8 potential COVID-19 Vaccines are in Clinical Trials; 102 are in Preclinical Evaluation, according to WHO Documents

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Eight potential COVID-19 vaccines are in clinical trials, and 102 are in preclinical evaluation, according to documents released by the World Health Organization (WHO) today.

 

The entities behind the eight vaccine candidates in clinical trials are based in the United States, United Kingdom and China. 

 

Tulane University’s potential vaccine is one of the 102 listed in the preclinical evaluation stage.


 

See the full list: novel-coronavirus-landscape-covid-194448f6cf724f4c3fbc86a3300ba0b812

 

According to the Centers for Disease Control and Prevention (CDC), the general stages of the development cycle of a vaccine are: exploratory stage, preclinical stage, clinical development, regulatory review and approval, manufacturing and quality control. 

 

The CDC says clinical development is a three-phase process: “During Phase I, small groups of people receive the trial vaccine. In Phase II, the clinical study is expanded and vaccine is given to people who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended. In Phase III, the vaccine is given to thousands of people and tested for efficacy and safety.”


 

Many vaccines undergo Phase IV formal, ongoing studies after the vaccine is approved and licensed, the CDC says. 

 

Massachusetts-based Moderna announced last Thursday that it has been cleared by the Food and Drug Administration (FDA) to begin Phase 2. 

 

“The imminent Phase 2 study start is a crucial step forward as we continue to advance the clinical development of mRNA-1273, our vaccine candidate against SARS-CoV-2. With the goal of starting the mRNA-1273 pivotal Phase 3 study early this summer, Moderna is now preparing to potentially have its first BLA [Biologics License Application] approved as soon as 2021. We are accelerating manufacturing scale-up and our partnership with Lonza puts us in a position to make and distribute as many vaccine doses of mRNA-1273 as possible, should it prove to be safe and effective,” said Stéphane Bancel, Moderna’s Chief Executive Officer.


He continued: “We also are continuing to progress our development pipeline and invest in our future. We are very pleased with Vertex’s decision, based on our preclinical progress, to extend our strategic collaboration working to develop the technology to allow for delivery of mRNA in the lung.”

 

Feature photo courtesy of the CDC.