The COVID-19 pandemic put tremendous pressure on drug-development organizations to accelerate product development far beyond anyone’s wildest roadmaps.
“The fast-track part [of producing COVID-19 vaccines] were regulatory approvals, funding, data analysis and submission to the FDA (Food and Drug Administration).
Those are all paperwork items.
What was not fast-tracked was enrollment of patients, clinical follow-up of these patients, capturing the events which occurred and the follow-up. These trials were executed very well.”
– Dr. Andrew Badley, infectious diseases physician at Mayo Clinic and head of Mayo Clinic’s COVID-19 Research Task Force, quoted in Mayo Clinic News Network article December 2020
Pharma companies had to do all their work without sacrificing product quality. The early iterations of the vaccines had to be safe enough for human-study populations to receive. The next generations had to be effective enough to be worth developing. The vaccines that received emergency authorization had to be safe, effective, manufacturable, and deliverable at the largest scale ever required on the planet.
To meet this worldwide need as quickly as possible, pharma companies collaborated. Not just with the universities, research foundations, and world health authorities that they work with on a regular basis, but also with each other.
Pfizer and BioNTech jointly developed “the Pfizer vax,” and Sanofi and Novartis helped manufacture it. Merck helped manufacture the Janssen/Johnson & Johnson vaccine.
By November 2021, almost 7.5 Billion vaccine doses had been administered around the world.
– Published online at OurWorldInData.org. Retrieved from: ‘https://ourworldindata.org/coronavirus’
The COVID-19 vaccines available in 2020 and 2021 were initially granted emergency authorization by the FDA, the EMA, Health Canada, and other health authorities.
It’s the Content
Health authorities and drug companies are quick to point out that they did not skimp on the drug development or on studies of its safety. Rather, to gain their “fast-track” approval – the Emergency Use Authorization – they cut back on the amount of “paperwork” involved.
In other words, they didn’t produce quite as much content.
What We Learned
The speed with which Pfizer-BioNTech, Moderna, Janssen/Johnson&Johnson, and AztraZeneca brought their first vaccines from the lab to the Emergency Use Authorization for real-world administration tells us many things:
- The way pharma companies currently produce content slows down the process of getting medicines to the people who need them.
- Speeding up how we create, store, manage, reuse, and publish content allows faster development of new medicines, without compromising on the good science.
- Other industries have already proven that content operations can be made much more efficient, without sacrificing quality or accuracy.
- Pharma is poised to leapfrog the learning experiences encountered by other industries and take advantage of a wealth of best practices, proven methodologies, and stable systems.
- One of the best investments that pharma can make in their future success is to tackle their content-transformation initiative now.
We call this need for change the Pharma Content Evolution. Want to know more? Download our whitepaper on the topic.
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