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Vaccines — Where are we headed?
Anthony S Rebuck
Head, Strategic Drug Development, Quintiles, Asia

A lmost 250 years after Edward Jenner inoculated a young boy with pus from the hand of a milkmaid who had cowpox, vaccines continue to make headlines.

The latest news comes from the US Center for Disease Control and Prevention (CDC) which reports that over 2011-2012, the flu infection rate was about half of that of the previous year. It appears that H1N1 and H3N2 virus circulations have shown low levels of activity and there has been a good match between the vaccines and the circulating strains. It has thus become the accepted practice to administer flu vaccines to children ages six to eight years.

Good news concerning vaccines continue to feature in the popular media, almost but not quite balanced by doom and gloom reports of vaccine-induced disasters accompanied by dire warnings and ongoing controversies. First the good news:

Vaccines improve immunity to particular and specific diseases. The altered form of microorganism that comprises the vaccine stimulates the immune system to recognize the agent as foreign, then to remember it, and finally to destroy it. The process is repeated if and when the immunized person later encounters the unaltered disease-causing microorganism. Vaccines cannot guarantee complete protection from the disease as the immune system in some individuals may not respond adequately or the quality of the vaccine might not be ideal. Nevertheless, their ability to prevent vaccine preventable diseases (VPDs) has been reflected in a 99% drop in polio since 1988, and a 78% decrease in measles deaths in the last decade. Whereas in 1988 there were approximately 350,000 cases of polio worldwide, there are now less than 1,300.

Sadly, it is estimated by the WHO that 8.8million children under five years of age die each year, mainly in poor countries. This horrific toll could be reduced by 2 million with more widespread use of available vaccines. Such preventable culprits include tetanus, rotavirus, pneumococcus, human papilloma virus, haemophilus influenzae, hepatitis, rubella, encephalitis, cholera, yellow fever and meningococcus. Access to such vaccines requires the establishment of adequate supply, cooperation in reaching targets and of course appropriate financial support.

The bad news, aside from the documented underuse of pneumococcal conjugate, meningococcal and rotavirus vaccines, is the shrill voices that would recommend they not be used at all. The headlines are frequent, repetitive, emotional and persistent. They range from a denial of disease risk, a claim that most diseases are relatively harmless, that there is inadequate research to support any immunity benefit beyond ten years, and the hottest debate of all –Adverse Vaccine Reactions. Cases have been presented of children who exhibited vaccine reactions that resulted in death within hours of receiving a vaccine. Vaccines have been blamed for Sudden Infant Death Syndrome (SIDS), autism, diabetes, brain damage and auto-immune disease. Are these reports merely anecdotes, or are they related to coincidental upsurges in some diseases? Perhaps they relate to vaccines being cultured in monkeys, the introduction of foreign proteins or other excipient chemicals such as stabilizers and antibiotics. Furthermore, there is the troubling issue of herd immunity, in which those in favor of vaccination have the objective of protecting the population as a whole. Some parents choose to make decisions purely for their own family; they question and indeed resent ‘sacrificing’ their own children for the good of the community.

The battle lines have now become clearly identified. On one side are the aligned troops comprised of the majority of medical doctors, the pharmaceutical companies and the CDC. Across the divide are some doctors and researchers, many alternative medicine practitioners, some religious groups and most deserving of our respect and concern, parents who are convinced that children have been harmed by vaccines. These parents firmly believe that they are not adequately given the opportunity for informed consent. They quite reasonably dislike being pressured by laws requiring vaccination, school admission requirements and threats of being turned in to Child Protective Services if they neglect their children’s vaccinations. Since society as a whole is only protected if nearly everyone gets the standard vaccines, they must be promoted to the public in a fully honest way. Regrettably, much of the material that parents might access to inform themselves is presented inaccurately or is distorted to the extent of being deceptive. Both the National Vaccine Information Center and CDC give balanced views, albeit opposing ones. Many of us used Robert Mendelson’s “How to raise a Healthy Child” as a good starting point for self education on the vaccine dilemma.

Each side argues passionately and persuasively. How can one ignore such articles as “Many vaccines are expired or improperly stored” from a US Government report, or “Vaccine madness: New mumps jab cultured from dog kidneys linked to canine allergies” blaming an unlicensed vaccine shipped into the UK? A parent can be forgiven for being concerned after reading that “Breast feeding can transmit dangerous vaccine viruses to newborns” in the Canadian Medical Association Journal (CMAJ). In a recent article published in a Natural Health brochure, readers were asked whether most United States citizens would opt out of getting vaccines if they knew that ‘modern-day vaccines have their root in Nazi medical experiments’. The most passionate anti-vaccine view would argue that toxic poisons injected into the body of humans to save lives is pure brainwashing by the medical community, qualifying as ‘the greatest health lie from Medicine’.

On the other hand, using Evidence Based Medicine as a guide would permit the conclusion that any risk or harm caused by vaccines is much less than the risk of harm from the disease itself. Many diseases we vaccinate against such as diphtheria, hepatitis B, measles, meningococcus, tetanus, whooping cough and the flu can kill or cripple children and adults and did so frequently before we had the vaccines. In the past, whereas most vaccines were aimed at children, future vaccines will target adults. We can look forward to seeing combinations of vaccines with five or more components. Eventually we will not even have to fear needles as the vaccines will be administered by skin patches and aerosols. We will be protected against the modern threat of bioterrorism which may try to use anthrax, plague and smallpox against us. In the near future we can even look forward to vaccines against HIV, malaria, tuberculosis and even hypertension.

With these developments, the global vaccine market is expected to grow from US$24billion in 2009 to US$56billion by 2016. The innovations, research and development will be conducted by the giant multinational companies, contract research organizations and in the early stages of preclinical and clinical development by biotechnology companies. Hundreds of millions of dollars will be invested in developing new vaccines with governments supporting the efforts through subsidies, rebates and tax exemptions. The prices of vaccines will continue to be related more to what the market can bear than the cost of production.

Asia is an area of special importance for travelers. Every backpacker will, or should know that they need to be immunized against diphtheria, polio, tuberculosis (BCG), Hepatitis A and B and Japanese B encephalitis. Many will have tried the berry flavored cholera drink and will have taken yellow fever and polio vaccines. For those exploring rural India, rabies vaccination is a worthwhile strategy as is tetanus for anyone contemplating snorkeling or motor cycle riding.

The challenge, therefore, is to develop vaccines and make them available where they are needed most. Diseases such as HIV, malaria and tuberculosis exist principally in poorer countries. Quintiles is a preferred provider to a consortium of 14 global health product development partnerships (PDPs) funded in part by the Bill and Melinda Gates Foundation.

If one can accept the evidence that overwhelmingly supports the benefit of vaccines, then the crux of the most important challenge we face is surely to reconcile the irony that pharmaceutical companies have little incentive to develop vaccines for these diseases due to:

  1. The minimal financial returns.
  2. The high risks.
  3. The inestimable stakes for global consciousness and harmony.

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