Insights

The silver lining of COVID-19: An opportunity for disruptive innovation in vaccine development

Written by Eneida Bushi — 2021-03-31.

The COVID-19 pandemic presented an urgent need for the development of a vaccine to combat the global health crisis. A handful of vaccine developers successfully spearheaded, what many perceived as an “impossible” task, a vaccine development journey and rollout in less than 1 year.

Several factors contributed to the development of COVID-19 vaccines at unprecedented speed, including strategic collaborations to maximize capabilities while leveraging the scientific “know-how” that already existed, seamless operational execution, massive public & private funding, as well as an accelerated response from regulatory authorities    

While leading vaccine players in the industry, by 2019 vaccine revenue, such as GSK and Merck have “lagged behind” or completely abandoned their efforts towards the development of COVID-19 vaccines, it is worth celebrating the collaborations that have merged. Merck has stepped in to support the manufacturing of the currently approved J&J vaccine, and GSK has partnered with Sanofi to co-develop its phase II vaccine candidate.   

Undeniably, 2020 marked a challenging year for pharma, but even more so for pharma companies trying to conduct “business as usual”. In a way, the COVID-19 pandemic put pharma and biotechs to the test and demonstrated to the world which companies were nimble enough to thrive in the face of adversity and turn what most, including Merck’s CEO Kenneth Frazier7, saw as an impossible challenge into an opportunity. A few among those companies moved swiftly in leading the race to develop COVID-19 vaccines at unprecedented speed.    

It took 4 years for the fastest vaccine on record to be developed for mumps in the 1960s. Since then, the vaccine development process has taken 10-15 years from the research stage to launch. On December 11th, 2020, Pfizer and BioNTech announced that the FDA had granted Emergency Use Authorization for their mRNA based COVID-19 vaccine, less than 8 months after their trials started. This, along with Moderna’s mRNA COVID-19 vaccine, and J&J’s viral vector vaccine now mark the three vaccines currently authorized by the FDA for use in the US, only nearly 15 months after the first case of COVID-19 was reported in the US. Globally there are now 12 different COVID-19 vaccines being administered including AstraZeneca’s adenovirus-based vaccine.    

Despite the urgent need for a COVID-19 vaccine to fight the global pandemic, the FDA and other regulatory agencies stood firm on ensuring quality and safety standards were met by vaccine developers. Regulatory agencies’ accelerated response in working with vaccine developers was certainly one of the important factors that contributed to the successful outcome of this record-breaking development. Additionally, many years of previous research on related coronaviruses and mRNA vaccine platforms paved the way for vaccine developers to quickly apply that knowledge to the development of the first mRNA COVID-19 vaccine candidates. These, combined with more simplified ways of manufacturing mRNA vaccines vs. the traditional protein-based vaccines, as well as an enormous amount of funding to support companies running clinical trials in parallel enabled the development process to advance quickly.    

“The COVID-19 vaccines went through the same trials, but the billions poured into the process made it possible for companies to take financial risks by running preclinical and phase I, II and III trials, as well as manufacturing, in parallel instead of sequentially. With the public investment of around US $10 billion, the US Operation Warp Speed vaccine programme represents the largest government stimulus package that pharma companies have ever seen”1. Lastly, the high prevalence of COVID-19 infections in the population meant that companies were able to run large-scale global efficacy trials and achieve statistically significant clinical data relatively quickly.    

A number of internal and external factors enabled the accelerated pathway for the development of COVID-19 vaccines including strategic partnerships to maximize capabilities, in the case of Pfizer/BioNTech and AstraZeneca/Oxford, and seamless executional excellence in managing parallel testing in human subjects. For example, AstraZeneca completely shook up its traditional governance process and swopped it for a more agile, singular focused team effort to drive quick decision-making. These, along with massive funding to support the cost of parallel trials, as well as an accelerated response by regulatory authorities contributed to the development of a COVID-19 vaccine in less than a year.   

It is difficult not to notice that the industry’s top vaccine players have been “lagging behind”, based on this new benchmark that has been set by Pfizer/BioNTech, Moderna, AstraZeneca, and J&J. There are now over 100 vaccine candidates in clinical development. GSK, the leading vaccine company by vaccine revenue (2019)6, has a candidate in collaboration with Sanofi in phase II clinical development. It is runner up by vaccine revenue (2019) Merck, has pulled out of the race by discontinuing two development efforts with Themis and IAVI.   

Leading Vaccine Candidates in Development for COVID-19 as of 08 March 2021 

Source: GlobalData Pharmaceutical Intelligence  Center, Accessed 23 February 2021 

On the other hand, it is worth celebrating the collaboration that has been demonstrated by companies like Merck, GSK, Sanofi and Novartis. During the COVID-19 pandemic, we have seen collaboration from historically competitor companies working together to help accelerate the fight against the global pandemic. Novartis has agreed to leverage its manufacturing capabilities to support the manufacturing of the Pfizer/BioNTech vaccine, Merck reached an agreement with J&J to support manufacturing of the J&J’s vaccine, and GSK has partnered with Sanofi to combine GSK’s adjuvant technology with Sanofi’s vaccine candidate.   

Now that companies like Pfizer, BioNTech, Moderna, and AstraZeneca have demonstrated how vaccine development can be drastically different from the traditional approach, why would we go back to the “old days”?  We are optimistic that this experience has disrupted the way companies develop vaccines in the future and that some of the learnings will continue to drive innovation in vaccine development moving forward.   

 References:   

  1. https://www.nature.com/articles/d41586-020-03626-1  

  2. https://www.fiercepharma.com/sponsored/innovation-to-immunity-covid-19-vaccine-process     

  3. Coronavirus Disease 2019 (COVID-19), Pharma Executive Briefing, GlobalData Mar2021 report 

  4. https://www.novartis.com/news/media-releases/novartis-signs-initial-agreement-provide-manufacturing-capacity-pfizer-biontech-covid-19-vaccine   

  5. https://jamanetwork.com/journals/jama/fullarticle/2777172   

  6. https://www.statista.com/statistics/1104110/top-global-pharma-companies-by-vaccine-revenue/   

  7. https://www.fiercepharma.com/vaccines/merck-ceo-frazier-says-covid-19-vaccine-hype-a-grave-disservice-to-public  

 

 

 

 

 

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