Don't Be Hasty With Flu Vaccine, Ex-minister Warns

[webfact]

Don't be hasty with flu vaccine, ex-minister warns

By THE NATION ON SUNDAY

Published on July 19, 2009

Dr Suchai Charoenrattanakul, a former public health minister, yesterday expressed concern that a hasty vaccine programme against the outbreak of A(H1N1) influenza could be risky. Usually, it takes two years to test a vaccine but the government said the current programme will be done in three months.

Suchai also said the government's policy on the so-called swine flu is also inconsistent, leading to failure to act quickly and sufficiently to contain the outbreak during its early stage.

On public updates on the situation of swine flu, he said the government should continue to be transparent and give updates every Monday, Wednesday and Friday rather than once a week.

He also called for more laboratories to test the virus so that results could be reported within 24 hours.

Meanwhile, a Bangkok woman died yesterday after several days of flu-like symptoms, prompting suspicion that her death might be the country's latest fatality toll from the type-A (H1N1) influenza virus.

With the official death toll at 26 in Thailand, Min Buri police yesterday morning reported the death of Misstine Thailand employee Saisunee Siripanyasuk, 47.

Her relatives told police that she had chronic high blood pressure and had suffered from high fever and flu-like symptoms since July 13.

As part of the "Big Cleaning Day" event, Deputy Bangkok Governor Dr Malinee Sukavejworakit yesterday presided over the cleaning of Bangkok Metropolitan Administration (BMA) Medical College and Vajira Hospital to prevent flu outbreaks.

Vajira Hospital also opened a fast track for type-A (H1N1) patients serving 600 people a day. BMA schools, which will reopen on Monday, have been ordered to use thermometers to check each student for fever before they enter the school and send those with a fever home.

Bangkok Governor MR Sukhumbhand Paribatra said BMA premises would also be cleaned more frequently.

Bangkok has had 2,400 type-A (H1N1) patients and 12 fatalities.

Prime Minister Abhisit Vejjajiva urged the public not to panic and suggested those with flu-like symptoms rest at home and take fever medicine. If after 2-3 days they still have a high fever, joint pain and diarrhoea, they should see a doctor immediately, he said.

Democrat Party spokesman Booranut Samutrak said former premier Chuan Leekpai had invited the Public Health, Labour and Education ministries to a meeting tomorrow on flu prevention at workplaces and schools.

National Institute of Education Testing Service (NIETS) director Uthumporn Jamornman said 62 students had presented medical certificates that their absence from General Aptitude Test and Professional Aptitude Test (GAT/PAT) exams had been due to the flu and NIETS would hold special GAT/PATs on August 8-9 at its office in the Phayathai Building. She said some 20 students from the provinces would be provided with accommodation and transport fees.

-- The Nation 2009/07/19

[imjustagirl]

Bloody ell, why is this man an ex-minister!!! Someone finally speaking some sense. Rushing any medication without testing is a recipe for disaster.

[sunreader]

UK plans to vaccinate 60 million people starting in September, the vaccines are already in the country, they were developed less than 12 weeks ago in Germany.

Imagine they do go ahead and vaccinate the entire country then sometime after discover the vaccine has some form of massive long term catestrophic effect?...they are looking to vaccinate an entire country with a drug that has no long term testing history to it.

At the same time the government here is busy downplaying the H1N1 flu, a stay in bed and have two paracetamol with plenty of fluids advise seems popular.

[thaimite]

UK plans to vaccinate 60 million people starting in September, the vaccines are already in the country, they were developed less than 12 weeks ago in Germany.

Imagine they do go ahead and vaccinate the entire country then sometime after discover the vaccine has some form of massive long term catestrophic effect?...they are looking to vaccinate an entire country with a drug that has no long term testing history to it.

At the same time the government here is busy downplaying the H1N1 flu, a stay in bed and have two paracetamol with plenty of fluids advise seems popular.

And of course the drug companies have made it impossble to take legal action against them should there be any side effects.

of course after reading this link I have every failth in the manufactirers!!

[animatic]

Bloody ell, why is this man an ex-minister!!! Someone finally speaking some sense. Rushing any medication without testing is a recipe for disaster.

