-Caveat Lector- http://www.health.gov.au/pubhlth/strateg/communic/factsheets/vaccine_statement.htm
""" A major problem, of course, is that the smallpox vaccine, as Frank Fenner put it recently, "is the worst of all vaccines". As he said, "It was knocked off [the list of vaccines] in the U.K. and U.S. in 1971-2, before the disease had been eradicated, because it was judged there were more problems from the vaccine than from smallpox itself." """ WORLD VACCINE CONGRESS 27 NOVEMBER 2002 PROFESSOR RICHARD SMALLWOOD Commonwealth Chief Medical Officer VACCINES TO COMBAT BIOTERRORISM In thinking about a role for vaccines in combatting bioterrorism, it seemed to me that it would be useful today to set vaccines in the wider context of potential health threats from bioterrorism, and the possible responses from the health sector in countering those threats. In doing so, I will be primarily referring to health sector preparedness in Australia, but also to the approaches of one or two other countries, insofar as there is information in the public arena. You will appreciate that some information about Australia's preparedness must remain secure and cannot be canvassed in a forum such as this. Nevertheless, I think that there is ample opportunity to consider the problems facing us and the possible ways of dealing with them. The possible threats we face comprise nuclear and conventional weapons on the one hand, and on the other chemical, biological and radiological threats (CBR threats for short). For overt attacks of the sort that took place recently in Bali, the health sector has to be able to respond to deal with the consequences of such an attack. The consensus appears to be that Australia's response to the outrage in Bali was prompt and effective. The coordination in the health sector was efficient, and the severely injured and burned victims transported to hospitals around Australia received exemplary care. Just how extensive a "surge capacity" the health sector has, or may need, to deal with the consequences of a major terrorist attack here in Australia is under active consideration at the moment. CBR incidents, by contrast, may be overt, and require emergency services to be mobilised - police, fire, ambulance - but they may be covert. In this case, the early detection of a CBR attack may be difficult, and critically dependant on the vigilance and skill of health care and public health practitioner. [Top of page] There are a number of epidemiological clues to suggest a deliberate release of a biological agent, some fairly subtle. any case of a rare disease (smallpox, viral haemorrhagic fevers) many cases of unexplained diseases or deaths unusual routes of infection (inhalational anthrax) an unusual disease outbreak for a particular geographic area or season an outbreak in an unusual age group unusual strains of organisms, or unusual antimicrobial resistance patterns similar genetic make up in agents located from distinct locations at different times. And a range of other clues that will alert the expert. I might say that one of the chief defences we have in this country against a CBR attack is a solid public health infrastructure with skilled public health and clinical professionals, together with a research workforce of outstanding bioscientists to advise government on its policies and plans to combat bioterrorism. For the dramatic attack, Australia has well-prepared disaster plans - nationally, in all States and Territories, and in major hospitals. Preparation for the Sydney Olympics in 2000 enhanced and refined these plans, and the thousands of "white powder" incidents late last year, following September 11 and the anthrax incidents in the U.S., meant that emergency services had a series of very instructive dry runs. Fortunately, none of the white powders proved to contain anthrax spores or any other harmful agent. In addition to the Commonwealth and State and Territory Departments of Health, there are a number of other health agencies which would potentially have important roles in the event of a terrorist attack. These include: The Australian Disaster Medicine Group The Australian Radiation Protection & Nuclear Safety Agency Food Safety Australia New Zealand and an organisation known as OZFOODNET, and particularly important in the event of a covert attack with a biological agent, two entities which sit under the National Public Health Partnership: Communicable Disease Network of Australia (CDNA) Public Health Laboratory Network (PHLN) These health sector organisations work closely with security and emergency response agencies such as: Emergency Management Australia Commonwealth Departments of Prime Minister & Cabinet, Attorney-Generals, and Defence. The Commonwealth health agencies are primarily there to provide resources, policy leadership, planning and coordination, public communication, and to administer quarantine and public health legislation. Frontline response capacity rest primarily with the States and Territories, whether that response be laboratory or clinical or public health. They also have the surveillance networks that will be required to spot a covert CBR attack early so that any harm can be kept to a