Showing posts with label vaccines. Show all posts
Showing posts with label vaccines. Show all posts

Friday, February 26, 2010

What has the 3rd medical school got to do with GSK and the H1N1 pandemic?

A strange nexus seems to have developed between the much anticipated 3rd medical school and happenings with respect to GSK and the H1N1 story.

As we all have been told the planned for 3rd medical school was supposed to be a tie up between Tan Tock Seng Hospital, NTU and Imperial College. One of the champions of the proposed tie up was apparently the past rector of the Imperial College, Professor Sir Roy Anderson. Sir Roy is a pretty influential person and has been listed as a VIP on the Board of GSK. But he apparently has a bit of checquered past. In July last year he was in the middle of a controversy about his role in the British SAGE (Strategic Scientific Advisory Group for Emergencies), a 20-strong task force drawing up the action plan for the H1N1 virus, while holding a highly paid position with the drug and vaccine manufacturer, GSK. Earlier he had been in another series of controversies which led to his resigning from Oxford University. You can read the details here.

In November last year, he abruptly stepped down as Rector for Imperial College. The reasons for his departure is unclear and there have been a number of speculations. His departure has however created a bit of a hiatus in leadership for Imperial College. Sir Keith O’Nions, the Director of Imperial’s Institute for Security Science and Technology, took over as Acting Rector. It is also not clear if the new leadership is as enamoured with the tie up with NTU/TTSH for the 3rd medical school. I hear in the grapevine that the vibes are not that positive. Which means the 3rd medical school is now left in a bit of a lurch and scrambling to find a suitor.

So ....a right royal mess......

Wednesday, February 3, 2010

Any proof of H1N1 vaccine safety and efficacy?

Here's something really interesting...... This is a 'no-duff' notice.

$10,000 reward offered for scientific proof of H1N1 vaccine safety and effectiveness

(NaturalNews) In conjunction with NaturalNews, the non-profit Consumer Wellness Center (www.ConsumerWellness.org) has publicly offered a $10,000 reward for any person, company or institution who can provide trusted, scientific evidence proving that any of the FDA-approved H1N1 vaccines being offered to Americans right now are both safe and effective.

Vaccine promoters keep citing their "science" in claiming that H1N1 vaccines are safe and effective. NaturalNews and the CWC ask one simple question: Where is this science?

For more details of this challenge, read here.

Any takers? Any scientific proof of efficacy or safety?

Tuesday, February 2, 2010

Monday, February 1, 2010

Canada investigates Gullain-Barre Syndrome from H1N1 vaccines

The Toronto Sun has reported that 17 cases had fallen seriously ill after the H1N1 vaccines. Four of these cases came down with the dreaded but rare Guillain-Barre Syndrome.It is not clear what the relationship is between these vaccines and the earlier GSK batch that had been yanked off the shelves.

The Canadian form of the vaccine appears to be slightly different from that which has been supplied to Singapore. It is called Arepanrix, and manufactured in Alberta, Canada. The one supplied to Singapore is called Pandemrix. They are essentially the same formulation but manufactured in different locations. Apparently Arepanrix has more turbidity even though the manufacturing process is same as Pandemrix.

Tuesday, January 12, 2010

H1N1 pandemic? Now we know what a sham it had been

I had never been convinced of the H1N1 pandemic. All the time there had been this dichotomy between the alarmist messages being spread and reality that nothing much was happening on the ground. People weren't really falling over and dying as much as the the alarmists were saying they were. Tamiflu was never as effective as they made it out to be. I think many people were also not convinced, but there was little bases to counter the pandemic signals being rung at every street corner.

Now that the pandemic that never was is pretty much over, we are beginning to hear of another reality.

Dr Wolfgang Wodarg, Head of Health at the Council of Europe has come out to criticize the actions of the WHO, saying that "the swine flu scare was a 'false pandemic' led by drugs companies that stood to make billions from vaccines", and that "major firms organised a 'campaign of panic' to put pressure on the World Health Organisation to declare a pandemic."