Yes tis too true ~Miss Girl, they need to test properly for sure.

Dr Suchai Charoenrattanakul seems like an excellent candidate for the job.

Did a week long trip last week, 4 air flights and thought I might have the bug, 2 days ago,

but i guess not.

Did have one harrowing 2 hour ride to the airport ride in a Pattaya taxi with a total prat of a driver

coughing and hacking into his mask. At least he had a mask....I told him if I had ANY spare time

I would have taken and another taxi and resented him driving me while this ill... got a blank look.

I refused to take his change at the end of the ride, after sitting next to the window rolled down for the trip.

Only in Thailand would someone like that transport someone to the airport and think this is OK.

Thoughtless idiot starts to state my feelings....

[webfact]

PM expects A (H1N1) flu's epidemic to remain until early next year

Prime Minister Abhisit Vejjajiva said he expected that the type-A (H1N1) influenza epidemic would continue until early next year.

He said the flu had spread to 130 countries worldwide and the World Health Organization had stopped reporting the figures of the outbreak but it has admitted the type-A (H1N1) flu had become local diseases of most parts in the world.

The prime minister said the people need to understand that no one has immunity against the virus but most people will be only mildly hit by it.

However, the people need to take care of themselves and need to see doctors if their fever remain high for two days.

-- The Nation 2009/07/19

[baht&sold]

Suchai also said the government's policy on the so-called swine flu is also inconsistent, leading to failure to act quickly and sufficiently to contain the outbreak during its early stage.

On public updates on the situation of swine flu, he said the government should continue to be transparent and give updates every Monday, Wednesday and Friday rather than once a week.

Dr Suchai raises some valid points. However, one can only look back in time when he took over as Health Minister from Sudarat, at how Mr Thaksin's govt handled the much deadlier bird-flu even one year on:

------------

Finding the virus present in Thailand, Dr Somsong Rugpao, then director-general of the Medical Science Department of the Public Health Ministry, issued an advisory for all those travelling to China, as well as the young and elderly, to obtain vaccinations. But these were no longer times for standard procedure. The very next day, Somsong was strongly reprimanded by then public health minister Sudarat Keyuraphan.

“She told me that Prime Minister Thaksin had been very upset during the Cabinet meeting and stated that, ‘Every time [somsong] opens his mouth the stock market goes down’,” Somsong recalls. “Everyone thought I would get fired”. It was clear to Somsong that in the post-Sars and current bird-flu era, the government was seeking to avoid negative publicity on public health issues.

Somsong retained his job until his retirement last October. However, doctors in epidemiology circles still cite his case as part of an ongoing resistance they feel exists toward issuing influenza warnings. In late 2003, Somsong was also one of the first doctors to internally call attention to avian influenza in Thailand’s poultry industry. It was not until the end of January 2004 that the government actually went public.

Senator Nirand Pitakwatchara, himself a medical doctor, is outraged at the scale of the cover-up. He points to the fact that the government knew as early as January 16th of that year that the first human case of bird flu was suspected, and it was confirmed three days later. Yet on January 20th - the day after it was confirmed -the prime minister and his cabinet staged a chicken lunch for the media to assure the public that bird flu was not a problem in Thailand. http://www.nationmultimedia.com/specials/influenza/part2.htm

---------------------

-Mr Suchai later resigned as Health Minister and became a Dep PM in the Thaksin Govt.

Also, it's unfortunate Mr Suchai's brother Sukit was recently transferred from his postion as Local Administrative Department Chief to an inactive post. The nefarious friends of Newin having control over the Interior Ministry allegedly had a hand in the reshuffle... http://www.bangkokpost.com/news/local/1324...f-faces-inquiry

One hopes this isn't another 'opportunist' attempt to further politicise flu-fear (now moving on to the spreading of vaccination-fear stage???) Political flu-ball aside, one expects the vaccines will be adequately tested but unfortunately the vaccines will also likely have similar extremely minute fatality & reaction rates similar to other flu vaccines (the tin-foil hat brigade and others may/will disagree)

Edited July 19, 2009 by baht&sold

[animatic]

Pretty clearly Thaksin's iron hand on the health department

led that idiotic dressing down of the Dr.

