Boasting ‘the most efficient clinical development and vaccine manufacturing capabilities the world has ever seen’ in the space, Pfizer has rapidly grown its capabilities since the pandemic started. Moving forward, it promises increased spending on mRNA projects will continue.
Its strategy will be executed by drawing on internal expertise built up during the pandemic, but also through tapping external companies working on cutting-edge tech, with four collaborations already in motion.
'Experience is on our side'
During Pfizer's FY2021 earnings call this week, CEO Albert Bourla said the mRNA strategy has two pillars: focusing firstly on expanding the vaccine portfolio and secondly by exploring where the tech can go next.
mRNA has emerged as a versatile technology, with potential applications across many infectious diseases, cancer, rare genetic disorders and even auto-immune diseases, he notes.
"Although mRNA is not the holy grail, we believe the technology has the potential to have a game-changing impact on global health, which is why we have developed a robust mRNA strategy and are aggressively building our platform," he said.
“While the pandemic has demonstrated that it’s not that easy to deliver mRNA vaccines at scale, Pfizer has emerged as a leader in this space. With decades of experience on our side, we’ve developed what is arguably the most efficient clinical development and vaccine manufacturing capabilities the world has ever seen.
"We also have rapidly scaled and built out new capabilities in record time by hiring nearly 2,400 new colleagues in these functions in a nine-month timeframe. Going forward, we plan to continue to invest to capitalize on the leadership we have built in terms of both mRNA R&D and manufacturing.”
Vaccine development: COVID, flu and shingles
Pfizer will continue to invest in what it now terms its 'core franchise': that of the COVID-19 vaccine.
Manufacturing capacity reached 3 billion doses in 2021, and will rise to 4 billion doses this year. Capacity is not a concern, notes the company: rather the question will be about adjusting around demand.
Furthermore, the franchise could grow around variant-specific vaccines - such as Omicron - as and when required.
Secondly, Pfizer pledges to grow its portfolio of prophylactic mRNA vaccines: including vaccines for shingles, flu, and other infectious diseases (particularly viral). It already has a pre-COVID agreement with BioNTech on a flu vaccine, signed in 2018. The two companies also see an opportunity to create a shingles vaccine with higher efficacy and better tolerability than those on the market: with clinical trials expected to start in the second half of this year.
New therapeutic areas
Pfizer will also pursue additional therapeutic areas which it considers to have the strongest benefit/risk ratio: such as in rare disease and oncology.
Launched in January, Pfizer's four-year research collaboration with Beam Therapeutics (a Massachusetts biotech working on base editing and mRNA/LNP delivery technologies) is focusing on three rare genetic diseases (CNS, muscular, liver).
Meanwhile, a partnership with Acuitas Therapeutics gives Pfizer the option to non-exclusively license LNP technology for up to 10 targets.
And Pfizer has also entered into a research collaboration with Codex DNA, a leader in the development of automated solutions for on-demand synthesis of genes and mRNA, potentially allowing enzymatic assembly of DNA at the front-end of the mRNA production process. “This could possibly reduce the time to produce a new vaccine from 3 months down to 2 months," notes Bourla. "If successful, this would be an important differentiator when developing a vaccine for the flu, for example, as it would allow us to select a strain much closer to the start of any flu season.”
The company also wants to explore opportunities in larger indications: such as inflammation and immunology.
The external agreements with BioNTech, Beam Therapeutics, Acuitas Therapeutics and Codex DNA "represent only four pieces of a much bigger strategic puzzle," notes Bourla.
"As we continue executing on our mRNA strategy, you should expect to see more targeted activity in this area."