Calling for a major inquiry, he called it "one of the greatest medicine scandals of the century".

More of Dr Wodart's comments in his blog, here.

View Al Jazeera report here: http://www.youtube.com/watch?v=hoQN1to3C2U

Countries are now stuck with massive stockpiles of vaccines that their citizenry were too smart to want to be exposed to. Some are still trying to persuade people to go for the vaccination even though the anticipated threats had had passed. Germany and Spain have cut back on their orders for the vaccine, and Canada is either trying to sell off, or 'lend' their stocks to other countries such as Mexico.

Meanwhile the WHO is undergoing a review of how it handled thre so-called pandemic, amidst accusations of big pharma complicity. The Council of Europe's Health Commission has voted to investigate.

And some people are laughing all the way to the bank!

Sigh....... who can you believe nowadays?

Wednesday, November 25, 2009

H1N1 vaccine toxicity?

The recent flurry of reports about side effects resulting from the recent H1N1 vaccines have caused many people to go into a flap.

The HSA reported a series of 27 cases, with one particularly problematic case of Sweet's Syndrome.

Canada reported high frequencies of unusual adverse reactions and some deaths, which resulted in cessation of the vaccinations, and withdrawal of the GSK vaccine.

Earlier China had reported 2 deaths, but evidence later discounted their relationship to the vaccine.

But actually, despite the fact that they are all H1N1 vaccines, they are all essentially different products. The China vaccine is China's own special product. The Singapore vaccine, I believe is pretty much the CSL version at the moment, while the Canadian vaccine is a GSK product manufactured in Canada.

It's interesting that the Canadian product is called Arepanrix and the Singapore GSK version is called Pandemrix. According to the GSK website, the difference is that Arepanrix is translucent and has particles..... Hmmmm...... poor manufacturing giving rise to allergies? We'll wait for the werdict.

Friday, October 23, 2009

H1N1 vaccination, anyone?

So Singapore gets her H1N1 vaccine fix in a couple of week's time. I think the MOH had spent about S$10-20 million to the one million shots for us so we should grateful for the preparedness. Word out is that most of these are the Australian CSL Panvax vaccines, and about a third might be the GSK version, Pandemrix. But no idea how these gets distributed so you might want to ask when you do go for your shots. Pandemrix is the one with the AS03 adjuvant.

A couple of things bother me though. There's been a lot of talk about a second wave emerging. The reason for the vaccinations are to mitigate against this second wave. But I never quite bought into this second wave thing for Singapore. If indeed there is a second wave, given there will be more herd immunity, it would be a lesser wave than the first, would it not? Unless of course, the virus mutates. But it hasn't as yet, and it looks like we are dealing with the same, not so virulent, not so lethal , not so pandemic virus.

Also seasonal flu? That applies to temperate countries with summer/winter type seasons. Since the only winter we have in Singapore is the styrofoam/soap variety in Orchard Road, there isn't going to be much in terms of seasonal change in flu transmission. In fact, a scan of the MOH epidemiological stats over 2004-2008 confirm that the incidence of acute respiratory infections were pretty flat throughout each year. The only interruption to this flatness was the rather short-lived H1N1 pandemic earlier this year. So the only seasonal change we may expect in H1N1 would be due to increased seeding by travelers from temperate zones who carry the virus to us. And given the increased herd immunity, such seeds may not transmit that well.

Actually, I wonder why the MOH does not survey the level of herd immunity in our population beefore embarking on any immunization programmes? This developing herd immunity would certainly be one of the reasons why the earlier first wave pandemic fizzled out. After representing more than 60% of samples at the peak fo the pandemic, it is now hovering at about 24% of cases surveyed.

So is there a rush to get vaccination? Apparently not if the health care workers are polled. But these are still early days.

Tuesday, September 29, 2009

Cervarix related death in UK

A 14 year old girl in Coventry UK died after receiving a jab of the HPV vaccine Cervarix (GSK). While not acknowledging that the death was directly attributable to safety issues pertaining to Cervarix, the FDA has delayed its review of the safety and efficacy of the GSK vaccine. GSK has meanwhile voluntarily realled the batch of vaccine.

