Vaccines

The health department launched the Biologicals and Vaccines Institute of Southern Africa yesterday - a R500m public-private partnership between government and a group of healthcare companies called the Biovac Consortium, aimed at revitalising local vaccine manufacturing capacity. The Biovac Consortium is led by Biovac Holdings, the only wholly South African-owned vaccine importer and distributor, and includes Heber Biotec (Cuba), UK-based VaxIntel and the Disability Concerns Trust, an empowerment investment trust representing 4,5-million disabled people. Government has a 40% equity stake in the business. The institute will upgrade facilities at the former State Vaccine Institute in Pinelands, Cape Town, and over the next five years will begin manufacturing vaccines to meet its obligations as the state's preferred provider for its Expanded Programme on Immunisation (EPI). The vaccines include diptheria, tetanus, and pertussis (whooping cough), which are combined to make a vaccine called DTP; hepatitis B and haemophillus influenza, which protects against meningitis Initially all the vaccines will be imported, and then labelled, packaged and distributed, but the institute plans to make combination vaccines on site, and ultimately hopes to manufacture local vaccines too, according to the institute's CEO, Selwyn Kahanovitz. The Biovac Consortium has signed a memorandum of understanding with the South African AIDS Vaccine Initiative, to pave the way for local manufacture should a successful HIV/AIDS vaccine be found. The consortium also plans to establish a vaccine research and development facility through a business unit called Probiotech, which will be manufacturing vaccines for clinical trials. (Source: Tamar Kahn: Business Day, 30 September 2003) The health department launched the Biologicals and Vaccines Institute of Southern Africa yesterday - a R500m public-private partnership between government and a group of healthcare companies called the Biovac Consortium, aimed at revitalising local vaccine manufacturing capacity. The Biovac Consortium is led by Biovac Holdings, the only wholly South African-owned vaccine importer and distributor, and includes Heber Biotec (Cuba), UK-based VaxIntel and the Disability Concerns Trust, an empowerment investment trust representing 4,5-million disabled people. Government has a 40% equity stake in the business. The institute will upgrade facilities at the former State Vaccine Institute in Pinelands, Cape Town, and over the next five years will begin manufacturing vaccines to meet its obligations as the state's preferred provider for its Expanded Programme on Immunisation (EPI). The vaccines include diptheria, tetanus, and pertussis (whooping cough), which are combined to make a vaccine called DTP; hepatitis B and haemophillus influenza, which protects against meningitis Initially all the vaccines will be imported, and then labelled, packaged and distributed, but the institute plans to make combination vaccines on site, and ultimately hopes to manufacture local vaccines too, according to the institute's CEO, Selwyn Kahanovitz. The Biovac Consortium has signed a memorandum of understanding with the South African AIDS Vaccine Initiative, to pave the way for local manufacture should a successful HIV/AIDS vaccine be found. The consortium also plans to establish a vaccine research and development facility through a business unit called Probiotech, which will be manufacturing vaccines for clinical trials. (Source: Tamar Kahn: Business Day, 30 September 2003)