minimum. [Top of page] So, what bioterrorism agents might we be facing, and what role might vaccines play in protecting people from harm? You will be aware of some of the bioterrorism incidents that have occurred in recent years. For example: Oregon, 1984, Rajnashu cult caused an extensive outbreak of salmonellosis by contaminating food in a salad bar; Tokyo, early 1990s - unsuccessful biological attacks; "partially" successful attack with Sarin nerve gas by the Aum Shinriko sect in the subway; Ohio, 1995 - Yersinia pestis sent in the mail; Dallas, 1996 - Shigella dysenteriae put in muffins and doughnuts; U.S., post September 11 - anthrax incidents. The USSR developed biological weapons, and amongst the organisms involved, it would seem, were anthrax and smallpox. The concern that has been often expressed since September 11 is that, with the break up of the USSR, some of the Russian smallpox virus stock may have fallen into the wrong hands. Smallpox, eliminated from the natural world over 20 years ago, is once again looming as a possible public health threat to the world, although no-one can say what the likelihood of that threat is. The CDC in Atlanta has drawn up a list of bioterrorism agents, which it has divided into three categories - A, B & C. The classification of these agents was done using the following criteria: Public health impact - propensity to cause widespread disease or death. Transmissibility and potential for dissemination. Infrastructure needed to achieve preparedness. Public perceptions of potential for harm. Well, who made the "A" team? The A team were: Smallpox, anthrax, plague, tularaemia, ebola et al, and botulinum toxin. I think there is quite a step down to the B-team, which comprises three toxins - ricin, clostridial toxin and staphylococcal toxin - and three diseases: Q fever, brucellosis and glanders. [Top of page] I would like to focus on Category A conditions, with a particular emphasis on smallpox, since it rates highly on all four criteria. As you know, smallpox is a highly contagious disease spread primarily by droplets. Close face to face contact is required for transmission, so in the past most infections have occurred amongst household contacts and other close contacts of an infected person who is symptomatic. Those who are incubating the disease are not infectious; they only become so once they have become ill, and when they are likely to be confined to bed. This allows the possibility of a primary strategy of effective containment for controlling an outbreak, once a case has been identified. Containment comprises: isolation of the infected person vaccination of household contacts and other close contacts e.g. attending medical personnel. Prompt vaccination of contacts i.e. within four days of exposure, confers substantial protection. Either the disease will be prevented, or it will be greatly ameliorated, and the propensity for the contact to spread the disease to others will be greatly reduced or eliminated. Thus a policy of "ring vaccination" to contain an outbreak is feasible in a technical sense, particularly if the initial case is detected early and, most importantly, promptly confirmed (by whatever method). This approach was used very successfully during the campaign to eliminate the virus, even amongst populations with a comparatively low herd immunity. Whether it is the best policy to pursue to respond to a terrorist incident, in which the virus is released at one or more points, is another question being currently considered by many governments around the world. Australia has no smallpox vaccine in the country - yet, but we expect to in a matter of days. The countries that have maintained stocks of old vaccine since the 1970s include France, the U.S. and Canada. These countries have also ordered sufficient supplies of new vaccine to cover either their whole population (the USA), or a large percentage of the population (Canada). The U.K. has also ordered enough vaccine for 30 million or more people. Nonetheless, both the U.K. and Canada are still pondering the question of who should be offered vaccine, if anyone, before any incident occurs, whether in their own country or anywhere else in the world. [Top of page] Should there be core teams of vaccinated health professionals who could care for cases and their contacts in the first instance? Should the notion of "first responders" to be vaccinated ahead of any incident, be expanded to include all doctors, nurses, other health care workers, emergency services (police, ambulance, fire) other essential services, etc.... In this country, that would take the numbers up to perhaps over a million people. As far as I am aware, no country has yet started to use the old vaccine for "first responders", although there is some conflicting information that one or two States in the U.S. have started. The U.S. has mooted that it intends to offer vaccine to everyone, but the President has not yet signed off on this policy. The only country that appears to be unequivocal about vaccinating the whole population is Israel, for perhaps understandable reasons. A major problem, of course, is that the smallpox vaccine, as Frank Fenner put it