December 27, 2013 - GlaxoSmithKline (GSK), one of the world’s leading research-based pharmaceutical and healthcare companies is seeking regulatory approval for the first malaria vaccine called RTS.S, developed with Path Malaria Vaccine Initiative, the most clinically advanced malaria vaccine candidate and supported financially by the Bill and Melinda Gates Foundation.
Testing showed that 18 months after vaccination, children aged 5 to 17 months had a 46% reduction in the risk of clinical malaria compared to unvaccinated children and there was a reduction of 27% for infants aged 6 to 12 weeks of age.
Severe malaria cases were reduced by 36% and 21 cases of severe malaria were prevented over 18 months of follow-up for every 1,000 children vaccinated. It is also important to note that malaria hospitalisations were reduced by 42%.
"Many millions of malaria cases fill the wards of our hospitals," said Halidou Tinto, a lead investigator on the RTS.S trial from Burkina Faso. "Progress is being made with bed nets and other measures, but we need more tools to battle this terrible disease."
Lynne Featherstone, International Development Minister stated, "Malaria is not just one of the world's biggest killers of children, it also burdens health systems, hinders children's development and puts a brake on economic growth."
"An effective malaria vaccine would have an enormous impact on the developing world," Featherstone added.
"We’re very encouraged by these latest results, which show that RTS.S continued to provide meaningful protection over 18 months to babies and young children across different regions of Africa," said Sir Andrew Witty, CEO of GSK.
Dr David C. Kaslow, Vice President of Product Development for the Program for Appropriate Technology in Health (PATH) stated, "Given the huge disease burden of malaria among African children, we cannot ignore what these latest results tell us about the potential for RTS.S to have a measurable and significant impact on the health of millions of young children in Africa."
"While we want to be careful about not getting ahead of the data, this trial continues to show that a malaria vaccine could potentially bring an important additional benefit beyond that provided by the tools already in use."
The malaria trial was Africa's largest-ever clinical trial involving almost 15,500 children in seven countries. GlaxoSmithKline has been developing the vaccine for the past thirty years.
Facts about Malaria
- Malaria is caused by a protozoan parasite that is transmitted by the bite of a mosquito.
- Malaria remains the leading cause of illness and death globally.
- Every 30 seconds a child dies of malaria.
- Malaria kills about 800,000 people a year internationally.
- 90% of all malaria cases are in sub-Saharan Africa.
Japanese Encephalitis (JE) Vaccine
The World Health Organization (WHO) approved prequalification for a vaccine that has the potential to protect four billion children under the age of fifteen throughout Asia and the Western Pacific from a devastating disease called Japanese encephalitis (JE).
JE is known as 'brain fever' which begins like the flu, then progresses to a brain infection and kills up to 30% of its victims. The virus is hosted by wading birds like herons and egrets, which flock to rice paddy fields, and by pigs commonly raised in rural areas. JE is transmitted to humans by mosquitoes which breed by the tens of thousands in rice paddies.
JE kills about 15,000 children and youth annually and leaves tens of thousands of survivors with permanent brain injuries including long-term disabilities such as paralysis, seizures and mental retardation, which places a tremendous strain on families, communities and health systems.
China vaccinated more than 200 million children against JE with excellent results. Unlike other JE vaccines that have existed since 1941 that were expensive and produced unpleasant side effects, China's solution is affordable and easy to administer in large campaigns but it remains out of reach for countries beyond China. The vaccine signals China's new venture in the global vaccine marketplace.
Program for Appropriate Technology in Health (PATH), a global non-profit organization that initiated clinical trials on the vaccine a decade ago, established a partnership with the Chengdu Institute of Biological Products (CDIBP), and is supported through the Bill & Melinda Gates Foundation. This partnership dramatically increased the vaccine's accessibility to countries that have endured adverse effects from JE and allowed them the opportunity to prepare the vaccine for an unparalleled launch in several countries that were particularly hard-hit by the disease, such as Laos and Cambodia.
Every child on this earth has the right to be safeguarded against preventable diseases through vaccination.
Before receiving WHO prequalification, eleven countries outside of China licensed or used the vaccine. 88 million children in India have been vaccinated against JE since 2006. JE has every capability in becoming not only a medical success but also a model in redefining the way our world takes great ideas to scale.
Globally pneumonia remains the single biggest killer of children under the age of five.
Dr Tabish Hazir, Pakistan Institute of Medical Sciences Children’s Hospital Paediatrics Head and Principal Investigator for Acute and Respiratory Illnesses in Pakistan stated that the Pakistani government introduced the pneumococcal vaccine last year in its 'Expanded Programme on Immunisation' making Pakistan the first South Asian nation to provide free vaccination against pneumonia to infants.
Pneumonia claims a child’s life every 30 seconds, making it the principal cause of child mortality. 92,000 children under five years of age die from pneumonia in Pakistan every year. Infants and children younger than two years of age are at a higher risk of contracting pneumonia because their immune systems are still developing.