South Africa is expected to begin it's first Aids vaccine trials at the end of September, following the approval by the Medicines Control Council (MCC) of a second HIV preventative vaccine candidate. The trials will form phase one of three trials that could take seven to 10 years to complete. The most recently approved vaccine candidate, named HIVA.MVA, was designed by the University of Nairobi in Kenya and the University of Oxford in the United Kingdom. Phase one human trials of the vaccine candidate have already have been completed in Kenya and the UK and are underway in Uganda. The trials are sponsored by the nonprofit International Aids Vaccine Initiative (IAVI). In June, the MCC gave approval for a phase one trial of AVX101, designed by the US biotechnology firm AlphaVax Inc. The trial will be conducted by the HIV Vaccine Trials Network of the US government's National Institute of Allergy and Infectious Diseases. A Phase One trial of AVX101 was recently completed in the US. The trials of HIVA.MVA and the AlphaVax candidate are separate, but will be conducted at the same sites: the Perinatal HIV Research Unit (PHRU) of the University of the Witwatersrand at the Chris Hani Baragwanath Hospital in Soweto and the SAAVI HIV Vaccine Research Unit at the Medical Research Council in Durban. Professor James McIntyre, Principal Investigator for the Aids vaccine trial sites in South Africa, said: South Africa's research community has linked hands with researchers cross three continents-Europe, North America and Africa-in the global effort to find a vaccine against Aids. There is no risk of either HIVA.MVA or AVX101 causing HIV infection or Aids. Neither vaccine candidate contains HIV or any substance from HIV infected individuals. A preventive vaccine would be given to people who are HIV negative, to prevent HIV infection. IAVI's HIVA.MVA and AlphaVax's AVX101 employ different vaccine design strategies. HIVA.MVA uses a vaccine strategy called modified vaccinia Ankara, a variant of the basis for the smallpox vaccine. AVX101 uses a carrier for it's vaccine called the Venezuelan Equine Encephalitis alphavirus vector. By studying different vaccine design strategies at once, rather than one at a time, South Africa will help reduce the time needed to identify which is the most effective, said Dr Seth Berkley, President and CEO of IAVI. In the search for an Aids vaccine, speed is of the essence. A preventive vaccine is our best hope to end the spread of an epidemic that infects 15,000 men, women and children around the world every day, Dr Berkley said. The Phase one trials will initially enroll roughly 50 volunteers each. Their aim is to test safety and gather preliminary data on the ability of the vaccine candidates to stimulate the immune system. By conducting the HIVA.MVA and AVX101 trials side by side, South Africa will help gather data to address how an AIDS vaccine may be able to combat the varying subtypes of HIV that are circulating. IAVI's HIVA.MVA is based on subtype A, which is common in east Africa. AlphaVax's AVX101 is based on subtype C, the subtype most common in South Africa. Ideally, a single Aids vaccine will be highly effective against all subtypes of HIV, said Dr. Wayne Koff, IAVI's senior vice president for Research and Development. Preliminary indications are that both of the vaccine candidates currently approved for testing in South Africa hold promise for meeting this goal, but only human trials will tell us for sure. (Source: Sapa, Business Day, 26 August 2003)

The first trial of an experimental AIDS vaccine in Southern Africa began this week in Botswana with the enrollment and injection of the first two volunteers at the Princess Marina hospital in the capital, Gaborone. The research is a joint initiative by the Ministry of Health and the Botswana-Harvard AIDS Institute Partnership (BHP), established in 1996 by the Botswana Government and the Harvard AIDS Institute. Phase 1 of the trials, currently being conducted, is open to individuals between the ages of 21 and 40, who are in general good health, HIV negative, available for 18 months, not pregnant and intending to remain so during the course of testing. BHP hope approximately 14 HIV-negative volunteers, from an initial group of 30 Batswana participating so far, will be enrolled. Potential volunteers continue to be screened. The experimental vaccine is composed of a non-infectious component of HIV's genetic material. During the study, side effects will be examined to determine the vaccine's safety at three different dosages, and the body's immune response. The vaccine was developed by Epimmune, a company based in San Diego, California. The BHP HIV Reference Laboratory is an ultramodern research facility that is also helping to build Botswana’s professional capacity by training the nation's future researchers and technicians. BHP is designed to identify opportunities for collaborative research, as well as pursue education activities in the fight against HIV/AIDS. The government of Botswana deserves recognition for the creation of the BHP laboratory and the capacity it has built with trained staff, state-of-the-art equipment and Botswana-specific research, noted Dr Max Essex, BHP Chairman. Botswana stands ready to conduct not only this study, but other important HIV research. It is important to stress that the road to a successful vaccine is long, and that this phase 1 trial is a first step for Botswana on that road. (Source: PLUSNEWS 8 July, 2003).

South Africa's first human vaccine safety trials have entered a critical stage of development, which, if all goes according to plan, will see participants receiving the initial dose before June. Dr Tim Tucker, director of the South African AIDS Vaccine Initiative, has confirmed that the final stages of implementation are under way, with top-level discussions in progress. According to human rights lawyer Anne Strode of the University of Natal's department of law in Pietermaritzburg, one of the main areas of concern being discussed this week by the country's top scientists and the Department of Health was the question of treatment for participants if they become HIV-positive during the trial period. She outlined some of the ethics that needed to be fully understood by participants and researchers. There was also a need for external structures where participants could discuss problems and concerns arising from the trials, she added. Among the major aims of the ethics process was to ensure that participants knew the methods used for the research, how many blood tests or clinic visits might be required, potential risks, expected benefits, the right to withdraw, and confidentiality. One of the thorny ethical issues facing researchers was the gaining of informed consent from people in rural areas where cultural dynamics came into play. Often in these cases, individual consent does not exist, Strode added. A wife cannot consent to participate in a trial without the approval of her husband or community leaders. These are ethical considerations that still need work. (Source: Liz Clarke: The Star, 26 February 2003)

