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Left) The genetically modified viral protein; the inserted peptides are marked with a blue arrow. (Middle) The viral particle. The blue areas represented the inserted peptides. (Right) The viral particle, with the grey shell representing a layer of calcium phosphate. Credit: R. Tang et al., PNAS.
Millions of deaths happen each year from vaccine-preventable diseases because vaccines break down from heat and developing countries often lack ways to properly refrigerate them. Now researchers suggest eggshell-like coatings can make vaccines more thermally stable.
One NGO in particular, Doctors Without Borders or Medecins Sans Frontieres, is urging drug manufacturers to investigate whether their vaccines can be shipped safely outside the so-called "cold chain" so the vaccines can become more widely available. The cold chain requires that vaccines be kept at a specific, constant, cool temperature until they reach their final destination and is meant to prevent spoilage and ensure that the medicine remains effective. The inability to keep some vaccines in the cold chain leads to vaccine shortages, causing 1-in-5 children under the age of 1 to miss the full schedule of vaccinations each year, said MSF.
Because most vaccines are produced by Western drug manufacturers, keeping the vaccines refrigerated is not a problem in developed countries, said Kate Elder, vaccine adviser to MSF. But when you get into countries like Chad and Democratic Republic of the Congo and South Sudan, where electricity is scarce and where roads are very poor and transportation very difficult, it becomes a huge challenge to keep these relatively fragile commodities cold all the way through to areas where kids need them," Elder said. So MSF is urging drug manufacturers to re-evaluate vaccines to see whether they can be kept stable at temperatures up to 40 degrees Celsius.
A Syrian girl cries after receiving the measles vaccine from UNICEF nurses Nadine Houjairi (2nd R), and Genivieve Bashalani (R) at the U.N. refugee agency's registration center in Zahleh, in Lebanon's Bekaa Valley
Researchers determined that one vaccine used to prevent meningitis A in children in sub-Saharan Africas so-called meningitis belt remains effective without refrigeration for up to four days. MenAfriVac was relicensed by regulators in 2012. MSFs research arm in France, Epicentre, recently conducted a study of Serum Indias tetanus toxoid vaccine in Chad. Epicentre found the vaccine retained its potency for up to one month at temperatures up to 40 degrees Celsius, providing the same level of protection as vaccine kept in a strict cold chain.
Elder said the results suggest that other immunization drugs probably do not need constant refrigeration to be safe and effective. A number of these vaccines might actually be more thermo-stable than what they are labeled for at refrigeration requirements of 2 to 8 degrees Celsius. So, what we are doing is pushing the manufacturers - the companies that make these products - to make sure that we can use them to that utmost thermo-stable potential," she said. MSF is urging drug companies to take the lead in generating data to show that vaccines are heat-stable and can be safely transported outside the cold chain. This would allow vaccines to be relicensed for use in remote parts of Africa and other regions where there is a lack of reliable refrigeration.
NGO Seeks Vaccines That Don't Need to Be Kept Cold
The international push to eliminate polio has put this disease on the verge of eradication worldwide. When that happens, no one will ever suffer paralysis or death from polio again. India is the latest country to become polio free. The GAVI Alliance GAVI Alliance is one of the organizations that gets vaccines to children in developing countries. Dr. Seth Berkley, GAVI's chief executive officer, said, "Since weve started, weve immunized more than 440 million children and have prevented more than 6 million deaths. The challenges that are still in front of us is that there are still about 22 million children that are not fully immunized."
The World Health Organization reports that immunization prevents 2 to 3 million deaths per year from childhood diseases and two types of cancer. This year, the WHO is encouraging people to make sure their family's immunizations are up to date. And while most parents in developing countries want their children immunized, a growing number of parents in Western countries are choosing not to. Steve and Victoria Carrico are among them. Like most parents who choose not to vaccinate their children, the Carricos say they are concerned about possible side effects.
