Vaccine Briefs

Ushering in the Decade of Vaccines

The Bill & Melinda Gates Foundation, which has made disease prevention a cornerstone of its philanthropic efforts, announced a US$10 billion commitment over 10 years to fund research, development, and distribution of vaccines to people in the world’s poorest countries. The Chronicle of Philanthropy said it was the largest pledge ever by a grant-maker for a specific cause.

The $10 billion pledge is in addition to the $4.5 billion already committed by the Gates Foundation for research and development of new vaccines—including AIDS vaccine research—and delivery of existing vaccines. The Foundation said its increase in vaccine funding was inspired by the remarkable progress in recent years in improving access to existing vaccines and the introduction of new vaccines against rotavirus and pneumococcal disease. The World Health Organization estimates that pneumonia and rotavirus infection, a cause of severe diarrhea, together account for 1.3 million deaths every year in children under age five, mostly in developing countries.

“We must make this the decade of vaccines,” said Bill Gates, after he announced the substantial donation during the World Economic Forum’s annual meeting in Davos, Switzerland, which took place from January 26-31. “Vaccines already save and improve millions of lives in developing countries. Innovation will make it possible to save even more lives.”

Julian Lob-Levyt, executive secretary of the GAVI Alliance, a Geneva-based non-profit organization that partners with drug companies, health agencies, and charities to provide both financial and programmatic support for vaccination programs in 73 of the poorest countries in the world, noted that the Foundation’s $10 billion pledge set a new precedent in global health.

“This is a fantastic announcement,” says Lob-Levyt. “It gives us great momentum.” But Lob-Levyt also warned that this funding won’t be enough. He said he hoped the Gates pledge would spur other public and private donors to expand their support. “Vaccines remain the most cost-effective way of saving children’s lives,” says Lob-Levyt.

The decision to pour more money into vaccines is based on mathematical models that suggest scaling up the delivery of life-saving vaccines in developing countries to 90% coverage—including the new rotavirus and pneumococcal vaccines—would prevent the deaths of an estimated 7.6 million children under age five by 2019. The Gates Foundation also estimates that an additional 1.1 million children could be saved with the rapid introduction of a malaria vaccine beginning in 2014. A Phase III efficacy trial of GlaxoSmithKline (GSK) Biologicals’ RTS,S malaria vaccine candidate began last year. If the results of this trial are encouraging, the candidate vaccine could be submitted to the European Medicines Agency for regulatory review by 2011 and be ready for distribution by 2012, according to GSK and the Malaria Vaccine Initiative.

Lob-Levyt stressed that a portion of the Gates Foundation’s latest commitment will be used to support the search for new vaccines, including AIDS vaccine research, although he said it is not known at this point how much of the money will go to research into new vaccines and how much will be spent on expanding access to existing vaccines. —Regina McEnery

Journal Retracts Controversial Article that Spurred Anti-vaccine Sentiment

A controversial 1998 research paper in The Lancet that attempted to link the onset of a number of behavioral symptoms with the mumps, measles, and rubella (MMR) vaccine in a handful of children—prompting an abrupt decline in childhood immunizations—was retracted after a UK panel determined that the authors who conducted the study acted unethically (1).

A one-paragraph statement released by the editors of The Lancet on February 2 said the judgment by the UK General Medical Council’s Fitness to Practice Panel in January prompted their decision to retract the paper (2). “It was utterly clear, without any ambiguity at all, that the statements in the paper were utterly false,” Richard Horton, editor-in-chief of The Lancet told the British newspaper The Guardian in February, the same day his journal issued the retraction. “I feel I was deceived.”

The 1998 research paper described an unexpected pattern of chronic enterocolitis in 10 of 12 children with developmental disorders. The authors of the study said the intestinal lesions occurred, in most cases, after the children received the MMR vaccine, which is typically given by 15 months of age. The paper also cited previous, unrelated studies that attempted to link patterns of colitis and another intestinal disorder, ileal-lymphoid-nodular hyperplasia, with sudden behavioral changes, including development or autism spectrum disorders in young children.

The study did not prove any causation between vaccination against MMR and intestinal disorders. Yet, Anthony Wakefield, a researcher from the Royal Free Hospital and School of Medicine in London who led the study, held a press conference following publication of the study, at which he urged parents to shun the combination MMR vaccine in favor of having their children vaccinated with the three vaccines individually, with a year interval between each dose. Ten of the paper’s 13 authors—not including Wakefield—submitted a partial retraction in 2004 saying they felt research into the intestinal lesions should continue, but stressed that the paper established no causal link between the MMR vaccine and autism (3). “The possibility of such a link was raised and consequent events have had major implications for public health,” the authors wrote in the retraction.