The world could see the re-emergence of old diseases if more money is not spent on vaccines, the World Health Organisation (WHO), UN Children's Fund (UNICEF) and World Bank warned on Wednesday. While vaccines have saved billions of lives in the past 100 years, they are still not reaching those most in need, the three organisations said in their joint State of the World's Vaccines and Immunisation report. The report is being launched in Dakar, Senegal, at a meeting of the partners of the Global Alliance for Vaccines and Immunisation (GAVI). Almost three quarters of the world's children are currently being reached with essential vaccines but the report complained of wide variations between North and South. Children in rich countries have access to additional, newer vaccines against diseases such as hepatitis. But in Sub-Saharan Africa, only half of children have access to basic immunisation against common diseases, such as tuberculosis, measles, tetanus and whooping cough, the report noted. In 2000, 1.7 million people died from tuberculosis, which is today re-emerging, fuelled by the rising prevalence of co-infection with HIV, especially in Africa, and by increasing resistance to medicines. The report underscored the urgent need for a new vaccine against tuberculosis, as well as for a vaccine against malaria, which kills more than one million people a year, mostly African children. Nearly three million people, two million of them children, die every year from common vaccine-preventable diseases. An extra $250 million a year would enable at least 10 million more children to be reached with basic vaccines, and another $100 million a year would cover the cost of newer vaccines, the report said. (Source: SAPA-AFP, 20 November 2002)

California-based Large Scale Biology Corp. yesterday signed an agreement with the Institute of Infectious Disease and Molecular Medicine at the University of Cape Town in South Africa to collaborate on the development of an AIDS vaccine, the Owensboro Messenger-Inquirer reports. The vaccine, which may be designed to treat as well as prevent AIDS, will be produced at Large Scale's plant in Owensboro, Ky., and will undergo testing in South Africa under the university's guidance. Under the agreement, Large Scale retains the rights to sell and market any vaccine in North America and Europe, and the university would hold the rights to sell the vaccine in Africa. Rights would be shared in other regions. The two groups did not announce a specific timetable for vaccine development, but said they would like to have an affordable, effective and locally relevant HIV vaccine

Scientists are more optimistic now than ever before about developing an AIDS vaccine in Africa, according to Medical Research Council (MRC) chairperson Malegapuru Makgoba. There is light now in the Dark Continent, he told journalists after the opening session of the first forum of the African AIDS Vaccine Programme (AAVP) in Somerset West on Monday. Expectations of a vaccine within seven to ten years were realistic, but it was important to be prudent rather than expedient. Makgoba said the first phase-one efficacy trials on a candidate vaccine for HIV sub-type C - the variant prevalent in southern Africa - could start in South Africa soon, and were only awaiting regulatory approval. However, this process could not be rushed.You need high ethical standards... we have to be sure that the day we start injecting we are not going to be facing the consequences of destroying the whole process, he said. Makgoba - who is also chair of the AAVP - said the programme brought African scientists together in the search of an accessible and affordable vaccine for the disease in the shortest time possible. The AAVP also aimed to guard against the exploratory and fly-by-night research that tends to come into this region in various forms, he said. Pontiano Kaleebu, the programme's principal investigator and Uganda Virus Research Institute scientist, said so far two studies had been completed in Africa - one in Kenya and one in Uganda - and one was ongoing. More were to start soon. A few trials have taken place, but there are a number that are lined up, he said. WHO-UNAIDS HIV Vaccine Initiative co-ordinator Jose Esparza said at the briefing that the first results of phase-three trials, conducted in the United States and Thailand, should be available in February or March next year. This will be the first opportunity to have an HIV vaccine, but nobody can say how effective that vaccine will be.He warned that vaccine trials were extremely complex from an ethical point of view and thus took a long time to complete. Esparza complained of the bias in AIDS research towards developed countries.Although Africa accounted for 70 percent of the world's HIV positive infections, only two of the 60 trials initiated so far had been on this continent. African vaccine research received less than two percent - about $50-million (about R500-million) -of resources directed towards such research worldwide. There is a feeling that Africa cannot contribute to research... but that model is not acceptable in the case of HIV. Plans had to be put in place now to ensure that Africa received the vaccines first, he said. Other scientists and health officials participating in the forum had earlier also be moaned what they believed was the cool response of the developed world towards investing in an African AIDS vaccine. We will continue to question and challenge the apathy of the rich nations to investing in vaccines for Africa, Health Minister Manto Tshabalala-Msimang said. The development of a vaccine for AIDS in Africa was critical and the South African government was committed to supporting such research.However, the holistic approach needed to fight the disease required resources that were way above what developing countries could afford, she said. World Health Organisation Africa director Ebrahim Samba said the European Commission spent about R10-billion a day in protecting agriculture in Europe. It is not a dream or an idle hope to think that they will be sufficiently generous to assist Africa, he said. The AAVP is a network of scientists working to promote and facilitate HIV research and evaluation in Africa and was initiated in June 2000 when 45 African scientists pledged collective commitment to find a vaccine. According to the World Health Organisation, the meeting in Somerset West aimed to define a plan of action for the next seven years and to raise R23,3-billion for the AAVP. (Source: SAPA, 3 June 2002)

