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Saturday, July 11

Britain's government announces plan to fast track their swine flu vaccination program (UPDATED)

UPDATE July 12, 4:30 AM ET
In this post I mention a letter leaked to the press about the vaccine situation for Scotland, news of which was published July 8. There was another leak, first reported on July 10 and reported today at U.K.'s First Post under the somewhat lurid headline:
Swine flu: NHS ‘muddle’ as London on brink of epidemic

A leaked NHS memo criticises emergency swine flu planning while the Chief Medical Officer says London is almost in an H1N1 epidemic


A leaked memo has revealed that senior NHS [National Health Service] officials consider emergency plans to combat the swine flu pandemic in Britain are muddled and pointless.

[...]

The memo, which was sent by an NHS trust executive and leaked to the Times, criticises the government's "muddled thinking" on emergency planning, including the setting up of a national diagnosis phone line, which is yet to materialise - forcing NHS trusts to set up their own.

[...]
It goes without saying that the memo would have factored into the British government's decision to announce a fast-tracked vaccination program.

I also asked in this post whether Britain's planned fast-tracking will extend throughout the European Union. I have found this report at Xinhua from July 6 titled EU to develop common strategy. The EU statement sounds vague:
[...] It pointed out that the cooperation will encompass different measures regarding vaccines, antiviral drugs and other public health measures. In this context, it is important to develop strategies to protect people in different risk groups.
So I don't believe it's yet known whether the rest of the EU nations will coordinate a fast-tracked vaccination program

If you read the entire First Post news report, you'll note it mentions three "ominous" developments with regard to the swine flu virus, as reported in the New Scientist. The second item is about a "mutation" found in Shanghai. But when you go to the New Scientist report, the discovery refers to a "mutation to the virus's polymerase enzyme, which makes it replicate more efficiently ..."

So here we are again, driving through pea-soup fog. At these times it helps to remember John Batchelor's oft-repeated dictum that in war the first three reports are always wrong.

This virus, as with any virus, is undergoing slight alterations all the time. Is the Shanghai discovery a "significant" mutation, or is it even a mutation in the technical sense? I am not qualified to pronounce on these questions, and I doubt the First Post reporter is, either.

See the June 26 update to my post on the Brazilian (Sao Paulo) swine flu mutation for the meaning of a "significant" mutation.

We have no choice but to await further developments because the New Scientist article does not provide a source for the information on the Shanghai discovery. This caused a correspondent to snap, "I want three independent confirmations" when I sent him the report.

Of more immediate concern is the New Scientist mention that the swine flu virus seems to be pushing out the seasonal influenza strain in a number of countries; if that turns out to be true, and the trend continues and expands globally, the vaccine for the seasonal flu won't be much help, if any. I suggest you read the entire report, which isn't lengthy, for more detail on this angle.

But again, take the discussion with a grain of salt. The winter influenza season is just gearing up in the southern hemisphere, and it's wound down in the northern one. So of course, right at this moment, there would not be that many 'regular' influenza cases.

Again, we have no choice but to wait on developments.
************************************
Dateline Sunday July 12 (London) Sunday Times Online:
[...] When the new vaccine for swine flu arrives in Britain, regulators said this weekend, it could be approved for use in just five days.

Regulators at the European Medicines Agency (EMEA) said the fast-tracked procedure has involved clinical trials of a “mock-up” vaccine similar to the one that will be used for the biggest mass vaccination programme in generations. It will be introduced into the general population while regulators continue to carry out simultaneous clinical trials. [...]
Given the EMEA's involvement the question is whether the planned fast-tracking will extend throughout the European Union.

Already there is concern among the union's health ministries that if the vaccines become more quickly available in some EU countries, this could cause 'vaccine tourism/shopping' in other EU countries. (See entire Times report, below.)

If the answer is yes, Britain's government clearly decided not to wait for an EU announcement about EU-wide fast-tracking. This was likely in reaction to a 'leaked' letter published on July 8, which explained that about half Scotland's population couldn't expect to receive swine flu vaccine until November 2010.

Another question is whether the EU and/or Britain actually intend to go through with the fast-tracking, or whether this is a move to tamp down rising concerns among the public about swine flu. At this moment I'd say that Britain's government seems determined to go through with the plan. Yet the plan is so gravely serious in its implications that below I'm posting the entire article from today's Times Online about the plan.

It's seemed to me that governments in the midst of big political fights have tended to treat the swine flu outbreak as a plot by their political enemies, and I fear that Britain's beleaguered Labor party is no exception. In the space of a couple weeks they've gone from downplaying the seriousness of the outbreak to rushing headlong into a campaign to quickly vaccinate Britons on the strength of 'mock-up' clinical trials of vaccine safety.

From the bottom of my heart I hope the plan works out, but I would also warn the British government that a cover-up would be impossible, if it doesn't. The letter I mentioned is distant thunder to what would be leaked, if the fast-tracked vaccine produces death or injury in large number.

