The life sciences industry has taken a remarkable journey over the last year. From rapid adaptation at the outset of the global pandemic to unprecedented vaccine advancements, the sector has been at the forefront of the fight. COVID-19 created new challenges—and opportunities—that will leave a lasting mark on the industry and continue to push it forward.
Traditionally, vaccine development requires a decade or more of ongoing effort. So it is a remarkable feat that not one, but multiple vaccines made it through the process to earn FDA and EMA emergency use authorization within a year of the pandemic’s onset. Collaboration, large-scale government funding, and a strong motivation to succeed were factors behind the achievement.
The fact that researchers managed to bring vaccines that rely on messenger RNA (mRNA) to the market adds to the significance of the achievement. The industry has been developing the approach for decades, and last year’s research built on this knowledge. “For over 30 years, various pharma companies have been researching and working to develop a simpler way of creating effective vaccines, that relied on the principle of understanding the exact structure of the mRNA,” Hannah Burke reports in her article ‘The lasting impact of 2020 on the life science industry’ for Proclinical.
“Once scientists had determined the structure of all of its genes, including the genes that make the spike protein, experts across the world were able to work on the design of an mRNA vaccine,” she continues.
The Pfizer/BioNTech and Moderna vaccines utilize the mRNA strategy, “which introduces engineered, single-stranded mRNA molecules providing the biological instructions for cells to pump out virus-killing proteins,” Chris Lo reports in ‘COVID-19: lessons learned across the life sciences’ for Pharmaceutical Technology magazine.
This approach was key to their rapid development. “The ability of mRNA vaccine developers to design antigens in silico allows for much faster testing of vaccine candidates, as they avoid complex and time-consuming cell culture production and fermentation-based manufacturing of target pathogens or antigens in traditional vaccine development,” Lo explains.
The potential of using mRNA goes far beyond COVID-19, or even vaccines, for that matter. The approach is the wave of the future. After bringing the mRNA-based COVID-19 vaccines to market, researchers are turning their attention to mRNA platforms to fight cancer and autoimmune disorders as well as a range of infectious diseases, from Ebola to the flu. The technology is still in development, but researchers are optimistic with regard to the potential.
“While researchers have been incredibly optimistic about mRNA vaccines’ potential in a wide range of viral disease, from HIV to hepatitis C, there’s still some way to go to prove the efficacy benefits of mRNA vaccines over their better-understood live-attenuated, inactivated and conjugate counterparts,” says Lo in ‘MRNA vaccines: the post-pandemic outlook after a breakthrough year’ for Pharmaceutical Technology magazine.
“Moderna and Pfizer/BioNTech’s jabs are the first mRNA-based vaccines to receive even emergency authorisation from key regulators, and real-world data from the global COVID-19 rollout will play an important role in validating their long-term efficacy and safety profiles against the coronavirus and other viral agents,” he adds.
The new approach and the rapid development of the COVID-19 vaccines have not been without controversy, however. An extremely rare but potentially deadly side effect, blood clots, has occurred in some patients who received certain vaccines.
Pharmaceutical companies will make hundreds of billions of dollars from the sale of the COVID-19 vaccines. Pfizer anticipates that sales of the vaccine it developed with BioNTech will reach $15 billion by year’s end—with a profit margin of almost 30 percent, Matt Egan reports for CNN Business. Not bad for a product priced at under $20 a dose. Even so, vaccines are not the industry’s biggest money-makers.
While there are exceptions—and the COVID-19 vaccine and boosters will bring in significant revenue in coming years—pharmaceuticals to treat chronic diseases tend to rake in the most money. Although $15 billion is a tidy sum, Egan points out that these vaccine sales “are simply not a game-changer,” for the big pharmaceutical companies. Pfizer, for example, will likely see revenue between $44 billion and $46 billion in 2021, and profits of at least $14 billion, not counting any increase in revenue from its COVID-19 vaccine.
Relatively new on the scene, Moderna stands out as an exception. The pharmaceutical company had no approved products for sale in 2019 and made only $60 million in revenue that year. In 2020, Moderna accepted $529 million in grants and $200 million from early sales of its vaccine. Revenue for 2020 is expected to skyrocket to $16 billion, the vast majority of which will come from vaccine sales, Egan reports. Accordingly, Moderna shares are up 187 percent over the past year.
