On Tuesday 12 May, Moderna Therapeutics received Fast Track designation from the Food and Drug Administration (FDA) for its Covid-19 candidate vaccine, mRNA-1273. A few days before the approval, the FDA also approved Moderna to initiate a Phase II clinical trial study. Both the Fast Track designation and the start of the Phase II trial mean that mRNA-1273 may be the first to be approved and launched for the Covid-19 pandemic, as it is the only vaccine that has received FDA approval to initiate a Phase II trial, therefore placing it ahead of all other candidate Covid-19 vaccines in development. The candidate vaccine has been developed by Moderna in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and is the first vaccine in human clinical trials as a prophylactic intervention for Covid-19.
Moderna plans to launch Phase III studies by this summer, assuming that the Phase II will be complete by then. The Phase II studies will include approximately 600 healthy volunteers, half of whom will be ages 18–55 years and half of whom will be over 55 years old. The volunteers will be randomly assigned to receive either a placebo or one of the two doses of mRNA-1273.
Other pharmaceutical companies have potential Covid-19 vaccines in development. One such company is AstraZeneca, which currently has its vaccine in a Phase I trial. This places it behind Moderna’s candidate vaccine, which will be in Phase II shortly. Therefore, GlobalData expects that Moderna’s vaccine will be the first to be FDA approved. However, it is notable that trials for Moderna’s vaccine are carried out in the US, whereas the trials for AstraZeneca’s vaccine are taking place in the UK.
In addition to vaccines, pharmaceutical companies also have several potential Covid-19 treatments in development, such as Gilead’s remdesivir, which recently received Emergency Use Authorization by the FDA. While there is an urgent need for a treatment to combat the Covid-19 pandemic, the development of a vaccine would be more effective as it could give immunity to the virus, therefore preventing the disease and the need for further treatment.
GlobalData believes that a Covid-19 vaccine would also be more cost-effective compared a treatment, as the vaccine will only need to be given once, whereas a patient would need regular medication if on treatment. Therefore, it would be highly beneficial to have a Covid-19 vaccine available globally.