But Gordon Brown and his Labor government -- which are already on very shaky political ground -- are making a triage decision that affects many millions of people. There are few win-win decisions in such situations. Here is the dilemma for triage planners:

Do you risk crashing an already-fragile economy by holding off on a mass vaccination program until extensive tests of vaccine safety are completed?

Or do you fast-track the program and risk severe side effects and deaths among a small number of the population from improperly tested vaccine?

If the answer seems a no-brainer, realize that fully adequate testing takes about six months from the time that volunteers are first injected with the vaccine.

That is Australia's plan; testing of the vaccine on volunteers is scheduled to begin July 15 with follow-up medical examinations spanning six months in order to look for side effects.

Or I should say it was Australia's plan; I don't know whether the news about a Tamiflu-resistant strain of the 2009 swine flu is causing them to consider moving up the timetable.

The news that the Tamiflu-resistant mutation is being transmitted human-to-human, with no falling off in the virulence of the strain, has changed everything for governments, around the world, and their public health systems.

Britain's fast-track vaccination plan is designed to address two critical considerations:

1) Without mass vaccinations, hospitals can be overwhelmed by large numbers of people seriously ill from swine flu; there simply won't be enough beds. The same is true for medical supplies. At the swine flu summit in Cancun a week ago Nancy Cox, chief of the CDC's infectious disease department, mentioned that medical supplies and government preparedness were crucial considerations in keeping deaths low from swine flu.

It's not just the anti-virals that are staving off deaths; it's also antibiotics to treat secondary infections and lung ventilators. Cox pointed out that Argentina, with its lower number of reported swine flu infections, had a much higher death toll than Chile -- despite that country's higher number of reported infections. She said that Argentina, already facing a huge caseload of bronchitis and common flu cases, hasn't had enough ventilators to treat everyone. According to this report, Chile was better prepared and more proactive than Argentina.

I interject that you have to be careful about accepting all of Cox's argument because Argentina's lower number of reported cases represented at that time a suppression of data. The government was trying to downplay the seriousness of the outbreak because they were heading into an election. And even though they released data on hundreds of confirmed cases after the election, it's unlikely their labs have been able to keep up with the outbreak.

But Cox's general observation holds true. This flu seems to have a propensity for attacking the lungs but even without that, obesity and other physical conditions that can limit lung capacity, such as asthma, can make a ventilator and anti-pneumonia antibiotics the difference between life and death for people seriously ill with flu -- of any kind.

If the swine flu outbreak continues to grow at a fast pace, by the height of winter in both hemispheres it's going to be attacking at just the time that regular influenza attacks. That can mean overwhelmed medical facilities and triage decisions about who gets a ventilator. Not a pleasant decision for hospital triage staff to have to make.

2) Britain's fast-track vaccination program also acknowledges that the great power of modern societies rests on highly complex systems that require constant human supervision to continue functioning:

Think of cell-phone towers, gas and electrical systems, garbage disposal, mass transit and vehicular traffic systems, fire and policing, financial markets, computer systems, municipal water supplies and delivery systems.

So it's not like 1918. Today a virus of far less virulence than the 1918 one can wreak devastation on entire societies if critical members of the workforce who maintain key infrastructures are laid up for a week or more with swine flu around the same time.

This observation takes on added weight during the present economic crisis. The grim truth is that many small companies that are barely hanging on through the recession would be pushed over the brink by high employee absenteeism because of swine flu.

And with large numbers of unemployed, the crime rate will shoot up.

So, what seems at first glance a simple decision about whether to rush a vaccination program or hold off for thorough testing is not so simple, is it?

I just received a report from a correspondent that deals with another angle relating to swine flu and the fragile position of the business community. From (U.K.) Guardian Observer datelined July 12:
Swine flu could bring UK to a halt, Whitehall told

Vital sections of society could be paralysed if swine flu reaches epidemic proportions as expected, the government has been warned.
A Whitehall meeting of emergency services and business chiefs has been told that more than a third of Britain's businesses have no response plans at all for dealing with the pandemic, while specific fears have been raised about the ability of the country's broadband network and the London Underground to operate effectively. [...]
If you wonder whether this news is conveniently coming at the same time as news about a fast-tracked vaccination program -- yes of course the government is trying to prepare the public for getting vaccinated in droves.

But this is no time for smirking at standard propaganda ploys. All governments (with the exception of China's) are now wide awake and scared half to death. They know now they've been outplayed and outwitted by a microbe.

I suspect China's government woke up sometime around 2005, after being nearly brought down by panics over SARS, H5N1, and the mysterious pig illness they continue to insist was strep suis. In any event, at some point between then and the 2009 swine flu outbreak they'd learned the hard lessons that other governments are just now learning. And so they decided to battle swine flu at the airports, which greatly slowed the spread of swine flu in their country.

