Getting from a mRNA COVID-19 vaccine to scaling to manufacture these vaccines for billions of people is far from simple:
Manufacturing mRNA vaccines for the first time in a very short timeframe
required significant innovation and remains a technically challenging
endeavor. The process proved to be technically challenging as Pfizer
developed a 50,000 step process. Pfizer identified and worked with 86
different suppliers. The vaccine required 280 materials in total, 10 to 15 of
which were novel to the mRNA vaccine. Through unstinting effort and
investment, Pfizer cut the initial production time in half, enabling it to
deliver more doses more quickly.
The production process for Pfizer’s vaccine needs to be completed from
start to finish inside a hermetically-sealed system. It took several months
of working with partners to identify the optimal process for making this
mRNA vaccine, even though BioNTech had been working with mRNA
technology for 25 years, possessed considerable knowledge related to mRNA
platforms, and had spent 10 years setting up the manufacturing processes
that allowed for their Covid-19 vaccine production. According to the
company itself, the validation of a single production site can still take up
to a year.
From the Geneva Network’s white paper “Trade Secrecy and COVID-19: How trade secrets and other IPRs underpin innovation and manufacturing of Covid-19 Vaccines.“