recently, "is the worst of all vaccines". As he said, "It was knocked off [the list of vaccines] in the U.K. and U.S. in 1971-2, before the disease had been eradicated, because it was judged there were more problems from the vaccine than from smallpox itself." If the U.S. were to vaccinate the whole of its population, there would be several hundred deaths (1-2 deaths per million vaccinees). The number of potentially life threatening reactions has been put at 15/ million, and "serious or severe reactions" warranting consideration of vaccinia immunoglobulin (VIG) treatment as high as 1-2 per 1000. The serious adverse events associated with the vaccine include encephalitis (1 in 300,000), generalised vaccinia, vaccinia necrosum (a gradual spread of the primary lesion, which could, for example, affect muscle and bone). Those who have or have had eczema, those who are immunocompromised, are particularly prone to severe reactions. There has been considerable debate internationally about the optimal approach that should be adopted by one or other country to combat the potential threat of smallpox, most of which has centred on the vaccine. [Top of page] An interesting pair of articles from the 15 November number of Science considered this question of the optimal approach to protecting the population by vaccination, both before and after any incident. It very evidently depends on which form of modelling you adopt, and the basic assumptions you make, as to what conclusion you come to, and all models are constrained by lack of data. I think one clear conclusion was that there is not yet enough information to decide unequivocally the best policy for protecting the population. Targeted vaccination? Mass vaccination? The debate goes on. As many of you will be aware, opinion varies on what should be done, from a minimalist, post-event, ring vaccination, to getting as many of the population vaccinated ahead of any incident as possible. WHO maintains its stand against mass vaccination. The proponents of the mass vaccination view consider that however technically feasible and effective "ring vaccination" might be in a strictly public health sense, once an incident occurs anywhere in the world, the demand for vaccine will rise sharply. What, then, is Australia's current approach? The first priority has been to get vaccine into the country, and this is about to happen. It has not been a straightforward task and it has taken a number of months; but 50,000 doses should be here within days. Another 50,000, we expect, will be here in the early part of next year. The first batch will be old vaccine produced over 20 years ago; the second will be one of the newly manufactured vaccines now about to come on stream. Although there will be information on both vaccines about immunological efficacy and safety, neither will be registerable by the Therapeutic Goods Administration (TGA) � the extensive data normally required by TGA, the regulator, just won't be available. Hence both vaccines will require an exemption from the Minister to be used in this country, and that requires a different regulatory process. In March of this year the Federal Parliament amended the Therapeutic Goods Act to allow the Minister, on TGA's advice, to bring in and stockpile unregistered compounds, and to use them to meet any emergency. However, any exemption granted has to be gazetted and tabled in parliament. The steps that have had to be taken to secure a supply of smallpox vaccine have comprised: finding an accessible supply of the old vaccine finding a supplier of the new vaccine assuring ourselves that prima facie any vaccine to be used was efficacious and "safe" (or any side effects were known or reasonably predictable) securing a contract solving legal issues e.g. indemnity sorting out regulatory matters arranging secure transport and storage. [Top of page] The next questions, having acquired a quantity of vaccine, are how is it to be used, and how much more, over and above what we have, might we need in the future? To obtain advice on these and other questions, the Commonwealth Government has established the "Infectious Diseases Emergency Response" working group, which comprises a number of public health and communicable disease experts, together with representatives from Emergency Management Australia and PSCC (Protective Security Coordination Committee). We will also be seeking a view from other bodies e.g. those organisations representing potential first responders. Our view is that the wider public issues about the use of vaccine - who has access before any event, how should the vaccine be deployed after an event - deserve discussion in the wider community. Given the imponderables and uncertainties, I don't personally think that these are matters purely for the experts and policy makers. The present view is that the initial vaccine stock should be primarily held in reserve, against the outside chance of there being a smallpox incident in the next months. But this is under review, as is the best estimate of future stocks that we might need on shore. In the short term, should it be necessary, we can considerably increase our capacity by diluting the vaccine, which is