91Èȱ¬

Many readers of this blog may be about to get a letter from their GP , or will receive an invitation in the coming weeks, if they fall into specific at-risk groups.

If so, they may well be interested in the (WHO).

The experts who advise the WHO and governments about immunisation have said that the H1N1 pandemic vaccines appear to be as safe as seasonal flu jabs.

The Strategic Advisory Group of Exerts (SAGE) on immunisation met earlier this week to review both clinical trials involving several thousand volunteers and the ongoing mass immunisation campaigns being conducted in at least 14 countries where several hundred thousand doses had been administered.

Details of its decision were released by the WHO.

This is what it says about vaccine safety and the use of the vaccine in pregnant women:

"The experts reviewed early results from the monitoring of people who have received pandemic vaccines and found no indication of unusual adverse reactions. Some adverse events following vaccination have been notified, but these are well within the range of those seen with seasonal vaccines, which have an excellent safety profile. Although early results are reassuring, monitoring for adverse events should continue.
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"Concerning vaccines for pregnant women, SAGE noted that studies in experimental animals using live attenuated vaccines and non-adjuvanted or adjuvanted inactivated vaccines found no evidence of direct or indirect harmful effects on fertility, pregnancy, development of the embryo or foetus, birthing, or post-natal development.
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"Based on these data and the substantially elevated risk for a severe outcome in pregnant women infected with the pandemic virus, SAGE recommended that any licensed vaccine can be used in pregnant women, provided no specific contraindication has been identified by the regulatory authority."

At a subsequent briefing, Dr Marie-Paule Kieny, WHO Director of the Initiative for Vaccine Research said:

"All the reports received to date... have shown that the safety profile of this pandemic vaccine is good and is very similar to the one known for seasonal flu vaccine. Nothing special about adverse events has been noted.
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Therefore SAGE has considered that in view of the particular importance to vaccinate pregnant women who are at significantly higher risk of severe adverse outcome following infection with a pandemic virus, especially in the second and third trimester of pregnancy, that these women can be vaccinated with any of the licensed vaccines."

Pregnant women and young people

I would like to quote another section of the SAGE advice as it highlights the increased risks facing both pregnant women and the young:

"Globally, teenagers and young adults continue to account for the majority of cases, with rates of hospitalization highest in very young children. Between 1% to 10% of patients with clinical illness require hospitalization. Of hospitalized patients, from 10% to 25% require admission to an intensive care unit, and from 2% to 9% have a fatal outcome.
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"Overall, from 7% to 10% of all hospitalized patients are pregnant women in their second or third trimester of pregnancy. Pregnant women are ten times more likely to need care in an intensive care unit when compared with the general population."

What stands out for me is the greatly elevated risks among pregnant women.

Pregnancy leads to changes in the immune, respiratory and cardiovascular systems and it has always been a risk factor for seasonal flu, but nothing like the potential threat posed by this pandemic strain.

Bear in mind, though, that since the outbreak began, the number of deaths from swine flu has been very low compared to seasonal flu (which mostly kills the frail elderly). The latest global death toll is 5,700 up around 700 in the past week.

This can be partly explained by the start of the northern hemisphere flu season. But set that against the fact that many millions of people worldwide had been exposed to the virus (around 500,000 in Britain alone).

All these figures are estimates only, but they help in setting in context the level of risk. The availability of a vaccine means that this is now a preventable disease.

SAGE said both the pandemic and seasonal flu vaccines can be given at the same time. As with the UK recommendation, it said one dose of vaccine is enough to protect those from 10 years of age.

For those older than six months and under 10, it says data are limited and more studies are needed. The UK is giving two doses, spaced three weeks apart to those under 10, but only to children in at-risk groups.

But as I said in my previous post, it seems just a question of time before this is extended to all children. SAGE had this to say:

"Where national authorities have made children a priority for early vaccination, SAGE recommended that priority be given to the administration of one dose of vaccine to as many children as possible."

