A vaccine is a biological preparation that provides active acquired immunity to a particular infectious disease. A vaccine typically contains an agent that resembles a disease-causing microorganism and is often made from weakened or killed forms of the microbe, its toxins, or one of its surface proteins. The agent stimulates the body’s immune system to recognize the agent as a threat, destroy it, and to further recognize and destroy any of the microorganisms associated with that agent that it may encounter in the future.
Vaccines are one of the biggest successes in modern medicine. They save up to 3 million people worldwide every year and protect millions more from disability and suffering. But the bar to create new vaccines is now higher than ever. Developing a vaccine is expensive and it can take a long time. From research and discovery to product development it can cost up to a billion dollars to make one vaccine and that process can last up to 15 years. The overall revenue of the pharmaceutical industry worldwide is over a trillion dollars while the vaccine market is only about 37 billion dollars.
History of vaccine
The genesis of modern-day vaccines began in 1796 when an English doctor took on smallpox. Dr. Edward Jenner observed that milkmaids who suffered the mild disease cowpox never contracted smallpox. Jenner experimented. He took material extracted from a cowpox sore on the hand of a milkmaid and inoculated it into the arm of an eight-year-old boy. The precursor to the smallpox vaccination was born.
Despite Jenner’s discovery, the 20th century saw smallpox wipe out an estimated 300 million people worldwide. Tens of thousands of children also died in the U.S. each year from diseases like whooping cough, diphtheria, and polio. Since their mass introduction following World War Two vaccines has saved millions of lives. Vaccines and have been one of the greatest public health success stories the world has seen. You know after clean water vaccines have saved more lives over the last century than any other intervention. There are many streams of medicines ranging from ancient methodologies like Ayurveda to more recent ones like Homeopathy, Allopathy etc but vaccines are a class apart because they operate on totally different level.
Who makes vaccines?
Historically vaccines were produced at a low price and sold at a low-profit margin. They were so low that many companies stopped producing them. In the 1960s more than two dozen companies produced vaccines. Those two dozen companies dwindled to just a handful. There are other players in the space but the four big drug companies that now dominate the market are Pfizer, Merck, Sanofi Pasteur, and GlaxoSmithKline.
Pfizer had vaccine sales of just over six billion dollars in 2018. Overall revenue with the company in 2018 was more than 50 billion dollars. Pfizer is best known for making Viagra and Lipitor but the company’s best selling product in terms of sales is a vaccine called Prevnar 13 which protects against pneumonia and meningitis.
The second is Merck and in 2018 Merck had vaccine sales of over 7 billion dollars. Merck’s top-selling vaccine Gardasil fights HPV the most common sexually transmitted infection in the U.S. that can sometimes cause cancer. The third vaccine maker is French drugmaker Sanofi. Its vaccine division Sanofi Pasteur’s two top-selling vaccines are a polio vaccine for emerging economies and a seasonal flu shot. Total vaccine sales were almost 6 billion dollars in 2018. And the fourth is GlaxoSmithKline sold 770 million doses of vaccines around the world in 2018 and had vaccine sales of over 7 billion dollars.
Making vaccine is tough
A vaccine works by triggering the body’s immune system to fight disease. Molecules from pathogens are injected into the body. The immune system recognizes the hostile intruder produces antibodies and remembers them for the future. There are enormous about a risk of investment with vaccines that generally goes beyond that for a drug. Compared to drug vaccines are tough to make.
Vaccine manufacturing and research process is an extraordinarily complex process. When you start back in basic research scientists are understanding those underlying mechanisms of protection and trying to decipher what the best approach is for a vaccine. Broadly speaking there are two main types of vaccines. The first is a preventive vaccine like a flu shot or a measles vaccine. It can prevent a disease you might get in the future. The second is a therapeutic vaccine that is given to people after the infection occurs. It stimulates your immune system to fight back.
The vaccine process starts in the lab where researchers gather data and test for safety. Clinical development is a three-phase process where trials are conducted in the lab on animals and later with large groups of people. The cost of the overall development of a typical vaccine is generally over a billion dollars to develop. Following clinical trials, the vaccine moves to the manufacturing stage. The lead time to build or establish a manufacturing facility that can make vaccine products is usually at least three years but it could be as long as five years.
Cost of vaccine
Vaccines like the flu shot often deal in high volume and low margins. But there are a few big factors that have been driving the price of vaccines higher in recent years. The price of vaccines is also on the rise because of upgrades to older vaccines. In 2001 the MMR vaccine made by Merck sold for 28 dollars a dose. The 2019 version of the same vaccine sold for 75 dollars. A dose of separate MMR vaccine that also includes chickenpox sells for over 200 dollars.
Patents don’t play nearly as big a role as you might think when it comes to vaccination pricing. Vaccines are very different and can have as many as 15 to 20 components that present complex technical challenges and require multiple patents. They also require large scale manufacturing facilities with the ability to produce vaccines in large volumes.
There are other manufacturers largely based in India and China who do produce other typical childhood vaccines like polio, measles. But often their production volumes are directed to their countries rather than the US. Essentially, when a big pharma company loses its patent or a combination of patents, that doesn’t mean the market is suddenly flooded with generic competitors.
Every year, 85 percent of the world’s children receive vaccines to protect them against tuberculosis, polio, and measles. Despite this, more than 3 million people die from vaccine-preventable deaths each year. Even in the U.S., about 100,000 young children have not received vaccinations for any of the 14 diseases that were recommended.
The U.S. government provides free vaccinations but some families may lack access to health clinics or don’t understand their importance. People with compromised immune systems could get sick if they receive a vaccination. And a few are intentionally not vaccinating their children. Parents in 17 states could opt out of vaccinating their kids for personal or philosophical reasons.
Over the past decade, the number of Americans who consider vaccines, for things like polio and measles to be vital to public health, has fallen by 10 percent. According to doctors vaccination rates dropped after anti-vaccination pamphlets were distributed. Those pamphlets say that vaccines are made from ingredients that include human cells from aborted fetuses, rabbit brain, and monkey kidney.
Future of vaccines
Globally some countries are making big gains like in Australia vaccination rates climbed after the government instituted a policy depriving families of a child benefit payment if their children were not vaccinated. Cervical cancer there could be eliminated in the next two decades thanks to vaccination efforts targeting the HPV infection.
In poor countries with severely underfunded health budgets, external donors and governments often provide critical funding for vaccine programs. The Bill and Melinda Gates Foundation donated more than 10 billion dollars to help organizations to increase access to immunization. Bill Gates says the gamble is paying off on a couple of different levels.
But critics argue that the pharmaceutical industry has neglected disease in poor countries and has invested too little in research and development in those areas. About 37 million people are living with HIV in 2019 and nearly one million people die for the disease every year. Two-thirds of people living with HIV reside in sub-Saharan Africa. A lot of big pharma has dropped out of HIV vaccine research.