USA: Clinical trials of coronavirus vaccine have begun

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In the United States, the first human clinical trials of a potential coronavirus vaccine have already begun. It was developed by the biotechnological company Moderna Therapeutics.

From sequence to vaccine testing in 63 days

Due to the high epidemiological risk and the progressing pandemic, work on vaccines and, possibly, drugs for coronavirus is progressing at a rapid pace. It is only just over two months since January 11, when China shared the genetic sequence of the new virus with the rest of the world. Two days later, Moderna Therapeutics together with the National Institute of Health (NIH) already had the mRNA-1273 vaccine sequence developed.

The National Institute of Allergology and Infectious Diseases (NIAID), part of the NIH, committed itself to conducting clinical trials.  On February 7, 25 days after the development of the coronavirus vaccine sequence, its version was already ready for clinical trials. In early March, the US Food and Drug Administration (FDA) completed  its review of the Investigational New Druga application filed by the NIH for mRNA-127 and allowed  o the study to proceed to begin clinical trials. Phase I of the study began on March 16 at the Kaiser Permanente Washington Research Institute. This means that the first participant in its Phase 1 study for mRNA-1273 was dosed, a total of 63 days from sequence selection to first human dosing.

Vaccine in one year at the earliest

The first phase of the research will involve 45 healthy participants aged 18-55 years. It is estimated that it will take about six weeks. The aim is to provide data on the safety and immunogenicity of the vaccine. The possible launch of the vaccine on the market, even at this record pace, will not take place before 1-1.5 years.

Moderna Therapeutics has already been involved in the development of a vaccine for MERS-CoV, another type of coronavirus. At that time, however, the program ended at the research stage and there were no clinical trials on humans. The development of a vaccine for COVID-19 in such a record time was possible thanks to the use of mRNA technology. It works with the virus sequence, not with the virus itself. mRNA is an information molecule that is a kind of a set of instructions for the cells in the human body to produce whites to prevent the virus or to fight the disease. However, it is not a biological medicine in the traditional sense.

Moderna is currently working on nine mRNA-based vaccines. Phase I of six clinical trials is already completed.

More about the impact of coronavirus on the sector we write in PMR Pharma & Healthcare Insight: Poland. It contains comprehensive analyses of the current situation and development prospects, together with comments of PMR experts on the development of the situation in Poland and abroad in connection with the COVID-19 epidemic, as well as revised forecasts and indicators developed on the basis of data collected by PMR, which will affect the market in the coming months.

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