More than 500 000 lives in developing countries stand to benefit from the discovery of a vaccine that reduces the incidence of pneumonia in vaccinated children by more than 20%. This comes after scientists from the University of the Witwatersrand and Emory University in Georgia, US, found that a new version of a pneumococcal vaccine reduced the incidence of pneumonia in vaccinated children following clinical trials among 40 000 children in Soweto. According to the World Health Organisation (WHO), pneumonia is the leading cause of death in children worldwide and is responsible for about four million deaths a year, most of which occur in developing countries. Although pneumonia has many different causes, the pneumococcus bacterium is the primary cause. Until recently, no vaccine was available to prevent pneumococcal disease in young children. In addition to pneumonia, pneumococcus can cause meningitis, ear infections and sinusitis. The universities said the vaccine reduced the incidence of invasive pneumococcal disease by more than 80% in children not infected with the HIV virus and by more than 50% in those that were HIV-positive. The study was conducted under the auspices of the WHO and the Medical Research Council of SA and Wyeth Pharmaceuticals, which developed the vaccine. (Source: Business Day, 9 May 2002)

South Africa is to test a new TB vaccine that could reduce the number of people infected by the killer disease worldwide. More than 100 000 South Africans are infected with the disease every year, of them 25 000 children. News of the new vaccine trial emerged this week at an international vaccine conference in Cape Town, attended by South African and world vaccine experts. The new vaccine - the most promising in 80 years since the introduction of the first TB vaccine that is still in use - is due to start this year in the Worcester area of the Western Cape, co-coordinated by infectious diseases expert Professor Greg Hussey, head of paediatric infectious diseases at the University of Cape Town. The trial, expected to last between three to five years, is a joint venture between South Africa, the University of Los Angeles and an American development agency. It follows a worldwide resurgence of TB and TB research, due largely to the HIV/AIDS pandemic. People who are HIV-positive are more at risk of developing TB and this has led to a resurgence of TB vaccines. Researchers at this week's conference were also upbeat about the chances of a HIV vaccine, expected within the next 10 years. A number of separate HIV vaccine trials across the globe are nearing the human trial phase. South Africa spends about R100-million a year on vaccinations. (Source: Sunday Times, 14 April 2002)

The first vaccine to prevent varicella, commonly known as chickenpox, was launched in Johannesburg on Thursday. Manufacturing company GlaxoSmithKline said it was the first time that a vaccine for this disease was available in South Africa. The vaccine can be safely administered to babies from the age of nine months and also to children, adolescents and adults who fall within risk groups. The company said it was difficult to give precise statistics on the prevalence and incidences of chickenpox and its complications because it was not a notifiable disease. It had, however, become apparent that more adults were contracting the disease than before. The disease had several complications that mostly occurred in adolescents, adults, and people with low resistance due to other medical problems and newborn babies. Pregnant women were also more susceptible to complications from chickenpox and could infect their unborn babies as well. Babies born with chickenpox could suffer from a low birth weight, poorly formed limbs and mental retardation. One of the most common complications from the disease was pneumonia. The risk of a chickenpox victim contracting pneumonia was significantly higher in smokers and children with compromised immuno-systems, the company said. The bacteria* that cause chickenpox could remain in a patient's body and later in life affect the nerve endings, leading to a painful condition commonly known as shingles. Chickenpox is a highly infectious disease that usually starts with flu-like symptoms after an incubation period of about two weeks. A rose-coloured rash usually appears on the infected person's skin with a fluid-filled blister in the middle of each spot. The rash may be itchy and a secondary infection can be contracted due to scratching. Infection of the skin could lead to scarring. (SAPA, 18 October 2001) * Please note that chickenpox is caused by a virus, not a bacterium. Error in original news article