When you bear in mind that SAGE is chaired by Professor David Salisbury, who is also the head of immunisation at the Department of Health, it appears to be a further pointer towards an eventual move to the mass immunisation of all children in the UK.

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The latest figures on H1N1 swine flu may get scant publicity, but they are worth investigating as they reveal an apparent contradiction which will become hugely important in the coming months.

The paradox is this: swine flu is a mild illness, yet intensive care units are under mounting pressure.

How to explain this? It is true, and worth repeating, that the vast majority of us who get swine flu will not be seriously ill.

Many will have extremely mild symptoms; others will feel lousy for a few days and be confined to bed, which still counts as a mild illness.

Rest and plenty of fluids will be all they require. Antivirals may help to reduce symptoms.

But a minority will get complications. While most of those will have underlying health problems (like asthma or heart disease), not all will - so it is impossible to predict who will be unlucky enough to need hospital treatment as a result of the virus.

Statistics released by the chief medical officer for England, Sir Liam Donaldson help illustrate the swine flu paradox.

This table shows that there were 751 patients in hospital in England with swine-flu-related illness as of yesterday, of whom 157 were in critical care. That means 20% of hospitalised swine flu patients require critical care.

That is both the highest number in intensive care since the outbreak began and the highest proportion of hospitalised patients. It means one in five people hospitalised with swine flu now require intensive care.

Sir Liam Donaldson said there was "an eerie similarity" with what happened in Australia during its recent winter, where 25% of hospital admissions for swine flu ended up in intensive care.

Another graph further illustrates the problem of predicting who will be struck down by swine flu.

This is a study of nearly 400 patients admitted to hospital in England with swine flu. Those who had existing health problems are coloured blue; those without are burgundy.

You can see that only 19% of the under-5s have existing conditions (the jargon term is comorbidity). Only 42% of those aged 5-15 who need hospital treatment have other health problems.

These figures should not alarm you. Remember that most people will get a mild illness (if I had a pound for every time I wrote that...).

It is simply worth pointing out that just because you are a healthy person with healthy children, it does not mean that swine flu cannot turn your life upside down.

On a positive note, most of those who end up in critical care will recover completely. But having seen patients on life support because of H1N1, I can assure you this is not a virus to dismiss out of hand.

Young children under five make up the group most likely to require hospital treatment and those most likely to have been entirely healthy before.

It's for this reason that it seems inevitable to me that the Department of Health will eventually offer swine flu immunisation to all children.

This will come after a recommendation from the JCVI (The Joint Committee on Vaccination and Immunisation). for everyone aged six months to 24 years, in addition to at-risk groups.

Sir Liam Donaldson confirmed today they would eventually extend the immunisation programme beyond at-risk groups and health workers. He said: "It will be expanded. It's just how we do it."

Expect an announcement expanding the programme to all infants and school age children before Christmas.

My hunch would be that the decision has probably already been made, but that health officials want to focus on getting the first wave of immunisation well under way before making any announcement.

Ian Dalton, national director for flu resilience, said all GPs in England should get their first box of 500 doses of H1N1 vaccine in the next three to four weeks.

That means many of those who have serious health conditions are likely to be waiting well into December for their jab.

Some, though, are getting letters (post strike permitting) inviting them to get a swine flu shot and may be wondering whether to have the jab. It's a personal choice. What people must ask themselves is why they wouldn't have it.

Is it because they think the virus will be mild for them (why take that chance?). Or because they worry about the safety of the vaccine? All medicines have potential side-effects, vaccines included.

(the jab being used for almost everyone in the UK) led to side-effects. These included headache, joint or muscle pain and sore arms.

Now look again at the numbers who are currently critically ill with swine flu, and then balance the risk of the disease against that of being immunised.

This graph shows that, of the deaths so far in England, 65% have been among people who would have qualified for the vaccine, among them several pregnant women.

The H1N1 virus is now a preventable illness, and it will be important to see in the coming months what effect immunisation has on death and hospitalisation.