I have posted on the HPV vaccine before. HSA had ahead of the FDA approved the vaccine for girls/women between the ages of 9-26. The discussion then had been the off label use of the vaccine for women outside of this age range.

This latest fatal adverse event will make a signficant dent in GSK's attempt to compete with the Merck vaccine. The GSk vaccine apparently induces a stronger response because it containsthe controversial suqalene adjuvant AS03. Unlike the Merck vaccine which covers 4 strains, the GSK product covers only 2.

Thursday, September 17, 2009

H1N1 vaccine - areas of concern

So the MOH has clarified that the vaccine will be offered pretty much at cost and for about the same price as the seasonal flu vaccine. Channelnewsasia reported price range of $22-38. Which is somewhat more than my earlier 'rojak' estimate of $10 per shot. But it's still affordable.

What MOH needs to clarify though is whether the GSK vaccine requires the squalene based AS03 adjuvant. The safety of the AS03 adjuvant, like the Novartis MF59, has been in question for some time. These adjuvants serve the purpose of heightening the immune response, resulting in the necessity of using a smaller amount of antigen. It was deemed necessary only because anitigens were difficult to produce in large quantities. The problem is that, theoretically the immune stimulation may induce the body to react against its own tissues. One of the suspected consequences has been the development of the Guillain Barre syndrome. This is a rare possible adverse event associated with the use of these vaccines. Whether this is a real consequence or not is hard to determine as these tend to develop over years after the vaccination event, and hence the causal link is hard to establish.

The US FDA has not yet licensed the use of these adjuvants, although it seems to preparing for their use should an H1N1 emergency arise. It has also not yet authorized the emergency use of these adjuvants.

Recent studies have shown that single doses of the un-adjuvanted vaccines are adequate to produce the antibody levels required for protection. So theoretically, we should not need the adjuvants.

Although the risk of Guillain Barre syndrome, even if real, is very low. It is nevertheless necessary to consider the risk when exposing children to vaccines containing these adjuvants. We need to appropriately balance the benefit of protection against a potentially fatal HiN1 infection, and the potential risk for a vaccine-adjuvant related auto-antibody response.

Parents do need to be aware. The MOH should also be mindful of parent's concerns and be transparent about whether such vaccines contain the squalene adjuvants. Patients do have a choice, and should be empowered to make a decision about the risks they are prepared to take.

There is a fairly decent review here:
http://www.slate.com/id/2228700/

A related question, and something that I have found difficulty in getting information about is, how the HSA regulates something like this? Does it have a policy about squalene adjuvants? How does it regulate such novel vaccines in a 'not sure if there is a pandemic' situation?

Wednesday, September 16, 2009

H1N1 vaccine - we give it to GSK!

So MOH has secured 1 million doses of the GSK vaccine. I wonder how much the windfall was for GSK.

Canada apparently bought 50 million doses for more(?) than Can$400 million. So I guess we'd be looking at something in the region of about S$10 million?

I wonder if these vaccines come with AS03, the controversial squalene loaded adjuvants?

Tuesday, September 15, 2009

Pneumococcal stats - my mistake!

Haha ... yes...I did make a mistake about the stats. The MOH bulletin reports all cases, whereas the cited figure of 70 is for children under 5 years.

Presumably the numbers will be compatible if approximately 28% of reported cases are less than 5 years old.

My apologies. My mistake. Missed my coffee this morning!

The Pneumococcus vaccine - I am confused and alarmed, but a bonus for Pfizer-Wyeth or GSK?

So Minister has now agreed to putting the Pneumococcal vaccine into our National Childhood Immunization Programme, despite being resistant to the idea 2 years ago. At that time MOH said the situation did not warrant it.

"The ministry has reviewed our local situation and has decided not to incorporate the pneumococcal vaccine into the National Childhood Immunisation Programme at this point in time," said an MOH spokesperson. This is because the hospitalisation rates for invasive pneumococcal disease in children in Singapore declined from 38 per 100,000 people aged five years and below in 2004 to 26 per 100,000 people last year."