The controversial paper is widely credited with sparking an anti-vaccination movement that resulted in declines in immunizations, particularly in the UK. In 1997, the year before the study was published, 91% of children in the UK were vaccinated. In 2003, the rate had dropped to 60% in some parts of the country.

Following the retraction by The Lancet in February, the US Centers for Disease Control and Prevention (CDC) released a statement reminding parents that vaccines are safe, effective, and that they save lives. “The Lancet’sretraction of Dr. Wakefield’s study is significant,” the CDC noted. “It builds on the overwhelming body of research by the world’s leading scientists that concludes there is no link between the MMR vaccine and autism.”

Jerome Kassirer, editor-in-chief of the New England Journal of Medicine from 1991-1999, said this was an unusual and unfortunate event. “It terrifies me that people are scared of vaccinating their children. There is a lot of fear and I think it is all a manifestation, in large part, of irrational reasoning,” said Kassirer. —Regina McEnery

1. Lancet 351, 637, 1998
2. Lancet 375, 445, 2010
3. Lancet 363, 750, 2004 

2011 US Budget Proposal Calls for Increase in HIV/AIDS Spending

Despite a three-year spending freeze being sought for many of the country’s domestic programs, US President Barack Obama unveiled a US$3.6 trillion budget proposal for fiscal year 2011 that includes a $1.2 billion increase in HIV/AIDS spending. The US Congress will consider the proposed budget request during a series of hearings later this year, and is expected to finalize the 2011 budget before it kicks in on October 1, 2010.

The $27.2 billion being sought for HIV/AIDS programs includes $2.7 billion for AIDS research allotted to the US National Institutes of Health (NIH)—a 3.1% increase from the 2010 budget—most of which will be allocated to the National Institute of Allergy and Infectious Diseases (NIAID). Obama’s budget proposal also allocates $4.8 billion in funding for NIAID, a 3.3% increase from this year. How much of that will be directed to AIDS vaccine research is unclear; however, NIAID has indicated in its 2011 budget justification document that there will be a “renewed focus” on vaccine discovery research and “continued support for the research of HIV pathogenesis, including the search for novel approaches that interrupt HIV transmission and studies that take a systems biology approach to understand the complex interactions between HIV and the immune system.”

Obama’s proposed budget also reflects an increased allotment for domestic HIV/AIDS programs, including a $31 million increase for HIV prevention programs at the US Centers for Disease Control and Prevention, a 4% increase over this year, as well as $9.6 billion for global health funding—a 9% increase from 2010. This includes a 2.6% increase in funding for the President’s Emergency Plan for AIDS Relief (PEPFAR), the mammoth HIV prevention, treatment, and care program that has brought ARV therapy to 2.4 million people in 30 countries.  PEPFAR, which was begun under the previous administration, is the main plank in a $63 billion Global Health Initiative (GHI) that was announced shortly after Obama took office in 2009. 

The GHI aim is to put more than four million people on ARVs and prevent more than 12 million new HIV infections by 2014.  But the premise of the GHI is also to take a more integrated approach to global health, and to tackle other global problems such as reducing maternal mortality, improving childhood nutrition, and combating neglected tropical diseases.

At the recent 17th Conference on Retroviruses and Opportunistic Infections in San Francisco, US Global AIDS Coordinator Eric Goosby said PEPFAR is the cornerstone of GHI, but he said the time has come to shift PEPFAR out of an “emergency response and into a more sustained response.”

“We hope to begin to talk about a shared responsibility and a global responsibility in the move to universal access,” said Goosby, during his address.

But groups advocating for increased spending for HIV/AIDS say the amount of money the Obama administration intends to spend next year, particularly to combat the AIDS pandemic in developing countries, is not enough. “PEPFAR has been a forceful engine driving down AIDS mortality, heading off new infections and extending lifesaving drugs to millions of HIV patients,” said Kenneth Mayer, co-chair of the Center for Global Health Policy’s Scientific Advisory Committee.  “Unfortunately, this budget could imperil the fragile gains made over the last decade in treating HIV. It could also force a Sophie’s Choice between prevention and treatment.” —Regina McEnery