Breakthroughs Blog: Vaccines

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Last April, Representatives Fred Upton (R-MI) and Diana DeGette (D-CO) launched the 21st Century Cures initiative, holding hearings and consultations to identify ways that Congress can accelerate Americans' access to new treatments from the development to delivery stage. A discussion draft of the legislation was released last week by Republican members of the House Energy & Commerce Committee. Senator Lamar Alexander (R-TN) announced on Thursday that the Senate Health, Education, Labor and Pensions committee will release legislation to complement the 21st Century Cures Act, stating that “One of the committee’s top priorities this year will be modernizing the Food and Drug Administration [FDA], helping to get treatments and medicines to patients as quickly and as safely as possible.” President Obama submitted his annual budget request to Congress yesterday, in which he asked for US$1.2 billion to fight antimicrobial resistance. This funding would be invested into developing new antibiotics and diagnostics, monitoring drug-resistant infections, and preventing the spread of resistant “superbugs,” particularly in healthcare settings. Obama also asked for $280 and $77 million, for the Centers for Disease Control and Prevention and FDA, respectively, to combat the overuse of antibiotics in both humans and livestock. Last week witnessed major wins for vaccine development and access. The US Agency for International Development announced that the US Government will commit $1 billion to Gavi, the Vaccine Alliance, over the next four years. Pfizer, Inc., a major American pharmaceutical company, pledged to reduce the price of its pneumococcal vaccine by 6 percent in poor countries. The announcement has been greeted with disparate responses. Kate Elder, a vaccines policy advisor at Doctors without Borders called the price cut "tiny" and "inadequate," however Bill Gates warned that such criticism discourages pharmaceutical companies from investing into the research and development of drugs for developing countries. Serum Institute of India is currently developing several products intended to rival existing vaccines and to be sold at significantly lower prices. The Institute’s human papillomavirus vaccine could be available as early as 2018, and the manufacturers plan to sell it at one-third of the price of Merck & Co.’s Gardasil vaccine.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Johnson & Johnson announced that it will share detailed information on its clinical trials through Yale University’s Open Data Access Project. This will include data on all Johnson & Johnson medical devices, diagnostics, and drugs approved since the beginning of 2014. "An open data movement is really gaining momentum," according to Dr. Victor Dzau, president of the Institute of Medicine, however "we need to develop a culture that supports data sharing, and we need to provide incentives and develop trust." The European Medicines Agency, which regulates drug approvals in Europe, is also contributing to the open data movement, and plans to publish detailed data for all new drugs approved by the agency. The Japan Times took an in-depth look at the Global Health Innovation Technology Fund (GHIT), a Tokyo-based member of the Global Health Technologies Coalition and a partnership between the Japanese government, five major pharmaceutical companies, the Bill & Melinda Gates Foundation, and the United Nations Development Program. GHIT seeks to promote the research and development of treatments for infectious diseases by subsidizing the costs for biotech companies and facilitating partnerships between the private and public sector. The Fund has contributed to the development of 30 drugs since its establishment in 2013, including several neglected tropical diseases such as leishmaniasis, schistosomiasis, and dengue fever. The ONE blog identified five major, deadly diseases for which vaccines are currently being developed. The blog highlights challenges to development and provides updates on leading vaccine candidates for HIV and AIDS, Malaria, Tuberculosis, Ebola, and cancers, including liver cancer caused by hepatitis C.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Kathy Neuzil, director of Vaccine Access and Delivery at PATH, reflects on the lessons learned from Meningitis Vaccine Project (MVP) in light of the achievement of its final milestone: World Health Organization prequalification of an infant version of the meningitis A MenAfriVac® vaccine. MenAfriVac® was approved for people aged 1 to 29 years in 2010, and has since been used to effectively protect 215 million people in sub-Saharan Africa. Neuzil attributes MVP’s success to the tenacity of its team and the inclusion of country partners at every stage from product development to distribution. A new type of antibiotic may be the key to treating drug-resistant infections, according to a study published in Nature last week. The antibiotic, teixobactin, was extracted from dirt, and fights infections by targeting the fatty molecules that bacteria use to build their cell walls. While most antibiotics target the bacteria’s DNA, which can be easily mutated, the study’s lead researcher, Kim Lewis, believes it would take at least 30 years for the fatty molecules to mutate and thus develop resistance to teixobactin. The antibiotic has been successfully tested on mice with no side effects, and could be available for use in humans in five to six years. Johnson & Johnson has started human trials of an experimental Ebola vaccine in the United Kingdom, and hopes to expand testing to approximately 2,000 people by mid-February. Johnson & Johnson has produced over 400,000 courses of the vaccine and has invested significantly in the Danish pharmaceutical company Bavarian Nordic to develop a booster shot to enhance the efficacy of the vaccine and to promote long-term protection against Ebola. Dr. Margaret Hamburg, commissioner of the Food and Drug Administration (FDA), sat down with Ryan Hohman of Friends of Cancer Research last week to discuss hot topics in FDA drug policy. Hamburg affirmed the FDA’s commitment to expediting research and development of new treatments, stating that in this “critical time for biomedical research and innovation” the FDA has a role to play in “translating all of the exciting new discoveries and opportunities and science into real world products that matter for people.”

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. According to a recent study out of Oxford University, rapid evolution of the HIV virus is slowing the virus’s ability to cause AIDS. In this study of 2,000 women in South Africa and Botswana, researchers found that the HIV virus had evolved to adapt to a specific gene known as HLA-B*57, which provides some protective effect against HIV, slowing the progress to AIDS. As the virus has adapted to reduce this protective effect in individuals, the virus has also reduced its ability to replicate, making it less virulent over all. Last Thursday, the UN Secretary-General launched his synthesis report for the sustainable development goals. In this report, Secretary General Ban Ki-moon reaffirmed his support for the 17 goals and 160 targets proposed by the United Nations Open Working Group, despite concerns from some member states that the current list is too long. Of the 17 proposed goals, two contain targets related to the research and development of new technologies. Researchers are developing a powdered form of the measles vaccine which could make it easier and safer to deliver the vaccine to people in developing nations. The current FDA-approved measles vaccine is a live virus that has been freeze-dried into a powder, which requires reconstitution with water before being administered via syringe. The new vaccine under development is a powder that can be inhaled. This new formulation would eliminate the need for sterile water and needles, as well as cold-chain storage. A modified regimen of the HIV vaccine candidate RV144 was shown to be safe and capable of inducing a robust immune response in safety trials in South Africa. RV144—which was developed by the US and Thai military—showed early promise in clinical trials, but it was found to lose efficacy over time. This new regime is the same earlier RV144 vaccine regime with an added booster shot one year later. Further clinical trials of this new regime are set to begin in South Africa in early 2015.