Sir Liam revealed that posters condemning vaccination as a "weapon of mass destruction" were put up in a Birmingham hospital at the weekend.

He said it appeared to be the work of an anarchist group who also believed that 9/11 was the work of the US government.

A brief look at their website left me slightly unsure what they stand for except that government is bad, as are taxes.

The latest figures for flu reveal that the second wave continues a steady upward, but not explosive, trend.

There were an estimated 78,000 new cases of swine flu in the past week in England, up from 53,000 the week before.

In Scotland, there were around 20,000 cases and 65 people were in critical care as of yesterday.



Look at the red line and you can see that the curve is still upward, but way below July and the last epidemic of 1999/2000. But the flu season has barely begun.

More than 500,000 people are now thought to have had swine flu since the outbreak began. The number of deaths remains, thankfully, comparatively low. The latest death toll for the UK is 137.

This is part of the swine flu paradox, because we would expect several thousand deaths from seasonal flu every year, mostly in the frail elderly.

By contrast, the majority of deaths from swine flu are in people aged under 45. So although the total number of deaths is low, hospitals are gearing up for what could be their busiest winter in intensive care for a generation.

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Just days after the UK began vaccinating priority groups against H1N1 swine flu, Germany began its immunisation campaign.

Both countries have bought vaccines from the same two manufacturers, GSK (Pandemrix) and Baxter (Celvapan).

But whereas the vaccination programme seemed to get off to a smooth start here, it was quite another matter in Germany.

The difference is that in Germany, ministers, government officials and the armed forces are getting Celvapan, while the general public will receive Pandemrix.

This has led to complaints of a two-tier health service, but a government spokesman said it was simply the results of different departments making their purchases without coordinating.

In the UK, (and if they do they will get the same jab as the public).

Likewise 15,000 British troops in Afghanistan are to receive Pandemrix.

Indeed, there are so few doses available of the Baxter jab in the UK that it is being reserved largely for those with a severe egg allergy. Unlike the GSK jab, it is not grown in eggs.

The German Chancellor Angela Merkel has made it clear that if she is advised to be immunised by her doctor, then she will get the Pandemrix vaccine, intended for the general public.

The 91Èȱ¬'s Tristana Moore filed a report from Berlin on the row which .

Much of the debate in Germany centred on the fact that Pandemrix contains an adjuvant, a booster chemical, called AS303 which I wrote about in my last post.

GSK has just released new data on Pandemrix and forecast that by the end of this week nearly 500,000 people across Europe will have been immunised with the vaccine.

It also published results from a small trial in Belgium suggesting that the vaccine is effective in the elderly as well as younger age groups.

This is important because some studies of seasonal flu vaccines have shown that they are less effective in older age groups.

The row in Germany is a reminder of how easy it is to undermine public confidence in healthcare.

Ministers and officials need to ask themselves, "what might people think?" with any decision they make.

Whilst it may have been a perfectly innocent purchasing decision that led to ministers and the armed forces being allocated a different vaccine to the general public, it doesn't look good. Forget the fact that both vaccines have been licensed by the European Medicines Agency.

However efficiently Germany conducts its H1N1 swine flu programme in the coming months, damage has been done and it will undoubtedly put some people off having the jab.

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The long-awaited UK-wide programme of vaccination against H1N1 swine flu will begin next week.

The first to get immunised will be the most vulnerable people in the population - namely, high-risk patients in hospital (for example, those with leukaemia who have a weakened immune system).

The Chief Medical Officer for England, Sir Liam Donaldson, who is the government's main advisor on tackling the virus, gave further details (for England) at his weekly press briefing.

As you can see, the GSK vaccine Pandemrix has become the jab of choice for the NHS, despite the government also buying stocks of a second vaccine Celvapan, from another manufacturer, Baxter. This is partly due to production problems with the Baxter vaccine.

Sir Liam Donaldson urged at risk groups, including pregnant women, to get immunised:

"I don't want to see anyone dying of an illness that can be prevented by vaccination. Only this week we have seen two deaths among pregnant women: one in Scotland and another in Wales."

