000, assuming that 30% of the population is infected.
These forecasts and others in the report are based on a “reasonable worst case” value and should not be taken as a prediction of how the pandemic will develop. Planning against the reasonable worst-case scenario will ensure, however, that plans for all likely scenarios are robust.
The Department of Health said: “In light of this new information, the estimates for the number of people who might need hospitalisation and the proportion of people with swine flu who could die have been reduced.”
Vaccination should cut hospitalisation
These new planning assumptions do not take account of the vaccination programme which, once it has begun, will help to further reduce the number of people needing hospitalisation. However, the department added, we must not be complacent. While in the majority of people it is mild, for some this virus can be a serious illness.
Advice for antivirals
Several newspapers reported that the World Health Organization (WHO) had changed its advice regarding use of antivirals for swine flu. Its advice suggests that while antivirals should always be given in serious cases, they may not always be necessary for otherwise healthy people.
The papers pointed out that this appeared to differ from the approach taken in the UK, where Tamiflu is being widely used.
However, the Department of Health said:
“We believe a safety-first approach of offering antivirals, when required, to everyone remains a sensible and responsible way forward. However, we will keep this policy under review as we learn more about the virus and its effects.
“The WHO recommendations are in fact in line with UK policy on antivirals. We have consistently said that many people with swine flu only get mild symptoms, and they may find bed rest and over-the-counter flu remedies work for them.”
Vaccinations for the vulnerable
Andy Burnham, the secretary of state for health, has confirmed which priority groups will be given the first doses of swine flu vaccine, which is expected to arrive in October.
Burnham said that the earliest doses of the vaccine would be given to at-risk groups in the following order:
- People aged between six months and 65 years in the clinically at-risk groups for seasonal flu.
- Pregnant women, subject to licensing by the European Medicines Agency, which will indicate whether it can be given throughout pregnancy or only at certain stages of pregnancy.
- Household contacts of people with compromised immune systems.
- People aged 65 and over in the current seasonal flu vaccine clinical at-risk groups.
The health secretary said: “Although the virus has so far proved to be mild in most people, for others it has been more serious. By vaccinating high-risk groups first, we aim to protect those most vulnerable to this virus.” He confirmed that frontline health and social care workers will begin to be vaccinated at the same time as the first at-risk group.
At-risk groups
At-risk groups will be the same as for seasonal flu vaccination. This includes people with serious heart disease, diabetes, and weakened immune systems due to cancer treatment.
The list has been drawn up according to advice from independent experts at the Joint Committee on Vaccination and Immunisation, which reviewed the evidence and advised the Department of Health on the crucial risk groups to be offered vaccination to help prevent serious illness.
A vaccination programme for the rest of the population will be based on the evolution of the pandemic as well as new clinical data on the use of the vaccine.
People in the priority groups outlined above do not need to take any action yet. Further announcements will be made as the vaccination strategy progresses, and those who need a vaccine will be contacted.
National Pandemic Flu Service
The National Pandemic Flu Service was launched in July. This online service assesses patients for swine flu and, if required, gives them an authorisation number that can be used to collect antiviral medication.
The system, which can also be accessed by phone, will take the strain off GPs as swine flu spreads. For the moment, it is being used only in England.
“The National Pandemic Flu Service is a new self-care service which will give people with pandemic swine flu symptoms fast access to information and antivirals,” said a Department of Health spokesman.
“This new service will free up GPs, enabling them to deal with other illnesses that need their urgent attention.”
The launch of the system brought important changes to the official advice that is given to people who think they may have swine flu. That advice – and the new system – is supported by the Royal College of General Practitioners.
Latest advice
If you have flu-like symptoms and are concerned that you may have swine flu, the advice is to stay at home and check your symptoms at the National Pandemic Flu Service.
Patients with swine flu typically have a fever or a high temperature (over 38°C / 100.4°F) and two or more of the following symptoms:
- unusual tiredness,
- headache,
- runny nose,
- sore throat,
- shortness of breath or cough,
- loss of appetite,
- aching muscles,
- diarrhoea or vomiting
Call your GP if:
- you have a serious underlying (existing) illness,
- you’re pregnant,
- you have a sick child under one year old,
- your condition suddenly gets much worse, or
- your condition is still getting worse after seven days (five for a child).
For people who do not have internet access, the National Pandemic Flu Service can be accessed by phone on:
Telephone: 0800 1 513 100
Minicom: 0800 1 513 200
For more information on the National Pandemic Flu Service, go to Flu Service: questions and answers.
People in Scotland, Wales and Northern Ireland can visit www.direct.gov.uk/pandemicflu
Advice for pregnant women
Pregnant women are one of the higher risk groups for swine flu, as they are for all influenza viruses. It is therefore important for them to take precautions.
This website provides full and up-to-date advice for pregnant women and parents of young children. The advice has not changed recently and is available at the following links:
Swine flu advice for pregnant women.
Swine flu pregnancy and parenting Q&A.
Swine flu symptoms, including high-risk groups.
Chief medical officer’s advice on pregnancy, holidays, and parents.
How dangerous is swine flu?
The vast majority of cases reported so far in this country have been mild. Only a small number have led to serious illness, and these have frequently been where patients have had underlying health problems.
There has been an argument put forward that the government should restrict antivirals to those groups who are most at risk of developing serious complications from swine flu. In other words, if people are otherwise healthy, then the NHS should let the virus run its course, treating it with paracetamol and bed rest, as for normal flu.
However, the government’s Scientific Advisory Group for Emergencies (SAGE) believes there is still some uncertainty about the risk profile of the virus. For instance, there are reports of some cases in Argentina where young, healthy adults have apparently become extremely ill from swine flu.
While there is still this doubt, the government has decided to continue offering Tamiflu to everyone with swine flu at their doctor’s discretion.
“We will keep this matter under review, with advice from SAGE,” said health minister Andy Burnham.
You can read the Department of Health’s guide for further information on the science of swine flu treatment.
Who is at greatest risk of serious complications from flu?
Some people are more at risk than others of serious illness if they catch swine flu. They will need to start taking antivirals as soon as they are confirmed with the illness. On occasion, doctors may advise some high risk patients to take antivirals before they have symptoms if someone close to them has swine flu.
The risk profile of the virus is still being studied but it is already known that certain groups of people are particularly vulnerable. These include:
- Patients who have had drug treatment for asthma in the past three years
- Pregnant women
- People aged 65 years and older
- Children under five years old
- People with chronic lung disease
- People with chronic heart disease
- People with chronic kidney disease
- People with chronic liver disease
- People with chronic neurological disease
- People with immunosuppression (whether caused by disease or treatment)
- People with diabetes mellitus
Why are healthy people over 65 and children not a priority for the swine flu vaccine?
Healthy people aged over 65 appear to have some natural immunity to the swine flu virus. And while children are disproportionately affected by swine flu, the vast majority make a full recovery – therefore the experts do not advise that children (other than those in at-risk groups) should be vaccinated initially.
Catch it, Bin it, Kill it
Although the UK has moved to a treatment phase for swine flu, it’s important that people continue to do everything they can to stop the virus from spreading.
The most important way to stop it spreading is to have good respiratory hygiene (i.e. sneezing and coughing into a tissue) and hand hygiene (keeping your hands clean). The video Catch it, Bin It, Kill It explains the importance of catching your sneeze in a tissue, placing it quickly in a bin and washing your hands and surfaces regularly to kill the virus.