The latest figures Minister cited yesterday was that the annual number of cases was about 70.

I have to say I am somewhat puzzled. Did the situation deteriorate so rapidly over a mere 2 years? I mean we were in the pink of health 3 years ago, and then suddenly things appear to have worsened to the extent that now we need to immunize.

I did a quick check of the MOH epidemiological stats. Strangely MOH didn't publish any invasive pneumococcal stats until 2009..... so I am presuming MOH did collect data except that they did not publish. The 2009 data is however very interesting in that in the first 36 weeks, MOH logged an even more astounding 183 cases of invasive pneumococcal disease. Extrapolating to the full year, we might be looking at something like 250 cases!!! This is more than 3 times the estimate of 70 that Minister Khaw cited.

Quite frankly, I find the figures rather confusing. Do we have a problem or do we not have a problem? We had a declining incidence of 26 per 100000 per year in 2006. Minister cites 70 cases per year. And the MOH bulletin reports an approximate annual incidence of invasive pneumocaccal disease of 250 for 2009. All in a space of 3 years. Mind boggling to say the least. Or did I make a mistake with the figures?

Meanwhile Pfizer-Wyeth must be rubbing their hands rather gleefully if MOH implements the programme. Pfizer was rumoured to have bought Wyeth because (at least one of the reasons) because of the Prevnar vaccine that Wyeth had, plus the new 13 strain vaccine that is about to come on board. The size of the Prevnar market for Wyeth has been estimated to be about US$2.4 billion, and that of the new vaccine will probably exceed that.

But Pfizer-Wyeth has competition in the wings, as GSK has set up a S$600 million plant in Tuas to make pneumococcal vaccines!! This will be ready in 2011.

So the market hots up. I wonder who MOH will choose to supply the vaccines for the NCI Programme? I wonder who will get the cake?

Meanwhile parents have to be prepared to fork out approximately $700 for the vaccines ($170 per dose x 4 doses). And yes, taking from Medisave is still paying for it.

Thursday, September 10, 2009

One dose H1N1 vaccine - No need for adjuvants

So an Australian study has demonstrated that with the new crop of H1N1 vaccines, a singlae dose is all that's required. No adjuvants are required. This data confirms what the China vaccine had earlier showed.

The importance in these findings is that firstly, it means the amount of vaccines available can reach twice as many people; and secondly, more importantly, we do not need to use any fancy adjuvants.

One of the major concerns of vaccine technology is the need for adjuvants. Adjuvants are often used to heighten the body's antibody response. This is often needed as the antigen is used in low quantity or does not by itself elicit a strong immune response. The problem with adjuvants is that the hyper-stimulation of the body's immune response (theoretically at least) may induce an unwanted immune response to the body's own proteins. The Guillain - Barre syndrome emerged as one of the problems associated with the US mass vaccination in 1976-77.

Of recent concern has been the use of squalene in commercial adjuvants such as the AS03 (GSK) and MF59 (Novartis). These adjuvants have not been approved for use in the US.

The one dose vaccines (sans adjuvants) should ameliorate these concerns.

Sunday, July 12, 2009

Managing and Reducing Uncertainty in an Emerging Influenza Pandemic

Interesting comments from the recent copy of the New England Journal of Medicine.

I excerpt some paras for your reading. Can go to the original by Marc Lipsitch from Harvard School of Public Health above if you want to read full article.

"Crudely speaking, the (H1N1) case fatality ratio thus appeared to be 0.2%, near the upper end of the range for seasonal influenza, and superficially, this statistically uncertain estimate seems remarkably accurate given the data available on May 27, by which point there were 11 deaths and 7927 confirmed cases (a case fatality ratio of 0.14%)."