Finding the virus present in Thailand, Dr Somsong Rugpao, then director-general of the Medical Science Department of the Public Health Ministry, issued an advisory for all those travelling to China, as well as the young and elderly, to obtain vaccinations. But these were no longer times for standard procedure. The very next day, Somsong was strongly reprimanded by then public health minister Sudarat Keyuraphan.

“She told me that Prime Minister Thaksin had been very upset during the Cabinet meeting and stated that, ‘Every time [somsong] opens his mouth the stock market goes down’,”

Another wonderful reason to bring Dr. T. back to fix the country... NOT!

[Chunkton]

UK plans to vaccinate 60 million people starting in September, the vaccines are already in the country, they were developed less than 12 weeks ago in Germany.

Imagine they do go ahead and vaccinate the entire country then sometime after discover the vaccine has some form of massive long term catestrophic effect?...they are looking to vaccinate an entire country with a drug that has no long term testing history to it.

At the same time the government here is busy downplaying the H1N1 flu, a stay in bed and have two paracetamol with plenty of fluids advise seems popular.

And of course the drug companies have made it impossble to take legal action against them should there be any side effects.

of course after reading this link I have every failth in the manufactirers!!

Nothing would surprise me about pharmaceutical companies, and lets face it there is nothing like a good pandemic to get to money rolling in if you have a vaccine. Likewise amp it up to terrify populations so they demand their governments buy up stock...cha ching.

Not entirely convinced about the whole conspiracy thing to thin out populations, a similar charge was also made about HIV re gays and Africans. But who knows there are some sick and greedy people out there.

[Orac]

Pretty clearly Thaksin's iron hand on the health department

led that idiotic dressing down of the Dr.

Finding the virus present in Thailand, Dr Somsong Rugpao, then director-general of the Medical Science Department of the Public Health Ministry, issued an advisory for all those travelling to China, as well as the young and elderly, to obtain vaccinations. But these were no longer times for standard procedure. The very next day, Somsong was strongly reprimanded by then public health minister Sudarat Keyuraphan.

“She told me that Prime Minister Thaksin had been very upset during the Cabinet meeting and stated that, ‘Every time [somsong] opens his mouth the stock market goes down’,”

Another wonderful reason to bring Dr. T. back to fix the country... NOT!

The problem here is that the hype surrounding Avian Flu was over the top so, in hindsight, Thaksin was right to play it down. There had only been 17 cases in Thailand at the time of this dressing down I believe and only another 8 cases followed over the next 2-3 years.

[Orac]

Maybe someone with some knowledge of the subject here can explain but, since the 'normal flu' vaccine changes every year as the flu mutates which is why there are annual vaccinations for those at risk, how is the vaccine for normal flu able to be tested for two years as is implied by the original argument.

[VSteve]

I had the flu (regular flu) last week, and the doc told me she didn't know what exactly was wrong with me. She said I did not have H1N1, but she could test me for it for or give me a vaccine. Then she wanted to give me all kinds of pills and told me to stay home and rest for 5 days, avoid public areas, and wear a face mask. Jeesh.

[venturalaw]

Bloody ell, why is this man an ex-minister!!! Someone finally speaking some sense. Rushing any medication without testing is a recipe for disaster.

Yes tis too true ~Miss Girl, they need to test properly for sure.

Dr Suchai Charoenrattanakul seems like an excellent candidate for the job.

Did a week long trip last week, 4 air flights and thought I might have the bug, 2 days ago,

but i guess not.

Did have one harrowing 2 hour ride to the airport ride in a Pattaya taxi with a total prat of a driver

coughing and hacking into his mask. At least he had a mask....I told him if I had ANY spare time

I would have taken and another taxi and resented him driving me while this ill... got a blank look.

I refused to take his change at the end of the ride, after sitting next to the window rolled down for the trip.

Only in Thailand would someone like that transport someone to the airport and think this is OK.

Thoughtless idiot starts to state my feelings....

