Washington: Scientists have proposed a new truncated process for developing vaccines quickly during the COVID-19 pandemic. They want to get started quickly and many steps are carried out in parallel to limit the time in finding the right vaccine. They say that in the current situation if a prolonged process is followed then it is not feasible to fight COVIDS-19.
Long and expensive process
Researchers from the Coalition for Epidemic Preparedness Innovation (CEPI) say vaccine development is a long and expensive process. There is a high level of friction, usually taking several candidates. It takes and years to produce licensed therapy.
CEPI in the United States is a foundation that funds independent research projects to develop vaccines against emerging infectious diseases.
Vaccine making process
In an article, published in the ‘New England Journal of Medicine’, CEPI experts say vaccine developers must make observations. They say scientists usually follow a series of linear steps, with several pauses for data analysis. Then came the inspection of the manufacturing process because of the high cost and failure rate of the process.
However, with a fast start and phases carried out in parallel, scientists believe the process can be tracked quickly. However, there is a high financial risk. They say for several vaccine platforms that have produced significant success in humans. So Phase I clinical trials may be continued in parallel with testing on animal models.
According to the researchers, the ideal platform for this new paradigm will support the development from virus sequencing to clinical trials. The whole process will take less than 16 weeks.
Such interrupted processes, they said, can demonstrate successful and consistent immune response activations in humans. Then it will be suitable for large scale manufacturing platforms that are independent of pathogens.
An ideal example
They also gave an example. They said candidates for the modern SARR-CoV-2 mRNA-based vaccine entered a Phase I clinical trial on March 16. It was less than 10 weeks after the first genetic sequence was released.
The proposed paradigm, say the scientists, requires several activities that must be carried out with financial risk. It is always possible that vaccine candidates will not be safe and the results will be effective.
Among those who have the greatest potential for rapid development are DNA and RNA-based platforms, the researchers noted in the article. They explained that both vaccines based on genetic material can be made quickly. This is because they do not require culture or fermentation, but instead use a synthetic process.
Another method for accelerating research
Among other ways to speed up the process, they say testing in suitable animal models, and strict safety monitoring in clinical trials will be very important. The scientists also suggested that the manufacturing steps could be increased to a commercial level before data about the trial results were available. However, they warned that building production capacity could cost hundreds of millions of dollars.
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