Every child on this earth has the right to be safeguarded against preventable diseases through vaccination.
Despite the government’s efforts to provide free vaccines for all children, an unavoidable 46% of the child population in Pakistan still has not been immunized. If the endeavour of preventing pneumonia was adopted nationally by all parents, children would not suffer the detriment of these diseases.
Immunization eliminates life threatening, infectious diseases and has proven to be one of the most cost-effective health investments. Vaccines protect children by preparing their bodies to fight many potentially deadly diseases such as smallpox, polio, measles, diphtheria, pertussis (whooping cough), rubella (German Measles), mumps, tetanus and haemophilus influenzae type b (Hib).
Since vaccinations were introduced in Pakistan, approximately 3,000,000 deaths were prevented and 750,000 children were saved from disabilities.
Renowned paediatricians have warned that child mortality cannot be eradicated until routine immunization is raised up to 95% from the existing vaccine coverage of 57.5% in the country.
Pneumococcal conjugate vaccine (pneumonia vaccine) was introduced in Pakistan in October 2012.
The Chairman of the National Immunization Technical Advisory Group, Professor Dr. Tariq Bhutta emphasized the importance of improving routine immunization coverage not only in Punjab but also all over Pakistan, and called for creating awareness among the people for completing the vaccination course of their children against nine vaccine preventable diseases.
Facts about Pneumonia
- 98% of all victims of pneumonia occur in developing countries.
- 151.76 million children contracted pneumonia in developing countries against 4.08 million pneumonia patients in developed countries of the world annually. Out of these at least four million patients, including children, died of pneumonia worldwide.
Mickey Chopra, UNICEF's Chief of Health stated that five simple but effective interventions, if implemented properly, will help reduce the burden of the disease that is responsible for almost 20% of all child deaths around the world:
- Breast-feeding for six months and continued breast-feeding complemented by nutritious solid foods up to the age of two,
- vaccination against whooping cough, measles, Haemophilus influenzae type B (Hib) and pneumococcus,
- safe drinking water,
- sanitation and hand-washing facilities,
- improved cooking stoves to reduce indoor air pollution, and
- treatment including amoxicillin dissolvable tablets and oxygen.
At the Nutrition for Growth Summit last June in London, many countries stepped up to fund country-level plans that will scale up strategies to fight undernourished children.
Since 2011, world leaders have ensured the GAVI Alliance - a public-private partnership that increases access to immunizations in developing countries has the resources required to reach almost a quarter billion additional children in 50 countries with new vaccines, including the Pneumococcal conjugate vaccine (PCV) by 2015.
It was just one year ago that the United Nations commission of experts and leaders created a plan to scale up access to life-saving commodities like amoxicillin, which could save 1.56 million lives if implemented.
The World Health Organization (WHO) and the United Nations Children's Fund (UNICEF) issued a joint statement on December 18th, 2013, confirming there was no evidence of danger of the 5 in 1 Quinvaxem vaccine in Vietnam and other countries.
A recent report citing an adverse event following immunization caused a major concern with parents. At the request of the Vietnamese government, WHO and UNICEF supported an investigation with independent national and international assistance wherein no evidence was found to indicate that the quality or safety of pentavalent vaccine has directly or indirectly led to child deaths following immunization.
Vietnam’s findings were presented at a global meeting of independent vaccine safety experts last June who also considered evidence from Bhutan, India and Sri Lanka. A thorough review concluded there was no evidence to suggest a problem with the safety of pentavalent vaccines in any of the countries.
The statement concluded that when thousands of children are vaccinated on a daily basis, a small number of reports of adverse events are to be expected, i.e. children who receive immunizations while suffering from undiagnosed illnesses such as pneumonia or diarrhea, or serious congenital diseases.
WHO and UNICEF stressed that the chances of dying or suffering from diphtheria, tetanus, pertussis, Haemophilus type B or Hepatitis B are far greater than any possible side effect from the Quinvaxem vaccine.
The Quinvaxem vaccine was included in the national expanded immunization program in Vietnam from June 2010 where 400 million doses have been used in 91 countries worldwide.
Canada has pledged $20 million to increase access to measles vaccines for children in developing countries such as Afghanistan, Pakistan, Chad, the Democratic Republic of Congo, Nigeria and Ethiopia. This pledge is a portion of Canada's commitment to the Muskoka Initiative on Maternal, Newborn and Child Health that was signed by G8 members in 2010.
“Canada is proud to partner with Global Alliance for Vaccines and Immunization (GAVI) to accelerate the introduction of life-saving vaccines for the world’s poorest countries,” said Stephen Harper, Prime Minister of Canada.
“Canada has been a GAVI donor since 2002.”
“We are very grateful to Canada for its commitment,” said Dr. Seth Berkley, CEO of GAVI Alliance. “As a leader of the Muskoka Initiative for Maternal, Newborn, and Child Health, Canada’s support paves the way for the introduction of the combined measles-rubella vaccine that will significantly improve the health of mothers and children.”