effective at 5-10 fold dilution. We would also have access to stocks currently held by other countries should a release of smallpox occur in Australia. One other point I would like to comment on concerning the use of smallpox vaccine. No country seems to have a sufficient supply of VIG (vaccinia immunoglobulin) to use to treat life threatening adverse reactions to the vaccine in a mass vaccination program. We hope to secure a small supply from overseas now, and larger stocks in future, but we would also be looking at the possibility of manufacturing VIG here. We have another expert group of scientists looking at this at the moment. One final point on smallpox. Are there any potentially useful anti-viral agents? The answer is an optimistic "yes". Cidofovir appears to be very effective against pox viruses in experimental situations, and the expectation is that it would be useful in treating smallpox or major side effects of the vaccine. Following the events in the U.S. post-September 11, and the "white powder" incidents here, it is not surprising that anthrax has also proved to be a bioterror agent that has received a lot of attention. Cutaneous anthrax occurs from time to time in this country, but inhalational anthrax has been exceedingly rare. Any case of inhalational anthrax occurring today would immediately raise the suspicion of a deliberate release of anthrax spores. Prompt epidemiological investigation and heightened clinical awareness would then come into play, and it's interesting that, as I understand it, with the U.S. anthrax incidents, good clinical surveillance led to the diagnosis of inhalational anthrax in most of the cases. [Top of page] What approach should be taken to those who in all probability have been exposed to anthrax spores? Prompt chemoprophylaxis is the answer. I understand that there was no instance of anthrax developing in anyone given chemoprophylaxis within 48 hours of exposure. The drugs to be used e.g. ciprofloxacin have been stockpiled, and these supplies are in place. There is no problem about shelf-life, since there is a regular rotation of drug from the stockpile out into the community for the treatment of various infections, and the new supply is moved into the stockpile to replace the old. In other words, the stockpile is just a staging post. The approach to an apparent exposure to anthrax, where there is a solid prima facie case, would be to start ciprofloxacin promptly, say, 500mg orally 12 hourly until anthrax was ruled out. The reason for starting prophylaxis ahead of confirmation of the diagnosis is that treatment begun after fully fledged pulmonary anthrax has developed is too late. It's easy enough to stop treatment after 2 or 3 days if anthrax is ruled out. If exposure is confirmed, then prophylaxis needs to be continued for an extended period - 60 days is recommended - to cover spores that might be lying dormant in the first instance, and hence not responsive to treatment. Is there a role for the vaccine? It is not at this point being considered as part of a first line response in this country. I believe that in the U.K. the same applies, although there may be a different policy for selected defence personnel. None of the three vaccines currently extant are registered or registerable in Australia. Questions have been raised about their safety and efficacy, but there is a paucity of published peer-reviewed, good quality studies to go on. Given that we have an effective armamentarium of antibiotics, it seems unlikely that we will be actively pursuing one or other of the current vaccines. However, were a new, effective and safe vaccine to emerge in the next few years, that would possibly put a different complexion on things. [Top of page] What about the other members of the "A" team - plague, tularaemia, ebola and botulinum toxin? Well, again, in no case at present does a vaccine loom large as a frontline defence, but in the future, we may be in better case to immunise a population or a specific group against such agents. For example, there is available from CDC a trivalent antitoxin for treating botulism; there is an investigational pentavalent botulinum toxoid; and there is a recombinant vaccine, I understand, in development. So the position may change markedly over the next few years, depending on what resources are forthcoming for new vaccine development. We appear to have entered an era where the use of biological agents to harm civilian populations has become a credible, if unlikely, threat. How best to protect people from a range of infectious agents which could possibly be used as biological weapons is exercising governments, health professionals, and scientists around the world. At this point, the place of vaccines in our protective armamentarium is simply as one of a number of defences. In the future, it may well be that vaccines will assume a more pre-eminent role in protecting us against, for example, the CDC's category A bio-agents, but as those of you in this audience would be well aware, there are many uncertainties in the development of a successful vaccine. We will have to wait and see how events unfold. 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