"Public communication of risk and uncertainty will be critical. It has been suggested that the existing criteria for moving to World Health Organization pandemic phase 6 (sustained transmission in multiple geographic regions) should be modified to incorporate a judgment that the world's population is at increased risk. We would argue against conflating assessments of transmissibility and severity in this subjective way, which risks adding to the confusion faced by decision makers and the public. Rather, the global extent of a pandemic should be described objectively and should be just one factor in decisions about how to respond."

"As we adjust our mitigation policies, there will be a continuing need to make decisions without definitive estimates of severity. For example, the decision to move from production of vaccine for seasonal influenza to that for pandemic influenza will need to be made in the next month or two. Similarly, the United States will need to decide soon whether to use adjuvanted vaccines to protect more people with a given amount of antigen, although such vaccines are not currently licensed in the United States. As always, however, the main losers from delays in such decisions are likely to be developing countries, which will have less access to vaccine while probably suffering the greatest clinical impact from this new pandemic virus."

Tuesday, July 7, 2009

The race for the H1N1 vaccine

Major producers are now in the race to produce the H1N1 vaccine. Obviously the dollar stakes are extremely high. Getting a contract to supply any country will represent enormous revenues for the manufacturer.

Recently the China company Sinovac claimed to be able to produce the vaccine by the end of the month and to have it out into the market by September after a 2 month clinical trial.

Novartis and Baxter using cell culture techniques, both made claims to be ready for clinical trials this month.

GSK, Sanofi and Australia's CSL are somewhat slower with the egg based methods and are projecting perhaps availability for trials in about September.

Efficacy and toxicity data for any of these vaccines will depend on clinical trials that are all yet to be conducted.

I am curious though, in a situation like this how does one decide who to contract the vaccine supply to? Would the MOH follow the usual GEBIZ open tender process? Or would they go down the road of a preferred supplier?

To what extent would this decision be coloured by the fact that of these companies, Novartis and GSK are huge investors here in Singapore, and are significant industrial partners in the manufacture of biologics and pharmaceuticals? Both Novartis and GSK have invested in excess of S$1 billion in Singapore.

Who would we eventually award the contract to?

If I were a betting person I would probably place my bets on the GSK vaccine. But I am not....so your guess is as good as mine.

Wednesday, July 1, 2009

Vaccine safety - preparing for the eventuality

I have posted on the topic of vaccines and vaccine safety before.

Here I want to highlight 2 recent scientific reviews on this topic which I think are important for us to consider as we hurtle down this road towards H1N1 mass vaccination programmes.

The first is a review in 2008, by Dr Fineberg in the Journal of Infectious Diseases (if you want the pdf of the original paper, just email me). This review was done when avian flu was a hot topic, and it draws upon lesson from the 1976 US mass vaccination programme for swine flu which resulted in a national fiasco where 25% of the poulation was vaccinated and no evidence of any pandemic. In the review, Dr Fineberg recalls the 7 features of the swine flu :

1. Overconfidence in theory spun from meager evidence.
2. Conviction fueled by preexisting agendas.
3. Zeal by health professionals to make lay superiors “do the right thing.”
4. Premature commitment.
5. Failure to address uncertainties.
6. Insufficient questioning of implementation prospects.
7. Insensitivity to media relations and to long-term credibility.


....and identifies 7 lessons today that we can learn from that fiasco:

1. Beware of overconfidence in models drawn from meager evidence.
2. Invest in a balanced portfolio of research and contemporary preparedness.
3. Clarify operational responsibilities in the federal government.
4. Refrain from overstatement of objectives and misrepresentation of risk.
5. Strengthen local capacity for implementation.
6. Communicate strategically.
7. Lay the basis for program review.


The second review is just hot off the press in the same august journal, entitled ""Prepandemic" Immunization for Novel Influenza Viruses, "Swine Flu" Vaccine, Guillain-Barré Syndrome, and the Detection of Rare Severe Adverse Events", by Dr Evans and his co-workers. (conclusions abstracted below)

"In summary, the risk of SAEs (serious adverse events) will remain important considerations in developing immunization policies for interpandemic use of novel influenza vaccines and implementing mass immunization programs. These issues are particularly challenging when the risks of severe illness or of a future pandemic are uncertain and, therefore, safety concerns more acute, as is the case in interpandemic vaccination. However, even if an association between SAEs and interpandemic vaccination could be discounted with confidence, the reality is that public perception of a link has the potential to undermine amass vaccination strategy over and above the scientific evidence, as clearly evidenced in the 1976 experience."