Profit from the COVID-19 vaccine did not come without risk. Egan calls the effort a “gamble” that would have brought significant financial consequences if those efforts had failed, even taking into account that most pharmaceutical companies accepted government funding to help offset that risk. Unlike many of its competitors, Pfizer did not take any taxpayer money to develop its vaccine, taking on all the risk of the $1 to $2 billion endeavour.
The race for the COVID-19 vaccine has left the life sciences industry forever altered. Pharmaceutical companies had to form new strategies to develop a vaccine in record time—while simultaneously managing the complications of a global pandemic. This meant that, in addition to researching treatments for a new disease, the industry had to manage operations remotely, deal with breakdowns in the global supply chain, and navigate new ways of interfacing with healthcare workers and clinical trial participants.
One of the most notable changes is the decentralization of clinical trials. During the pandemic, the industry had to overcome the challenge of developing new therapies and vaccines while maintaining social distancing requirements to keep everyone safe. Digital technologies allowed researchers to administer pharmaceuticals and monitor the response from afar, allowing clinical trial participants to remain at home during quarantine.
These technologies are not new, but the pressures of the pandemic greatly increased their use. Ryan Jones, Chief Executive Officer of clinical trial software company Florence Healthcare, wrote in Forbes magazine that decentralized clinical trials (DCTs) are likely to become a new standard, offering a more diverse patient pool for better results.
Another area of significant change is in post-clinical-trial regulatory submissions. The FDA granted emergency use authorizations for COVID-19 treatments when the need for their accelerated development became evident. This meant that regulators had to increase efficiency in order to shorten the time required to complete the drug development process. Pharmaceutical companies are eager to keep these new efficiencies in place after the emergency passes.
Now that the industry has developed COVID-19 vaccines, the next challenge is getting them out to the masses to obtain global herd immunity. Not surprisingly, the developing world is at a disadvantage when it comes to distribution. “Wealthy nations have tended to dominate orders of first-generation vaccines through exclusive bilateral deals, with many low and middle-income countries struggling to find affordable supply lines,” Chris Lo reports in ‘COVID-19: lessons learned across the life sciences’ for Pharmaceutical Technology magazine. Global organizations such as Gavi, the Vaccine Alliance, and the World Health Organization are working to alleviate the problem, but the imbalance remains an ongoing issue.
In response, suggestions have been presented at the World Trade Organization to waive intellectual property rights for vaccines, including patents, to allow developing nations to jumpstart domestic production and diversify their supply sources. After the massive investment put into the vaccine’s development, the pharmaceutical industry and many developed nations are against this approach.
Johnson & Johnson has announced in a press release that it will provide its vaccine on a not-for-profit basis as long as the crisis continues, while Pfizer has provided its vaccine at cost to nations unable to afford the less-than-$20 per dose.
Pharmaceutical companies will see substantial sales of the COVID-19 vaccine in the future. Booster shots are expected to be a significant source of ongoing revenue long after the pandemic ends, particularly as new variants of the virus surface, Egan reports for CNN Business.
In addition to securing an ongoing source of revenue, pharmaceutical companies have enjoyed a public relations boost like never before. Consumers rarely remember the name of the company that produces a specific medicine. But as the vaccine race became front-page news, company names became daily headlines. Public perception of ‘Big Pharma’ shifted radically, from greedy profit mongers to dedicated scientists working tirelessly to save the world. Controversy still lingers of course, but the positive image boost the industry received could counteract the recent push for government to drive down pharmaceutical prices, reports Egan.
Overall, the life sciences industry remains strong and the outlook for its future is bright. The industry has proven its ability to deliver during a crisis and has enjoyed a positive shift in public perception. After the changes made to clinical trial procedures and post-clinical trial regulatory submissions, the industry is likely to enjoy a more efficient environment in which to operate. Armed with new research tactics and new mRNA advances to tackle a variety of diseases, the years ahead promise exciting opportunities for an already robust industry.