Experienced exactly the same horror of a ride in a taxi from Bkk to Pattaya about 3 years ago except the driver had no mask and I came down with a cold within 48 hours of arrival. Thoughtless? Yes, you can definitely say that! It's universal.

[Scott]

Personally, I will wait for about a year to get a vaccination. By then I can just look around and see the test results.

I have worked in direct contact with several people who were actively infectious and didn't catch it, so I will continue to take my chances for the time being.

[hazz]

Maybe someone with some knowledge of the subject here can explain but, since the 'normal flu' vaccine changes every year as the flu mutates which is why there are annual vaccinations for those at risk, how is the vaccine for normal flu able to be tested for two years as is implied by the original argument.

When drugs are licensed it is not just the drug which is licensed; but the combination of the drug, the delivery system(pill etc), the manufacturing process and the factory where the stuff is made. Change any of these and the drug needs relicensing. So say you cannot make enough of your latest block buster, you need to relocate manufacturing to a factory with more capacity.... it really can take years.

Its almost certain that the licensed manufacturing process for existing plants includes taking the WHO supplied vaccine candidates, growing it and putting it through a testing regime. This is why although the chicken egg plants can make the vaccine in 3 months its will take them 6 months or so to get the first batch to market rather than years.

In principle, Thailand's new facility should go through a full licensing process which could take years. however if they are not planning to sell the vaccine outside thailand then they only need to consider thai rules and laws when making the decision. There are a number of examples where what appeared to be a small change in a manufacturing process to cause a safe product to become dangerous, which is why these rules exist in the EU and US.

The chances of us ever receiving vaccine from this plant is small, its planned output is 2 million doses per year and really is there to secure vaccine for front line medical staff and people who feel they are important enough to the country that they need early vaccination, politicians, their families, their second, third, forth... wife's etc.

In the middle of a serious pan-epidemic I cannot see the vaccine producing countries allowing vaccines to leave their country until their own populations are protected, as thai international's mr wallop said ' there's not contract that cannot be cancelled or renegotiated'. So all countries need to make sure they have some local manufacturing capacity.

Personally, given a choice, I would not want to use vaccine from this plant in the near future.

[Orac]

Maybe someone with some knowledge of the subject here can explain but, since the 'normal flu' vaccine changes every year as the flu mutates which is why there are annual vaccinations for those at risk, how is the vaccine for normal flu able to be tested for two years as is implied by the original argument.

When drugs are licensed it is not just the drug which is licensed; but the combination of the drug, the delivery system(pill etc), the manufacturing process and the factory where the stuff is made. Change any of these and the drug needs relicensing. So say you cannot make enough of your latest block buster, you need to relocate manufacturing to a factory with more capacity.... it really can take years.

Its almost certain that the licensed manufacturing process for existing plants includes taking the WHO supplied vaccine candidates, growing it and putting it through a testing regime. This is why although the chicken egg plants can make the vaccine in 3 months its will take them 6 months or so to get the first batch to market rather than years.

In principle, Thailand's new facility should go through a full licensing process which could take years. however if they are not planning to sell the vaccine outside thailand then they only need to consider thai rules and laws when making the decision. There are a number of examples where what appeared to be a small change in a manufacturing process to cause a safe product to become dangerous, which is why these rules exist in the EU and US.

The chances of us ever receiving vaccine from this plant is small, its planned output is 2 million doses per year and really is there to secure vaccine for front line medical staff and people who feel they are important enough to the country that they need early vaccination, politicians, their families, their second, third, forth... wife's etc.

In the middle of a serious pan-epidemic I cannot see the vaccine producing countries allowing vaccines to leave their country until their own populations are protected, as thai international's mr wallop said ' there's not contract that cannot be cancelled or renegotiated'. So all countries need to make sure they have some local manufacturing capacity.

Personally, given a choice, I would not want to use vaccine from this plant in the near future.

Thanks for the detailed reply. Are you saying though that the concerns being stated are to vaccines made at a specific location or a more general problem.

[geriatrickid]

Maybe someone with some knowledge of the subject here can explain but, since the 'normal flu' vaccine changes every year as the flu mutates which is why there are annual vaccinations for those at risk, how is the vaccine for normal flu able to be tested for two years as is implied by the original argument.