I will leave it to you to form your own impressions about our current approaches towards the H1N1 vis a vis the comments contained in these reviews. I would certainly recommend these as compulsory reading for those interested in vaccine safety, and also for our decision makers in MOH who may be contemplating a mass vaccination strategy.

Saturday, June 13, 2009

H1N1 - pandemics, vaccines and the global economy

So the WHO has declared a pandemic....after apparently much agonized handwringing. But from where I sit....it seems like nothing much has changed, and for the most part, it's life as per normal.

Any impact on the global economy? So far no apparent negative impact. It's travel as per normal. Shopping as per normal.

One good thing about the pandemic is the super boost for the vaccine industry, and all related industries with regards to pandemic preparedness.

Market Research Media estimates that the size of the global pandemic preparedness market is in the region of a staggering US$52 billion in 201o-2015. The orders for vaccines alone is sizeable. The supply of influenza vaccines to the European market itself will net GSK US$1 billion.

Vaccine safety

The safety of existing and new vaccines has been the subject of a raging debate. Much of the controversy centres around the inclusion of mercury (thimerasol) and aluminium in the preparations of the various vaccines. Thimerasol is used largely as a preservative, but has been incriminated in CNS and renal toxicity. There have also been suggested associations with autism in children. Aluminium on the other hand is use mainly as an adjuvant to increase the immunological response to the antigen. It has also been suggested to be involved in brain damage and behavioural problems in children.

Most of these claims are pretty alarmist and poorly substantiated but there have been a lot of pressures to remove these from vaccine preparations.

One other problem with vaccines relates to the fear of the unknown. Vaccines are usually produced throgh fairly complex biological means, many of which are proprietary and unique to companies. Many of these processes are fairly recent innovations, the safety of which have not been extensively validated. We really don't know too much about the long term consequences of being exposed to products and contaminants from these commercial bio-industrial processes. On surface they appear to be safe. We can only hope that the longer term effects will be just as innocuous.

Gor more information about vaccine safety:
US Centers for Disease Control and Prevention, Immunization Safety Office

Vaccines are still one of the most effective means to control infections, and good access to vaccines is of critical importance in managing epidemics and pandemics such as those caused by the current novel H1N1. The issue of vaccine safety is difficult to resolve because many of the suggested toxic effects are much delayed effects whose postulated causal relationship with the vaccines are extremely difficult to prove. Nevertheless it is vitally important for health authorities to address these issues openly and provide a high degree of public reassurance. In this pandemic, there will be pressures to embark on vaccination programmes early, and perhaps prematurely, before full clinical trialing has been completed. Full public disclosure of data relating to the vaccine safety will be even more important.

Friday, June 12, 2009

H1N1 - How do we know vaccines are effective and safe?

There's been a lot of talk recently about vaccines especially since we have gone 'pandemic' and begun moving into the mitigation zone. See Wall Street Journal article.

Vaccines are made by producing either live 'bugs' which have been attenuated so that they don't produce disease, or by engineering a protein that carries all the required antigens and that will be able to 'teach' the human body to immunologically recognize the bug and therefore to produce an immunological defense against it. These are usually industrially complex processes many of which are proprietarily protected and unique to each manufacturer. This generally makes it difficult for the regulators like the FDA and our own Health Science Authority (HSA) to figure out which processes are safe and acceptable etc. The final vaccine is analyzed principally as a chemical product to ensure it does not contain known pathogens, and biological contaminants and toxins.

Preclinical or animal testing for safety and effecacy is kinda useless although it is often done as part of the vaccine development process. Vaccine efficacy and toxicity is highly species specific because it engages the immune system, and in this case animal indicators of efficacy and toxicity are almost totally unrepresentative of whatever may happen in humans. At best, it picks up only very gross and obvious effects.

