With vaccinations for Covid now being approved in the UK, across the EU and in the USA we look at how this historic event in vaccination history has come to pass.
On average it takes 10 years for a new vaccine to be developed although in the 1960s the new mumps vaccine was developed within 4 years, this was helped in part by research going back to World War II and incremental breakthroughs in lab technology as vaccines were created for other diseases. There were plenty of scientific voices during the early days of the Covid-19 pandemic saying a vaccine could be developed within a year to eighteen months. This unprecedented speed can be attributed to several key factors.
Wealthy countries who faced economic devastation called for an urgent solution to the pandemic and poured vast funding from both public and private sources into vaccine development, freeing pharmaceutical companies from their usual financial concerns.
Governments also pre-bought vaccines enabling pharmaceutical companies to take greater financial risks than they would normally. Vaccine manufacturing was therefore carried out in parallel with preclinical studies and phase I/II and III clinical trials, rather than sequentially, greatly speeding up the time usually taken. Recruiting clinical trial participants can take months but instead was almost overnight due to advances in data recording, the use of social media and the public desire to help. The global prevalence of Covid-19 also enabled widespread efficacy trials to be run, previous cases such as MERS (Middle Eastern respiratory syndrome) had patchy outbreaks hampering efforts to develop a vaccine.
Previous lethal outbreaks of viruses such as Zika and Ebola motivated the creation of national and global infrastructure to better coordinate the global responses and speed up the vaccine development. The Coalition for Epidemic Preparedness Innovations (CEPI) was launched in 2017 with the goal of creating the technological infrastructure needed for the rapid and affordable development of vaccines for several viruses known to have the epidemic potential, such as MERS and Ebola. CEPI part funded work on the SARS-CoV-2 vaccines. National regulators were able to swap information on their Covid-19 vaccine trials using the International Coalition of Medicines Regulatory Authorities which was set up in 2012 with the aim of reaching a consensus on best end-points for vaccine trials and monitoring any side effects as vaccines are rolled out.
New vaccine technology has played a part. Both the Pfizer/BioNTech vaccines and the Oxford University/AstraZeneca vaccines were developed using messenger RNA (mRNA) platform technology. DNA and RNA vaccines use biotechnologies that have been in development for two decades. They have the advantage of being quicker to develop once the genome sequence has been published (the SARS-CoV-2 genome was released in January 2020) than conventional vaccines which contain viral proteins or disabled forms of the virus which will have been developed by producing part of the virus in the lab. Rather than needing the whole virus, as in the past, vaccine makers have been able to substitute a single protein to generate a robust immune response.
Vaccines work by training the immune system to recognise and attack pathogens. They do this after harmless molecules called antigens are introduced into the body via a vaccination in order to trigger an immune response. The immune system safely learns to recognise them as hostile invaders and remembers them for the future giving you protection from the disease. Years of advance research on related coronaviruses such as SARS (severe and acute respiratory syndrome) and MERS also helped to accelerate the process, researchers already knew which way they should tune the RNA sequence to create effective antigens.
Large scale clinical trials for the Covid-19 vaccine and the duration are reassuring, and although most of the first vaccines were approved under emergency-use regulations, there has been no relaxing of the stringent criteria for vaccine approval. Whereas in the past it typically took six to nine months to get approval for new medicines that is partly due to the data being delivered to the regulatory agencies in one go.
The Covid-19 vaccines went through an accelerated process of rolling review, data was released immediately for regulatory review, and this does not normally happen as the approval stage is expensive and risky for companies. Once again the funding helped accelerate the process. However although funding played a huge part in the development of the new Covid vaccines it could only happen with the solid foundation of science and new technologies to build upon and they have been decades in the making.
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The Coda Team.