Innovation in the life sciences can be considered either to be “radical” (fundamental advances in our understanding) or “incremental” (improvements on existing technology), and can take the form of products (e.g. vaccines or robots), services (e.g. tele-medicine or robotic surgery) or processes (e.g. DNA sequencing or randomized control trial methodology). Innovation covers a vast number of activities from landmark inventions like penicillin and X-rays, through to incremental innovations such as second-generation drugs with lower toxicity and ‘super generics’ (The Economist Intelligence Unit, 2016. “Innovation in life sciences: An emerging markets perspective.”)
The progress we see today is revolutionizing how we treat disease, saving patients’ lives and improving quality of life and public health across a broad range of chronic and rare conditions. In this new era of medicine, many diseases previously regarded as deadly are now manageable and potentially curable. Today, there are more than 8,000 medicines in clinical development around the world. Across the medicines in the pipeline, 74% in clinical development have the potential to be first-in-class treatments, representing entirely new approaches to treating a disease. The future has never been brighter as researchers explore new frontiers that just a few years ago may have been regarded as science fiction, but now transform patients’ lives. (https://www.phrma.org/Advocacy/Research-Development )
Patients deserve access to the best healthcare possible. That’s why Pfizer invests in research and development: to produce groundbreaking treatments, including gene therapy, immunotherapy, and precision medicine, that improve people’s lives. It’s this investment in innovation that enables our scientists to make dramatic strides in healthcare. Their work advances life-changing therapies for the patients we serve. (https://www.pfizer.com/responsibility/ready-for-cures/improving-access-to-cures-through-innovation, https://www.pfizereupolicy.eu/article/eu-research-and-innovation-policy)
Vaccine innovation has been fundamental in how far we have come in our efforts to find a COVID-19 vaccine. And for Pfizer, global collaboration and partnership has also played a significant part in bringing this innovation to life. Our lead vaccine candidate we are developing with German biotech company, BioNTech is an mRNA vaccine – only possible thanks to innovation and advances in gene sequencing and gene synthesis. Most vaccines work by injecting a dead or weakened form of the virus into the body to help build immunity. The key to building this immunity is that the portion of the pathogen called the antigen trains the immune system to recognise and respond to the infectious agent. However, RNA vaccines work by introducing into the body a messenger RNA (mRNA) sequence that contains the genetic instructions for the person’s own cells to produce the vaccine antigens and generate an immune response.
We have been able to accelerate our timelines by doing steps in parallel rather than sequentially, which requires more financial capital to be deployed at risk but is the only way to cut significant time from the development program while maintaining safety as the key priority.
Safety was, is, and will always be our priority in vaccine R&D. We believe that safe and effective vaccines are key to defeating this pandemic and helping to provide protection from this devastating disease.
Even though Pfizer is moving with extraordinary speed, preservation of high quality and safety standards is critically important throughout development. We are taking all of the regulatory and operational steps that we would normally take for all of our vaccine trials, maintaining the highest standards in our development process.
If approved by regulatory authorities, there are a number of steps that need to be taken in order to bring this pandemic under control.
Pfizer is committed to bringing this candidate vaccine to help meet the global public health need. We will work closely with international initiatives, governments, and other stakeholders, as appropriate, to supply the world as quickly as we can, together.
In terms of how countries allocate within their borders, this should be the responsibility of the health authorities of each country and we will work with them to provide input into developing equitable and affordable plans.
We want to collaborate closely with governments to enable them to provide a potential candidate vaccine to areas of greatest need in line with health authority guidance, but believe that front line health care workers, essential workers, immunocompromised individuals, and public safety officials should be prioritized consistent with global public health guidelines.
Our purpose is to develop breakthroughs that change people’s lives. It took just 248 days to get from the day we announced our plans to collaborate with BioNTech to our first regulatory submission date – with the FDA in the US. We have operated at extraordinary speed in our clinical development program from concept to regulatory filing, while always maintaining our focus on safety.
So many things went into making this happen: advances in technology, tremendous collaboration, thousands of courageous trial volunteers around the world, and, of course, the purpose-driven colleagues at both companies – Pfizer and BioNTech.
We thank everyone who volunteered to participate in the clinical trial, our academic collaborators and investigators at the study sites, and our colleagues and collaborators around the world who have been working day and night to help ensure that “Science will win”.