More than six months into the COVID-19 pandemic, all eyes are on biopharma companies to deliver a safe and effective vaccine and to do so at record-breaking speed. To truly understand how colossal of a feat this is, we look at the vaccines that changed history and how they compare to the innovation of today.
Smallpox was one of the deadliest diseases known to humankind. While its origin is largely unknown, the earliest written description of a disease that resembles smallpox dates back to the 4th century. Centuries later in 1796, Edward Jenner observed that milkmaids who previously caught cowpox did not catch smallpox. Using this observation, he demonstrated that “inoculated vaccinia protected against inoculated variola virus” and introduced the smallpox vaccine – the first successful vaccine. People were vaccinated through “arm-to-arm inoculation,” taking fluid from a blister of someone infected with cowpox and injecting it into another person’s skin. Smallpox remained widespread until 1966 until it was officially declared eradicated on May 8, 1980 – one of the greatest public health victories of our time. But the history of this disease also demonstrates just how long it can take to research, develop, and produce an effective vaccine. Like smallpox, many other notorious viruses articulate a similar story.
At the height of the polio epidemic, parents lived in fear for their children. The first major epidemic in the U.S. occurred in 1894 and by the late 1940s, polio outbreaks in the U.S. increased in frequency and scope, affecting more than 35,000 people each year. Research for a vaccine began in the 1930s, but early attempts were rendered unsuccessful. Nearly two decades later, Jonas Salk introduced an effective vaccine, the inactivated polio vaccine (IPV), in 1953. Clinical trials for the vaccine began in 1954, enrolling over one million schoolchildren, and in April 1955 it was announced that the vaccine was safe and effective, sparking a nationwide inoculation campaign.
Salk’s vaccine was unique – unlike vaccines that used a weakened version of the live virus, like the vaccines for measles or mumps, the polio vaccine used an inactivated version. Because the immune system cannot distinguish between an activated virus and an inactivated one, when someone was injected with the polio vaccine the immune system still recognized the intruder and created antibodies to protect that person from future infections. Despite Salk’s resounding success, it took roughly 20 years from when research first began to develop an effective polio vaccine. Though polio has not been completely eradicated, cases have decreased by over 99% since 1988 because of widespread vaccination. Contrary to this virus and smallpox, influenza cases spike every winter with vaccines serving as a means for yearly protection, versus a one-time solution.
The flu has been around for over 100 years. In fact, the first mention of influenza appeared in a public health report during the 1918 flu pandemic. Roughly 20 years later and with the support of the U.S. Army, Thomas Francis, Jr. and Jonas Salk – the same doctor that developed the polio vaccine – developed the first inactivated flu vaccine using fertilized chicken eggs, the same method used to produce most flu vaccines today. A vaccine that offered protection against both strains of influenza was discovered and developed later in 1942. A few years later and decades after the world learned of influenza, a flu vaccine was officially licensed for use in people. However, the flu virus does not behave in the same way as smallpox or polio. It frequently acquires new mutations – even from season to season – forcing scientists to analyze the virus each year and modify the vaccine to best protect people.
Each of these three viruses highlight the arduous path from the discovery of a virus to vaccine development and approval. They also paved the way for the innovative vaccines we are seeing today that are being developed and tested at unprecedented speeds.
In early January, Chinese scientists published the SARS-CoV-2 sequence. In less than 10 weeks, a team from the National Institute of Allergy and Infectious Diseases and a Massachusetts-headquartered biopharma company had a vaccine candidate ready for a Phase 1 clinical trial. While some approaches to vaccine development still use a weakened or inactivated form of the virus, as was done with polio, the innovative techniques we are seeing unfold today enable scientists to bypass this lengthy process and instead look to the virus’ genetic sequence to accelerate the first stage of vaccine development. Prior to COVID-19, the current record for vaccine development was four years (mumps). The mumps vaccine saw quick success largely because it was built on the triumphs and failures of vaccines past – similar to what we’re seeing today with a COVID-19 vaccine.
Not only have past learnings helped shorten the timeline from research to commercialization, funding is another factor in expediting the vaccine timeline. Previously, companies would spend years raising capital to fund their research, but because of the devastating social and economic impact caused by COVID-19, companies, investors, and government agencies have poured hundreds of millions of dollars into vaccine candidates to ensure they can swiftly move from one phase to the next. We’re also seeing heightened levels of collaboration between biopharma, government, and academia to advance science as efficiently and safely as possible. As a result of these factors and the degree of scientific progress we see today, a COVID-19 vaccine could potentially receive FDA approval in less than 12 months.
We are lucky to benefit from the knowledge of the past, and as science continues to advance, the life sciences industry is ripe to transform future drug discovery and development. Never before has a vaccine been more pivotal to the future of humankind and the recovery of our world’s economy. Fortunately, we are living through an era of unprecedented innovation and it will ultimately be science that will lead us through this pandemic.