Fitting vaccine research into one year – Were animals used?
- For all SARS-CoV-2 vaccine candidates it is necessary to obtain data in animals and to characterise the immune response induced by a SARS-CoV-2 vaccine candidate.
- It is not required to demonstrate the efficacy of the SARS-CoV-2 vaccine candidate in animal challenge models prior to proceeding to FIH clinical trials (doing animal testing in parallel with human testing).
- Global focus on vaccines – At the time of writing this blog, there were 4 approved in EU, 184 in preclinical development stage and 103 in clinical trials. Never before have so many laboratories, institutions been working at the same time to identify a vaccine against the same virus.
- Global sharing of the genetic sequencing of the RNA of the virus right at the start of the spread of the virus ensured a quick start.
- Many of the technologies used have been under development for many years (mRNA). It was therefore about adapting these technologies towards COVID-19 vaccine development. Furthermore, there had been years of extensive research on other Coronaviruses (SARS, MERS) which gave scientists a head start.
- Regulators accepted that preclinical studies could be conducted in some cases in parallel to the first clinical studies to save time considering the urgent need for COVID-19 vaccines.
- Huge sums of funding were made available globally towards vaccine development.
- Collaboration – Sharing practices and technologies, partnering on development has speed up the science and vaccine development. A stand out example in the EU is the Innovative Medicines Initiative.
- CRO and laboratories, including animal species, were prioritised for COVID-19 vaccine development and testing.
- Clinical phase: Clinical trials started without delay, research data was collected electronically, studies attracted huge numbers of volunteers and trials yielded rapid results.