But again, there's no time now for smirking at your government's failings. Time's up; it was up in March 2009. Right now a virus is running humanity's show.

So, how many ventilators does your hospital have on hand? What kind of pandemic plan does your company have? Understand? The time for you to act to protect yourself, your family, and your community is yesterday.
From The Sunday Times
July 12, 2009

Swine flu vaccine to be cleared after five-day trial
Jon Ungoed-Thomas

The path of a popular medicine from the laboratory to the chemist or doctor’s surgery can involve years of clinical trials on a select group of patients.

When the new vaccine for swine flu arrives in Britain, regulators said this weekend, it could be approved for use in just five days.

Regulators at the European Medicines Agency (EMEA) said the fast-tracked procedure has involved clinical trials of a “mock-up” vaccine similar to the one that will be used for the biggest mass vaccination programme in generations. It will be introduced into the general population while regulators continue to carry out simultaneous clinical trials.

The first patients in the queue for the jab - being supplied to the UK by GSK and Baxter Healthcare - may understandably be a little nervous at any possible side effects. A mass vaccination campaign against swine flu in America was halted in the 1970s after some people suffered Guillain-Barré syndrome, a disorder of the nervous system.

However, regulators said fast-tracking would not be at the expense of patient safety. “The vaccines are authorised with a detailed risk management plan,” the EMEA said. “There is quite a body of evidence regarding safety on the trials of the mock-up, and the actual vaccine could be assessed in five days.”

The UK government has ordered enough vaccine to cover the entire population. GPs are being told to prepare for a nationwide vaccination campaign.

Dr Peter Holden, the British Medical Association’s lead negotiator on swine flu, who has been attending Department of Health meetings on the outbreak, said GPs’ surgeries were prepared for one of the biggest vaccination campaigns in almost 50 years.

He said although swine flu was not causing serious illness in patients, health officials were eager to start a mass vaccination campaign, starting first on priority groups. First, the jabs would reduce the chances of a shortage of hospital beds because of people suffering from swine flu. Second, it would reduce the effect on the economy by ensuring workers were protected from the virus.

“The high-risk groups will be done at GPs’ surgeries. People are still making decisions over this, but we want to get cracking before we get a second wave, which is traditionally far more virulent.”

Holden said it was likely the elderly would be given their seasonal flu jab as well as the swine flu vaccination. The new vaccine is likely to require two doses.

Details of the inoculation plans emerged after the death of a patient, reportedly a middle-aged man, at a hospital in the Basildon area of Essex. The victim had no underlying health problems, but officials say there is no evidence the swine flu virus had mutated into a more dangerous strain.

Holden said it would be the biggest campaign in response to an outbreak since mass vaccination against smallpox in 1962. He said surgeries would be aiming to inoculate about 30 people an hour in a “military-style operation”.

The Department of Health said it had still not finalised which groups would be vaccinated first, but children, frontline health workers, people with underlying illnesses and the elderly are likely to take priority.

The European Commission is also identifying population groups which it believes should get priority. It is keen to ensure that countries such as the UK, which had ordered supplies of the vaccine in advance, do not cause inequities in treatment elsewhere in Europe.

It warned health ministers in a note circulated last month that if the vaccines were more readily available in some countries it could cause “vaccine tourism/shopping in other member states”.

About 15 people have died of swine flu in Britain, but most of those infected get only mild symptoms. According to the latest figures from the Health Protection Agency, the UK has had 9,718 confirmed cases of the disease.

Comments:
A couple of comments. A vaccine could easily save thousands of lives in Britain so the triage decision is more likely to fall down on the side of administering the vaccine without the full medical trials. In my opinion if we end up with a vaccine which causes 1 death per 100,000 people administered with it we should still probably use it. Its an awful gamble to have to make but this is one instance where medical trials might be justifiably sidelined.

Secondly I've heard reports that swine flu is out competing and replacing the seasonal flu strains. Previous pandemic strains have wiped out the pre-existing seasonal strain and that appears to be happening with swine flu. In Victoria, which is is its flu season, for example 99% of flu cases are swine flu. Elsewhere in the Southern hemisphere more than 90% of flu is currently found to be swine flu.

I found this blog post interesting. I suspect that the best way for the UK government to handle this is to be honest and explain the situation as it is. If they make a triage system which retrospectively looks bad they will then be in a much better position. More importantly people would be more likely to accept the vaccine if they think that its risks have been carefully considered and weighed against the risks of not taking it.
 
Thanks, Barnaby. I'm currently working on an update to the post, which I'll have up within 15 minutes or so.

Re news about swine flu strain pushing out seasonal influenza, see the link I'm posting with the update.
 
The update is posted, along with a sentence I added as an afterthought:

"We are in the early days of what could be a long war. Steady on."

If Britain is really going ahead with their fast-track vaccination program -- and if the rest of the EU goes along -- expect a steady diet of dire reports on swine flu as a means to encourage the public to line up for their jabs.
 
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