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Moderna’s COVID-19 vaccine is at Phase 3 trial: Preclinical and clinical trials explained

Moderna’s COVID-19 vaccine is at Phase 3 trial: Preclinical and clinical trials explained
A coronavirus vaccine named mRNA-1273, produced by US-based Moderna may receive the nod of FDA by November this year.

President Donald Trump is expecting a COVID-19 vaccine to be approved by the FDA by November this year. Currently, the vaccine is at its Phase 3 clinical trial. Here is our low-down on the various stages of clinical trial that a vaccine goes through.

Written by Saswati Sarkar |Updated : August 10, 2020 3:54 PM IST

Recently, US President Donald Trump shared with reporters that a coronavirus vaccine could be ready by as soon as November 3. Well, a coronavirus vaccine named mRNA-1273, produced by US-based Moderna may receive the nod of FDA by November this year. However, there is no confirmation on the date yet. Moreover, it is likely to take months for the vaccine to be widely available. Currently, Moderna's COVID-19 vaccine candidate is at the Phase 3 Clinical trial, which involves around 30,000 volunteers. Apart from this, several other vaccines are at this phase of clinical trial, the one by Oxford University and biotech company AstraZenica being the most prominent among them.

Phase 3 clinical trial is a crucial stage in the development of any vaccine. It reflects the efficacy of the vaccine against the targeted disease. There is one preclinical trial and three clinical trials that every vaccine has to go through before it is approved by the FDA for release. Phase IV follows the approval. Here, we guide you on these stages of vaccine development.

Preclinical Trials

At this stage, a vaccine, or any treatment for that matter, is tested on cells or animals in the laboratory. Preclinical trials shed some light on its safety and efficacy. However, it doesn't confirm the effect of the vaccine on humans. A vaccine can move on to the Phase 1 clinical trial if it shows some positive results.

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Phase I Trial

The duration of this phase is around two months and it includes about 20-100 healthy human volunteers or people with the disease that the vaccine I targeted towards. Phase I clinical trial focusses on the safety and efficacy and administers lowest possible safe dose to the participants. A vaccine that is proved to be safe in this phase moves on to phase II. However, its efficacy is yet to be proved.

Phase II Trial

A vaccine is experimented on 100-300 volunteers in this phase which lasts for several years. Unlike phase I, this phase focusses more on efficacy than safety. It also reviews the side effects of the vaccine, if any. If any of these phases hints that it is unsafe, then the vaccine doesn't make it to the next phase.

Phase III

In this phase, the number of volunteers ranges from a few hundreds to 3000. It aims to collect more information about safety and efficacy of a vaccine after studying different population demographics and using it in varying doses and along with other drugs. After this phase, FDA reviews the risks vs. benefits with the help of the data collected and approves usage if the findings are positive.

Phase IV

It occurs after the FDA approval. The intention is to check the impact of the vaccine in a different dosage and for a different group of people in terms of age, ethnicity, so on and so forth. Sometimes, the results vary and also, the side effects manifest after using it in a larger cross section of the population.