HEADQUARTERS PRESS CONFERENCE BY INTERNATIONAL AIDS VACCINE INITIATIVE

HEADQUARTERS PRESS CONFERENCE BY INTERNATIONAL AIDS VACCINE INITIATIVE

It was a global disgrace that 20 years after the HIV/AIDS epidemic began, no effective vaccine had emerged from the pipeline, and no one had been fully tested anywhere to see if there was one that worked, correspondents were told this morning at a Headquarters press conference by the International AIDS Vaccine Initiative (IAVI), a non-profit scientific organization whose mission is to ensure the development of effective HIV vaccines for use throughout the world.

Dr. Seth Berkley, President and Chief Executive Officer of IAVI, said that, meanwhile, the world must prepare for success even though an effective vaccine was years away.  The normal path for a vaccine was development for the North, namely for the United States, Europe, and Japan, and then 10 to 15 years more before it trickled down to the developing world.  That was unacceptable for any vaccine, but especially for HIV.  Dr. Berkley was joined by David N. Kuhumro Apuuli, Director General of the Uganda AIDS Commission, and Wayne C. Koff, IAVI's Senior Vice President for Research and Development.

Dr. Berkley drew attention to the key obstacles to the development and delivery of an effective HIV/AIDS vaccine.  Therewas no ideal animal model, so the principal work had to be done on people.  Also, HIV was variable around the world, and it was not yet known whether a universal vaccine could be achieved, or mixtures and cocktails of vaccines were needed.  His organization was releasing a report today which described a new access paradigm for ensuring swift global access to AIDS vaccines.  It was a five-point programme that centred on:  financing and delivery, including the setting up of delivery mechanisms to adolescents, commercial sex workers, and IV drug users; differential or tiered pricing geared towards affordability for all countries; accelerated research and development through increased global support; improved regulatory process; and the assurance of adequate manufacturing capacity.

Six weeks ago, he said, the organization issued a call to action to stimulate the support of world leaders.  So far, there were more than

50,000 signatories from 145 countries, parliamentarians from every continent, and many prominent individuals.  The focus was on the need to drive forward the AIDS vaccine.  It was easy to ignore vaccines with the global emergency going on, but vaccines were not going to evolve without attention and leadership.  The process was still grossly under-funded.  Currently, less than 2 per cent of global AIDS funds was being applied for that purpose.  Much could be done to accelerate it and ensure that the day a vaccine was ready, it could be made available to everyone in the world in need.  That would not happen without an intervention.

Mr. Apuuli said that Uganda had been treading a difficult path.  By the early 1990s, it had become the epicentre of HIV/AIDS in the world.  Prevalence rates were as high as 30 per cent in some of the urban areas and 18 per cent in the general population.  The latest figures indicated that prevalence in the general population had dropped by 6.2 per cent.  He was proud to have been able to do something -- and talking about the victims of so much carnage and misery put a human face on the figures.  His country had been helped by a number of factors, including political commitment at the highest level and openness about the disease.  The vision that HIV/AIDS was a multi-sectoral problem that went beyond a

mere health issue had led to the creation of a coordination mechanism directly under the President. 

Also helpful had been the perception in Uganda that HIV/AIDS was a development issue, he said.  That made it easier to move related initiatives forward through political channels and get certain things cleared by the Government.  All of those factors had played a crucial role in preparing the ground for mobilizing the vaccine initiative, which had taken root in Uganda.  Even when the vaccine appeared to be a fantasy in the early 1990's, Uganda had begun work on a vaccination plan.  Indeed, his country was proud to have been the first in Africa to have undertaken a trial with one HIV/AIDS vaccine.  That phase had been completed and publication of the results was awaited.  The partnership between Uganda and IAVI had led to the setting up in the early 1990s of an institutional capacity to undertake HIV/AIDS research.  So, in Uganda, there was a new pool of people who had been trained in some of the best institutions and laboratories.  It had also been agreed that an IAVI-sponsored AIDS vaccine clinical trial centre would be established at the Uganda Virus Research Institute. 