There is a mandatory period of clinical testing. But again, this is often very artificial because at best it only demonstrates the ability of the vaccine to induce an immunological response. This antibody response does not mean there is immunity against the bug in a real infection since this clinical testing is in normal uninfected individuals, and the anitbody produced tested against a test tube bug. So real efficacy against the bug can only be presumed. One can really only know the true efficacy when the vaccine is trialed in the context of the prevention of a real infection/epidemic. This is difficult to do and takes a lot of time because the occurence of an epidemic is unpredictable.

So most vaccines are licensed into the market, based on very indirect evidence of efficacy and safety. To makes matters even more uncertain, many postulated toxicity effects of vaccines appear very late after the vaccination. For a new vaccine, such delayed toxicity may never ever be discovered until many many years down the road. Many toxic effects will in fact never ever be detected or proven.

All this makes the licensing of vaccines very difficult. Even for large regulators such as the FDA. You can read more about this here. (FDA’s Role in the Regulation of Vaccines ). Our HSA doesn't even tell us how this is done. Vaccination programmes unlike most other drug treatments are given prophylactically to normal healthy people, on only the anticipation of a possible infection. In this context, our expectation of safety should be even more critical. But in fact, for vaccines, our knowledge of the efficacy/toxicity balance is even more clouded.

So how does our HSA do it? Even more clouded.

When an emergency situation arises, such as the occurence of a pandemic, there can be a suspension of regulatory restrictions. In the US, :
"An additional tool available to speed product availability is the ability for FDA to allow the use of unapproved products and unapproved uses (so-called “off-label” uses) of approved products, in a declared emergency, under the Emergency Use Authorization (EUA) provision of the Food, Drug, and Cosmetic Act. This authority was expanded under the Project BioShield Act. To authorize such emergency use, FDA would need to find that the agent can cause a serious or life-threatening disease or condition; that based on the available information it is reasonable to believe that the product may be effective against the disease or condition; that the known and potential benefits of the product’s use outweigh the known and potential risks; and that there is no adequate, approved and available alternative. "

We don't know if such an 'emergency use authorization' exists in the Singapore context, and under what conditions it make be activated. For the current H1N1, there seems no justification since for it (yet) since there does not seem to be any evidence that it can be considered to 'cause a serious or life threatening disease/condition'.

So HSA/MOH, can provide us some assurance that should we try and move into mass vaccination programmes for H1N1, that the vaccines being rushed into production (especially by our A*star/EDB boutique biotech companies), are safe and effective?

Thursday, May 14, 2009

Exposure to virus 'a bad idea'....Really?

I was quite amused reading about MOH Director of Medical Services, Dr Satku having been quoted as saying 'Generally, as a principle, it is not good practice to expose an individual to a contagious disease to gain immunity as any infectious disease might give rise to complications'.

Really, Dr Satku?

I think the good doctor meant well in defending his Ministry, but I think he is way off wrong.

Infections occur all the time, and being contagious have always spread through the community in some way or other. This is the way the community builds up 'herd immunity' to bugs. We are not talking about some serious illness, or devastating infection, rather in this case, a viral infection that has way less bite than the seasonal flu.

Dr Satku, in case you haven't noticed, we don't live in a sterile bubble.

Thursday, May 7, 2009

Swine flu - Missed opportunity to build immunity?

TODAY carried a report by AFP entitled "Will getting H1N1 now protect you later?"

It's a very good question. Scientists everywhere are working round the clock to develop a vaccine against the virus, but here is the virus, relatively mild, going round the block, and we try so hard to prevent it from infecting people when that innocuous infection will clearly build up an immunity against that very virus.

So did all our overzealous health authorities overdo their pandemic hysteria and miss an opportunity to innoculate the community and produce immunity against the virus?

Methinks ....yes. Even though the US CDC says it's a bad idea. Maybe because the pharma industry won't make any money from a naturally occurring vaccination programme.