Those under 10 will need two jabs, spaced three weeks apart, because their immune systems don't respond as well.

By contrast, anyone who has Celvapan will require two doses. Professor Salisbury said he specifically wanted pregnant women to have the GSK jab, because it meant they would be protected quicker. He said:

"If a pregnant woman has an interval of three weeks to wait for immunity to kick in, that could put the pregnancy at risk, so it is seriously beneficial for them to be protected after one dose of Pandemrix."

Adjuvanted flu vaccines have been around for at least a decade, but there is not nearly the same degree of clinical data as with unadjuvanted flu jabs.

Because of the lack of clinical data, the that swine flu vaccines without adjuvants, should be used in pregnant women, where possible.

This suggestion came from the influential Strategic Advisory Group of Experts on Immunization (Sage). That would have meant Celvapan being used, not Pandemrix.

But Professor Salisbury, who chairs Sage as well as being the head of immunisation at the Health Department, indicated that this advice was now out of date.

"It was made before the GSK vaccine was licensed and based on what we knew at the time. The regulators were able to look at studies involving pregnancy in animals and at other clinical data."

The clear advice is that those who are pregnant should be immunised because they are at considerably higher risk, as a result of the body's natural suppression of the immune system.

The further along the pregnancy, the greater the risk to the mother and her unborn child. Earlier this week, a pregnant teenager in Scotland died after contracting swine flu, leading to the death of her unborn child. Recently, a new mother in Wales died two weeks after giving birth following infection with the virus.

Many will want to find out as much information as possible about Pandemrix before agreeing to be immunised. There have been clinical trials - including .

To date, 2,000 people have received the jab. None of those was pregnant because ethical committees will not usually allow pregnant women to take part in trials.

So what is in the adjuvant, known as AS03, found in the GSK jab? The key ingredient is something called squalene, which is derived from fish oil. The .

Squalene has been used in flu vaccines before, as the WHO makes clear:

"22 million doses of Chiron's influenza vaccine (FLUAD) have been administered safely since 1997. This vaccine contains about 10mg of squalene per dose. No severe adverse events have been associated with the vaccine."

GSK has .

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Just as last week, there continue to be encouraging signs with swine flu. The much predicted second wave has begun but the increase in cases in England and Wales is much slower than officials had dared hope. In Scotland, cases actually fell, but remain very high in Northern Ireland.

Just one graph for you this week, which sums up the spread of flu in England and Wales.

Take a look at the red line and you'll see that although cases are rising, the curve is shallow, in stark contrast to the first wave in June and July. If this continues, it will mean that vaccination of at-risk groups can be carried out before the autumn/winter peak.

Some of the main points this week from the briefing of Sir Liam Donaldson, Chief Medical Officer for England:

• Estimated number of cases in England in the past week: 18,000 up from 14,000 the previous week

• Rate of GP consultations for flu-like illness: 26.3 per 100,000 up from 22.2

• School outbreaks since autumn term began:116 of which 67 are in Yorkshire and Humber

• Two hundred and ninety people were in hospital as at 7 October of whom 47 were in intensive care

• Total number of confirmed deaths related to H1N1 virus in England 76 (four deaths in the past week), Scotland (10), Wales (1), Northern Ireland (3) giving a UK total of 90

• Around a fifth of the deaths were in those who had no underlying illness

The Health Protection Agency has a more detailed UK weekly epidemiology update.

Sir Liam Donaldson said:

"We are well into the second wave of pandemic flu but it is proving so far to be a slow burn. There is a possibility it might peak and at a lower level than we thought. This would be incredibly positive because it would mean we could roll out the vaccine. It would mean we might be able to avert a subsequent very big peak. But on the other side of the coin we have a worrying number of people going into hospital and intensive care. It isn't a killer virus but it can kill."

Why is flu rising slowly? Sir Liam said:

"There is a bit of herd immunity out there because of the earlier peak in July, especially among school children but it's too early to say whether it will continue to be a slow burn. We are still early in the flu season."