Mr. Koff said there had really been an expansion of activity over the years with respect to vaccines in the pipeline.  At present, however, one vaccine had only reached stage III, during which its efficacy was evaluated.  That vaccine, AIDSVAX by Vaxgen, was based on the outer protein of the HIV virus and was currently being evaluated in approximately 8,000 individuals.  At the current pace, it would take about one more year to learn of its true efficacy.  A second vaccine, Alvac, had been evaluated in a variety of countries.  Basically, it would put a few HIV genes into an analogue of one of the pox viruses and use that as a delivery vehicle.  The concept was presently at stage II.  He anticipated that a phase III trial of that vaccine would begin in about a year, but it would be

2006 before the data was fully processed.  Two or three more interesting ideas, based on combination vaccines, had just entered into phase I trial.

Over the next year or so, six to eight other vaccines would enter clinical trials, including really interesting ideas applicable in the developing world, such as orally administered and single-shot vaccines.  But it was a long road to an AIDS vaccine, and the HIV virus was very challenging.  The nuances of the virus itself also posed scientific problems.  Then there were the industrial challenges.  Even if there was an effective vaccine in the vial at present, there would be no way of really engineering the vaccine to serve all the populations in need.  Thus, IAVI was looking at research and development and access issues simultaneously. 

There was also the problem of clinical trials, he noted.  Infrastructures in the developing world could not cope with a number of the large vaccine trials at the same time.  If a vaccine was ready to go, large trials could not presently be conducted in places of high interest, such as Africa, India or China.  Moreover, a vaccine that cost $1,000 a dose and required eight shots was not a realistic vaccine.  He had to think of vaccines that could be used in the developing world.  It was also important to move the lead candidates into efficacy trials as fast as possible.  There might already be a vaccine in the vial that had not yet been evaluated.  If the initial vaccines were not as good as believed, it must be ensured that the second-generation vaccines showed improvements and were moved into clinical trials as soon as possible. 

Asked whether the declaration of commitment to be adopted at the special session was a lost opportunity in terms of research, Dr. Berkley said that the declaration had emphasized the importance of research and development.  There was somewhat softer language, however, on financial commitments and on ensuring that the day the vaccine was available it could be accessed by everyone who needed it.  Of course, that would require a complex system of pricing, but a new vaccine required the prior creation of a mechanism.  Governments could make that firm commitment now, especially given what was happening with respect to access to drugs.  "Let's get it right from the start", he said.

Replying to another question, he said that it was critical to show industry and the world that AIDS vaccines would get financing once they were “out there”.  Working with the World Bank to use a letter of credit type mechanism had been considered.  That way, promissory notes would assure the future availability of funds.

To a question about licensing vaccines, Mr. Koff said that if the vaccine was licensed, others had to run against it and show improved efficacy.  It was unclear what level of efficacy was "licensable" in a clinical trial.  Generally, however, if a vaccine was already licensed, the bar was set at that point, and others had to improve on that.

Dr. Berkley added that if a vaccine worked and the homework had not been done, it would be five or more years before that vaccine made it to the developing world, and that would be a tragedy.

In response to a question about research underway for vaccines geared towards already infected people, Mr. Koff said that a variety of industries were looking at improvements in the anti-virals and also at vaccines as potential adjuncts to anti-virals.  Because of industrial efforts in that area, IAVI's  research and development programme had imposed a laser-like focus on a vaccine that would block infection and disease. 

Mr. Apuuli reiterated that Uganda was in the forefront of that vaccine initiative, and as such, it was also looking at curative vaccines.  Dr. Berkley added that there was no precedent for therapeutic vaccines, so it was going to be a tough issue.

Another correspondent asked about the pursuit of clinical trials against strains in developing countries.  Mr. Koff said that the two vaccines on trial had been developed against strains in the western part of the world and in southeast Asia.  The first was for a subtype known as "B".  The other vaccine was aimed at subtype "E", which was in southeast Asia.  The initial trial of the "B" subtype was about a year or so ahead of the "E" subtype trial.  So, data should be available in six to nine months or so on the "B" subtype trial, and about a year later, on the "E" subtype.

To a question about whether people who had been vaccinated with HIV antibodies could be distinguished from people who were infected, Mr. Koff said that it depended on the vaccine.  One vaccine made antibodies that would make it difficult to distinguish between the two groups, but generally, there were other available tests making it possible to differentiate.

In response to another question, he said that the present end-point in terms of vaccines was to control the disease rather than block the infection.

Dr. Berkley added that the vaccines in phase I trials looked very promising, and efforts were under way to accelerate them as fast as possible in both the United Kingdom and Kenya.  He also had trials planned in three other African countries, and sought to move vaccines along for India and China.  An even broader effort was under way worldwide. 

* *** *