As mentioned further along in here, it is the process that matters. However, flu vaccine has been made in the same basic way since the 1950's. You take 11 day old fertilized eggs that have been raised under pristine pure conditions and that are verified free of pathogen and defect and then you introduce the virus bits you want to target. I bet you just clicked into what Thailand's problem is. Yes there is the manufacturing aspect (it's inadequate to produce the needed doses) but more importantly, the eggs aren't there. One can't run down to Surat Thani and pick them up. They have to be raised in special facilities and Thailand just doesn't have them.

I'm not concerned about the safety of the conventional flu vaccine since they have been around for almost 50 years. If someone was going to grow horns from the head, we would have seen it by now. My concern though is that Thailand plans to use the nasal spray vaccine which relies on the "live" virus. I just can't accept it. The flu vaccine has always been mostly the dead virus which is injected. The reason some groups favour the live variant is that it has been presumed to be more effective in older people. What most people may not know is that the flu vaccine loses efficacy in the older patient group, the ones that are at risk. Instead of the usual 70-85% efficacy, the literature reports 15-25% efficacy. That's why the live variant is being tried. However, it doesn't make sense to go with a live strain in Thailand. The reason I say that is that Thailand's population is skewed to youth. If it was Japan or the EU where older people are a significant pat of the general population, then yes I could see the logic.

Know what I am doing? I'll probably get the GSK dead virus variant injection. No nasal spray for me. However, I'm under 50 so it doesn't matter. I stopped taking flu vaccine 3 years ago after I had a bad reaction. (sick for 3 days after dosing and then caught 2 bad colds that year.) Maybe it was illogical but boy was I knocked out that year.I am still pondering if I will get dosed. If my employer says I have to, then I will. Until then, I am dithering.

[verydumbubba]

The Krauts are infamous in the meds business - no thank you.

Watching some very interesting documentaries on HIV/AIDS & BSE/CJD diseases on the boob tube - oh boy! -

we really did pull some very stupid stunts on ourselves - especially when we start crossing DNA divides.

That we would actually change & use Rhesus monkeys, then add spinal cord & brain tissue to our food supply is freaky.

This 'influenza' the next horror-show we are about to launch on an unsuspecting globe.

I am off to the bar for a very brown Whiskey!!

Bubba

[swisshusband]

Being professionally involved in the vaccine business I have difficulties understanding the rationale of the GPO in Thailand to produce nasal spray vaccine against flu.

First of all the nasal spray vaccine is more critical and inherently more dangerous since it is based on a live attenuated virus - whereas the common flu shot is based on a "dead" or inactivated virus. Mainly for that reason nasal spray vaccine has much more safety issues attached and production under world class state of the art GMP conditions are essential. I would certainly not trust the GPO in that respect since I have not seen any GMP installations there that are comparable to adequate world standards.

The nasal vaccine is only safe for healthy people from 2-49 years. What about babies under 2 years and the people above 50 years?? Are they not worthy to be protected too?

For the children the nasal spray vaccine requires two doses given at least 6 weeks apart otherwise it will not be effective.

The nasal spray flu vaccine technology is well protected by international patents. Has the GPO got a technology license from MedImmune or are they just neglecting international patents and agreements again?

Recent reports in the medical literature point towards findings that for healthy adults the live virus nasal spray vaccine is less effective than the traditional flu vaccine.

The nasal spray vaccine costs up to double the price than the traditional flu shot. On July 8 it was published that the relevant authorities in the USA (the CDC) are paying between US$ 6-8 for the traditional flu vaccine and over US$ 15 for the FluMist nasal spray vaccine.

The USA have already invested over a billion US$ to produce up to 80 million doses of traditional vaccine this year. Holland published investments of close to 100 million Euros...Spain recently published similar investments for 30 million doses....

Now Thailand wants to be able to produce 10 million doses with an investment of 300 million baht?? If this would be possible and the vaccine would be up to international standards in terms of quality, efficacy and safety how comes that the rest of the world is not having its vaccine produced in Thailand...?

I have my serious doubts that any significant quantity of efficient and safe H1N1 vaccine that is comparable to international standards will be produced in Thailand within this year.