There are also encouraging signs from the United States where cases seem to have peaked.

Vaccine

The body which advises ministers on vaccination - - has been meeting today and a key point of discussion has been whether to extend H1N1 swine flu vaccination beyond at-risk groups. If this does happen, it would be healthy children who would be the first group targeted, on the grounds that children are the most likely to catch the disease, and the most likely to require hospital treatment.

Vaccination against seasonal flu has already begun in many parts of the UK and swine flu jabs will be sent to GPs from later this month. Sir Liam said:

"There's been a supply of half a million doses of Baxter vaccine in warehouses for some time. We expect to get considerable numbers of the GSK vaccine quite soon. The only doses here so far (of the GSK vaccine) have been for clinical trials and there hasn't been a major delivery yet."

Scotland

The rate of GP consultations for flu-like illness are 86.1 per 100,000, down from 103.7 the previous week, but still higher than expected for the time of year.

Yesterday there were 24 people in hospital with swine flu.

Health Protection Scotland has .

Northern Ireland

Finally, there is a sad reminder from Northern Ireland that although swine flu is mild for most, it can be deadly for a tiny minority. A 12-year-old boy died this morning in the Ulster Hospital in Dundonald. He had swine flu and had a serious underlying medical condition.

Health Minister Michael McGimpsey made this statement:

"It is very sad when a child dies and my thoughts and sympathies are with the family. I would ask everyone to respect the privacy of the family at this very sad time.

"Incidents of swine flu in Northern Ireland remain high and we must expect further increases in cases in the weeks ahead. Swine flu remains a major public health threat but we are well prepared and have been planning for a pandemic for some time."

Further information about swine flu can be found on the or .

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Research from Mexico City suggests that the seasonal flu vaccine may offer some protection against swine flu, particularly the most severe complications of the disease.

The research team involved admits that the study has several limitations - and that the findings should be considered cautiously "and in no way indicate that seasonal vaccine should replace vaccination against pandemic influenza A/H1N1 2009".

Having put those markers down, it's nonetheless an interesting bit of research which needs further examination. The study was led by Dr Jose Luis Valdespino from Mexico and investigated the link between the 2008-9 seasonal flu vaccine with cases of influenza A/H1N1 during the epidemic in a speciality hospital in Mexico City.

The authors say the reason the seasonal vaccine seems to offer some protection is because it boosts existing antibodies in individuals who have previously been exposed to a similar flu virus, either by infection or vaccination.

They compared the health outcomes (hospitalisation, mechanical ventilation and death) of 60 patients with swine flu and 180 control patients with other diseases (note the small numbers). Both groups of patients informed the authors directly, by telephone or via a close relative whether they had received the 2008-9 seasonal flu vaccine.

The results suggest that the uninfected participants were significantly more likely to have received the seasonal flu vaccine and that it protected them against particularly severe forms of swine flu. However, the authors say the results must be taken in context and argue that given the small sample size "it will be key to conduct similar studies in other settings to confirm or refute our results."

In an accompanying editorial, Dr Menno de Jong from the concurs with Dr Valdespino that the results do not mean that there is no need for a specific vaccine against swine flu.

So what is the take-home message? Well, if you have a seasonal flu jab every winter, there's just a chance that it might protect you against the complications of H1N1 swine flu.

But if you are in an at-risk group, you should not see this as an alternative to having a swine flu vaccine. Indeed, the majority of those who will be offered the swine flu jab this autumn will be asked to roll up both sleeves. In one arm, they will be given the H1N1 swine flu (pandemic) vaccine and in the other, the annual seasonal flu jab. Those at risk of complications of flu need both because there will be several strains of flu doing the rounds over the coming months.

Dr John McCauley from the National Institute for Medical Research in north London said:

"The results look interesting. There does seem to be some degree of protection from the seasonal flu vaccine but it's in an unusual age group, the 41-60-year-olds. In the young and old, it didn't seem to make a difference. It definitely does not mean that people should rely on the seasonal flu vaccine, especially since the pandemic vaccine will be rolled out shortly."