Measles causes approximately 430 child deaths every day, predominantly in developing countries. The goal of the Muskoka Initiative is to raise $7.3 billion before 2015.
HPV for Boys in Alberta
A free school vaccination program that includes the HPV (human papillomavirus vaccine) will be administered to 47,500 boys in Grades 5 and 9 in the fall of 2014. The HPV was administered to Grade 5 girls in 2008 in Alberta and since that time, about 61% of girls between the ages of nine and thirteen have received the shot.
HPV infection is associated with a high percentage of cancers of the mouth, nose and throat as well as cancers of the penis and anus in males and cervical cancer in females. It has also contributed to over 90% of genital warts in both sexes.
The Society of Obstetricians and Gynaecologists of Canada has been urging provincial health ministers to include boys in their HPV vaccine programs. Prince Edward Island was the first province to provide the HPV vaccine program for boys.
California Takes a Step Backwards Jeopardizing Children's Health
Governor Jerry Brown (picture below) and the California Department of Public Health are on the verge of taking action that could violate the integrity of California's law, undermine the much-needed effort to get more children immunized and ultimately threaten the health of all children.
California has a religious 'personal belief' exemption that allows parents to opt out of immunizing their children simply by printing out a form and signing it.
While some parents have decided not to vaccinate their children due to ill advised web-based information and others opted out because they simply object to vaccinations, some parents have not vaccinated their children because signing the form was easier than making an appointment for the vaccinations.
Parents who have decided not to vaccinate their children are jeopardizing the health of the entire community – especially infants, other children, the elderly and those with compromised immune systems. Vaccinations are only effective if a high percentage of children are immunized.
In 2010, California experienced the worst whooping cough (pertussis) outbreak in 50 years because clusters of parents refused to vaccinate their children. From 2005 to 2013 'personal belief' exemptions doubled in Marin County, California and as many as 75% of new kindergartners in that county were enrolled with a 'personal belief' exemption.
To increase child vaccination rates Assemblyman Richard Pan, a Sacramento pediatrician, authored the Assembly Bill 2109, which passed the Assembly with broad bipartisan support, and sponsored by the Health Officers Association of California, the California Medical Association, the California Immunization Coalition and the American Academy of Pediatrics. Parents that chose not to vaccinate their children had to procure a form signed by a health professional stating they are aware of the risks and benefits of vaccines.
Although Governor Jerry Brown signed the bill, he directed the Department of Public Health to include a separate religious exemption that would allow parents to sidestep the integral communication they would normally receive from a health care professional about the risks and benefits of vaccines by simply checking a box and rendering AB 2109 ineffective at stopping convenience exemptions.
The Department of Public Health is currently considering what will and will not be included in the form.
What's Next in Vaccines
"Despite ongoing improvements in paediatric vaccination, it is estimated that at least two million children die each year from diseases that could have been prevented by already existing vaccines. This problem is most significant in low-income countries, with the health disparity between rich and poor countries resulting in average life spans of about 77 and 52 years, respectively. In addition to this high death toll, millions more suffer disability and illness because they have not been immunized. Adult immunization is an important, but frequently overlooked, part of patient care. Vaccination programs typically focus on children, yet adults in industrialized countries are more likely to die as a result of vaccine-preventable diseases than are children."
Key issues in the global vaccine market today include product safety, refusal to immunize, supply shortages, the use of vaccines to prevent pandemics and address bioterrorism, and innovations in vaccine delivery systems. Included in this report is current market size and forecast for the following paediatric vaccines: Combinations, Hepatitis, HIB, MMR, Pneumococcal, Poliovirus, Varicella and others.
The following issues are discussed in this report.
- Vaccine Safety
- Refusal to Immunize
- Post-Licensure Surveillance
- The Future of Vaccine Safety
- Vaccine Shortages
- Preventing Pandemics
- Project Bioshield Act
- National Bio and Agro-Defense Facility
- DNA Vaccination
- Mucosal Delivery
- Intranasal Delivery
- Vaccine Patches
- Vaccine Chips and Microneedles
- Innovations in Vaccine Production
- Nanoparticle Systems
Program for Appropriate Technology in Health (PATH) is an international, non-profit organization that transforms global health through innovative technology. Its approach blends the entrepreneurial spirit of business, the scientific expertise of a research institution, and the passion and on-the-ground experience of an international NGO.
PATH has a bold vision where health is within reach for everyone - no matter where they live.
PATH believes that no child should die of a preventable disease, that all mothers should have safe births and healthy newborns, and that every community should have the tools it needs to thrive.
Global Alliance for Vaccines and Immunization (GAVI) is a public-private global health partnership committed to saving children’s lives and protecting people’s health by increasing access to immunization in poor countries.
The Alliance brings together developing country and donor governments, the World Health Organization, UNICEF, the World Bank, the vaccine industry in both industrialized and developing countries, research and technical agencies, civil society, the Bill & Melinda Gates Foundation and other private philanthropists.