Question

How will a vaccine against the COVID-19 virus be developed?

Answer 1

Vaccine against COVID-19

There are multiple attempts in progress to develop vaccine against COVID-19.

It is said that vaccine will be available under emergency use in less than 2021.

The phases of clinical researches involve different steps in which scientists conduct experiments to obtain sufficient evidence for a process which would be useful as a medical treatment.

Preclinical studies	Invitro & animal experiments- wide range in doses To obtain primary efficacy & toxicity of pharmacokinetic information
Phase zero	Also known as microdosing study Development of promising drug Conducted in smaller number of healthy subjects (10-15) Preliminary data on pharmacokinetics
Phase 1	First in human studies. To test safety , side effects, best dose , formulation method for drug. 20-100 healthy volunteers will be recruited Dose ranging, Dose escalation studies. Single ascending dose & multiple ascending dose.
Phase 2	Performed on large group trial 100-300. Phase 2 A- Clincal efficacy / Biological activity Phase 2 B- Optimal dose, mininmum side effects.
Phase 3	Randomised controlled multi- centre trials. Large patient groups - 300-3000
Phase 4	Also known as post marketing survillence Safety survillance / pharmacovigilance

Entire process of developing a drug may take 10-12 years & may Cost over 1 billion dollar.

Development of COVID-19 is in pipeline with maximum efforts around the globe.