At the U.S. National Institutes of Health, Dr. Anthony Fauci said that in developed countries, the success of vaccines has been their downfall. "Years and years ago, when there were many children throughout the world -- developed countries and developing nations -- getting ill and dying or getting maimed from diseases like polio, measles, mumps, rubella, haemophilus. Vaccinations were so successful in decreasing the burden of disease that people now, when they think about vaccinations, they think about the very rare event of a possible adverse event from a vaccine, and shy away from vaccines, thinking that vaccines are the problem when in fact, vaccines are preventing us from getting very serious illness," said Fauci.
Berkley said money spent on vaccines means less money is needed to treat disease and disability. "Vaccines are among the most effective and cost effective interventions that exist," he said. Berkley says some parents worry that a vaccine might be damaged if it is not properly refrigerated. He said such a situation might make the vaccine ineffective, but it is not likely to be harmful.
Success of Immunizations Becomes Its Weakness
Although so-called immunotherapy drugs from the likes of Merck & Co, Bristol-Myers Squibb and Roche are starting to revolutionize cancer care, they still only work for a limited number of patients. By adding a personalized cancer vaccine, scientists believe it should be possible to improve substantially the effectiveness of such immune-boosting medicines.[ Twelve skin cancer patients, out of a total of 19 across both the trials, avoided relapses for two years after receiving different vaccines developed by German and U.S. teams, researchers reported in the journal Nature on Wednesday.
Larger studies are next
The small Phase I trials now need to be followed by larger studies, but the impressive early results suggest the new shots work far better than first-generation cancer vaccines that typically targeted a single cancer characteristic. The new treatments contain between 10 and 20 different mutated proteins, or “neoantigens,” that are specific to an individual's tumour. These proteins are not found on healthy cells and they look foreign to the immune system, prompting specialist T-cells to step up their attack on cancer cells. One vaccine was developed at the U.S.-based Dana-Farber Institute and Broad Institute and the other by privately-owned German biotech firm BioNTech, which uses so-called messenger RNA to carry the code for making its therapeutic proteins.
A health agent prepares a vaccine during a campaign of vaccination against yellow fever in Rio de Janeiro, Brazil
Roche, the world's largest cancer drugmaker, is already betting on BioNTech's technology after signing a $310 million deal last September allowing it to test the German vaccine with its immunotherapy drug Tecentriq. BioNTech's co-founder and CEO Ugur Sahin told Reuters that combination trials using Roche's drug were due to start later this year against a number of different cancers. Rival biotech firm Neon Therapeutics, which was formed to exploit the U.S. research, initiated tests of its personalized neoantigen vaccine in combination with Bristol-Myer's Opdivo drug last year.
Expensive treatment
New drugs like Opdivo and Tecentriq that enlist the body's immune system are improving the odds of survival, but their typical price tag of more than $150,000 a year is controversial and adding a personalized vaccine will jack costs up further. Sahin acknowledged such vaccines would be expensive at first but said costs could be brought down by economies of scale and automation. “In the mid to long term the cost will fall dramatically ... it is an individual treatment but it is a universal process,” he said. “We are at a very early stage at the moment but in the long-run this approach could change everything.”
Potential confirmed
Cornelius Melief of Leiden University Medical Center, who was not involved in either study, said the research confirmed the potential of neoantigen vaccines. “Controlled, randomized Phase II clinical trials with more participants are now needed to establish the efficacy of these vaccines in patients with any type of cancer that has enough mutations to provide sufficient neoantigen targets for this type of approach,” he said. Mainz-based BioNTech is one of Europe's largest private biotech companies, with more than 500 employees and deals with Sanofi and Eli Lilly, as well as Roche. It is majority-owned by twin brothers Andreas and Thomas Struengmann, who sold generic drugmaker Hexal to Novartis in 2005. Sahin said BioNTech would probably stay private for another two to four years before deciding on an initial public offering.
Personalized Vaccines Hold Cancer at Bay in Two Early Trials
