In a public health emergency such as the Covid-19 pandemic, none of these development stages can be neglected. However, efforts can be made at all levels to make the process faster and more efficient.
First, in the context of Covid-19 vaccine development, several newly developed technologies have proved critical to accelerate the pre-clinical development stages:
- High-speed genomic sequencing was used to identify the pathogen within record time using samples collected in December 2019. The complete genome sequence of SARS-CoV-2 was released online on 10th January 2020, allowing scientists to share information rapidly and to start searching for vaccine targets as early as January 11th.
- While multiple types of Covid-19 vaccines are currently under investigation/development, the newest generation of vaccines based on DNA and RNA platforms are likely to be safer (no use of live viruses) and to speed up the development process as they are easily produced without need for culturing.
Second, vaccine developers have managed to reduce clinical development time by conducting several clinical studies simultaneously, by overlapping clinical trial phases, and by increasing the human resources appointed to discuss development strategies and to analyze study results.
Moreover, the European Medicines Agency (EMA) has helped to accelerate the evaluation stage (while still following the mandatory standard procedure) by:
- creating the COVID-19 EMA pandemic Task Force and the EMA COVID-19 Steering Group, which are fully dedicated to addressing the challenges raised by the Covid-19 pandemic;
- providing early scientific support to vaccine developers so that the most reliable methods and study designs are used to generate robust data, and that acceptance criteria for quality, safety and efficacy are considered in early development stages; and
- adopting a rolling review cycle (i.e. data is evaluated continuously as it becomes available instead of waiting for the usual marketing authorization application) and reducing the official evaluation timeline from a maximum of 210 to 150 working days.
Of note, this accelerated evaluation process may result in a “conditional marketing authorization”, valid for one year, and subjecting the vaccine developer to specific obligations (e.g. completing additional studies for more comprehensive data) within defined timelines.
Finally, at the manufacturing level, considerable increases in human and financial resources help to ensure rapid large-scale production of approved Covid-19 vaccines. The EMA is also following up on Covid-19 vaccine-related safety risks through the development of a Covid-19 pharmacovigilance plan.
In conclusion, the dramatic acceleration observed in the development of Covid-19 vaccines appears to largely rely on a massive increase in human and financial resources, together with more flexible/continuous dialogue within the scientific community, as well as between vaccine developers and RAs. In addition, the emergence of promising new technologies may prompt faster and more efficient vaccine development in the future, even outside the context of a pandemic.
CLS Writer Life Sciences
- EMA website: European Medicines Agency | (europa.eu)
- European vaccination portal: Vaccine facts (vaccination-info.eu)
- “Vaccine Against Covid-19 Disease – Present Status of Development”, Ashok Kumar Dutta 2020, The Indian Journal of Pediatrics, DOI: 10.1007/s12098-020-03475-w.
- “The COVID-19 Vaccine Race: Challenges and Opportunities in Vaccine Formulation”, Wang et al, AAPS PharmSciTech (2020) 21:225; DOI: 10.1208/s12249-020-01744-7.
- “Vaccine development and therapeutic design for 2019‐nCoV/SARS‐CoV‐2: Challenges and chances”, Ghaebi et al., The Journal of Cellular Physiology, DOI: 10.1002/jcp.29771.