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At first glance, the latest weekly swine flu figures for England look worrisome. Cases are up by more than 50% and several hundred people are in hospital. Northern Ireland and Scotland (see below) have also seen big increases.

In England at least, look a bit closer and the overall picture is somewhat reassuring. Yes, cases are continuing to rise, but not at the rate we saw in July when there was a doubling of cases each week. That dramatic growth could still happen - and the trend is upwards - but we are well below the levels of flu in the community of three months ago. The biggest increases continue to be among school-age children.

Here are some of the main points from the weekly briefing of Sir Liam Donaldson, chief medical officer for England.

Figures for England:
• Estimated cases 14,000 - up from 9,000 the previous week

• School outbreaks since autumn term began - 79
• 39 of those in Yorkshire and Humber

• 286 people were in hospital with swine flu on 30 September
• 36 of those were in critical care

• Total number of swine flu related deaths so far in England - 72 - two more deaths in the past week

• Total deaths in the UK so far 84 (one in Wales, nine in Scotland and two in Northern Ireland)

Now for a few graphs.

Influenza-like illness: Weekly GP consultation rate England and Wales

It's the red line that you need to look at here. Yes, the rate is up on last week, but still way below that in July when it was above 150 per 100,000. So we are still in the foothills of the second peak of swine flu and should expect it to rise - at some point - way above 200 per 100,000 (see Northern Ireland below).

Age distribution of fully investigated deaths

Of the 84 deaths - the biggest proportion have been among the 16-44 age group, though there have been deaths among people of all ages. A quarter of the deaths have been among the over 65s - a much lower proportion than with seasonal flu.

Underlying conditions information for fully investigated deaths

This shows that around half the deaths have been among people with severe underlying health conditions (such as leukaemia). Around one in five of those who died had been entirely healthy.

A more detailed UK weekly epidemiology update can be found here.

Vaccines

Immunisation of the first at-risk groups is drawing nearer, but there is no firm date yet. Sir Liam Donaldson: "If everything goes well it will be in the second half of October but we are not tying ourselves to any date."

And a word of caution from the Department of Health's head of immunisation, Professor David Salisbury who made clear that the start date for immunisation depends on when they get sufficient supplies of vaccine:

"We have not got GSK vaccine in stock yet, but the critical step is the licensing step. There were delays in the initial production process but we've been assured that we'll have sufficient stocks for the priority groups. But we are dependent on the manufacturers to supply it."

ECMO

I've written a lot about the technique called ECMO which involves adding oxygen to the blood outside the body. It's a treatment that is used for the most dangerously ill patients whose lung function has totally failed. The only adult unit is in Leicester and has five beds (which are also used for treating children).

Sir Liam said that an expert review led by Dr Judith Hulf has approved the doubling of capacity in Leicester. There are also paediatric ECMO units at three other UK hospitals which have a total of 10 beds between them. But it remains to be seen whether the doubling - to 10 beds - of capacity in Leicester, will be sufficient. That would make a total of 20 ECMO beds in the UK.

Australia, which has just gone through its first winter with swine flu, found ECMO to be a life-saver. At one stage there were 23 people on ECMO machines, most of them adults. Australia's population is around a third of that of the UK.

Swine flu cases in the rest of the UK

Northern Ireland now has the highest level of swine flu in the UK. Figures show that there has been a marked increase in cases every week since the schools went back. GP consultations for flu-like illnesses have reached 208 per 100,000.

The chief medical officer for Northern Ireland, Dr Michael McBride said:

"The number of contacts for flu-like illness made to GPs during this period has risen again over this last week, reaching the highest level for nine years. The rate remains highest in the 5-14 age group. Although, calls made to GPs Out of Hours for flu like illness have risen for the fourth week in a row, primary care services continue to cope well despite the increased demand on their services. The ongoing increase in swine flu activity suggests that we are in a second wave. This is something we are monitoring closely."

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