[hazz]

Thanks for the detailed reply. Are you saying though that the concerns being stated are to vaccines made at a specific location or a more general problem.

Manufacturing a vaccine is fundamentally glorified brewing. And as with beer if thailand builds a carbon copy of a facility that is known to make good vaccine; there will be changes in environmental factors that mean the vaccine being produced will not be identical the to the output of the plant that was copied.

As for what the plant was going to make, I kind of assumed they would be making standard dead vaccine using cell culture rather than eggs. Currently most vaccine is grown in eggs in a three month batch process + the time it takes to engineer a virus that will grow in chicken embryos without killing them too quick. The cell culture systems use mammalian cells, can grow the original pan epidemic and WHO engineered viruses; plus they are more successful with H5 viruses that tend to kill the embryos far too quickly to yield much vaccine.

There is a big debate as to the use of the lie nasal vaccine and the std dead vaccine. However for mass vaccination a nasal administered vaccine would be logistically much easier to administer; you just need to be very careful to engineer a virus that produces immunity to the real pan epidemic virus, does not cause too many flu like symptoms cannot mutate into something dangerous. This last one is a b*ger... its why you can catch polio from your recently vaccinated baby!!!!!

As for me, like the other poster.. given a choice a established vaccine from an established manufacturer

Its true that the pharm's have been given some blanket protection against law suits; but this was unfortunately the price of getting them to work on vaccines. vaccine manufacturing has always been a very low margin business and the financial risks from making a bad vaccine are astronomical. As a result a lot of companies pulled out and there was very little progress in the second half of the 20th century. Its not nice, but when you choose to rely entirely on private enterprise for medical advancement its the price you pay.

For conspiracy theorists, the pharms really do document everything they do and archive it no matter how damming it is too them. when you sue them they will hand over this evidence to you and the only problem you will have is finding this evidence within the multi tonne pile of paper work they give you. They are that process driven.... not good for conspiracies.

[swisshusband]

@hazz

Unfortunately your assumption that Thailand might use cell cultures and dead virus or any other kind of modern manufacturing approach is wrong. Instead they are using the antiquated egg process and a very dangerous live-virus approach using a Russian technology that hasn't got any international approval from the big and important regulatory authorities.

In my eyes the egg-based approach is totally inadequate for any kind of future pandemic response. The rest of the world is heavily investing into continuous cell culture based technologies but Thailand wants to spend more money in the future on the egg based approach - even though the facilities to produce such eggs are not existing in Thailand and no one has ever set aside a budget to build such infrastructure.

Well, the next pandemic will happen - and I don't expect Thailand being a country that is prepared adequately...

The right approach would be to take a regional perspective and build a modern cell culture facility that can supply neighbouring countries as well. A well designed large scale cell culture facility offering state of the art facilities and flexible operations can handle not only vaccines against pandemic flu but also vaccines against common flu, JE, Dengue or many others - therefore such a facility will not be idle during inter-pandemic periods. Problem is that such a facility would require an investment of well above US$ 200 million and no government here wants to spend so much on vaccine facilities. I can speak with authority here after having been involved in leading positions in the establishment (planning, building, commissioning and validating) of several such kind of facilities worldwide. Only private companies have invested into such facilities so far and these facilities are used to make profit. As long as governments here think that vaccines that can save million of lifes and must not cost anything, they are not ready to pay the price for an adequate protection of the people. If no one can make any commercial gains from a pandemic vaccine then no one will really invest into what is really required - that's the way our economy works.

[fiddlehead]

I've never gotten a flu shot in my life.

Don't see any reason to change my ways.

[verydumbubba]

In OZ they have just started clinical trials - scary stuff - even the scientists dont know.

Bubba

http://www.bloomberg.com/apps/news?pid=206...id=axGUR71t446g

[swisshusband]

Yes- they start clinical trials on a conventional vaccine - produced with a dead virus. And Thailand wants to use a Russian experimental vaccine based on live virus. If they don't kill virus during the production process - how many other nasty virus will the Thais supply with their vaccine?? ooops, sorry - we didn't test for that one... much more scary stuff!!