Specialist
Director at Jiangsu Simcere Pharmaceutical Co Ltd
Agenda
- 2019 novel coronavirus (COVID-19) vaccine R&D directions – inactivated vaccine, viral vector vaccine, nucleic acid vaccine and mRNA vaccine
- R&D challenges – virus analysis, isolation, antiviral compound synthesis, screening and production quality control
- Vaccine R&D cycle, processes, costs, clinical trial scale and critical resources
- Comparison of vaccine developers’ technical capabilities
Questions
1.
News about the COVID-19 coronavirus has been updated rapidly lately. A few days ago, researchers managed to isolate the COVID-19 coronavirus, which was regarded as a major breakthrough. What does the completion of COVID-19 isolation and whole-genome sequencing mean? What is the minimum time it takes to prepare vaccine strains from wild virus strains?
2.
So far, studies on COVID-19 vaccines are still conducted in vitro. How come vaccine R&D companies have not started animal tests yet? Is it because there is no effective animal model? Or are there any other reasons?
3.
Suppose there is already an effective animal model, how long will it take for vaccine R&D companies to complete the evaluation of the efficacy, safety and stability of their COVID-19 vaccines? How many tests will they conduct and how much cost will they incur?
4.
What are the differences among major types of vaccines, including inactivated vaccines, attenuated vaccines and genetically engineered vaccines? Which type of vaccine is more likely to be effective against COVID-19?
5.
The mRNA vaccine has been frequently mentioned over the past months. The US-based Moderna is working with the National Institutes of Health (NIH) on developing mRNA vaccine and has announced that they will carry out the phase I clinical trial of the mRNA vaccine in three months. Shanghai-based Stemirna Therapeutics has also announced to finish producing the sample of mRNA vaccine in 40 days. Can you introduce to us the technological advantage of mRNA vaccine? According to your understanding of mRNA vaccine technology, is these companies’ progress reasonable?
6.
How is vaccine R&D different from drug R&D? Can you roughly introduce the major phases from vaccine R&D to launch plus clinical trial scale, R&D cycle and costs of each phase?
7.
Could the R&D experience in developing SARS vaccines about 17 years ago be applied in developing COVID-19 vaccines? Chongqing Zhifei Biological Products and Chinese Academy of Sciences jointly developed MERS vaccines against coronavirus, could their experience be borrowed?
8.
COVID-19 is a type of RNA virus which is reported to mutate easily. Will this affect the R&D of the COVID-19 vaccine? Did the same problem exist in the R&D of MERS vaccine?
9.
Gao Fu, an academician of the Chinese Academy of Sciences, said the COVID-19 vaccine may be developed quickly. WHO Director-General Tedros Adhanom Ghebreyesus also said on February 11 that the COVID-19 vaccine would be ready within 18 months. What do you think about their prediction? Why did they make such judgements?
