Pre-clinical and clinical drug development (Phase I to III) typically takes at least 10 years on average, but the global race is on to have a SARS-CoV-2 coronavirus vaccine on the market by early next year.
Currently, over 30 vaccines are being tested in clinical trials. Of these, Phase III trials have been started for nine vaccines. Check out the status of some of the high-profile Phase III clinical trials that are underway:
AstraZeneca (UK/Sweden) & University of Oxford (Adenovirus vaccine, AZD1222): AstraZeneca voluntarily halted the global trial on September 6th for a safety review. The trial resumed in the UK on September 12, but the trial is still on hold in other countries.
Moderna (mRNA vaccine, mRNA-1273): This US-based company started Phase III testing in July and will enroll 30,000 healthy people in 89 study sites around the US.
BioNTech (Germany) & Pfizer (US-based) (mRNA vaccine, BNT162b2): At the end of July, the companies announced a Phase II/III global trial and now plan to expand enrollment. In September, Pfizer announced that they could know if the vaccine works by October 2020.
Of local interest, Novavax(US-based), with a local facility in Uppsala, Sweden, is currently running a Phase II trial with a Phase III trial expected to start in October.
Phase I: first-in-human trial to investigate the safety and pharmacokinetics of the test drug in a small number of healthy volunteers. In oncology studies, a small number of patients are treated and the study may be a combined Phase I/Phase II clinical trial to investigate both efficacy and safety.
Phase II: investigates the efficacy and safety of the test drug, typically in up to a few hundred patients. Phase II clinical trials may be randomized, blinded or use a control group (i.e., to compare the test drug with placebo, a control drug or both).
Phase III: usually includes hundreds or even thousands of patients in a randomized trial. Phase III trials intend to provide unambiguous, evidence-based data confirming the efficacy and safety of the test drug that will be used to submit an application for market approval to the regulatory authorities.